Archive for December, 2021

OverviewWhat is hypogonadism?

Hypogonadism occurs when sex glands called gonads produce little, if any, sex hormones. It affects teenagers and adults of all genders. The condition causes a low sex drive or libido. Hypogonadism is sometimes called gonad deficiency.

Testicles (testes) in the male reproductive system produce testosterone, the main male hormone. Hypogonadism in men is the result of low testosterone.

Ovaries in the female reproductive system produce estrogen, progesterone and testosterone. Women with hypogonadism are often low in estrogen and progesterone.

Two glands in your brain, the hypothalamus and pituitary, send signals to sex glands. These signals tell your body to make sex hormones. When you have hypogonadism, something within the brain or sex glands interferes with hormone production.

Healthcare providers look at the cause to determine if hypogonadism is:

Starting in their late 40s or 50s, everyone has lower amounts of sex hormones. As a result, sex drives decrease. These changes are expected. They arent necessarily a sign of hypogonadism. Younger people who have little to no interest in sex may have hypogonadism.

Conditions and treatments that raise the risk of primary hypogonadism include:

Risk factors for secondary hypogonadism include:

It isnt clear why some people develop hypogonadism. For unknown reasons, a problem with the sex glands or brain affects the bodys production of sex hormones.

Hypogonadism symptoms vary depending on the cause and a persons gender. Teenagers may get a diagnosis of secondary hypogonadism when they dont start puberty on time. For example, teen girls with hypogonadism may not get their periods or develop breasts. Boys might not grow facial hair or have underdeveloped testicles.

Adults may experience a low sex drive (sexual dysfunction), as well as hair loss and hot flashes. Other common complaints include fatigue and difficulty concentrating.

Signs of hypogonadism in females include:

Signs of hypogonadism in males include:

Your healthcare provider will assess your symptoms and perform a physical exam. Women may also have a pelvic exam.

You may get one or more of these tests:

Hypogonadism can cause:

Hypogonadism treatments vary depending on the cause. For primary hypogonadism, hormone replacement therapy can raise hormone levels. Men may have testosterone therapy, while women may have estrogen and progesterone hormone therapy. These treatments come in gels, implants, pills, shots and skin patches. Female hormone therapy may slightly increase a womans risk of uterine (endometrial) cancer, blood clots and strokes.

If a pituitary gland problem like a tumor causes secondary hypogonadism, you may need medication, radiation therapy or surgery.

Primary hypogonadism can be a chronic condition that requires ongoing treatment. If you stop hormone replacement therapy, hormone levels can plummet, causing symptoms to return.

If a treatable condition like a pituitary gland tumor causes hypogonadism, hormone levels should return to normal after your healthcare provider treats the tumor.

You should call your healthcare provider if you experience:

You may want to ask your healthcare provider:

A note from Cleveland Clinic

Low sex hormone levels can negatively affect your physical and mental health. Teenagers may be self-conscious about their underdeveloped appearance. Many adults experience some disinterest in sex as they get older. But a sudden drop or complete halt to any sexual desire may indicate hypogonadism. Dont be embarrassed to tell your healthcare provider whats going on (or not going on) in the bedroom. Treatments can get hormone levels back in the normal range.

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Low Sex Drive (Hypogonadism): Symptoms, Treatment

This article was originally published here

Am J Mens Health. 2021 Nov-Dec;15(6):15579883211058606. doi: 10.1177/15579883211058606.

ABSTRACT

It has been suggested that hypogonadism increases the risk for inguinal hernia (IH). The aim of this study was to investigate any association between androgen deprivation therapy (ADT) for prostate cancer and increased risk for IH. The study population in this population-based nested case-control study was based on data from the Prostate Cancer Database Sweden. The cohort included all men with prostate cancer who had not received curative treatment. Men who had been diagnosed or had undergone IH repair (n = 1,324) were cases and controls, where not diagnosed, nor operated on for IH, matched only on birth year (n = 13,240). Conditional multivariate logistic regression models were used to assess any temporal association between ADT and IH, adjusting for marital status, education level, prostate cancer risk category, Charlson Comorbidity Index, ADT, time since prostate cancer diagnosis, and primary prostate cancer treatment. Odds ratio (OR) for diagnosis/repair of IH 0 to 1 year from start of ADT was 0.5 (95% confidence interval [CI] = [0.38, 0.68]); between 1 and 3 years after, the OR was 0.35 (95% CI = [0.26, 0.47]); between 3 and 5 years after, the OR was 0.39 (95% CI = [0.26, 0.56]); between 5 and 7 years after, the OR was 0.6 (95% CI = [0.41, 0.97]); and >9 years after, the OR was 3.68 (95% CI = [2.45, 5.53]). The marked increase in OR for IH after 9 years of ADT supports the hypothesis that low testosterone levels increase the risk for IH. The low risk for IH during the first 8 years on ADT is likely caused by selection of men with advanced cancer unlikely to be diagnosed or treated for IH.

PMID:34918553 | DOI:10.1177/15579883211058606

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Androgen Deprivation Therapy and the Risk for Inguinal Hernia: An Observational Nested Case Control Study - DocWire News

Having low testosterone levels can prove to be a serious problem. This hormone is well-known because it plays a critical role in sexual desire. It also controls a number of important bodily functions, and not only during puberty. For example, testosterone is involved in muscular development. As a result, it is in charge of your physical growth above anything else.

As a result, regardless of gender, healthy production of the hormone is critical for your well-being. It is natural for testosterone levels to drop as men age, but fortunately, there is a way to break out from such a vicious cycle. You can rely on testosterone boosters to help you when you need them.

These products are being sold on tens of thousands of authority websites. You can easily come across a dozen with a quick web search. However, many of these sites may lead you astray. They have a reputation for relying on sponsorships and the like. As a result, doing your research is the best way to make an informed decision. This is especially true when it comes to testosterone boosters and other such medications.

To come up with this roundup, we looked at a wide variety of options, and our results are based on extensive, non-biased testing. No argument is based on a whim since all evidence is gathered from reliable sources, including customer reviews and clinical test reports.

After that, we were able to compile a roundup of the best testosterone boosters. These are the products that effectively stand out from the crowd and boost your bodys testosterone production naturally. These are also made from ingredients that havent been linked to any adverse effects. In a nutshell, these are the safest and most effective testosterone boosters available on the internet. We present the top five testosterone boosters based on these factors and expectations.

TestoPrime is a creation of Wolfson Brands (UK) Limited. The brand developed this supplement over five years ago. It quickly gained traction on the market, and even today, it stays at the top of our list. Such occurrences arent random, though. The company invests its resources in third-party testing to ensure that they create the best testosterone booster possible.

TestoPrime utilizes a formula that naturally rejuvenates your body. It results in gradual changes without sudden stress. A daily dose of only four TestoPrime capsules will increase the supply of testosterone to the bloodstream. In turn, the conversion of fat to energy will hasten. Also, due to the vitamin content, TestoPrime allows for testosterone retention, improving the blood flow and your sex drive.

The product uses only 12 organic ingredients, including minerals, vitamins, and extracts. It does not contain chemical additives or allergens, and it is also non-GMO. Customers report significant improvements within the first 20 days of use. The benefits include fat loss, increased muscle strength, and a better physique.

Visit the Official Website of TestoPrime

Since TestoPrime is a 100% natural product, you dont need a special prescription for it. You can simply go to their website and buy the booster whenever you want one. As for feedback, TestoPrime boasts an almost perfectly positive review score.

This popular testosterone booster comes from Muscle Club, a U.K.-based company. Testogen can combat the declining testosterone levels even in elderly users. Also, unlike certain artificial treatments or illegal anabolic boosters, its an entirely natural compound. So, it provides a simple and viable alternative to invasive hormonal therapy.

Testogens formula comprises 11 natural ingredients to boost your testosterone levels. In addition, it features a carefully selected mix of vitamins and minerals. Its primary ingredients are D-aspartic acid, fenugreek, and zinc. These elements also act as testosterone-preserving agents, so they postpone their conversion into estrogen.

Visit the Official Website of Testogen

Zinc protects cells against oxidative stress, according to a 1996 study. Oxidative stress, according to another study, is common to the male reproductive system and testicular tissue. Yet, antioxidants can help fight against this imbalance, thus improving sperm production.

Testogen also contains Vitamin D3. This element increases the free testosterone levels. Next, the body will use it to boost your energy levels, sex drive, muscle growth, etc.

The manifestation of these benefits varies from person to person. Some people begin to notice positive changes in the first week. For others, it may take longer. Testogens website recommends a dose of 4 capsules per day for best effect.

According to Crazybulks website, Testo-Max is an effective alternative for artificial testosterone boosters. Plus, it is an entirely safe and legal supplement. Each capsule contains various pure and natural ingredients. Among others, there is vitamin D3, magnesium, d-aspartic acid, etc.

Testo-Maxs blend features potent and effective elements. For instance, d-aspartic acid is vital in restoring hormonal balance in resistance-trained men. Its also proven to increase testosterone production by 45% in just a few weeks.

On the other hand, magnesium boosts testosterone levels by 26%, according to clinical studies. However, this is only one of the ingredients, and they all combine in Testo-Max. Finally, intake of vitamin D is always welcome, even though sunlight is its most consistent source. According to an NCBI study, low vitamin D levels in males reflect low testosterone levels.

Visit the Official Website of Testo-Max

On CrazyBulks website, there is sufficient information about this product, along with frequently asked questions. Hence, visitors can easily find their way and place an order or complaint. Thats why Testo-Max is rated so highly on popular review sites and forums. Its a well-rounded, affordable product thats also easy to find.

As we age, our bodies cease to function with the same efficiency. This slowing down translates into reduced testosterone secretion. In turn, well feel a decline in our energy levels. That is not a good thing in the slightest: it means reduced physical performance and libido. But the negatives wont stop there. Another common symptom is sudden weight gain. Also, according to recent studies, the average man loses 1% of their testosterone store every year, beginning at age 30.

The decline of testosterone levels can bring about a host of problems, even if it is a naturally occurring facet of life. Fortunately, the Prime Male natural testosterone booster offers a way to contradict this body tendency.

Prime Male is a combination of several organic ingredients that help you get back on track. Some of these substances include ashwagandha extract, magnesium, and luteolin (found in citrus fruit). They work in tandem to reinstitute the hormonal balance. Also, they govern the percentage of free (unbound) testosterone in your body.

The body is then free to use free testosterone for many purposes, including fat loss, building lean muscle, and boosting sexual drive. Finally, the Prime Male supplement card breaks down the percentage composition of the ingredients used in the mix. So, each customer will know exactly how it works.

Visit the Official Website of Prime Male

TestRX, made by Leading Edge Marketing Ltd, is a natural testosterone booster formulated to replenish dwindling testosterone levels. Its ingredients include vitamins like K2, B6, and D3, various minerals, and other plant-based ingredients. So, its a perfectly safe mixture suitable for any adult to intake.

If one follows the instructions, TestRX will soon build up in their bloodstream and cause beneficial changes. By steadily increasing the testosterone level, TestRX elicits a notion of youthfulness within the body. So, its a confidence booster that also helps with muscle growth and your sexual stamina.

TestRXs trifecta of zinc, magnesium, and d-aspartic acid (DAA) is indeed famous for its efficacy. This formula is proven time and time again to be completely risk-free, too. Hence, its not an experiment but more of a carefully measured blend.

According to a study, zinc helps in the preservation of testosterone and boosts all muscle-building processes. The supplements official website also points to another aspect: the noticeable increase in energy levels. With that, TestRX may manage to mimic the effects of some popular energy drinks.

Visit the Official Website of TestRX

Another essential element is magnesium. As studies indicate, it can boost athletes performance and improve testosterone levels. Finally, the fenugreek extracts have a similar effect on the immune system, adding even more to the overall effectiveness of TestRX.

Leading Edge Marketing Ltd. recommends a cycle of two capsules of TestRX in the morning and two before dinner. Thats the best way to allow this formula to dissolve into your bloodstream. Also, this supplement is entirely risk-free, so youll be able to order it without a note from your physician.

You can buy TestRX on their official website. However, its prices are constantly changing with current demand. So, you might run into some good discounts, too.

To develop this list, we started by searching for the most popular testosterone boosters available today. Since these products are fairly sought-after, the list had many, many entries at that point. So, we proceeded by digging deeper into their ingredients and effectiveness.

We looked at the history of the brands and how they source their ingredients. Any past reports of foul play or overwhelmingly negative feedback resulted in the elimination of that product. Instead of those, we focused primarily on risk-free products.

This multi-layered process allowed us a detailed insight into this landscape. Finally, after evaluating all that data, we came up with a list of the five best testosterone boosters you can order today.

Some of the criteria we considered when trimming down the list of testosterone boosters include:

Of course, customers may have specific relationships with some elements. As a result, its critical to understand whether a product could cause an allergic reaction. Finally, those substances determine the products overall effectiveness. Stress prevention, fat burning, higher energy levels, endurance, muscle strength all such aspects depend on them.

When suffering from subnormal testosterone levels, one must promptly take action. Hormonal imbalance is a serious condition that will impede your life in a significant way. Worst of all, it is a naturally occurring part of the aging process. So, even if it isnt an after-effect of a disorder, it can cause problems. Either way, it demands your attention.

From a medical standpoint, the usage of testosterone boosters is among the safest remedies for such predicaments. This is because theyre intricately made with heavily researched formulas. Also, they dont pose added stress to the body-rather, theyll elicit a more gradual and beneficial change.

However, given how many similar products you may come across online, a more critical eye is needed. Knowing when to give a brand a hard pass is a type of skill. Plus, its a decision best made early on before anything goes south.

Hence, one should keep in mind some essential pointers while researching for a testosterone booster. Heres what to look out for:

Companies will do their best to draw your attention. Theyll use clever catchphrases that sound familiar or present some miracle effects. Yet, when it comes to testosterone boosters, one should be 110% clear on what to expect. Luckily, the most reputable brandslike the five mentioned abovego far and beyond to remain in the spotlight.

In other words, if a brand is well-known, its earned that status the hard way. In todays world, word of bad results spreads faster than light. Every single negative review tends to stick to a product for years to come. Therefore, trusted brands mustve done a lot of things right and not just in a few months. Theyve climbed there over a much longer span, all while working hard not to drop the ball.

Also, popular products carry multiple efficiency evaluations. The companies go through much scrutiny before the green light. And even afterward, they are held accountable for all cases. Helpful customer support service is only one aspect of this, but one that might indicate a caring company.

Its no secret that companies are ever-evolving when it comes to scientific research. Especially for testosterone boosters, there is a steady stream of inventions that push the industry forward. However, one should keep track of all this. It is advisable always to check what the box states for its primary ingredients.

Naturally, the presence of chemical additives and preservatives should be a definitive no. Artificial steroids have a high chance of causing adverse side effects, and thats only the best-case scenario. As a result, it is prudent to ensure that the product you are about to purchase is entirely pure and natural.

On a related note, consider your medical history at all times. If theres a history of blood-related conditions, please remember to consult with an expert first. Pre-existing disorders might spiral further still if you were to take chances. For example, they can over-increase the red blood cell production, thus escalating the risk of a heart attack. Another consequence is an enlarged prostate, making urination painful and difficult.

Brands with license and approval from government-sanctioned boards are obligated to meet specific standards. Hence, you can rest sure that they adhere to rigorous manufacturing practices.

As a result, those products carry a lower risk factor. So, buying from FDA-approved companies should be a priority. Make sure to develop this instinct before opting for a testosterone booster.

Trusted brands incorporate fair refund policies and money-back guarantees. They back up all of their products, which instills a sense of security within the buyer. By navigating these rules, youll never have to puzzle out what to do next. If a product proves inefficient, you should file a complaint and get refunds. Hence, make sure that such a development is part of the plan right at the start.

Buy products from companies that use clinically-proven ingredients and are

A 2015 FDA study indicates that testosterone boosters may or may not cause a sporadic increase in testosterone levels in men. However, most of these supplements contain zinc and B vitamins which are natural energy boosters. They also improve the biological availability of testosterone in the blood.

Many of these testosterone boosters contain aspartate, magnesium, mono-methionine aspartate, or ZMA. Those ingredients may enhance exercise performance and post-exercise recovery. In short, most testosterone boosters are herbal testosterone supplements.

The best testosterone boosters are natural supplements that enhance testosterone and related hormones in your body. Many of these boosters work by blocking the supply of estrogen (the female sex hormone) and its effects on the male body.

For patients suffering from hypogonadism, testosterone boosters can indeed turn their lives around. These products are built to increase your energy levels and libido.

Some reports indicate positive mood swings and a stronger sex drive. Usually, this goes hand-in-hand with steady muscle growth. In addition, testosterone boosters can quell problems associated with erectile dysfunction too.

Above all else, however, take note if youre suffering from any kind of heart condition. If you doubt whether it would be OK to start taking testosterone boosters, dont hesitate to see your doctor ASAP.

According to studies, resistance exercises such as weight lifting have a tremendous effect on testosterone production in men. Surprisingly, studies have found only a minor increase in the hormone in women who do a similar exercise.

High-intensity interval training also produced good results in men. In comparison, such an approach could significantly increase testosterone levels in far less than 45 minutes.

Some testosterone boosters, especially those bought over the counter (OTC), may be safe when consumed in moderation. They also come with a unique set of beneficial side effects.

However, they cannot permanently guarantee that your testosterone level will always remain high. The best way to stay safe is to sift through the ingredients. Plus, make sure to follow the doctors orders, and focus on the FDA-approved testosterone supplements.

The best testosterone boosters are herbal supplements as they do not contain harmful anabolic steroids, although there is evidence of the contrary. Most notably, athletes who use the best testosterone booster supplements to boost muscle mass and improve performance. However, when things go too far, there come risks related to kidney or liver damage.

Healthy, natural boosters like the ones discussed in this article can help you achieve the desired hormonal balance. Yet, dont think of them as a lifelong therapy solution. Instead, just take things one step at a time and do frequent re-checks.

So, buying testosterone boosters from verified sources is still the best way to go. Such testosterone boosting supplements will most likely provide you with a boost in testosterone production.

Testosterone levels tend to decrease with age. According to American Urological Association studies, about 2 out of 10 men in their 60s suffer from low testosterone. The number increases to 3 out of 10 men in their 70s and 80s.

A blood test is used to determine the testosterone level in your body. In men, a range of symptoms appears when testosterone levels fall below normal. If that happens, it may result in slower sex drive, hair loss, decreased energy levels, weak erections, sudden mood changes, etc.

On average, a mans testosterone peaks at the age of 20. Then, in the next few years, the levels move to a gradual decline. Experts believe that the healthiest men have testosterone levels between 400 to 600 ng/dL. Measures severely outside these limits point to a hormonal disorder.

However, signs of low testosterone become more apparent after the age of 30. A decrease in libido often accompanies it, leading most men to lose confidence in that aspect. While the reasons may simply accompany older age, this pattern may not be universal. In truth, many factors contribute to erectile dysfunction in men.

At first, youll probably notice your skin getting thicker. This is because your pores will become larger, resulting in a more oily appearance. Also, you might start to sweat more often. In tandem with this, the odors of your urine and sweat might change, too.

Following all this, a change in your emotional state is expected. You may start to develop a narrower range of feelings. However, you should generally enjoy a more positive mood. Studies confirm that an increase in testosterone affects your temper.

Finally, increased testosterone may improve your gym performance and age-related erectile dysfunction. Your healthy testosterone levels & energy levels will probably increase as well.

There are several ways to improve testosterone in men naturally. One of the most common and evidence-based methods is resistance training. By including weight lifting and other physical activities in your daily routines, youll experience a significant jump in testosterone levels.

An improved diet of more protein, carbs, and healthy fats can help boost testosterone levels, too. We recommend a diet based solely on whole foods because they contain larger amounts of testosterone-boosting nutrients.

Furthermore, high-stress levels can elevate the hormone cortisol, according to some studies. These unnatural amounts of cortisol in the bloodstream can rapidly deplete your testosterone store.

Also, you can take advantage of the sun to boost your vitamin D supply. Several studies have shown that vitamin D is capable of working as a natural testosterone booster. You can also avoid estrogen-inducing compounds commonly found in junk food. To do so, one might have to change their unhealthy eating habits, though.

Finally, you can opt for any one of the five best testosterone boosters featured on our list. In doing so, youll end up supporting the other methods mentioned here. Either way, they all function even better when combined.

As men age, their testosterone level is expected to decline naturally. It is a fact of life that likely wont be avoided. And when it takes a swing, youll probably notice its benefits. They often include lower overall energy, reduced muscle mass, unstable mood, and difficulty in weight loss.

These changes can occur even if you follow a healthy diet and workout routine. So, even the most disciplined of us suffer as a result of this. Regardless, theres a solution fit for everyone. Testosterone boosters are a smooth path towards hormonal balance, and the right testosterone boosting supplements are entirely natural and clinically tested.

Lastly, if you have any pre-existing conditions, make sure to consult your doctor before choosing a testosterone booster. These products can affect many critical bodily functions, and you wont want to test your luck there.

See the rest here:
5 Best Testosterone Boosters to Increase Testosterone Levels in 2022 - Us Weekly

On December 16, the U.S. Food & Drug Administration (FDA) decided to permanently allow doctors to administer medical abortions by telemedicine and through the mail. The prior rule (from before the pandemic) required a doctor to see a patient in person while giving her the two medications that terminate a pregnancy of up to 10 weeks gestation. The first medicine, mifepristone, blocks progesterone, the pregnancy hormone (literally pro-gestation) that directs the uterus to thicken and become hospitable to a growing embryo and fetus. The second medicine, misoprostol, induces uterine contractions that expel the excess uterine lining and the products of conception.

Medication abortions are safe and effective, so it is unclear why a doctor ever had to hand the medicine to the patient in person, especially when the patient goes on to take the drugs somewhere else. Doctors prescribe other medicines for their patients without having to interact with them in person or hand them pills directly. Even controlled substances like Fentanyl do not require this special procedure. Only politics could explain the old rule.

The pandemic presented another reason not to demand that doctor and patient see each other in person during the transfer of pills. Attempts to limit the spread of COVID-19 seemed inconsistent with enforcing a rule that lacks a plausible rationale and has the downside of exposing many more people to the virus. Indeed, medication abortion may be the primary method of abortion during the first eleven weeks of pregnancy. And the overwhelming majority of abortions happen during the first trimester (thirteen weeks). With almost 900,000 abortions a year in the United States, a rule requiring face-to-face pill handoffs amounts to a lot of unnecessary face-to-face meetings, particularly during a pandemic.

In response to COVID-19 and for its duration (whatever that might have meant), a federal judge suspended enforcement of the in-person medication abortion rule. Under the suspension, a doctor could meet the patient virtually (e.g., over Zoom) and then send her the medicine by mail. In anticipation or in response, nineteen states have already banned telemedicine visits for abortion medication, and others have put limits on the practice, presumably in the expectation that the Supreme Court will overrule Roe v. Wade this term.

Even in states that prohibit telemedicine abortion or limit it to some number of weeks short of ten, women still have more options than they did before. Traveling to another state to terminate a pregnancy is burdensome, to be sure. But driving to another state to talk with a doctor in that state on ones laptop through telemedicine, after which the doctor mails the woman two pills, exposes her to far less harassment and intimidation by advocates of forced pregnancy and birth than visiting an actual clinic to have the procedure. Patients can take the two pills at home or anywhere they feel comfortable and enjoy the privacy that both legislators and protesters have routinely denied them. Telemedicine abortionseven out of statewill also generally cost less than the surgical variety.

Abortion may soon become completely illegal in many states and perhaps in the whole country, if Republicans take over both houses of Congress and the presidency. Nonetheless, the illegal termination landscape too will look different with the availability of medical abortion. Asking a friend or an unlicensed practitioner to scrape products of conception out of the womb is far more likely to end in infection and death (of the woman) than is ordering some pills over the internet. The drugs may occasionally not be entirely pure, of course, but the image of the coat hanger can recede a little in the wake of medical abortion, at least for early terminations. And as the proportion of medication abortion rises in response to legal developments, first trimester terminations might now involve a choice between a nonexpert in a back alley and a couple of pills purchased from another country over the internet. For the government to keep track of who orders such pills would require something close to a police state, which even the most zealous anti-abortion advocates might prefer to avoid.

So medical abortions are likely to make terminating a pregnancy more accessible and affordable and less dangerous even when illegal, a welcome development in light of the Courts no-longer-hidden plans for Dobbs v. Mississippi, the abortion case it heard earlier this month. There is something especially satisfying for opponents of forced pregnancy and birth about a technology that takes some of the power to successfully regulate abortion away from states just as the Court is poised to give them that very power.

Beyond bringing good news for people who support the right against forced pregnancy and birth, medical abortions also offer an ethical argument to consider for those who generally condemn abortion. When I have discussed the issue with people on the other side, I generally explain (the rather obvious fact) that pregnancy is an active state in which the body works hard, and the placenta siphons nutrients away from the mother to meet the needs of her fetus, thus burdening the woman. The other side insists, by contrast, of speaking as though all it is asking from the pregnant woman is that she refrain from committing an act of violence. Just as you may not stab your neighbor or co-worker to death (even if you would very much like to do so), the pregnant woman may not kill the embryo or fetus. In reality, being pregnant is an affirmative burden of hard and hazardous work, not a passive refraining from attack.

Still, if I must answer the question of whether terminating a pregnancy involves direct violence to the embryo or fetus or whether it just involves ending a pregnancy, the question is hard to answer. Most abortion methods involve killing the embryo or fetus and then removing it from the womans body. Later in pregnancy, the abortion methods that bother many people involve suctioning the brain and then taking apart the fetuss body and removing each of the parts. The reason for the latter procedure is that later in pregnancy, the fetuss head is already large, and it seems pointless to force the woman to endure hard labor when the fetus cannot even survive outside the womb. Disassembling the fetuss body makes removal less injurious to the patient.

Nonetheless, if one believes that killing an embryo or fetus directly is wrong, then all of these surgical methods of abortion are wrong. Medication abortion is different. Taking the first pill simply blocks progesterone and thus stops the building of the uterine lining, and the second removes the products of conception (the embryo, blood) from the body by causing contractions. Neither pill poisons the embryo or otherwise kills it. The death of the embryo is an incidental effecta collateral casualtyof removing it from the womans body. The woman is therefore deciding not to have the embryo in her body, and it is the embryos pre-viability status that results in its death.

So long as it is legitimate for the woman not to want to invest the enormous and intimate bodily effort involved in turning an embryo into a baby inside her body, there is an argument that she is at least as justified in removing it as she would be in removing a catheter that connected her to someone (a full person) who was using her body as a respirator or a dialysis machine. (And yes, I am aware of similarities to Judith Jarvis Thompsons violinist.) The death results from the other entitys or persons need, not from the direct action of the pregnant woman or the human respirator/dialysis machine in disconnecting the embryo or person. The Supreme Court has insisted, in keeping with this distinction, that even though an individual has a presumed right to remove life support if she no longer wants it, she does not enjoy a right to physician assistance in dying.

Those familiar with Catholic theology will recognize that I am making what sounds a little like a Doctrine of Double Effect (DDE) argument. I am putting the finishing touches on a scholarly article about my own version of DDE. Most people understand this doctrine to hold that if a person intends something bad, then the action he takes with that intent is wrong, but if he intends something legitimate and sufficiently good to justify the bad effect, then the action he takes with the good intent is fine or even good. A familiar example is that if you want to help your patient dieand assisting a suicide is, by hypothesis, wrongthen giving the patient a morphine overdose to that end is wrong. If, on the other hand, you want to alleviate your patients excruciating painand alleviating terrible pain with the high morphine dose is necessary and legitimate and proportionate to the harm of death caused by the overdosethen giving your patient that same overdose is a fine thing to do.

Many have criticized the DDE, as described above, for distinguishing between identical actions based on intention and defining one as legitimate and the other as bad. I propose in my article (and here, briefly) that the more sensible application of DDE is that we do not literally ask what is in the persons mind as a matter of intent. If a doctor gives a patient enough morphine to alleviate terminal pain, and that amount of morphine brings about death, then even someone opposed to assisted suicide should be comfortable with what the doctor did and need not inquire into her true motives. But if the doctor kills the patient in a way that could not possibly alleviate pain, like injecting a poison, then there is no DDE defense because the only way the injection could address the patients pain is by killing the patient and therefore his pain forever. That is direct killing as a means of ending pain, and that is illegitimate, by hypothesis.

I support the right to physician assistance in dying as well as the right to direct abortion (i.e., even the type that involves killing the embryo or fetus). However, I understand the difference between directly doing something objectionable and having something objectionable happen as a result of doing something legitimate. For instance, if a military bombs a munitions plant knowing that three civilians will die (and that there is no way to spare the civilians without aborting the mission), then that mission might be legitimate. It pursues an acceptable objective, and the harm is not disproportionate relative to the benefit. By contrast, if a military just dropped a bomb on three civilians, that action would not be legitimate at all. It is clearly not a side effect of some legitimate action because there is no such legitimate action. We can tell when we are dealing with a DDE situation because we can plausibly explain the action as aimed at a permissible objective (regardless of what the actual intentions of the actors might be). Likewise, when we cannot explain the actions by resort to a legitimate and proportionate objective, then the action is impermissible.

Returning to abortion, for people who believe that killing an embryo or a fetus directly is wrong, the medication abortion offers a potential loophole. A person can be anti-abortion because affirmatively killing the embryo or fetus strikes the person as wrong. But in medication abortion all we are doing is removing the embryo or fetus from inside the woman because the woman does not want to be a respirator, a dialysis machine, and a source of calcium and other nutrients all rolled up into one. Neither medication kills the embryo. Each simply moves it from inside the woman who does not want it there to outside of her body. She does not wish to aid the embryo. Because the embryo is not viable, death is a collateral consequence of removal.

Now it is quite possible and even likely that the person getting a medication abortion intends for the embryo to die. Its death is part of why she is having an abortion. Under my approach to DDE, however, we do not care what her true intention is. We simply ask whether her actions could be understood as aimed at a legitimate purpose whose benefits are sufficient to justify the harmful impact (here, the death of the embryo). One could have a medication abortion because one refuses the extremely invasive, burdensome, and risky experience of pregnancy and birth. One could do so without specifically wanting the embryo to die. The situation is accordingly a double effect circumstance. Death is a side effect of removal.

Some might say that gestation is not sufficiently burdensome to justify removing the embryo and the pregnancy at the cost of the embryos dying. Such people may be ignorant of what it feels like to be a person who does not want to have her body taken over in the way that gestation takes over a womans body but who must be a respirator, etc. because someone or something is forcing her to. I know of people who consider themselves pro-life who have acknowledged privately that if all the woman does is to induce labor (which is effectively all that a medication abortion does), then it seems that she is choosing not to kill the embryo or fetus but simply not to keep it inside her body. We all presumably have the right to consent or not consent to being physically occupied by a foreign body, even the body of our own embryo.

Medication abortion thus opens some new windows on a very old problem. Terminating a pregnancyfinallycan truly be private so that unwanted third parties have no access to the pregnant woman. It can be less expensive than surgical abortions so that poorer women can afford it. And finally, it can be morally defensible even for those whose religious beliefs tell them that embryos are people but distinguish between killing someone and refusing aid in the form of serving as a 40-week life support machine. If you believe you have the right not to donate blood or a kidney or even your dead body once your life ends, then it seems that medical abortions ought to calm your objections to women who choose not to grow a baby from raw materials inside their wombs.

Link:
How Medical Abortion Challenges the Practice and the Moral Condemnation of Ending a Pregnancy - Justia Verdict

DURHAM, N.C., Dec. 20, 2021 /PRNewswire/ -- REVIAN Inc., an aesthetic medical technology company dedicated to stimulating the body's natural processes to rejuvenate hair and skin with light, today announced the REVIAN RED System was named as the best treatment cap for androgenetic alopecia in a storypublished by New York Magazine. Tagged as "Recommended by Experts" the authors spoke with numerous doctors and dermatologists about the most effective products to treat hair loss, from topical and oral pharmaceuticals to more "natural" methods like scalp serums and light treatments.

The doctors and dermatologists interviewed for this story all agreed that hair loss can be slowed, stopped, or even reversed if the underlying problems are addressed. The REVIAN RED System uses patented dual colors of LED light in the 620 and 660 nm wavelength ranges, to stimulate the body's generation of nitric oxide and unlock the body's natural ability to accelerate healing and renew the cells that grow hair. Nitric oxide targets the three main pathogenic factors known to be associated with androgenetic alopecia: reduced local blood flow, inflammation, and elevated levels of DHT (dihydrotestosterone - a hormone responsible for shrinking hair follicles, which ultimately leads to hair loss and eventually baldness).

"The cap delivers precisely engineered red light to the scalp, which enhances circulation to the hair follicles. Improved delivery of oxygen and nutrients helps optimize activity of hair follicle. I use it to amplify the efficacy of other hair growth products," said Dr. Joshua Zeichner M.D., Director of Cosmetic and Clinical Research in Dermatology and Associate Professor of Dermatology at Mount Sinai Hospital.

The REVIAN RED System consists of a lightweight rechargeable cordless cap controlled by a user-friendly mobile app designed to control treatments, provide treatment feedback, and keep users on track. Understanding that ease-of-use and lifestyle fit are of paramount importance, this integrated system allows for complete freedom of movement and use almost anywhere during the 10-minute daily hair growth treatments.

"The biggest issue with any treatment is patients' compliance," added Dr. Zeichner. "Making it easy to fit into their personal daily routines can make all the difference."

"We believe the first place to seek help for hair loss is a qualified doctor or dermatologist. They can diagnose the problem and make sure it is not a symptom of a more serious disorder," said Tim Waite, VP of Sales, Revian, Inc. "If you are one of an estimated 50million menand 30 million women suffering with pattern baldness in the in the United States, you should talk to your physician about the REVIAN RED System and learn more at http://www.revian.com."

About REVIAN RED

The REVIAN RED System is an FDA cleared, wireless wearable cap controlled by a mobile "smart" app that functions to provide a hair loss treatment for men and women using LED light. The patented dual-band, LED technology provides broader scalp coverage and better skin penetration than red lasers used in low level laser therapy (LLLT). Dual wavelengths of LED light facilitate and accelerate scalp healing, allowing the body to renew cells associated with hair growth and retention.

Indications for use: The REVIAN RED System is indicated to treat androgenetic alopecia and to promote hair growth in males who have Norwood-Hamilton classifications of IIaV patterns of hair loss and to treat androgenetic alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types IIV.

About REVIAN

REVIAN is an aesthetic medical technology innovator dedicated to stimulating the body's natural processes to rejuvenate hair and skin with light. We create products that precisely deliver light and allow people to experience its regenerative potential in the convenience of their own home. We are committed to partnering with health-care providers and other caring professionals to deliver meaningful results, backed by scientific data. For more information, visit http://www.revian.com

REVIAN Inc., headquartered in Durham, is an operating subsidiary of KNOW Bio, LLC.

Media Contact:Al SafarikasKNOW BIO, LLC [emailprotected] (919) 887-4350

Investor Contact: John OakleyKNOW BIO, LLC[emailprotected] (919) 939-7715

SOURCE REVIAN, Inc.

Here is the original post:
REVIAN RED System, Among the Best Hair-Loss Treatments According to Doctors - PRNewswire

Canadas decision to remove restrictions on the abortion pill did not impact its safety, a new study has found.

Researchers at the University of British Columbia say the study shows the drug remains a safe, effective option and signals to other countries that restrictions on the medication are unnecessary and burdensome.

Having access to medication that can be taken at home without a trip to the doctor or an abortion clinic, which are often harder to find in rural areas, became more crucial in a pandemic, said Dr. Sheila Dunn, a scientist and family physician at Womens College Hospital who co-authored the study published this month in the New England Journal of Medicine.

The potential for this drug is you dont need an operating room, or surgical training to be able to deliver that care. You can deliver it from your office ... and your office could be in a small town, she said.

It has the potential to widen the number of providers. The change in the regulations really made a difference in whether or not providers would pick it up, she said.

Previously, the restrictions on the medication were onerous, she said.

Prior to November 2017, physicians were required to observe their patients taking the medication and in order to prescribe it, a doctor would need to be specially trained and registered with the manufacturer.

The abortion pill was approved in Canada in July 2015, while in 57 other countries like France and Britain, it had been available for decades. The U.S. approved the drug in 2000.

The drug provides an alternative to surgical abortions, and can be used up until 63 days into the pregnancy.

It works in two parts: first a patient takes mifepristone, which blocks the hormone progesterone, which sustains a pregnancy. It stimulates the uterus to expel the pregnancy tissue, said Dunn. Then a second pill containing the hormone prostaglandin is taken one to two days later.

The process is similar to what would happen during a miscarriage, said Dunn.

The research showed that prescribing the drug without restrictions showed no increase in abortion-related health complications.

Researchers analyzed 315,000 abortions in Ontario between 2012 and 2020 and found no increase in health issues following the removal of the abortion pill restrictions.

Our study is a signal to other countries that restrictions are not necessary to ensure patient safety, Wendy Norman, the studys senior author and professor in UBCs department of family practice, said in a press release about the research.

The previous restrictions had no scientific justification and made it more difficult for people to access the care they needed, she said.

The uptake of the abortion pill was rapid following policy changes, the study says. When the medication became available without restrictions, within two years, 31.4 per cent of abortions in the country were provided using the drug.

The abortion rate also declined slightly after restrictions were removed, from 11.9 abortions per 1,000 female residents aged 15-49, to 11.3 indicating an increase in access does not mean an increase in abortions, said Dunn.

The abortion pill allows the experience of an abortion to be more private, and allows the patient to avoid the harassment many face around abortion clinics. Ontario launched protest-free buffer zones of 50 metres outside clinics and 150 metres outside abortion providers homes in 2017 for this reason.

Canada is the first country in the world to remove the restrictions, and its hoped other nations will follow suit, said Dunn.

It provides very good evidence that theres no rational reason for [restrictions] in terms of safety. Weve shown that really doesnt exist, she said.

Last week, the U.S. Food and Drug Administration removed a long-standing requirement that women had to pick up the medication in person.

Go here to see the original:
Remove restrictions on abortion pill didn't impact safety: Study | The Star - Toronto Star

William Culbert| Guest column

State Rep. John Ragan, 33rd District,is misguided in his efforts to usurp the authority of the Tennessee Board of Medical Examiners in its efforts to protect Tennesseans from COVID-19. Despite his stated motivations, he has contradictory political views and legislative precedents.

The General Assembly may grant rule-making authority to the TBME, but the 71 medical boards that exist in every state and territory are established by the U.S. Constitution with a federal mandate to protect the public from the unprofessional, improper, unlawful, or incompetent practice of medicine … and gives authority to a medical board to enforce the acts provisions.

Ragans justification for his threat to have the Government Operations Committee disband the board is based on protecting the autonomy of physicians and their patients and the lack of regulatory specificity toward physicians that purvey misinformation and disinformation about COVID-19.

Rep. Ragan has advocated using taxpayer dollars to study the appropriateness of treating COVID-19 with drugs like a deworming medicine for horses with no anti-viral properties. This conflicts with the recommendation of major medical groups and disregards the significance of a highly effective anti-viral pill that has recently received approval for emergency use from the Food and Drug Administration (FDA) advisory committee.

In his House Bill 578 regarding gender identity, Ragan expressly undermines the autonomy of the physician, minor patient, and the responsible parent by requiring a second medical opinion from a different medical specialist with no specific training in endocrinology that is often expensive and difficult to obtain. Without meeting this requirement, the bill prohibits use of hormone therapy in these pre-pubertal patients despite medical assurances of its safety and reversibility.

Ragan says this legislation was drafted to protect Tennessees children, but he rejects Medicaid expansion, forgoing a million dollars a day in federal subsidies for direct health benefits for tens of thousands of the states children.

There are very few rules in medicine, but there are a lot of practice guidelines. They frequently have minor inconsistencies, and good physicians routinely operate within this penumbra. Unfortunately, the practices of some doctors are more motivated by social media, political news programs, or religious doctrine that do not represent good medicine.

Because what these physicians say matters, their opinions can be particularly dangerous, and medical boards may need to use broad regulatory terms like misinformation or disinformation to rein them in.

Even when regulators have known that physicians are addicted to drugs or alcohol or they over prescribe opioids, it has been difficult to stop them from practicing medicine. This is rapidly changing, but potentially more dangerous for patients are the doctors that knowingly reject the quality medical practice standards of their peers. They dont need more protection from politicians.

Physician William Culbert lives in Oak Ridge and has a practice in Clinton.

Go here to read the rest:
Politician oversteps his authority with COVID-19 - Oak Ridger

The American Journal of Managed Care (AJMC) recently spoke with Nicholas McAndrew, MD, MSCE, a medical oncologist and breast cancer specialist at UCLA Health and assistant clinical professor of Medicine at UCLA in the Division of Hematology/Oncology. AJMC asked McAndrew, about the arrival of CDK4/6 inhibitors in the treatment landscape.

AJMC: What is HR-positive HER2-negative breast cancer?

McAndrew: HR-positive stands for hormone receptor positive, and HER2-negative means that the breast cancer is does not overexpress the HER2 protein; hormone receptor positive means positive for either the estrogen receptor or the progesterone receptor. HER2-negative metastatic breast cancer is the most common subtype of breast cancer. Hormone-positive, HER2-negative metastatic breast cancer represents about 60% to 80% of all cancer diagnoses, with HER2-positive breast cancer being about 20% and triple negative breast cancermeaning it's negative for estrogen, progesterone, and negative for HER2, representing about 10% of breast cancers.

AJMC: What are the goals of therapy in treating patients with this type of breast cancer?

McAndrew: The main goal of therapy for anybody with metastatic breast cancer, but in particular, hormone-positive HER2-negative breast cancer, is to control the progression of their cancer. Unfortunately, with metastatic breast cancer, once cancer cells have left the breast and have spread to distant organs in the body, or just in lymph nodes in the body not within the regional lymph node chain of the breast tissue, its no longer curable. Now, of course, the minority of patients develop thatmost patients who have been diagnosed with breast cancer are found at an early stage. But [some] patients either recur or present with de novo metastatic disease. And so, when a breast cancer is not curable, the main goal is to try and control the growth of the cancer in order to try and delay or avoid any kind of complications that could arise from where metastasis can develop. Also, that's in conjunction with helping maintain somebody's quality of life. So, the main goal of therapy is really to prolong someone's life, but also to prolong a good quality of life. And that takes into account trying to control the disease, but also especially for hormone-positive HER2 negative breast cancer, trying to give treatments that will achieve that goal with a minimum amount of toxicity. Thats really the most important part for hormone- positive, HER2-negative breast cancer.

AJMC: Could you give us a brief overview of the current treatment landscape for HR-positive HER2-negative breast cancer?

McAndrew: In advanced or metastatic hormone-positive HER2 negative breast cancer, the broad overview is that because we're trying to help patients feel as well as possible for as long as possible, you want to start off with therapies that are going to be well-tolerated and maximally effective. And so, we prioritize giving hormone-based therapies or hormone-blocking therapies that are usually in conjunction with some kind of a molecular therapy. We do that first to try to extinguish those options, because oftentimes, those drugs can be tolerated for a longer period of time and have a better side effect profile. Then with chemotherapy, which is traditionally prior to the advent of all these amazing hormone-blocking therapieswe try to use those prior to having to give chemotherapy. In terms of a brief overview, we start off by trying to control the cancer with the less toxic hormone-blocking therapies before moving on to trying to control it with chemotherapy, which is oftentimes more toxic and less effective.

AJMC: How has the arrival of the CDK4/6 inhibitors change the treatment landscape?

McAndrew: It's really been game changing. They've been incredible drugs that have drastically improved survival in patients with metastatic breast cancereven in the first-line setting. In patients who have first-line metastatic disease, for hormone-positive HER2 negative breast cancer, traditionally, patients have initially been started on single-agent endocrine therapy. What Dr. [Richard] Finn and Dr. [Dennis] Slamon [had shown] in their labs is that it was hormone-positive HER2-negative breast cancer cell lines that seemed to be especially sensitive in a synergistic fashion with a different therapy to CDK4/6 inhibitors;1 [this] launched the first of many trials that showed that when we add these compounds to first-line and second-line endocrine therapy, it significantly improves progression-free survival, and importantly, with some CDK4/6 inhibitors, overall survival in both the first- and second-line settings. We have a couple studies now showing that that when ribociclib is added to a first-line endocrine therapy for both premenopausal patients and postmenopausal patients, it significantly improves overall survival.

AJMC: What are your preferred treatment regimens for treating patients with HR-positive HER2- negative advanced breast cancer?

McAndrew: I take certain things into consideration when I'm trying to select a treatment for patients. So, these drugs the CDK4/6 inhibitors do have different toxicities. For instance, abemaciclib (Verzenio) has more [gastrointestinal] GI toxicity and more diarrhea associated with it, but less neutropenia; it's given on a daily basis, rather than a 1 week on, 1 week off basis. Ribociclib (Kisquali) is has less GI toxicity and has more overlapping toxicity profile with palbociclib (Ibrance), with the exception that ribociclib additionally does carry the risk of QT prolongation. So, for patients whom I'm worried that they're not going to be able to reliably come in EKGs during the first 4 weeks of treatment, I sometimes consider not prescribing that one because I want to make sure they're safe and monitored on therapy.

And then with palbociclib, theres nothing of concern for QT prolongation; however, some of the overall survival data with palbociclib has not been positive. And so, I generally dont prefer that one when I'm considering between ribociclib and abemaciclib because the survival data in those drugs has been consistently positive. So, those are some of the factors that I take into account.

AJMC: In addition to concerns about patients coming in for an EKG, has the pandemic has the pandemic affected treatment choices? We know that cancer screenings dropped during the early months of the pandemicwas there any impact on the treatment of metastatic breast cancer?

McAndrew: In my practice it really hasn't impacted the treatment of metastatic breast cancer. I certainly think that many of the patients who were concerned about coming in for regular follow-ups in regular chemotherapyespecially for patients who were getting treatment for early-stage diseasein the end, I did see some patients concerned about coming in for their chemo and even in some rare cases, decide not to do chemotherapy. [This was] because of the concern for leaving the home during the pandemic, but that's a minority of patients. And I would say that most patients were able to come in; [with metastatic breast cancer] these patients are highly motivated to remain in close contact with their oncologist to continue to receive care. So, I actually haven't seen a major impact when it comes to the availability of treatment and the treatment decisions during the pandemic.

But certainly, one of the major things, especially early in the pandemic, in the early-stage setting was that patients who were diagnosed with low-risk hormone-positive or negative early-stage breast cancerback when the operating rooms were not running at full capacitywe were managing a lot of these patients with neoadjuvant endocrine therapy until they were able to book their surgery, usually months down the line. Typically, these patients will go right to surgery, but because of the institutional decision to try and preserve ventilators for the ICU, and to minimize the number of nonemergent surgeries and elective surgeries, a lot of patients were managed with neoadjuvant endocrine therapy until the operating rooms open back up at full capacity. And that was pretty successful. We didn't see any delay, or anyone's care be compromised from a cancer perspective, we didn't see any progressions, because of that decision. So that was good.

AJMC: Your earlier response about using CDK4/6 inhibitors in first-line treatment is consistent with responses we are hearing from oncologists who treat several types of cancersthat the trend in the first-line setting is to use the best drugs available. Is this true across the board with CDK4/6 inhibitors?

McAndrew: Yes, absolutely. Often, these drugs are very, very well-tolerated. And in many of these studies, patients would have gone on to receive a subsequent CDK4/6 inhibitor. And despite that potential source of confounding in the studies, we still see a maintained overall survival benefit when you start by giving them the CDK4/6 inhibitor plus the endocrine therapy. At this point, unless there are patient-specific comorbidities or tolerability [that] preclude the physician from being able to prescribe the CDK4/6 inhibitor, there's really not a reason not to start with the CDK4/6 inhibitor. Because when cancers become resistant to a line of therapy, it's not the same type of cancer, and we don't know whether delaying the addition of the CDK4/6 inhibitor until they progress on endocrine therapy is really the right thing to do. Because you're now dealing with a different type of cancer that was resistantthat has already become an acute resistance. So, if you capture the opportunity to try to control the disease when it's as endocrine-sensitive as possible, with the strongest tools possible, youre likely offering the patient the maximum amount of benefit.

AJMC: Is there's anything we haven't covered that you'd like to add?

McAndrew: The main focus at this point in terms of where the field is headed is trying to understand the mechanisms behind CDK4/6 resistance and trying to really tailor subsequent therapies to the different ways that patients may become resistant to these drugs. I think that that next-generation sequencing with both liquid biopsies and with solid tumor biopsies is going to be a huge part of where we see this field moving in the future. And hopefully, we'll be able to tailor subsequent lines of therapy specifically to patients mutations as they as they arise throughout the course of treatment, to stay one step ahead of the cancer.

Reference

Finn RS, Dering J, Conklin D, et al. PD 0332991, a selective cyclin D kinase 4/6 inhibitor, preferentially inhibits proliferation of luminal estrogen receptor-postive human breast cell lines in vitro. Breast Cancer Res. 2009;11(5):R77 doi: 10.1186/bcr2419.

Original post:
McAndrew: No Reason Not to Start With CDK4/6 Inhibitors in Metastatic HR+ HER2-Negative Breast Cancer - AJMC.com Managed Markets Network

PALM BEACH, Fla., Dec. 21, 2021 /PRNewswire/ -- FinancialNewsMedia.com News Commentary - Breast cancer is cancer that develops in the breast tissue. Breast cancer signs include the formation of a lump in the breast and red patches on the skin. Obesity, lack of physical activity, excessive radiation exposure, and alcohol use are all risk factors for breast cancer. Breast cancer is more prevalent in developed countries than it is in developing countries. Post diagnosis, cancer therapy requires different procedures depending upon the form and severity of cancer. The cancer care market is increasing at a substantial pace due to the rise in the occurrence of cancer cases, growing knowledge among people about different stages, and availability of treatment of cancer. Breast cancer treatment relies on different factors, such as breast cancer origin, tumor size, and breast cancer phase, and cancer grade. Operations, radiation therapy, chemotherapy, hormone therapy, targeted therapy, and bone-led therapy are some of the most popular approaches used in the management of breast cancer. A report from Facts and Factors states that the global breast cancer treatment market was registered at about USD 19.24 Billion in 2019 and is expected to generate revenues worth around USD 34.06 Billion by end of 2026, effectively growing at a CAGR of around 8.5% between 2020 and 2026. Active biotech and pharma companies in the markets this week include Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), Galera Therapeutics, Inc. (NASDAQ: GRTX), Lineage Cell Therapeutics, Inc. (NYSE: LCTX), Gilead Sciences, Inc. (NASDAQ: GILD).

The report added: "The rising number of females diagnosed with breast cancer is a major driver of market development. Aside from this, the demand has grown due to the acceptance of unhealthy lifestyles, an increase in the women geriatric population, exposure to toxic radiation, and increased government initiatives. Since no absolute cure exists, there is room for the industry to develop globally. The global breast cancer treatment market is driven by America on a regional basis. The demand has grown as a result of changing lifestyles and the increased incidence of breast cancer in the United States. Europe is the market leader in breast cancer. The development of this market in America and Europe is due to technological advancements, increased life expectancy, and increased healthcare spending by people. The market is expected to expand at the fastest rate in the Asia Pacific."

Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC) BREAKING NEWS: Oncolytics Biotech Promotes Thomas C. Heineman, M.D., Ph.D., to Chief Medical Officer - Oncolytics Biotech ) today announced that Thomas (Tom) C. Heineman, M.D., Ph.D., has been promoted to the role of Chief Medical Officer (CMO). Dr. Heineman has over two decades of experience leading clinical development programs and previously served as Oncolytics' Global Head of Clinical Development and Operations.

"Tom's clinical expertise, deep understanding of oncology drug development, and impressive track record make him an ideal fit as our CMO," said Dr. Matt Coffey, President and Chief Executive Officer of Oncolytics Biotech Inc. "Since joining Oncolytics in August 2020, Tom has provided crucial insights that have enabled the efficient advancement of our lead breast cancer program and facilitated our pipeline's expansion into additional indications. Looking forward, Tom's strategic guidance will continue to be an invaluable asset as we move towards a registration study in metastatic breast cancer and advance our broader pipeline."

Dr. Heineman added, "The opportunity to serve as Oncolytics' CMO is exciting. Pelareorep's ability to recruit anti-cancer immune cells into tumors and promote an inflamed microenvironment positions it as a potential immunotherapeutic backbone that can enable the success of a wide range of immuno-oncology agents. We have demonstrated clinical proof-of-concept in several high unmet need indications and are now building on these results in ongoing trials. As CMO, I look forward to leading the clinical development of pelareorep through these and future trials, and to my continued work alongside my highly talented colleagues at Oncolytics."

Prior to joining Oncolytics, Dr. Heineman was Senior Vice President and Head of Clinical Development at Denovo Biopharma. Prior to his time at Denovo, he served as Vice President and Head of Clinical Development at both Genocea Biosciences and Halozyme Therapeutics. At Halozyme, Dr. Heineman was also Head of Translational Medicine and oversaw clinical trials in indications such as breast and pancreatic cancer. Dr. Heineman's experience further extends to big pharma and academia, as he previously worked as Senior Director, Global Clinical Research and Development at GlaxoSmithKline and as an Associate Professor at the Saint Louis University School of Medicine.

Dr. Heineman has co-authored over 60 peer-reviewed publications and is board certified in Internal Medicine and Infectious Diseases. He completed his fellowship in Infectious Diseases at the National Institutes of Health and his internship and residency at the University of Maryland. Dr. Heineman earned his M.D. and Ph.D. in Virology at the University of Chicago. CONTINUED Read this full press release and more news for ONCY at: https://www.financialnewsmedia.com/news-oncy/

Other recent developments in the biotech industry of note include:

Intra-Cellular Therapies, Inc. (NASDAQ: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, recently announced that the U.S. Food and Drug Administration (FDA) approved CAPLYTA for the treatment of depressive episodes associated with bipolar I or II disorder in adults, as monotherapy and as adjunctive therapy with lithium or valproate.

"CAPLYTA is the only medication approved by the FDA to treat depressive disorders associated with bipolar I or bipolar II as both monotherapy and adjunctive therapy with lithium or valproate. CAPLYTA has shown a consistent favorable profile on weight, cardiometabolic parameters and extrapyramidal symptoms (movement disturbances). We are positioned to launch immediately and are excited to offer CAPLYTA to the millions of patients living with bipolar depression," said Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies. "We thank the patients, healthcare professionals and our Intra-Cellular team for all their contributions that led to this approval."

Lineage Cell Therapeutics, Inc. (NYSE American: LCTX) recently announced that Lineage and its subsidiary, Cell Cure Neurosciences Ltd., have entered into an exclusive worldwide collaboration and license agreement with Rocheand Genetech, a member of the Roche Group (SIX: RO, ROG;OTCQX: RHHBY), for the development and commercialization of a retinal pigment epithelium (RPE) cell therapy for the treatment of ocular disorders, including advanced dry age-related macular degeneration (dry AMD) with geographic atrophy (GA).

Genentech will assume responsibility for further clinical development and commercialization of Lineage's OpRegen program, which currently is being evaluated in a Phase 1/2a open-label, dose escalation clinical safety and efficacy study in patients with advanced dry AMD with GA. Under the terms of the collaboration agreement, Lineage will complete activities related to the ongoing clinical study, for which enrollment is complete, and perform certain manufacturing activities. Genentech will pay Lineage a $50 million upfront payment and Lineage is eligible to receive up to $620 million in additional development, approval and sales milestone payments, in addition to tiered double- digit royalties.

Gilead Sciences, Inc. (NASDAQ: GILD) recently announced new data from the Phase 3 ASCENT study evaluating Trodelvy(sacituzumab govitecan-hziy) in relapsed or refractory metastatic triple-negative breast cancer (TNBC) who received two or more prior systemic therapies, at least one of them for metastatic disease. In this subgroup analysis of Black patients, Trodelvy improved progression-free survival (PFS), with a 56% reduction in the risk of disease worsening or death (HR: 0.44; 95% CI: 0.24-0.80; P=0.008) and a median PFS of 5.4 months (n=28) versus 2.2 months with chemotherapy (n=34).

Trodelvy also extended median overall survival to 13.8 months versus 8.5 months with physician's choice of chemotherapy (HR: 0.64; 95% CI: 0.34-1.19; P=0.159). The results were presented at the 2021 San Antonio Breast Cancer Symposium (SABCS) (Poster #P5-16-07).

Galera Therapeutics, Inc. (NASDAQ: GRTX) closed up over 28% on Monday on heavy trading volume of over 112 Million Shares and was up slightly in aftermarket trading. Galera Therapeutics recently announced that corrected results from its Phase 3 ROMAN trial of avasopasem for the treatment of RT-induced severe oral mucositis (SOM) in patients with locally advanced head and neck cancer (HNC) achieved statistical significance on the primary endpoint of reduction in the incidence of SOM. Avasopasem has been granted Breakthrough Therapy Designation (BTD) by the U.S. Food and Drug Administration (FDA) for the reduction of SOM induced by RT.

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The Global Breast Cancer Treatment Market Expected To Reach $34.06 Billion By End Of 2026 - PRNewswire

Immortality could also be cause for alarm. An uploaded brain, in a sense, will have beaten death, which raises basic psychological and philosophical questions. We can say that death is at the root of consciousness, normative law and human existence, Kauffman says. The loss of death is likely to radically alter who or what the being or creature is.

Theres no guarantee that this being would be the same one who first entered into the cryogenic process, either. As de Grey says, the question remains of whether scanning the brain and uploading it into a different substrate is revival at all, or if youd be creating a new individual with the same characteristics.

Regardless of who or what that ghost in the machine turned out to be, programming in a digital suicide option would likely be necessary just in case the experience proved too overwhelming or oppressive. I think theyd have to decide in advance what the escape hatch would be if it didnt work out, Callahan says. Is it that the company is authorised to kill you, or are you left to do it yourself?

Despite the unknowns, some would still be willing to give such an existence a shot. If the option was complete oblivion and nothingness or uploading my mind into a computer, Id like to at least try it, Kowalski says. It could be pretty cool.

--

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If cryonics suddenly worked, wed need to face the fallout ...

JUPITER, Fla. A fun-loving baby with plenty of energy. That's how Linda Trantham describes her daughter Shandra.

"She loved to go to the beach even when she was a toddler and jump in the sea and go to Dubois Park," Linda said.

But one day that changed.

"I first noticed when we went to England on vacation and there was an indoor pool with a wave machine. And the next wave coming along and she like had a funny walk," she added.

A doctor diagnosed Shandra with Friedreich's Ataxia, known as FA, when she was 12 years old. It's an inherited rare disease that affects the nerves and muscles.

WPTV

Shandra herself noticed the change.

"I really couldn't walk in a straight line anymore and I had scoliosis, a sideways curvature of the spine. I had chest pain with exercise," Shandra explained. " So it's estimated that there are about 15-thousand people with it in the entire world. It's like four to five thousand in the U.S."

Shandra graduated from Jupiter High School and went on to the University of Florida. She's now 24 years old and in the Ph.D. program. She's on a path to help people dealing with neurological diseases.

WPTV

She said she's doing gene therapy research in a lab at UF.

"Working on gene therapy in general, kind of contributes to the project for FA, so it's really nice being in the center of all that and getting to see firsthand all of the things that are happening in the development," she said. "My hope is that science will come far enough along that we can just treat people on an individual basis, it would be really cool.

"I'm amazed and in some ways not surprised she's so inquisitive and into science," said Linda.

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Jupiter High School graduate helping in gene therapy research at UF - WPTV.com

DUBLIN--(BUSINESS WIRE)--The "Global Cell and Gene Therapy Manufacturing Services Market 2021-2027" report has been added to ResearchAndMarkets.com's offering.

The global cell and gene therapy manufacturing services market is projected to grow at a potential CAGR during the forecast period (2021-2027).

The key aspect that drives the growth of the market includes the rising incidence of cancer coupled with the increasing R&D by pharmaceutical companies and partnerships & agreements between pharmaceutical companies and contract development and manufacturing organizations (CDMOs). Benefits of partnering with a cell or gene therapy CDMOs include scalability, speed to market, access to technical expertise without overhead costs, and cost-efficiency.

Covid-19 has affected economies and industries in several countries due to lockdown, travel bans, and business shutdowns. The global healthcare industry is one of the major industries facing serious disruptions such as breaks in supply chains and disruptions in manufacturing due to lockdown and office shutdowns. However, an increased number of investigational studies based on cell therapies for the treatment of COVID-19 patients have led to a positive impact on the market.

The global cell and gene therapy manufacturing services market is segmented based on therapy, scale, indication, and end-user. Based on therapy, the market is segmented into cell and gene therapy. Among, therapy, the cell therapy segment is expected to grow at a decent rate during the forecast period.

The attributable factor for the growth of the segment is increasing awareness about cell therapy coupled with the development of genomics methods for cell analysis. Based on the scale, the market is segmented into pre-commercial/ R&D scale manufacturing, commercial-scale manufacturing. Among scale, pre-commercial/ R&D scale manufacturing holds a lucrative share in the market during the forecast period owing to the expansion of cell and gene pipelines across the globe.

North America held a major market position in the global cell and gene therapy manufacturing services market in 2020. The presence of key companies involved in the development of cell and gene therapy and growing investments in the field are some of the key factors driving the growth of the regional market. Europe is the second-largest market in 2020 owing to the presence of a strong workforce coupled with strong facilities.

Further, Thermo Fisher Inc., Merck KGaA, and F. Hoffmann-La Roche Ltd., among others are some of the prominent players operating in the market.

Strategic initiatives may support an increase in the market share of the players during the forecast period. The manufacturers are extensively investing in new technologies. Moreover, new launches & developments, partnerships and collaborations, and mergers and acquisitions are some of the growth strategies adopted by the players to sustain in the highly competitive market.

Key Topics Covered:

1. Report Summary

1.1. Research Methods and Tools

1.2. Market Breakdown

2. Market Overview and Insights

2.1. Scope of the Report

2.2. Analyst Insight & Current Market Trends

2.3. Porter's Analysis

3. Competitive Landscape

3.1. Key Company Analysis

3.1.1. Thermo Fisher Scientific Inc.

3.1.1.1. Overview

3.1.1.2. Financial Analysis

3.1.1.3. SWOT Analysis

3.1.2. Merck KGaA

3.1.3. Lonza Group Ltd.

3.2. Key Strategy Analysis

3.3. Impact of COVID-19 on Key Players

4. Market Determinants

4.1. Motivators

4.2. Restraints

4.3. Opportunities

5. Market Segmentation

5.1. Global Cell and Gene Therapy Manufacturing Services Market by Therapy

5.1.1. Cell Therapy

5.1.2. Gene Therapy

5.2. Global Cell and Gene Therapy Manufacturing Services Market by Scale

5.2.1. Pre-commercial/ R&D Scale Manufacturing

5.2.2. Commercial Scale Manufacturing

5.3. Global Cell and Gene Therapy Manufacturing Services Market by Indication

5.3.1. Cancer

5.3.2. CVD

5.3.3. Orthopedic

5.3.4. Infectious Diseases

5.3.5. Others

5.4. Global Cell and Gene Therapy Manufacturing Services Market by End User

5.4.1. Pharmaceutical and Biotechnology Companies

5.4.2. Academic and Research Institutes

6. Regional Analysis

6.1. North America

6.1.1. US

6.1.2. Canada

6.2. Europe

6.2.1. UK

6.2.2. Germany

6.2.3. Italy

6.2.4. Spain

6.2.5. France

6.2.6. Rest of Europe

6.3. Asia-Pacific

6.3.1. China

6.3.2. India

6.3.3. Japan

6.3.4. South Korea

6.3.5. Rest of Asia-Pacific

6.4. Rest of the World

7. Company Profiles

7.1. bluebird bio, Inc.

7.2. Boehringer Ingelheim International GmbH

7.3. Catalent, Inc.

7.4. Cell and Gene Therapy Catapult

7.5. Innovative Cellular Therapeutics Co., Ltd.

7.6. Charles River Laboratories International, Inc.

7.7. F. Hoffmann-La Roche Ltd.

7.8. FUJIFILM Holdings Corp.

7.9. Miltenyi Biotec B.V. & Co. KG

7.10. Nikon CeLL innovation Co., Ltd.

7.11. Novartis AG

7.12. Oxford Biomedica plc

7.13. Samsung Biologics

7.14. Takara Bio Inc.

7.15. WuXi AppTec Co., Ltd.

For more information about this report visit https://www.researchandmarkets.com/r/66e8ge.

Read more here:
Global Cell and Gene Therapy Manufacturing Services Market Research Report 2021-2027 Featuring Prominent Players - Thermo Fisher, Merck KGaA, and F....

The This research service discusses the cell and gene therapy (CGT) market and highlights some key roadblocks in viral vector manufacturing. While many CGT candidates exist in the pipeline, there is a huge capacity deficit that the industry is collaboratively trying to address.

New York, Dec. 21, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Technology Developments in Viral Vector Manufacturing for Cell and Gene Therapies" - https://www.reportlinker.com/p06192548/?utm_source=GNW

Scalability, costs, reproducibility, and overall process efficiency are some of the main pain points at each step of the viral vector manufacturing process.Many industry stakeholders are capitalizing on innovative, sustainable business models and capacity expansion investments to address shortage issues.

Biotechnology companies, such as Merck, Novartis, and Pfizer, and key contract development and manufacturing organizations, such as Thermo Fisher Scientific, Catalent, and FUJIFILM Diosynth Technologies, are investing in new capacities, expanding capacities, and developing innovative technologies to stay ahead in the CGT market. The research covers emerging technologies and trends, challenges, and opportunities across the manufacturing workflow, from upstream (viral vector production) to downstream (viral vector purification). Key developments in upstream processes for viral vector production include advanced transfection agents, novel plasmids, suspension-adapted cell culture, and stable producer cell lines. The research also discusses the general industry shift toward adopting automation, digitization, and advanced analytical processes, including on-line and in-line analytics and robust real-time analytics, to highlight the importance of analytical tools throughout the value chain. Smart technologies, such as automation and digital tools, and the adoption of artificial intelligence and big data support progress in process control and optimization while improving overall efficiencies and safety. The CGT industry works through orchestrated collaborations to develop reference standards and build process analytical technologies (PAT) to optimize manufacturing further. The research presents a birds eye view of key stakeholders and their innovative platforms and a snapshot of the collaborative ecosystem to understand the CGT industrys dynamic and fast-paced nature.Read the full report: https://www.reportlinker.com/p06192548/?utm_source=GNW

About ReportlinkerReportLinker is an award-winning market research solution. Reportlinker finds and organizes the latest industry data so you get all the market research you need - instantly, in one place.

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Technology Developments in Viral Vector Manufacturing for Cell and Gene Therapies - Yahoo Finance

RESEARCH TRIANGLE PARK The nearly 30 million Americans who suffer from rare diseases have received some good news.

The National Institutes of Health, the U.S. Food and Drug Administration, and a cadre of pharmaceutical companies and non-profit organizations have teamed up to speed the development of new gene therapy treatments. Its good news for North Carolina as well, which is home to close to 50 gene therapy and rare disease-focused businesses that provide jobs for several thousand Tar Heel residents.

Whats called theBespoke Gene Therapy Consortium or BGTC was launched a little less than two months ago. Its part of the NIHs Accelerating Medicines Partnership (AMP), a public/private collaboration to speed drug development across different diseases. Ten global pharmaceutical companies and half as many non-profit patient organizations, as well as 11 NIH institutes, centers and initiatives have signed on.

The project is managed by the Foundation for the National Institutes of Health, whose mission is to promote biomedical discoveries that improve peoples lives.

Currently there are about 7,000 rare diseases in this country, 5,000 of which are due to genetic factors, according to BGTC. A single damaged gene causes nearly 80% of rare genetic illnesses, leaving millions of patients in the U.S. to suffer without much hope of improvement. Currently, only two of these diseases have FDA-approved gene therapy treatments.

BGTC said most rare inherited diseases stem from a specific gene mutation that is already known, which makes gene therapy a promising solution.

A customized or bespoke therapy could correct or replace defective genes with functional ones, according to NIH Director Francis S. Collins, M.D., Ph.D. There are now significant opportunities to improve the complex development process for gene therapies that would accelerate scientific progress and, most importantly, provide benefit to patients by increasing the number of effective gene therapies, he said.

But development is costly, complex and time consuming. And rare disorders by definition affect only a small number of patients. So most pharma companies arent willing to invest years of research and millions of dollars to bring a single-disease gene therapy to market, said Joni L. Rutter, Ph.D., acting director of NIHs National Center for Advancing Translational Sciences.

BGTC hopes to change that paradigm. The consortium wants to start with a common gene delivery vector known as the adeno-associated virus (AAV). Its considered one of the most effective gene delivery platforms for many human diseases.

The partnership said it will support a series of research projects and clinical trials to create new tools for AAV clinical development and regulatory evaluation. The BGTC aims to make it easier, faster and less expensive to pursue bespoke therapies in order to incentivize more companies to invest in this space and bring treatments to patients, Rutter pointed out.

The goal, over time, is to find ways to cut up-front gene therapy development costs, standardize the technology, and make it available for a broader range of diseases. The BCTC program will create a universal set of analytical tests to speed up gene and vector manufacturing. And the consortium will look for ways to streamline the regulatory framework.

By leveraging on experience with a platform technology and by standardizing processes, gene therapy product development can be accelerated to allow more timely access to promising new therapies for patients who need them the most, said Peter Marks, M.D., PhD., director of the FDAs Center for Biologics Evaluation and Research.

The consortium members will contribute about $76 million over the next five years to back its projects. BGTC said it will fund research for between four and six clinical trials each focused on a different rare, single-gene disease for which no gene therapies or commercial programs currently exist. Three disease areas are targeted: Lupus, Alzheimers and Type 2 diabetes.

People with terrible genetic disorders are in dire need of solutions, Collins said. The BGTC promises to transform the field of gene therapy so we can treat, or even cure rare diseases for which no current therapy exists.

North Carolina, with its substantial biotechnology and academic resources, has become a prominent incubator for leading-edge biotechnology startups. Gene therapy is a fast-developing area within our states biotech infrastructure, said Sara Imhof, Ph.D., senior director of precision health for the North Carolina Biotechnology Center. Our related ecosystem is well positioned to contribute to and benefit from the Bespoke Gene Therapy Consortium. Its an exciting time, both for the patients who desperately need the benefits gene therapy can provide and for our innovators and industry leaders who are dedicated to this important area of science.

Original post:
Rare disease consortium is good news for NC gene therapy companies - WRAL TechWire

Wilmot Cancer Institute researchers are a step closer to understanding the complex gene interactions that cause a cell to become malignant. In a new Cell Reports study published today, the group used network modeling to hone in on a set of such interactions that are critical to malignancy, and likely to be fertile ground for broad cancer therapies.

Discrete genetic mutations that can be targeted by drugs have only been identified for a small fraction of cancer types. But those mutations rely on a downstream network of non-mutated genes in order to cause cancer. Those downstream genes and their intricate interactions may be common across many cancers and could offer a giant leap forward in cancer therapy.

One of the lead authors of the study, Hartmut Hucky Land, Ph.D., who is the deputy director of the Wilmot Cancer Institute and the Robert and Dorothy Markin Professor of Biomedical Genetics at the University of Rochester Medical Center and has worked to identify common core features of cancers for over 10 years. His goal is to find cancers shared vulnerabilities and exploit them.

Targeting non-mutated proteins that are essential to making cells cancerous is a broader approach that could be used in multiple cancers, said Land, but its hard to find these non-mutated, essential genes.

That is why Land turned to Matthew McCall, Ph.D., MHS, a Wilmot Cancer Institute investigator who is an associate professor of Biostatistics and Computational Biology at URMC, for collaboration. McCall, who is the other lead author of the study, developed a new network modeling method, called TopNet, that the group paired with genetic experiments in cells and mice to pinpoint functionally relevant gene networks.

Lands group previously identified a very diverse set of non-mutated genes that are crucial to cancer. In this study, the group wanted to see how those genes interact starting with a subset of 20 genes. Increasing or decreasing the expression of one gene in cultured cells would have numerous effects on the expression levels of the other genes in the set.

There were so many interactions, you could waste a lot of time, energy and money testing interactions that might not be useful, McCall said. To hone in on the interactions that are more likely to be useful, we used network modeling, and compared our model networks back to the lab findings, McCall said.For context, the number of possible gene network models considered by TopNet was many times greater than the estimated number of atoms in the universe. After weeding out models that didnt closely fit the observed data and further focusing in on gene interactions that appeared in at least 80 percent of the models, the team was left with a manageable set of 24 high-confidence gene interactions. Subsequent experiments demonstrated that these interactions often play an important role in malignancy.

Dr. McCalls elegant and mind-boggling methodology is essentially helping us disentangle a hairball of genetic networks, said Land. These networks are usually very messy and its nearly impossible to extract useful information from them. But Dr. McCall has found a way to cut through this Gordian knot.

The group has already tested a sampling of the genetic interactions revealed by TopNet, and confirmed via experiments in cells and mice that the interactions are functionally linked. Next, the group intends to test the limits of TopNet, with the intent to use this method to find potential cancer therapies that are broadly effective.

This work was completed as part of a $6.3M National Cancer Institute Outstanding Investigator Award granted to Land in 2015 and a K99/R00 grant from the National Human Genome Research Institute to McCall. Helene McMurray, Ph.D., assistant professor of Biomedical Genetics and Pathology and Laboratory Medicine at URMC was the first author of the study.

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Honing in on Shared Network of Cancer Genes - URMC

DUBLIN, Dec. 21, 2021 /PRNewswire/ -- The "Global Advanced Therapy Medicinal Products CDMO Market Size, Share & Trends Analysis Report by Product (Gene Therapy, Cell Therapy, Tissue Engineered), Phase, Indication, Region, and Segment Forecasts, 2021-2028" report has been added to ResearchAndMarkets.com's offering.

The global advanced therapy medicinal products CDMO market size is expected to reach USD 12.9 billion by 2028, according to the report. It is expected to expand at a CAGR of 12.0% from 2021 to 2028.

The advanced therapy medicinal products are a group of biological products for human use that involve gene therapy products, cell therapy products, and tissue-engineered products. The growth of the market is credited to the increasing clinical trials of ATMP and the rising awareness and belief among researchers regarding the benefits of advanced therapy. The COVID-19 pandemic has significantly disrupted the cell and gene therapy industry due to the complexity in the manufacturing process.

The COVID-19 pandemic has adversely affected the overall medical industry, but the pandemic boosted the operations and development of advanced therapy due to the high requirement of the products such as mesenchymal stromal cells (MSCs) for the treatment of the virus. The regulations put forward by the FDA and government authorities have created a safe environment for the healthcare workers and allowed emergency approval for the supply of essential raw materials and faster development of the vaccines and other therapy products.

Technological advancement has been a major part of tissue engineering in the last few years. This method helps to replace or restore the injured tissues and organ function. Similarly, gene and cell therapy is attracting many patients for the treatment of rare diseases, the cases of which are augmenting globally.

Advanced Therapy Medicinal Product CDMO Market Report Highlights

Key Topics Covered:

Chapter 1 Methodology and Scope

Chapter 2 Executive Summary

Chapter 3 Advanced Therapy Medicinal Products CDMO Market: Variables, Trends, & Scope3.1 Market Segmentation and Scope3.2 Market Dynamics3.2.1 Market Driver Analysis3.2.1.1 Rising number of clinical trials for ATMP3.2.1.2 Increasing outsourcing activities3.2.1.3 Growing awareness of the treatment3.2.2 Market Restraint Analysis3.2.2.1 Stringent regulatory approvals3.2.2.2 High cost of outsourcing3.3 Penetration & Growth Prospect Mapping3.4 Advanced Therapy Medicinal Products CDMO: Market Analysis Tools3.4.1 Industry Analysis - Porter's3.4.1.1 Porter's Five Forces Analysis3.4.2 PESTEL Analysis

Chapter 4 Advanced Therapy Medicinal Products CDMO Market: Product Estimates4.1 Market Share Analysis, 2020 & 20284.2 Gene Therapy4.2.1 Gene therapy market, 2016 - 2028 (USD Billion)4.3 Cell Therapy4.3.1 Cell therapy market, 2016 - 2028 (USD Billion)4.4 Tissue Engineered4.4.1 Tissue engineered market, 2016 - 2028 (USD Billion)4.5 Others4.5.1 Market, 2016 - 2028 (USD Billion)

Chapter 5 Advanced Therapy Medicinal Products CDMO Market: Phase Estimates5.1 Market Share Analysis, 2020 & 20285.2 Phase I5.2.1 Phase I market, 2016 - 2028 (USD Billion)5.3 Phase II5.3.1 Phase II market, 2016 - 2028 (USD Billion)5.4 Phase III5.4.1 Phase III market, 2016 - 2028 (USD Billion)5.5 Phase IV5.5.1 Phase IV market, 2016 - 2028 (USD Billion)

Chapter 6 Advanced Therapy Medicinal Products CDMO Market: Indication Estimates6.1 Market Share Analysis, 2020 & 20286.2 Oncology6.2.1 Oncology market, 2016 - 2028 (USD Billion)6.3 Cardiology6.3.1 Cardiology market, 2016 - 2028 (USD Billion)6.4 Central Nervous System6.4.1 Central nervous system market, 2016 - 2028 (USD Billion)6.5 Musculoskeletal6.5.1 Musculoskeletal market, 2016 - 2028 (USD Billion)6.6 Infectious Disease6.6.1 Infectious disease market, 2016 - 2028 (USD Billion)6.7 Dermatology6.7.1 Dermatology market, 2016 - 2028 (USD Billion)6.8 Endocrine, Metabolic, Genetic6.8.1 Endocrine, metabolic, genetic market, 2016 - 2028 (USD Billion)6.9 Immunology & inflammation6.9.1 Immunology & inflammation market, 2016 - 2028 (USD Billion)6.10 Ophthalmology6.10.1 Ophthalmology market, 2016 - 2028 (USD Billion)6.11 Haematology6.11.1 Haematology market, 2016 - 2028 (USD Billion)6.12 Gastroenterology6.12.1 Gastroenterology market, 2016 - 2028 (USD Billion)6.13 Others6.13.1 Others market, 2016 - 2028 (USD Billion)

Chapter 7 Advanced Therapy Medicinal Products CDMO Market: Regional Analysis

Chapter 8 Company Profiles8.1 Strategic Framework8.2 Company Profiles8.2.1 Celonic8.2.1.1 Company Overview8.2.1.2 Financial performance8.2.1.3 Product Benchmarking8.2.1.5 Strategic Initiatives8.2.2 Bio Elpida8.2.2.1 Company Overview8.2.2.2 Financial performance8.2.2.3 Product Benchmarking8.2.2.6 Strategic Initiatives8.2.3 CGT Catapult8.2.3.1 Company Overview8.2.3.2 Financial performance8.2.3.3 Product Benchmarking8.2.3.6 Strategic Initiatives8.2.4 Rentschler Biopharma SE8.2.4.1 Company Overview8.2.4.2 Financial performance8.2.4.3 Product Benchmarking8.2.4.6 Strategic Initiatives8.2.5 AGC Biologics8.2.5.1 Company Overview8.2.5.2 Financial performance8.2.5.3 Product Benchmarking8.2.5.6 Strategic Initiatives8.2.6 Catalent8.2.6.1 Company Overview8.2.6.2 Financial performance8.2.6.3 Product Benchmarking8.2.6.6 Strategic Initiatives8.2.7 Lonza8.2.7.1 Company Overview8.2.7.2 Financial Performance8.2.7.3 Product Benchmarking8.2.7.5 Strategic Initiatives8.2.8 WuXi Advanced Therapies8.2.8.1 Company Overview8.2.8.2 Financial performance8.2.8.3 Product Benchmarking8.2.8.5 Strategic Initiatives8.2.9 BlueReg8.2.9.1 Company Overview8.2.9.2 Financial performance8.2.9.3 Product Benchmarking8.2.9.6 Strategic Initiatives8.2.10 Minaris Regenerative Medicine8.2.10.1 Company Overview8.2.10.2 Financial performance8.2.10.3 Product Benchmarking8.2.10.5 Strategic Initiatives8.2.11 Patheon8.2.11.1 Company Overview8.2.11.2 Financial performance8.2.11.3 Product Benchmarking8.2.11.5 Strategic Initiatives

For more information about this report visit https://www.researchandmarkets.com/r/rjc62f

Media Contact:

Research and Markets Laura Wood, Senior Manager [emailprotected]

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Outlook on the Advanced Therapy Medicinal Products CDMO Global Market to 2028 - Rising Number of Clinical Trials for ATMP is Driving Growth -...

SAN RAFAEL, Calif. and SHANGHAI, Dec. 16, 2021 /PRNewswire/ -- BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) and Skyline Therapeutics (formerly Geneception), a gene and cell therapy company focused on developing novel treatments for unmet medical needs, today announced a multi-year global strategic collaboration for the discovery, development and commercialization of Adeno-Associated Virus (AAV) gene therapies to treat genetic cardiovascular diseases.

The partnership will leverage Skyline Therapeutics' integrated AAV gene therapy platform based on its proprietary vector engineering and design technology and manufacturing capability to develop innovative gene therapies with a focus on genetic dilated cardiomyopathies (DCM), a group of progressively advancing, devastating diseases with no targeted treatment options.

Under the agreement, BioMarin and Skyline Therapeutics will collaborate on discovery and research through to an Investigational New Drug Application (IND). BioMarin brings experience in gene therapy development, cardiovascular biology and insights into genetic basis of diseases, and Skyline contributes its expertise in developing gene therapy products including vector engineering and design technology and manufacturing capabilities to this collaboration. Each company will advance the programs through clinical development in their pre-defined territories.

In support of its R&D efforts for the collaborative projects, Skyline Therapeutics will receive an undisclosed payment associated with signing, comprising an upfront payment and an equity investment from BioMarin, and is eligible to receive pre-specified payments for R&D, regulatory and commercial milestones.

BioMarin will have the rights to commercialize therapeutic products resulting from the collaboration in its territories, including the United States, Europe, and Latin America, and Skyline Therapeutics will be responsible for commercialization in the Asia-Pacific region. In addition, Skyline Therapeutics will be eligible to receive royalty payments on future sales from BioMarin in its territories.

"We are thrilled to announce what we anticipate will be a fruitful collaboration at the interface between Skyline's innovative approach to AAV vector engineering and design and our team's proven expertise in creating and developing gene therapies," said Kevin Eggan, Group Vice President, Head of Research and Early Development, from BioMarin.

"We are excited to partner with Skyline Therapeutics to tackle these genetic forms of dilated cardiomyopathy. This collaboration strengthens our leadership in cardiac gene therapy and extends our R&D collaboration to Asia, where a large number of patients suffer from these devastating diseases," said Brinda Balakrishnan, Group Vice President, Corporate and Business Development at BioMarin. "We look forward to fostering this collaboration and bringing transformative medicines to patients worldwide."

"Dilated cardiomyopathy is a serious cardiac disorder in which structural or functional abnormalities of the heart muscle can lead to complications such as arrhythmia and heart failure, resulting in substantial morbidity and mortality. Mutations in many genes are associated with the development of DCM, among other etiologies for the disease," said Jay Hou, Chief Scientific Officer at Skyline Therapeutics. "Together with BioMarin's team we have identified a number of critical genes associated with DCM. We are delighted to work closely with BioMarin and apply our AAV vector technology to interrogate these new targets and develop novel treatments for DCM patients."

"The collaboration with BioMarin leverages both companies' capabilities in the development of gene therapies. With the BioMarin team, we share the goal of working in concert to develop therapies for genetic cardiovascular disease that address high unmet medical needs," said Amber Cai, CEO of Skyline Therapeutics. "Together, we will utilize gene therapy to tackle cardiovascular diseases with a disease modifying trailblazing approach that could change the treatment paradigm in these conditions."

About Dilated Cardiomyopathy (DCM)

DCM is a common cause of heart failure and end-stage DCM, which often leads to heart transplantation. Despite improvements in pharmacotherapy and care, the five-year survival rate of DCM is only about 50%. Hundreds of thousands of patients suffer from the genetic forms of DCM in U.S., EU, China, and Japan. More than 50 genes associated with DCM have been identified, accounting for 40-50% of familial DCM cases. Many of these genes encode proteins with important known functions in cardiomyocytes related to cytoskeletal, sarcomere and nuclear envelope biology. Our aim is to correct the pathways altered by these genetic contributors to DCM through AAV based gene therapy, in each case addressing the root cause of the disease.

About BioMarin

BioMarin is a global biotechnology company that develops and commercializes innovative therapies for patients with serious and life-threatening rare genetic diseases. The company's portfolio consists of seven commercialized products and multiple clinical and pre-clinical product candidates. For additional information, please visit http://www.biomarin.com.Information on such website is not incorporated by reference into this press release.

About Skyline Therapeutics

Skyline Therapeutics is a fully integrated gene and cell therapy company dedicated to the discovery, development and delivery of innovative therapies. Established in 2019, Skyline Therapeutics has built a proprietary AAV-based gene therapy platform that integrates novel capsid engineering and vector design, analytical and process development, and state-of-the-art GMP manufacturing capabilities that support large scale clinical-grade vector production. The Skyline team of world-class experts and leaders in science, technology and business brings industry-leading know-how and is advancing a pipeline of diversified programs that address multiple diseases including ocular, neurological, metabolic and blood disorders. Skyline Therapeutics is also broadening its therapeutic expertise to cover more disease areas with high unmet need such as cardiovascular disorders through strategic partnerships. Headquartered in China, Skyline Therapeutics currently has research, development and manufacturing capabilities in Shanghai and Hangzhou. http://www.skytx.com

Forward-Looking Statements

This press release contains forward-looking statements about the business prospects of BioMarin Pharmaceutical Inc., including, without limitation, statements about: expectations related to themulti-year global strategic collaboration with Skyline for the discovery, development and commercialization of AAV gene therapies for dilated cardiomyopathy and pre-specified payments to Skyline for R&D, regulatory and commercial milestones, and the rights to commercialize therapeutic products resulting from the collaboration in its territories, including the United States, Europe, and Latin America. These forward-looking statements are predictions and involve risks and uncertainties such that actual results may differ materially from these statements. Additional important factors to be considered in connection with forward-looking statements are detailed from time to time under the caption "Risk Factors" and elsewhere in BioMarin's Securities and Exchange Commission (SEC) filings, including BioMarin's Quarterly Report on Form 10-Q for the quarter ended September 30, 2021, and future filings and reports by BioMarin. BioMarin undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in its expectations.

BioMarin is a registered trademark of BioMarin Pharmaceutical Inc.

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Traci McCarty

Debra Charlesworth

BioMarin Pharmaceutical Inc.

BioMarin Pharmaceutical Inc.

(415) 455-7558

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Felisa Feng

Skyline Therapeutics

[emailprotected]

SOURCE BioMarin Pharmaceutical Inc.

http://www.biomarin.com

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BioMarin and Skyline Therapeutics Announce Strategic Collaboration to Develop Novel Gene Therapies for Cardiovascular Diseases - PRNewswire

Paris (AFP) Camille Abbey was two months away from giving birth to twins when she sensed something wasn't right.

"I felt strange all week. I had swelled enormously. I had a lot of trouble moving," said the 33-year-old French journalist.

Abbey's midwife found her blood pressure spiking and sent her to hospital where doctors confirmed she had preeclampsia, a potentially life-threatening complication.

The risks of preeclampsia have been known about for centuries, but there is still no cure or prevention and a lack of awareness remains a problem.

"Although one in every 12 pregnancies are affected by preeclampsia, many pregnant women have never heard of the disease," Patricia Maguire, director of the Institute for Discovery at University College Dublin, told AFP.

Doctors made a breakthrough 10 years ago that allowed them to develop the first diagnostic test, and Maguire is working on a second one, with trials under way in Ireland.

Early diagnosis is lifesaving because the condition sets in without symptoms.

Once they appear, the only way to stop complications like liver and kidney failure, or death, is to deliver the baby -- even if it is premature.

A 2021 study showed that hypertensive disorders of pregnancy have increased in the last nearly 30 years, though better screening and population growth may account for the rise.

The study in the BMC Pregnancy and Childbirth journal also said that most deaths occur in low-income settings where doctors say the toll is likely higher than reported.

An estimated 76,000 women and 500,000 babies die every year due to hypertensive pregnancy conditions like preeclampsia and eclampsia, a rare complication, according to a 2015 study in the Journal of Family Medicine and Primary Care.

Sarah Kilpatrick, an obstetrician-gynecologist specialising in preeclampsia at Cedars-Sinai hospital in Los Angeles, says educating women is crucial.

"The hard part for women is many times they feel fine," Kilpatrick told AFP, "so you can't even believe you have something like preeclampsia."

- Like 'lightning' -

Emmanuelle Honore survived eclampsia -- named after the Greek word for lightning -- which can develop if preeclampsia goes undetected and lead to potentially fatal seizures.

Her decision to walk herself to hospital after monitoring her own blood pressure saved her life.

"They didn't wait for the blood test results to come back to decide to do an emergency cesarean," said the Paris-based archaeologist, 37.

Immediately after giving birth, she began to convulse.

"It was a question of minutes. The baby and I were incredibly lucky," she told AFP. "During the seizure I felt myself leaving my own body."

Today, her son is healthy and turns three in February.

But the eclampsia has left Honore psychologically scarred and unable to give birth again.

"For me, there is a before and an after -- it's two different lives."

The world's first diagnostic test, developed by kidney specialists Ananth Karumanchi and Ravi Thadhani by linking the levels of two proteins to the disorder's onset, has been available in Europe for a decade.

It is in clinical trials in the United States, where preeclampsia disproportionately affects Black women due to a higher prevalence of risk factors like diabetes, obesity and stress, the American Heart Association says.

"(The trials) include the diversity of women in the United States and by the end of this year we will be able to determine whether the diagnostics have just as much benefit and specificity as in Europe," Thadhani told AFP.

The test developed by Maguire not only detects preeclampsia with a blood sample, it uses artificial intelligence to provide a timeframe for safe delivery, allowing as much time as possible for the foetus to develop.

An article published in May said the test had the potential to be streamlined so that kits could be sent to hospitals with easy-to-collect samples analysed using online information.

"The big dream is to reach every person who needs this test across the world," Maguire said.

Even after labour, preeclampsia sufferers are not necessarily out of danger.

Kilpatrick said about one in 10 women whose preeclampsia was their first time with high blood pressure need to stay on anti-hypertensive medication after giving birth.

When her twins were born in October 2020, Abbey thought her ordeal was over but her blood pressure failed to go back to normal.

She was later diagnosed with the dangerous preeclampsia-related condition HELLP (Hemolysis, Elevated Liver enzymes and Low Platelets) syndrome, which affects some 15 percent of women with severe preeclampsia.

While her premature babies received state-of-the-art care, Abbey said she stayed in a post-op recovery room for days where doctors could do little more than monitor her vital signs and try to control her blood pressure.

Vassilis Tsatsaris, an obstetrician-gynecologist at Paris' Port Royal hospital, said research on finding treatments for preeclampsia and other complications has been impeded by the risks for the unborn baby.

"We live in an era where therapeutic innovations for cancer, vaccines or gene therapy are advancing very, very quickly," he told AFP.

"Unfortunately when it comes to pregnancy, things move much more slowly."

2021 AFP

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Preeclampsia: an ongoing battle to save lives - FRANCE 24

It has been more than a year since Markus Mapara, MD, a professor of medicine and director of blood and marrow transplantation at Columbia University Irving Medical Center in New York, first used an experimental CRISPR gene-editing treatment in a patient with sickle cell disease, an inherited blood disorder that can cause severe pain, organ damage, and premature death.

Although the clinical trial is still in early stages and has only been tested in a few patients, so far, the results are promising.

[The patient is] doing phenomenally well, says Mapara, who is a hematologist, oncologist, and blood transplant physician. He has not had a single crisis.

Sickle cell disease, which currently affects about 100,000 people living in the United States and millions worldwide, is the result of a genetic mutation that produces an abnormal type of hemoglobin, the protein that red blood cells use to deliver oxygen throughout the body. The abnormal cells take on a sickle, or curved, shape, which can clot within narrow blood vessels.

This is a huge health problem for these patients, Mapara says. It has a huge impact on their quality of life and well-being.

At the moment, a bone marrow transplant from a healthy donor is the only curative option, but this approach can have severe complications.

Youre running into risks of introducing foreign cells into a recipient, Mapara says. [The body] may reject them, or the donor cells might attack the recipient.

But with the development of CRISPR (which stands for clustered regularly interspaced short palindromic repeats), new opportunities for treatment using the patients own cells have opened up.

[CRISPR is] a tool that scientists and clinicians around the world are using to understand our genetics, the genetics of all living things, and most importantly to intervene in genetic disease.

Jennifer Doudna, PhD, University of California, Berkeley

CRISPR, as it is known today, was developed by two scientists, Jennifer Doudna, PhD, who runs a lab at the University of California, Berkeley, and Emmanuelle Charpentier, PhD, scientific and managing director of the Max Planck Unit for the Science of Pathogens in Berlin, Germany, who were awarded the 2020 Nobel Prize in chemistry for their work on this technology.

The scientists worked together to uncover precisely how bacteria have evolved to fight off viruses and to apply that same process to engineer human cells. In particular, Doudna and Charpentier found that an enzyme known as Cas9 can be guided by a programmable RNA to locate specific genetic sequences in any organism. The enzyme then works like a pair of scissors, cutting the DNAs double helix and allowing for sequences to be deleted, added, or replaced.

Its a tool that scientists and clinicians around the world are using to understand our genetics, the genetics of all living things, and most importantly to intervene in genetic disease, Doudna said during a speech at Learn Serve Lead 2021: The Virtual Experience, the AAMCs annual meeting, in November.

The technology has been celebrated throughout the scientific community as a significant advancement that is changing the way research is done across fields. CRISPR has been used to experiment with gene-edited mosquitos to reduce the spread of malaria, for engineering agriculture to withstand climate change, and in human clinical trials to treat a range of diseases, from cancer to transthyretin amyloidosis, a rare protein disorder that devastates nerves and organs.

Still, the technology comes with significant ethical implications, including ensuring it does not have unintended negative consequences, that it is used equitably, and that a consensus is reached on where to draw the line in the technologys use.

AAMCNews spoke with researchers, physicians, ethicists, and educators on the cutting edge of CRISPR technology about its enormous potential for both good and harm to the future of humanity.

The clinical trial that Mapara enrolled his patient in last year was one of the first to attempt to use CRISPR to treat a genetic disorder in humans.

Though researchers and physicians are pursuing several gene therapy treatments for sickle cell disease and beta thalassemia, a similar blood disorder, this approach targets the gene that stops the production of fetal hemoglobin. Experts have found that people produce fetal hemoglobin up until about three months after birth, at which time their cells begin to produce adult hemoglobin, Mapara explains. It is the adult hemoglobin in people with sickle cell disease and beta thalassemia that takes the irregular shape and causes health problems.

For a physician-scientist it is a dream come true when you can be part of and witness the development of a revolutionary new treatment modality.

Markus Mapara, MD, Columbia University Irving Medical Center

You get rid of the repressor and have enhanced production again of fetal hemoglobin, he says, explaining that the patients who are now producing higher numbers of fetal hemoglobin rather than the mutated adult hemoglobin are experiencing fewer crises.

National Public Radio has been documenting the journey of the first person to join the clinical trial, Victoria Gray, since her first treatment in 2019.

This is really a life changer for me, Gray told NPR last December.

Mapara says that the initial results of the clinical trial were published in December 2020 and that follow-up results continue to be very promising.

This is really a potential game-changer for those patients, he says. For a physician-scientist it is a dream come true when you can be part of and witness the development of a revolutionary new treatment modality.

CRISPR is also being used in a clinical trial aimed at treating Lebers Congenital Amaurosis, a genetically determined progressive form of congenital visual loss and blindness.

While there are more than 300 genes that are linked to vision defects, this trial focuses on one gene mutation that causes a particularly severe form of degeneration.

Its what we call a problem with splicing of mRNA, says Mark Pennesi, MD, PhD, who leads Oregon Health & Science Universitys involvement in the trial and is the Kenneth C. Swan professor of ophthalmology in the OHSU School of Medicine and chief of the OHSU Casey Eye Institutes Paul H. Casey Ophthalmic Genetics Division. The mutation creates a little stop sign in the sequence so the whole protein doesnt get produced [for the treatment, guide] RNAs will target sequences on either side of the stop sign, the Cas [CRISPR-associated] protein will cut them out, and the DNA will repair itself. Hopefully, the cells will start to make the protein.

Its groundbreaking. The eye is one of the most accessible parts of the brain and vision is such an important thing for people. This really does open the door for many other therapies.

Mark Pennesi, MD, PhD, Oregon Health & Science University School of Medicine

Last year, clinicians at OHSUs Casey Eye Institute performed the CRISPR procedure on a patient, marking the first time CRISPR has been used in a human in vivo, or within the body, as opposed to removing the genetic material for editing.

Its groundbreaking, Pennesi says. The eye is one of the most accessible parts of the brain and vision is such an important thing for people. This really does open the door for many other therapies We are hoping we could use CRISPR in neurological or muscular diseases.

Initial results from the clinical trial involving six patients show that the procedure is safe and that it could improve vision.

One patient treated at our site has gone public, he says. Shes experienced an improvement in visual acuity, she can see objects, and she feels she is actually seeing color.

Pennesi says they will continue to increase the doses of the treatment in order to monitor if results improve and adds that they hope to eventually make this treatment available to children, who are more likely to experience reduced effects of degeneration.

Its really a wonderful time to be in this field because its changing from a field where we had no options to now one where we do, he says.

CRISPR is also causing a buzz in the field of cancer treatment.

At the University of Pennsylvania in Philadelphia, physicians and researchers have used CRISPR to genetically engineer immune cells to better fight tumors.

Edward Stadtmauer, MD, section chief of hematological malignancies at Perelman School of Medicine at the University of Pennsylvania and principal investigator of the clinical trial, started working on this project around 2016, when CRISPR technology was very new.

Stadtmauer had long been working with CAR T-cell therapy, which edits the immune T-cells by adding a warhead to the outside that targets cancer cells. While this method has been extremely effective with many blood cancers, Stadtmauer hypothesized that CRISPR could take the treatment to the next level.

Using the technology, Stadtmauer and his team were able to take the patients T-cells, remove three genes and add one gene that, together, lengthened the life of the immune cell and made them more potent at targeting cancer. It was the first investigational use of multiple edits with CRISPR to alter the human genome.

Remarkably, and probably to me the most important finding of the study was that these triple gene-edited cells with the additional insertion of another gene actually had tremendous proliferation and expansion ability and continue to survive for nine months to a year later without any sign that they were going down in their number, Stadtmauer says. He adds that patients who received the edited cells did not experience any serious unintended consequences or severe side effects. Those things were reassuring and why we consider it to be safe.

While these results are promising, there is still much research to be done to maximize the technologys potential in cancer treatment. Blood samples from the three patients involved in the trial showed that the edited cells thrived, but none of the patients responded to the therapy.

One of the limitations of using your own cells is that the cells may not be as functional in a patient as cells from a healthy, younger person because of age or exposure to chemotherapy, Stadtmauer says. And the other problem is that it can take a month or so from the day that the patient gets the cells harvested to actually infusing the cells, and that requires patients who are sick with their disease to have some sort of bridging therapy to keep them well until the product is created. So, the most exciting current approach is to use allogenic or donor immune cells as a source for an off-the-shelf product that can be infused in a timely manner and directed at whatever antigens you want and there's a tremendous amount of research going on right now in this promising area.

One of the most remarkable things about CRISPR technology is how rapidly it has developed. But as exciting as this is for the advancement of science and medicine, experts in fields ranging from research to bioethics, including Doudna, have cautioned that the advancement should not outpace the tackling of ethical complications that arise.

Among these is determining who will have access to advanced gene therapies.

We have to really grapple with equity and accessibility, Doudna said at the AAMC annual meeting. We have to be cognizant of how to be sure that everyone who can benefit from this technology has access to it.

This is an issue that Eric Kmiec, PhD, had on the top of his mind in 2015, when he became the founding director of the Gene Editing Institute at ChristianaCare in Newark, Delaware, the only institute of its kind that is based in a community health system.

All due respect to major medical centers they do amazing work but somehow the community cancer center always felt to me to be on the ground in cancer, Kmiec says. We ought to think about how those technologies are going to affect all people.

The Gene Editing Institute has what Kmiec calls a bench to bedside paradigm. He and his researchers have offices in the same building where the oncologists are seeing patients. They attend grand rounds and have an open-door policy with the physicians. A surgical oncologist regularly attends lab meetings where research is discussed.

Interacting with the clinicians almost daily taught me a lot about how challenging this damn thing [treating cancer] is, Kmiec says. A lot of really bright people have worked on cancer therapy for years we have to sculpt our approach on what the clinicians are telling us usually [researchers] come in and tell clinicians how to use tech. We did the opposite.

The institutes commitment to equity goes beyond the development of therapies that reach underserved populations; it also extends to diversifying the recruitment base for the next generation of CRISPR scientists. In a partnership with Delaware Technical Community College, it created CRISPR in a Box, an educational kit that gives high school and community college students the tools to study and use CRISPR in the classroom. The resource has been accompanied by a concerted outreach effort that includes instructional videos and opportunities for students to interact with scientists through Zoom to help explain the technology.

Kmiec is hopeful that lighting the spark of interest in CRISPR and showing young people, particularly people of color and those who come from under-resourced communities, that using this technology does not require an advanced degree will inspire a more diverse labor force in the future.

We want to engage communities of color not just to learn about something we already know about, but to engage directly in [its development], Kmiec says. [That way] the minority groups will be standing with us at the finish line.

Austin Keeler, PhD, a postdoctoral student at the University of Virginia, uses CRISPR in the lab to alter the genetic makeup of mouse embryos to create transgenic animals for research. Though he finds CRISPRs potential exciting, he thinks a lot about its ethical implications on issues that currently resemble science fiction more than reality. These thoughts inspired the subject of a course he teaches to undergraduate students entitled Homo CRISPR Future Humans?

Keeler provides his students with resources to explain how gene editing works and then opens up classroom time to discussions about a variety of its current and potential uses: from gene-editing mosquitoes to control the spread of malaria to the use of CRISPR for cosmetic changes in humans.

I wanted to hammer home how fast weve moved into this technology and how much potential it has to drastically change our lives, Keeler says. It is going to have profound ramifications in their adulthood and in the lives of their children. Im not sure how much of what is happening has made its way to outside of academia.

These ethical issues have made headlines in recent years. In 2018, a Chinese biophysicist, He Jiankui, announced to the world that he had created the first genetically altered babies. He had used CRISPR to edit the germline of three embryos to make them less susceptible to HIV.

The announcement was met with outrage from scientists and ethicists alike and He was ultimately sentenced by the Chinese government to three years in prison for illegal medical practice. It was a reminder that the technology, which is so efficient and easy to use, has the potential to be abused without clear regulations and oversight.

Like any new technology, CRISPR comes with risks, Doudna said at the AAMCs annual meeting. It was clear early on that there were going to be some real ethical challenges.

In an effort to facilitate public discourse on these challenges, Doudna will be participating in the Third International Summit on Human Genome Editing in March 2022, where stakeholders from across the world will discuss the current state of the science as well as ethical and cultural considerations, the development of regulations, and the role of the public in directing the research agenda, among other issues.

Christopher Scott, PhD, a bioethicist and the Dalton Tomlin professor of medical ethics and health policy at Baylor College of Medicine in Houston, Texas, is currently working on a National Institutes of Health-funded project that will be the first comprehensive empirical study into how society might go about regulating the ethical use of genome editing moving forward.

Like any new technology, CRISPR comes with risks It was clear early on that there were going to be some real ethical challenges.

Jennifer Doudna, PhD, University of California, Berkeley

Scotts team has met with dozens of people, including lawyers, disability rights advocates, ethicists, and futurists, but has also focused on engaging members of the public who are not regularly involved in discussions about scientific technology.

We get their feedback about their opinions and values, Scott says of the members of the public. The results have been super eye-opening.

As part of the study, groups of laypeople were presented with different future scenarios involving gene editing and were asked about their comfort level with them. Scott has found that, in general, there is a major distinction between somatic cell editing, which is the altering of often disease-causing genes that are not involved in reproduction, and germline editing, which changes heritable traits.

With germline editing, the answer was, generally, We shouldnt do that yet, Scott says. One question [posed] was, If it were as safe as we could make it, [should it be done?] There were not a lot of unanimous, absolutely, yes we should do that [answers].

Keeler observed similar reservations among the students in his class. Many of the students were disturbed at the idea that a humans genetic traits could be changed without their consent. Some worried that, if someday it is possible to enhance certain traits that are perceived as beneficial, it might further increase inequities between the super elites and people not afforded such enhancements.

You have all the normal ethical issues that arise in the context of using technologies that can be used in ways one might find problematic, says Inmaculada de Melo-Martin, PhD, a professor of medical ethics in medicine at Weill Cornell Medicine Medical College in New York. [For example,] selecting for particular traits, or against particular traits, [and] what this means for the things we value.

Although some of these technologies are not yet possible, Scott says that its important to create clear governance structures and ethical guidelines now before the next generation of gene editing technologies develop.

There is a way to deliberate this with foresight rather than with hindsight, Scott says.

So far, there is little international consensus on what is acceptable when it comes to experimental gene editing in humans. In the meantime, responsibility rests on researchers and the institutions that support them to examine the ethics of their own work.

This technology is so powerful. It can provide so many benefits its easy to just put aside the possible concerns and say we will solve those problems when they arise, de Melo-Martin says. My concern is that the possibilities, the promises of these interventions, are so significant that it can prevent us from realizing we need to be careful and pay attention to what the consequences might be.

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The future of CRISPR is now - AAMC

Sonodynamic therapy (SDT) is an emerging approach involving low-intensity ultrasound and specialized chemical agents known as sonosensitizers. It releases harmful reactive oxygen species (ROS) at the tumor site.

Cancer cells can activate antioxidant defense systems to counteract it, so the treatment is not considered very effective.

Scientists reported breaching these defenses using CRISPR/Cas9 gene editing in a new study. CRISPR/Cas9 gene-editing allows sonodynamic therapy to shrink tumors in a mouse model of liver cancer effectively.

Cancer cells can quickly overcome sonodynamic therapy by activating a nuclear factor erythroid 2-related factor 2 (NFE2L2) gene. The NFE2L2 deploys the cells detoxification and antioxidant enzyme defenses. Cas9 gene-editing technology is known for breaking down gene expression in the lab.

Hence, scientists wondered if they could increase sonodynamic therapys effectiveness by using this technology to reduce NFE2L2 expression.

Scientists started with encapsulating the CRISPR/Cas9 system and a ROS precursor molecule in lipid nanoparticles. They then treated hepatocellular carcinoma cells in a petri dish with the nanoparticles.

The cells lysosomes then took the lipid nanoparticles. ROS formation caused by ultrasound treatment ruptures lysosomes. It also enables the CRISPR/Cas9 system to enter the nucleus and break down NFE2L2 gene expression. The ROS also damaged other cellular components.

As a result, the therapy kills more cancer cells without NFE2L2 gene editing.

Scientists injected the nanoparticle treatment into mice with implanted human hepatocellular carcinoma tumors. After 15 days of follow-up, scientists did not find any tumor in the mice. The tumors in the mice disappeared and didnt come back.

Scientists acknowledged, Mice treated with sonodynamic therapy alone had fewer tumors than untreated mice, but the addition of the CRISPR/Cas9 gene-editing significantly improved the therapys effectiveness. Because gene editing occurs only in tumor tissues under ultrasound irradiation, it wont cause gene mutations in healthy tissues.

Journal Reference:

Read more:
CRISPR/Cas9 gene-editing increases the effectiveness of ultrasound cancer therapy - Tech Explorist

Bacteria get a bad rap, and often deservedly so: Different strains cause a range of infections and diseases, including pneumonia, strep throat, and tuberculosis. However, any well-researched health food advocate can list the many benefits of the bacteria present in yogurt, and your local pub would be doomed without the strains integral to crafting their signature brews. What might be even more surprising is that a recent, revolutionary gene-editing technology, once exclusively the subject of science fiction, is based on the bacterial genome.

Bacteria and archaea, the original hosts of the CRISPR-Cas9 system, use this DNA-protein system to defend themselves from viruses. CRISPRs are DNA sequences that repeat in the genome of a bacterium, interspersed with fragments of genetic code from past viral invaders. When a virus enters a bacterial cell, the remnants of that same virus held in the bacterias DNA help identify and eliminate the virus. Once a virus is identified by a bacterium, Cas9 proteins try to figure out whether the new viral intruder matches any of the genetic information contained in the CRISPRs sequences of their DNA. If the virus matches the stored genetic information, the Cas9 protein will cleave it into pieces.

In 2011, researchers, including Nobel laureates Jennifer Doudna and Emmanuelle Charpentier, discovered that Cas9 proteins can be used to cut genomes that do not contain viral information, inspiring a plethora of research projects that have widened the scope of biotechnological possibility.

One such project is spearheaded by Daniel Sapozhnikov, a PhD candidate in the Department of Pharmacology and Therapeutics at McGill, and Moshe Szyf, a professor in the same department. The project aims to develop a way to remove methyl groupsone carbon atom bonded to three hydrogensfrom genes. Many diseases and disorders are dependent on whether specific genes are expressed, or turned on. Since varying amounts of methylation are associated with whether or not a gene is active, then being able to remove methyl groups could have important consequences for gene manipulation in scientific studies.

Since the 1980s, its been shown that [] genes with less [methylation] tend to be expressed [more] and genes with more tend to be expressed [less], Sapozhnikov said in an interview with The McGill Tribune. Thats basically the same conclusion that we have been stuck with in 2020. Without the ability to manipulate the DNA methylation levels at specific genes, there is really not much causational evidence for how DNA methylation and gene expression interact.

In order to better understand the relationship between methylation and gene expression, Sapozhnikov and Szyf developed a technique to demethylate select regions of a cells DNA.

CRISPR-Cas9 plays an integral role in the demethylation technique developed by Sapozhnikov and Szyf. By using guide RNA and Cas9 to block the methylation of genes, the effect of DNA demethylation can be evaluated in different cases. The specific system of CRISPR-Cas9 the team used is known as dCas9, which is CRISPR-Cas9 with a modified protein that prevents the cutting of DNAa potentially lethal consequencewhile retaining the important function of gene targeting. Once the dCas9 protein reaches the desired target of a genome, it binds to the site, preventing methylation of whatever it is attached to by physically blocking the process.

Although other teams have developed techniques for demethylation, Sapozhnikov believes that their method is the most exact.

There have been other tools that have been made that do similar things, but we argue that our tool is better from a causational perspective because [] it has fewer other activities, Sapozhnikov said.

The technique developed by Sapozhnikov and Szyf only works to remove methyl groups. Understanding the correlation between demethylation and gene expression could help the development of therapies to treat the numerous problems that arise from the improper functioning of gene expression.

CRISPR-Cas9 is still a very new technology, and it can often have unforeseen consequences in the cells it is used onnot to mention the ethical concerns raised by editing someones DNA, which is a topic of heavy debate and even outrage amongst the scientific community. Despite the many unanswered questions, CRISPR-Cas9 represents an incredible step toward revolutionary gene therapy, and with research like that of Sapozhnikov and Szyf, important new uses will continue to be explored.

Read more:
CRISPR-Cas9, the unwitting revolutionary - McGill Tribune

Agreement with Corteva Agriscience and Broad Institute of MIT and Harvard grants FuturaGene access to gene editing technology to research and develop varieties of eucalyptus that are adapted to climate change

SAO PAULO, Brazil, December 08, 2021--(BUSINESS WIRE)--FuturaGene, a wholly owned subsidiary of world-leading eucalyptus pulp producer, Suzano, will use patented genome editing technology from global pure-play agriculture company, Corteva Agriscience, and non-profit research organization, the Broad Institute of MIT and Harvard, to develop new, improved eucalyptus varieties.

FuturaGene intends to apply the gene editing technology to research and develop new varieties of eucalyptus that are more productive, resistant to diseases and pests and have improved fiber properties. In addition, the company aims for the new varieties to be more resilient to climate change and to serve as an alternative to products derived from fossil fuels. FuturaGene has the option to convert the worldwide research license to cover commercial applications.

Dr. Stanley Hirsch, CEO of FuturaGene, commented: "With our extensive experience and growing pipeline, FuturaGene is well placed to apply gene editing technology from our licensors to develop eucalyptus varieties that can help the world meet the growing demand for renewable wood-based products. This includes fibers and the potential to replace carbon-intensive fossil fuel-based materials, such as plastics, in a sustainable way.

"Our ability to share the benefits of this major enabling technology with small farmers within our supply chain, royalty free, was an important part of our negotiations with the licensors. This commitment is strongly aligned with Suzanos sustainability goal to mitigate income inequality and help lift people out of poverty. FuturaGene has always seen shared value as a vital part of our purpose".

The multi-institutional license covers CRISPR-Cas9 patent rights owned by a collection of leading universities and institutes.

Story continues

The licensed genome editing technology gives scientists the ability to edit an organism's DNA by altering and silencing genes or adding genetic material at specific locations in a highly targeted way. This can potentially be used to change wood properties, ablate susceptibilities to disease or chemical agents, or select for and instill desirable traits. The technology therefore has huge potential in forestry to help farmers optimize productivity.

- Ends -

About FuturaGene

FuturaGene is a leader in plant genetic research and development for increasing productivity and resilience in the global renewable forestry sector. With facilities in Brazil and Israel, the company develops sustainable, ecologically sound technology to meet the ever-increasing demands for fiber, alternatives to fossil fuel-based products such as plastics and energy crops in the face of declining land and water resources and climate change. In April 2015, FuturaGene became the first company in the world to obtain regulatory approval to commercially deploy a yield enhanced genetically modified eucalyptus variety. Since July 2010, FuturaGene has been a wholly owned subsidiary of Suzano S.A., the worlds leading eucalyptus pulp producer and one of Latin Americas largest paper producers.

For more information, visit http://www.futuragene.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20211208005555/en/

Contacts

For additional information please contact: FuturaGene Sara El Kadri+55 11 997398249Global Communications and Public Affairs Manager, FuturaGenesara.kadri@futuragene.com

Agnes Stephens+44 207 457 2002Media relations, Instinctif Partnersfuturagene@instinctif.com

Read more:
FuturaGene Secures License to CRISPR-Cas9 Technology to Develop Sustainable Varieties of Eucalyptus with Improved Productivity, Stress Resistance and...

Gene editing techniques like CRISPR could revolutionize the poultry industry in the future, improving yield, resistance to disease and leading to better welfare.

Gene editing itself has become a topic of much research and great interest in the academic and in the commercial work, Mark Fife, Ph.D., head of biotechnology, Aviagen, said during the Poultry Tech Webinar Series.

CRISPR functions like a pair of molecular scissors. The technique can cut DNA from a specific location at the gene, deleting the sequence entirely or replacing it with an alternative sequence.

It has several applications from medical to plants to livestock and aquaculture and micro-organisms. The bulk of the stories in the news refer to potential breakthroughs in human medicine, such as cancer treatments and genetic disorders.

In livestock, much of the discussion about gene editing currently applies to disease resistance, yield and quality, welfare and sex determination. For example, in cows, CRISPR has been used to create polled cattle and heat tolerant cattle, which can be beneficial to both welfare and management.

Poultry require a slightly different gene editing approach compared to other livestock. For mammals, a technique called somatic cell nucleic transfer (SCNT) is used, but it requires access to the developing embryo.

In chickens, thats obviously a different story because we cant access the embryo to implant the edit, Fife explained,

Instead, the process used for avian species makes genetic edits to primordial germ cells, the progenitors for sperm and ovum cells in the chicken.

What we do is we get into the developing embryo at a very early stage, about two and a half days into embryonic development. We then isolate the primordial germ cells, he added.

Researchers can perform various gene edits on the primordial germ cells, which continue to grow and develop in cell culture. At HH stage 14-17 of the chick development, the primordial germ cells are reinserted into the embryo, resulting in a chimeric chicken.

As you can see, not only is it very different from somatic cell nuclear transfer, it also takes a very long time, said Fife.

Recent advancements in this gene editing technique have resulted in poultry resisted to the avian leukosis virus and avian influenza.

Gene editing currently faces regulatory hurdles throughout much of the world. In the U.S., gene editing is highly regulated by the Food and Drug Administration (FDA). Meanwhile, the process is completely prohibited in Europe, although a post-Brexit UK is currently looking at deregulating gene edited crops.

Although everyone is incredibly excited by this at the moment, the gene editing peak is probably at a max and we are talking about food security, sustainability and animal welfare. But often what happens with technology is we hit this trough of disillusionment, Fife said.

Hopefully, this technology will clear regulatory hurdles and enter the sight of the slope of enlightenment and the plateau of productivity, he added.

Aviagens breeding techniques are exclusively based on traditional and established selection methods, Fife said, and although the company also recognizes its potential value as a research tool, there are no plans to introduce gene editing or any other genetic modification technique for commercial breeding purposes.

For more on the technologies set to advance the poultry industry, join industry-changing innovators, researchers, entrepreneurs, technology experts, investors and leading poultry producers at the Poultry Tech Webinar Series, scheduled for November 2, 4, 10, 11, 17, 30 and December 2.

During the webinar series, industry experts will preview whats coming next from prospective solutions to developing technology for the poultry industry.

This webinar series is proudly sponsored by: Arm & Hammer, Aviagen, Baader, Boehringer Ingelheim, Cargill, Ceva, Chore-Time, Cobb, Evonik, Marel, Phibro Animal Health, Staubli and Zoetis.

Visit our website for more details on the webinar series, topics and speakers.

Register for free today and join us for a glimpse at the future of the poultry industry.

Read more here:
Will CRISPR transform the poultry industry? | WATTPoultry - WATTAgNet Industry News & Trends

One 2021 study looked at the genome of Solanum sitiens a wild tomato species which grows in the extremely harsh environment of the Atacama Desert in Chile, and can be found at altitudes as high as 3,300m (10,826ft). The study identified several genes related to drought-resistance in Solanum sitiens, including one aptly named YUCCA7 (yucca are draught-resistant shrubs and trees popular as houseplants).

They are far from the only genes that could be used to give the humble tomato a boost. In 2020 Chinese and American scientists performed a genome-wide association study of 369tomato cultivars, breeding lines and landraces, and pinpointed a gene called SlHAK20 as crucial for salt tolerance.

Once the climate-smart genes such as these are identified, they can be targeted using Crispr to delete certain unwanted genes, to tune others or insert new ones. This has recently been done with salt tolerance, resistance to various tomato pathogens, and even to create dwarf plants which could withstand strong winds (another side effect of climate change). However, scientists such as Cermak go even further and start at the roots they are using Crispr to domesticate wild plant species from scratch, "de novo" in science speak. Not only can they achieve in a single generation what previously took thousands of years, but also with a much greater precision.

De novo domestication of Solanum pimpinellifolium was how Cermak and his colleagues at the University of Minnesota arrived at their 2018 plant. They targeted five genes in the wild species to obtain a tomato that would be still resistant to various stresses, yet more adapted to modern commercial farming more compact for easier mechanical harvesting, for example. The new plant also had larger fruits than the wild original.

"The size and weight was about double," Cermak says. Yet this still wasn't the ideal tomato he strives to obtain for that more work needs to be done. "By adding additional genes, we could make the fruit even bigger and more abundant, increase the amount of sugar to improve taste, and the concentration of antioxidants, vitamin C and other nutrients," he says. And, of course, resistance to various forms of stress, from heat and pests to draught and salinity.

Excerpt from:
The tomatoes at the forefront of a food revolution - BBC News

EMERYVILLE, Calif.--(BUSINESS WIRE)--Metagenomi, a genetic medicines company with a versatile portfolio of next-generation gene editing tools, today announced that the company will share data related to their novel, compact, and hypo-immune gene editing systems at the 63rd Annual Meeting and Exposition of the American Society of Hematology (ASH), which is taking place in Atlanta, GA and virtually, December 1114.

The development of CAR T therapies and other genetically engineered cell therapies in recent years has resulted in significant benefits for patients, yet there remains a large unmet need for gene editing systems that can be used to develop novel immunotherapy approaches to treat blood cancers, said Brian C. Thomas, PhD, CEO and Co-Founder of Metagenomi. At ASH, we are presenting data on our novel nucleases that display highly efficient and specific gene editing both in vivo and ex vivo and hold significant potential to drive the development of new and efficacious therapies for patients.

In a poster titled A Novel Type V CRISPR System with Potential for Genome Editing in the Liver, it is shown that Metagenomis novel Type V CRISPR-associated nuclease was highly active in the liver of mice when systemically administered via lipid nanoparticles (LNP). The nuclease was derived from a unique natural environment and is phylogenetically distinct from previously identified Type V systems. Moreover, no antibodies to the nuclease were detected in serum from 50 healthy human donors, while between one third and half of the same serum samples contained antibodies that bind to spCas9, which is derived from a Streptococcus bacteria that commonly infects humans. In summary, this novel Type V CRISPR-associated nuclease is a promising new gene editing system for in vivo editing of the liver.

In a separate poster titled Novel CRISPR-Associated Gene Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genomic Engineering for Cell Therapy Development, three novel gene editing systems were used to make reproducible and efficient edits to human immune cells, demonstrating utility for the next generation of cell therapy development for blood cancers. Metagenomis novel gene editing systems were used to disrupt the T cell receptor alpha-chain constant region and the T cell receptor beta-chain constant region in approximately 90 percent of cells. Beta-2 microglobulin was edited in 95 percent of T cells. A chimeric antigen receptor (CAR) construct was also shown to be integrated in up to 60 percent of T cells. Novel gene editing systems were deployed in NK cells to disrupt CD38 a cell surface immune modulator that can be targeted in the development of cancer immunotherapy and to integrate a CAR construct that led to robust CAR-directed cellular cytotoxicity. B cell editing occurred in approximately 80% of target cells with successful transgene integration. Whats more, as these gene editing systems are taken from environmental samples as opposed to human pathogens, pre-existing immunity is expected to be rare. In summary, these novel systems were shown to result in highly efficient and specific gene edits in human immune cells and display the potential for use in cell therapy development.

Details of the presentations are below:

Presentation Title: A Novel Type V CRISPR System with Potential for Genome Editing in the LiverSession Title: 801. Gene Therapies: Poster IPresenting Author: Morayma Temoche-Diaz, PhDPublication Number: 1862 Session Time: Saturday, December 11, 5:30 p.m. ET

Presentation Title: Novel CRISPR-Associated Gene-Editing Systems Discovered in Metagenomic Samples Enable Efficient and Specific Genome Engineering for Cell Therapy DevelopmentSession Title: 801. Gene Therapies: Poster IIIPresenting Author: Gregory Cost, PhD, Vice President of Biology, MetagenomiPublication Number: 3984 Session Time: Monday, December 13, 6:00 8:00 p.m. ET

About Metagenomi

Metagenomi is a gene editing company committed to developing potentially curative therapeutics by leveraging a proprietary toolbox of next-generation gene editing systems to accurately edit DNA where current technologies cannot. Our metagenomics-powered discovery platform and analytical expertise reveal novel cellular machinery sourced from otherwise unknown organisms. We adapt and forge these naturally evolved systems into powerful gene editing systems that are ultra-small, extremely efficient, highly specific and have a decreased risk of immune response. These systems fuel our pipeline of novel medicines and can be leveraged by partners. Our goal is to revolutionize gene editing for the benefit of patients around the world. For more information, please visit https://metagenomi.co/.

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Metagenomi to Present Preclinical In Vivo and Ex Vivo Gene-Editing Data at the 63rd American Society of Hematology (ASH) Annual Meeting - Business...