Archive for February, 2020

CORPUS CHRISTI, Texas In today's world, millions are spent on cosmetic surgery to keep that healthy glow everywhere we go. However, if you don't have thousands of dollars to pay for it, there are other, more safe alternatives that are non-surgical.

A few years ago I started noticing that no matter how much sleep I got, I just didn't look as fresh as I did when I was younger. I thought maybe it was time to talk to a professional about how I could get back that youthful appearance.

Stress, the daily rigor of life, and gravity all take their toll on the face, and there's nothing wrong with admitting you need a little help to look and feel a little better.

I visited with Dr. Vijay Bingdingdavale, a local cosmetic surgeon, to address my concerns and explore some options. The first thing he suggested was injections to relax my forehead area.

"That'll lift the eyebrows as well. What happens is when we inject these two areas, your eyebrows come a little bit higher, and giving you more of a refreshed look," Dr. Bingdingdavale said.

Then adding fullness to the upper cheeks would bring some balance to my face.

"You see how when you have a little bit more cheek fullness it harmonizes the face? It lifts this and fill this in as well," Dr. Bingdingdavale said.

Using fat transfer as opposed to artificial fillers has an additional benefit.

"We see this a lot, because there are stem cells in the fat, it makes the overlying skin more refreshed and more young-looking," Dr. Bingdingdavale said.

In the end, that's what we all want -- a more refreshed appearance even if we don't get our eight hours every night.

You can catch Dr. Vijay Bingdingdavale on First Edition on Sundays discussing skin care and healthy living.

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Fountain of Youth within reach without surgery - KIIITV.com

The defense for Joseph Sentore Coleman Jr. rested their case Wednesday with witnesses who contradicted previous statements by the prosecutions witnesses.

Both sides of the aisle are expected to make their closing statements today, before the jury is let out to deliberate the verdict in the case against Coleman, 38.

Coleman, who allegedly robbed and murdered Christopher Wilkins on Aug. 30, 2016, at 505 Park Ave., is already serving two life sentences for a double homicide on Halloween 2016.

Previously unknown to the jury, Louis Martin, frequent visitor of the Park Avenue residence, was called by Jeana Longo, Colemans attorney.

As Coleman and James Rooks allegedly entered the Park Avenue home with the intention of robbing the known drug dealers, Wilkins and Savoy Jennings, Martin said he was just waking up in Jeff Greenes adjacent bedroom from a long night of doing drugs and watching movies.

I was sitting in a chair, just closing my eyes, said Martin, when he heard shouts from the second bedroom.

I aint got nothing, I aint got nothing,' he said a voice shouted.

Then a pop it was a gunshot, said Martin.

Peering out from inside the room, he said two masked people came out of the room and looked at the body of Wilkins before running out.

One was short, slim and was built, he said. One was taller with really dark skin neither of them had dreadlocks.

Martin said he was familiar with Coleman from passing him in the street, but was not a friend of his.

However, Martin said he was familiar enough with Coleman that if his face were covered in a mask that he would know.

When they left, I waited two to three seconds. I see Chris on the floor, he said. I shook him, but Wilkins didnt move.

Martin said he alerted Jeff Greene before he left. The situation had traumatized him.

Ill be honest, I needed a drink to calm down, so I went to the bar, he said.

Later that day in initial police interviews, Martin told police that he drank about a six-pack of beer.

Martin gave a description of the men he thought murdered Wilkins for sketches to be made of their faces after police insisted, he said.

You cant make out their features, but I know what I saw, he said.

The defense also called John Greene, brother of Jeff Greene, and who lived in the second floor apartment of 505 Park Ave.

He too said he doubted Coleman committed the crime.

(Coleman) had been there plenty of times, he said, and didnt need help figuring out the layout of the home.

John Greene testified that he had seen Brown a native of New York wearing a hat similar to the one found at the scene. Namely, a Brooklyn Dodgers baseball hat.

Although Wilkins killer is still legally unproven, Dr. Barbara Bollinger, the forensic pathologist who conducted the autopsy on Wilkins, said she knew the man died immediately from the gunshot.

The projectile entered Wilkins brain near his left earlobe, passed through his cerebellum and brain stem, which collectively control balance, coordinating movement and breathing.

I think this would have incapacitated him within the span of seconds, she said.

Additionally, the gunshot caused stippling, she said, or abrasions from unburned gunpowder or debris, which typically indicates the gun was 12 inches to three feet away.

Colemans DNA was found on both the hat and a cut-off pant leg, which were used as disguises in the crime and discarded at the scene, said Regina Kuzero and Brittney Lenig, forensic scientists with the Pennsylvania State police, and Jennifer Bracamontes, a data analyst.

Though up to five peoples DNA was found on the two articles, Bracamontes said using a supercomputer to allow her to identify Coleman as the major contributor. This method does not allow anyone to learn when or how the DNA, which is typically obtained through skin cells, was rubbed into the masks.

The trial resumes at 10 a.m. today in courtroom three before Judge Marc F. Lovecchio.

Williamsport Bureau of Fire remains without a chief as of Friday, as former chief Todd Heckman has decided to go ...

The average daily inmate population decreased from 331.52 in December 2019 to 319.51 in January, according to ...

HARRISBURG The first Democratic presidential candidates are filing voter signatures to get on Pennsylvanias ...

CLARION State Rep. Cris Dush (R-66) announced he is seeking the nod from constituents of Senate District 25 ...

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Defense presents witnesses on day 3 of trial | News, Sports, Jobs - Williamsport Sun-Gazette

Technological innovations in the area of stem cell therapy and tissue engineering has led to rapid growth of the regenerative medicine market size.

Regenerative medicine is a comparatively new area of science that involves the restoration of damaged cells, tissues or organs by applying cell therapy, tissue engineering, immunotherapy or gene therapy techniques. On contrary to the present clinical therapeutics that act on slowing the disease progression or relieve symptoms, regenerative medication has a promising therapeutic approach of restoring the function and structure of damaged organs and tissues.

The global regenerative medicine market is expected to witness significant growth during the forecast period,due to the increase in the prevalence of chronic diseases, orthopaedic injuries, genetic disorders, growing aging population, increasing government funding along with the private funding in the research & development of regenerative medicines with the advancement in nanotechnology based drug delivery system, and moderate healthcare reforms. Currently, major breakthrough in the area is the development of tissue engineered trachea, transplantation of retinal pigment differentiated by stem cell based therapy to treat age-related macular degeneration.

However, recently research labs have started to focus on regenerating solid organs such as heart, kidney, lungs and other organs to curb the problems associated with organ transplantation.

The rise in number of regulatory approvals of regenerative medications is expected to further drive the regenerative medicine market during the forecast period. Moreover, there has been strategic partnership between many companies that has encouraged increased involvement of these companies in the global market.

Improvised drug delivery systems for regenerative medicines is also expected to contribute to the growth of the global market.

Download sample copy of this report at:www.psmarketresearch.com/market-ort-sample

The key factors which drive the growth of the global market include increase in the demand of orthopaedic surgeries, government healthcare reforms in certain countries such as the U.S. and Canada, aging population, rise in chronic diseases, increasing prevalence of bone and joint diseases, and innovations in nanotechnology that aids in drug delivery mechanism.

Globally, North America is the largest market for regenerative medicine followed by Europe. The largest regenerative medicine market size of North America is attributed to the high rate of incidence of cardiac disorders, autoimmune diseases, and increasing prevalence of cancer patients among the American population.

Additionally, the involvement of government organization for funding in the area of R&D of regenerative medicines, technological advancement and other policies are driving the growth of the North American market.

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Early data trends from first patient dosed in the AVR-RD-04 investigational gene therapy program for cystinosis show improvements across multiple measures

Data from the Phase 1 and Phase 2 trials of AVR-RD-01 support potential long-term engraftment and durable, endogenous production of functional enzyme in patients with Fabry disease

First Phase 2 Fabry patient treated using plato gene therapy platform shows plasma enzyme activity at one month 4.0 times higher than mean activity of other Phase 2 patients treated using academic platform at same timepoint

Analyst and investor event will be webcast today, Feb. 10, 2020, at 7:00 p.m. ET, in conjunction with WORLDSymposiumTM

AVROBIO, Inc. (NASDAQ: AVRO), a leading clinical-stage gene therapy company with a mission to free people from a lifetime of genetic disease, today announced new initial data from the first patient dosed in the investigational gene therapy program for cystinosis, showing improvements in early measures at three months compared to baseline. The company also unveiled new clinical data showcasing a sustained biomarker response in patients for up to 32 months after receiving the companys investigational gene therapy for Fabry disease across metrics including vector copy number (VCN), substrate levels and enzyme activity. Additionally, the company reported on the clinical debut of its platoTM gene therapy platform. These data showed improved enzyme activity, transduction efficiency and VCN in drug product manufactured using plato compared with drug product produced using the academic platform, as well as higher in vivo enzyme activity at one month in the first patient treated with plato, as compared to other patients treated using the academic platform. All these data will be presented today, during the 16th Annual WORLDSymposiumTM in Orlando, Fla.

"We have now dosed 10 patients across three trials for two lysosomal disorders and were delighted with the data were seeing. We have followed six patients in our Fabry trial for more than a year and one for nearly three years, and they are consistently producing the functional enzyme that was missing as a consequence of their genetic disease, suggesting a potentially durable effect from a single dose," said Geoff MacKay, AVROBIOs president and CEO. "Furthermore, we believe that early data from the first clinical application of plato support our decision to invest heavily from AVROBIO's earliest days in this state-of-the-art gene therapy platform. We believe these data collectively indicate that were making exciting progress toward our goal of freeing patients and families from the life-limiting symptoms and relentless progression of lysosomal disorders."

Three-month data from first patient in investigational AVR-RD-04 trial in cystinosisAVROBIO reported initial data from the first patient dosed in the investigator-sponsored Phase 1/2 trial of the companys AVR-RD-04 investigational gene therapy for cystinosis, a progressive disease marked by the accumulation of cystine crystals in cellular organelles known as lysosomes. Patients with cystinosis accumulate the amino acid cystine, which can lead to crystal formation in the lysosomes of cells, causing debilitating symptoms including corneal damage, difficulty breathing and kidney failure, often leading to a shortened lifespan. The current standard of care for cystinosis, a burdensome treatment regimen that can amount to dozens of pills a day, may not prevent overall progression of the disease.

As of the safety data cut-off date of Jan. 27, 2020, which was approximately three months following administration of the investigational gene therapy to the first patient in the AVR-RD-04 program, there have been no reports of safety events attributed to the investigational drug product. In addition, no serious adverse events (SAEs) have been reported as of the safety data cut-off date. Adverse events did not suggest any unexpected safety signals or trends.

Three months following administration of AVR-RD-04, the first patient had a VCN of 2.0. VCN measures the average number of copies of the lentiviral-vector inserted transgene integrated into the genome of a cell and can be used to help assess the durability of a gene therapy. Initial data on another biomarker show that the patients average granulocyte cystine level -- one of the trials primary endpoints -- decreased from 7.8 nmol half cystine/mg protein two weeks after cysteamine discontinuation, to 1.5 at three months post-gene therapy.

The ongoing open-label, single-arm Phase 1/2 clinical trial evaluating the safety and efficacy of AVR-RD-04 is sponsored by AVROBIOs academic collaborators at the University of California San Diego (UCSD), led by Stephanie Cherqui, Ph.D. The trial is actively enrolling up to six participants at UCSD.

Interim data continue to support potential first line use of AVR-RD-01 in Fabry diseaseFour patients have been dosed in the Phase 2 trial (FAB-201), and five patients in the Phase 1 investigator-led trial of AVR-RD-01 in Fabry disease.

VCN data continue to be stable at 32 months following AVR-RD-01 treatment for the first patient in the Phase 1 trial, suggesting successful engraftment, which is critical to the long-term success of investigational ex vivo lentiviral gene therapies. The VCN data trend was generally consistent across the seven other Phase 1 and Phase 2 trial participants out six to 24 months.

The first three AVR-RD-01 Phase 2 patients entered the study with minimal endogenous enzyme activity. At nine, 12 and 18 months after dosing, data from these three patients indicate sustained increased leukocyte and plasma enzyme activity, suggesting that they are now producing an endogenous supply of functional alpha-galactosidase (AGA) enzyme. This enzyme is essential for breaking down globotriaosylceramide (Gb3) in cells; without it, a toxic metabolite, lyso-Gb3, may accumulate, potentially causing cardiac and kidney damage and other symptoms.

For two Phase 2 patients, data indicate that their decreased plasma lyso-Gb3 levels, a key biomarker for monitoring Fabry disease, have been sustained below their baseline at six and 18 months after dosing. The third Phase 2 patient, a cardiac variant who does not have classic Fabry disease, did not show a decrease in plasma lyso-Gb3 levels, as expected. Cardiac and kidney function measures in the Phase 2 trial remained within normal range for patients who had available 12-month data.

As previously reported, a kidney biopsy taken at 12 months post-treatment for the first patient in the Phase 2 trial showed an 87-percent reduction in Gb3 inclusions per peritubular capillary. The company believes this data point, the primary efficacy endpoint for the Phase 2 trial, supports the potential of AVR-RD-01 to reduce Gb3 levels in tissue, including in the kidney.

In the Phase 1 trial of AVR-RD-01, four of the five patients had their plasma lyso-Gb3 levels reduced between 26 and 47 percent compared to their pre-treatment baseline levels. Data from the other patient in the trial, who remains off enzyme replacement therapy (ERT), through month six showed an initial decline and at month 12 showed a 23-percent increase in lyso-Gb3 levels, as compared to pre-treatment levels. This patients lyso-Gb3 levels remain within the range for the Fabry disease patients on ERT observed in this study.

Overall, three of the five Phase 1 patients have discontinued ERT and all three remain off ERT for six, 14 and 15 months.

As of the safety data cut-off date of Nov. 26, 2019, there have been no safety events attributed to AVR-RD-01 drug product in either the Phase 1 or Phase 2 trial. Through the safety data cut-off date, four SAEs have been reported in the FAB-201 trial and two SAEs in the Phase 1 trial. The fourth Phase 2 patient, who was dosed after the safety data cut-off date, has reported an SAE, which was not attributed to AVR-RD-01 and which subsequently resolved. Across both studies, each of the SAEs has been consistent with the conditioning regimen, stem cell mobilization, underlying disease or pre-existing conditions. Pre-existing low anti-AGA antibody titers have been detected in four patients in the Phase 1 trial and a transient low titer was observed but not detectable in subsequent measures in one patient in the Phase 2 trial.

The Phase 1 trial is fully enrolled. AVROBIO continues to actively enroll the Phase 2 trial in Australia, Canada and the U.S. The FAB-201 trial is an ongoing open-label, single-arm Phase 2 clinical trial evaluating the efficacy and safety of AVR-RD-01 in eight to 12 treatment-nave patients with Fabry disease.

Successful clinical debut of platoTM gene therapy platformAVROBIO also shared preliminary results from the first two patients to receive busulfan conditioning. Conditioning is an essential step in ex vivo lentiviral gene therapy designed to clear space in the bone marrow for the cells carrying the therapeutic transgene to engraft. The conditioning regimen developed as part of AVROBIOs plato platform includes therapeutic dose monitoring to assess how rapidly the individual patient metabolizes busulfan so physicians can adjust the dose as needed, with a goal of minimizing side effects while maximizing the potential of durable engraftment.

AVROBIO is implementing its precision dosing conditioning regimen across its company-sponsored clinical trials as part of the plato platform. The fourth patient in AVROBIOs Phase 2 Fabry trial received a precision dosing conditioning regimen with busulfan as part of the plato platform, while the first patient in the investigator-led cystinosis trial received busulfan but not as part of the plato platform.

These two patients both had rapid neutrophil and platelet count recovery, with a trajectory that was similar to the patients who enrolled earlier in the Fabry trials and who received a melphalan conditioning regimen. Side effects, which included nausea, mucositis, fever, rash and hair loss, developed eight to 10 days after dosing with busulfan and then resolved quickly.

The company also reported preliminary data from the first drug product produced using the plato gene therapy platform, which was used to dose the fourth patient in the Phase 2 Fabry trial (FAB-201). Early data indicate that enzyme activity and transduction efficiency for the drug product used to dose the fourth patient were 2.2 times higher than the mean of the drug product used to dose the first three patients in FAB-201. VCN for the drug product used to dose the fourth patient was 1.8 times higher than the mean of the drug product for the first three patients dosed in FAB-201. The drug product for the first three patients in FAB-201 was manufactured using a manual process first developed by AVROBIOs academic collaborators. The automated manufacturing embedded in plato leverages optimized processes developed at AVROBIO.

At one month following administration of the plato-produced investigational gene therapy for the fourth patient in the Phase 2 Fabry trial, initial data show the patients plasma enzyme activity level to be 4.0 times higher than the mean activity level of the first three patients in the Phase 2 Fabry trial at the same timepoint.

The investigational drug product used to dose the first patient in the AVR-RD-04 program for cystinosis, which included a four-plasmid vector but not platos automated manufacturing process, also showed increased performance in line with the increased performance recorded for the drug product in the Fabry trial. The investigational drug product and VCN assay are different for each trial.

"We believe these data are an early, but exciting, validation of our decision to invest in technological innovation rather than build expensive bricks-and-mortar manufacturing facilities," said MacKay. "The plato platform gives us control over the production and scaling of our investigational gene therapies through an efficient, automated manufacturing system that is designed to be deployed in standard contracted sites around the world. The four-plasmid vector, conditioning regimen with precision dosing and other elements of plato are designed to optimize the safety, potency and durability of our investigational lentiviral gene therapies."

About AVROBIOs ex vivo approach to gene therapyOur investigational ex vivo gene therapies start with the patients own stem cells. In the manufacturing facility, a lentiviral vector is used to insert a therapeutic gene designed to enable the patient to produce a functional supply of the protein they lack. These cells are then infused back into the patient, where they are expected to engraft in the bone marrow and produce generations of daughter cells, each containing the therapeutic gene. This approach is designed to drive durable production of the functional protein throughout the patients body, including hard-to-reach tissues such as the brain, muscle and bone. It is a distinguishing feature of this type of gene therapy that the corrected cells are expected to cross the blood-brain barrier and thereby potentially address symptoms originating in the central nervous system.

Lentiviral vectors are differentiated from other delivery mechanisms because of their large cargo capacity and their ability to integrate the therapeutic gene directly into the patients chromosomes. This integration is designed to maintain the transgenes presence as the patients cells divide, which may improve the expected durability of the therapy and potentially enable dosing of pediatric patients, whose cells divide rapidly as they grow. Because the transgene is integrated ex vivo into patients stem cells, patients are not excluded from receiving the investigational therapy due to pre-existing antibodies to the viral vector.

Analyst and investor event and webcast informationAVROBIO will host an analyst and investor event today, Monday, Feb. 10, 2020, in conjunction with the WORLDSymposiumTM, an annual scientific meeting dedicated to lysosomal disorders, in Orlando, FL. The presentation at the event will be webcast beginning at 7:00 p.m. ET. The webcast and accompanying slides will be available under "Events and Presentations" in the Investors & Media section of the companys website at http://www.avrobio.com. An archived webcast recording of the event will be available on the website for approximately 30 days.

About AVROBIOOur mission is to free people from a lifetime of genetic disease with a single dose of gene therapy. We aim to halt or reverse disease throughout the body by driving durable expression of functional protein, even in hard-to-reach tissues and organs including the brain, muscle and bone. Our clinical-stage programs include Fabry disease, Gaucher disease and cystinosis and we also are advancing a program in Pompe disease. AVROBIO is powered by the plato gene therapy platform, our foundation designed to scale gene therapy worldwide. We are headquartered in Cambridge, Mass., with an office in Toronto, Ontario. For additional information, visit avrobio.com, and follow us on Twitter and LinkedIn.

Forward-Looking StatementsThis press release contains forward-looking statements, including statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements may be identified by words and phrases such as "aims," "anticipates," "believes," "could," "designed to," "estimates," "expects," "forecasts," "goal," "intends," "may," "plans," "possible," "potential," "seeks," "will," and variations of these words and phrases or similar expressions that are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding our business strategy for and the potential therapeutic benefits of our prospective product candidates, the design, commencement, enrollment and timing of ongoing or planned clinical trials, clinical trial results, product approvals and regulatory pathways, and anticipated benefits of our gene therapy platform including potential impact on our commercialization activities, timing and likelihood of success. Any such statements in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Results in preclinical or early-stage clinical trials may not be indicative of results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented.

Any forward-looking statements in this press release are based on AVROBIOs current expectations, estimates and projections about our industry as well as managements current beliefs and expectations of future events only as of today and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that any one or more of AVROBIOs product candidates will not be successfully developed or commercialized, the risk of cessation or delay of any ongoing or planned clinical trials of AVROBIO or our collaborators, the risk that AVROBIO may not successfully recruit or enroll a sufficient number of patients for our clinical trials, the risk that AVROBIO may not realize the intended benefits of our gene therapy platform, including the features of our plato platform, the risk that our product candidates or procedures in connection with the administration thereof will not have the safety or efficacy profile that we anticipate, the risk that prior results, such as signals of safety, activity or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or trials involving AVROBIOs product candidates, the risk that we will be unable to obtain and maintain regulatory approval for our product candidates, the risk that the size and growth potential of the market for our product candidates will not materialize as expected, risks associated with our dependence on third-party suppliers and manufacturers, risks regarding the accuracy of our estimates of expenses and future revenue, risks relating to our capital requirements and needs for additional financing, and risks relating to our ability to obtain and maintain intellectual property protection for our product candidates. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause AVROBIOs actual results to differ materially and adversely from those contained in the forward-looking statements, see the section entitled "Risk Factors" in AVROBIOs most recent Quarterly Report on Form 10-Q, as well as discussions of potential risks, uncertainties and other important factors in AVROBIOs subsequent filings with the Securities and Exchange Commission. AVROBIO explicitly disclaims any obligation to update any forward-looking statements except to the extent required by law.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200210005767/en/

Contacts

Investor Contact: Christopher F. BrinzeyWestwicke, an ICR Company339-970-2843chris.brinzey@westwicke.com

Media Contact: Tom DonovanTen Bridge Communications857-559-3397tom@tenbridgecommunications.com

Original post:
AVROBIO Presents Positive Initial Data for its Investigational Cystinosis Program and Plato TM Platform, as well as Positive Data Out to 32 Months for...

Many instances in on a regular basis life, we dont understand concerning the coming illness and that illness takes a type of type because of which harmful penalties need to be suffered. One such drawback is leg burning. Lack of vitamin B, folic acid or calcium within the physique is the primary reason behind burning sensation within the toes. The drawback of burning within the toes could be because of many causes, today were going to share with you about a few of these causes, so whats the delay, tell us about it.

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Burning on the toes could be gentle, sharp and extreme. Often this irritation is because of nervous system dysfunction or dysfunction. Or vitamin B12 deficiency can improve Vitamin B12 performs an necessary position in lots of capabilities of our physique together with nervous system. Due to lack of which this drawback arises.

Additionally, neuropathy illness will also be a reason behind burning of the toes, as neuropathy has an impact on all nerves. Therefore it may well primarily have an effect on all organs and methods. In this, burning, ache and prickling within the toes are felt in a really delicate method. Burning within the toes will also be brought on by hypertension. Blood circulation can also be troublesome because of hypertension. Due to this, theres a change within the colour of the pores and skin, pulsate of the toes and a lower within the temperature of the arms, because of which the toes really feel burning.

It has been discovered that these individuals who have kidney issues are additionally present in these folks, even when theres a kidney illness, its attainable to burn the toes. Diabetes is the main reason behind burning sensation within the toes. These folks dont require any additional testing to diagnose the illness. And the physician instantly controls it. Or the decrease ranges of thyroid hormone additionally trigger burning sensation within the toes.

Therefore, dont ignore the issue of burning sensation within the toes, who ought to get therapy instantly and forestall the issue. This drawback could be handled higher provided that this drawback is much less, so deal with your well being and observe medical recommendation with therapy.

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If you're additionally troubled by the issue of burning toes, then this therapy - Sahiwal Tv

Face-to-face communication is very important in human interactions because it gives the other person a chance to read your facial expressions. Just by looking at a persons facial expressions when you talk, you can deduce if theyre happy, angry, sad, disgusted, afraid and so on. Facial expressions which can occur as fast as 1/15 or 1/25 of a second, are a great indicator of what someones emotions. Similarly, when you go to the doctor, they partly rely on your face to arrive at a diagnosis. Certain symptoms might manifest on your face which may give your doctor vital clues about underlying health conditions.Here are some signs of disease that could be written on your face:Dry, flaky lips

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Endocrine Testing Market (2018) Report Provides an in-depth summary of Endocrine Testing Market Status as well as Product Specification, Technology Development, and Key Manufacturers. The Report Gives Detail Analysis on Market concern Like Endocrine Testing Market share, CAGR Status, Market demand and up to date Market Trends with key Market segments.

The latest report about the Endocrine Testing market provides a detailed evaluation of the business vertical in question, alongside a brief overview of the industry segments. An exceptionally workable estimation of the present industry scenario has been delivered in the study, and the Endocrine Testing market size with regards to the revenue and volume have also been mentioned. In general, the research report is a compilation of key data with regards to the competitive landscape of this vertical and the multiple regions where the business has successfully established its position.

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Leading manufacturers of Endocrine Testing Market:

segmented as follows:

Global Endocrine Testing Market, by Test, 2013-2023 (USD Million)

Global Endocrine Testing Market, by Diagnostic Technology, 2013 2023 (USD Million)

Global Endocrine Testing Market, by End User, 2013 2023 (USD Million)

Global Endocrine Testing Market, by Geography, 2013 2023 (USD Million)

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Scope of The Endocrine Testing Market Report:

This research report for Endocrine Testing Market explores different topics such as product scope, product market by end users or application, product market by region, the market size for the specific product Type, sales and revenue by region forecast the Market size for various segments. The Report provides detailed information regarding the Major factors (drivers, restraints, opportunities, and challenges) influencing the growth of the Endocrine Testing market. The Endocrine Testing Market Report analyzes opportunities in the overall Endocrine Testing market for stakeholders by identifying the high-growth segments.

A detailed overview of the geographical and competitive sphere of the Endocrine Testing market:

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Table of Content of The Report

Chapter 1- Endocrine Testing Industry Overview:

1.1 Definition of Endocrine Testing

1.2 Brief Introduction of Major Classifications

1.3 Brief Introduction of Major Applications

1.4 Brief Introduction of Major Regions

Chapter 2- Production Market Analysis:

2.1 Global Production Market Analysis

2.1.1 Global Capacity, Production, Capacity Utilization Rate, Ex-Factory Price, Revenue, Cost, Gross and Gross Margin Analysis

2.1.2 Major Manufacturers Performance and Market Share

2.2 Regional Production Market Analysis

Chapter 3- Sales Market Analysis:

3.1 Global Sales Market Analysis

3.2 Regional Sales Market Analysis

Chapter 4- Consumption Market Analysis:

4.1 Global Consumption Market Analysis

4.2 Regional Consumption Market Analysis

Chapter 5- Production, Sales and Consumption Market Comparison Analysis

Chapter 6- Major Manufacturers Production and Sales Market Comparison Analysis

Chapter 7- Major Classification Analysis

Chapter 8- Major Application Analysis

Chapter 9- Industry Chain Analysis:

9.1 Up Stream Industries Analysis

9.2 Manufacturing Analysis

Tags: Endocrine TestingEndocrine Testing Market Definitions and OverviewEndocrine Testing Market DynamicsEndocrine Testing Market Segmentation and ScopeEndocrine Testing Market Trends Analysis

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Endocrine Testing Market: Analysis and In-depth study on market Size Trends, Emerging Growth Factors and Regional Forecast to 2027 - TechNews.mobi

Magnesium is the mineral that just keeps growing. Nutritional Outlook has included magnesium in its annual Ingredients to Watch projections for a few years runningand reasons are strong for highlighting magnesium again in 2020.

First, sales: Market researcher SPINS (Chicago) reports that in the 52 weeks ending October 6, 2019, magnesium saw impressive sales growth that pushed the mineral, for the first time, to rank within the top-10 ingredients, in terms of dollar change, that SPINS tracks cross-channel (mainstream, natural, and specialty gourmet channels). Combining these channels, magnesium experienced double-digit sales growth last year of 11%, taking sales to $151 million by the periods end. (For more insights on this cross-channel growth, click here.)

As many have predicted in years past, magnesium is set to overtake calcium as the mineral markets superstar. Says Nick Dehnert, vice president of brand marketing for supplements company Nutranext, The rapid growth of the magnesium category helped it recently surpass the size of the calcium category in the natural channel of trade, and we expect magnesium to continue its healthy growth trend as consumer awareness grows.

Consumer interest in magnesium is on the rise. The Council for Responsible Nutritions (CRN; Washington, DC) latest Consumer Survey on Dietary Supplements, conducted on more than 2000 U.S. adults in August 2019, ranked magnesium as one of the top-10 dietary supplements U.S. consumers take. In the 2019 survey, 18% of supplement users surveyed said they take magnesium. In fact, says Andrea Wong, PhD, senior vice president of scientific and regulatory affairs for CRN, According to CRNs Consumer Survey on Dietary Supplements, consumer usage of magnesium supplements overall has increased over the last five years.

Andrea Rosanoff, PhD, is an expert on magnesium research. As the director of research and science information outreach for the Center for Magnesium Education & Research LLC (CMER; Pahoa, HI; http://www.magnesiumeducation.com), Rosanoff has been studying magnesium for 35 years. Until recently, she says, magnesium has been a very underevaluated and underwatched nutritional supplement. (CMER, soon to be a nonprofit organization, comprises independent scholars whose mission is to promote nutritional magnesium awareness and the peer-reviewed science behind magnesium.)

But while magnesium has been underrated in the past, she says, that is slowly changing. I would say that in the last three to five years, people have come up to me and said, Oh, I read about magnesium, and its really important, wanting to know a little bit more about it. Interestingly, Rosanoff says, the dieticians that her Center speaks to are often less aware about the research and importance of magnesiumthat, in fact, it is consumers who seem to be giving magnesium its boost. Its the consumer who seems to be interested in driving the desire for knowledge about magnesium, she says.

Chalk that up to growing research and media attention on magnesiums role in good health. Rosanoff says there is more than 50 years worth of research on magnesium by now. So, what does research show?

Studies are revealing magnesiums role in many body systems, says Vanessa Pavey, ND, who is also an education scientist for supplements brand Life Extension. Magnesium helps regulate heart muscle contraction and relaxes arterial smooth muscles to promote healthy blood flow. Magnesium aids in synaptic connections between neurons to support memory. It is also a cofactor for enzymes that regulate the neurotransmitters associated with mood. And, it is becoming common knowledge that magnesium supports more regular bowel movements.

Given these benefits, its no surprise to see, per SPINS data, that magnesium sales were up in the following health supplement categories: digestive health (mainstream channel), brain health (natural channel), heart health (natural and specialty gourmet channels), mood (natural and specialty gourmet channels), and bone health (specialty gourmet channel). Magnesium is also linked to healthy blood sugar management.

Where is the scientific evidence for magnesiums efficacy strongest?

Studies are long-reaching on magnesiums benefits for heart health, especially its benefits for those suffering from high blood pressure. Rosanoff, who in 2003 co-authored a book called The Magnesium Factor together with her mentor, the late Mildred S. Seelig, MD, MPH, says that in the cardiovascular space, the research is quite robust on magnesium. And while pharmaceuticals and antihypertensive medications have taken over as treatments prescribed for heart disease and high blood pressure, Rosanoff says she believes that the real cause of heart disease epidemic in the Western world and spreading globally is a low-magnesium diet.

The whole heart disease epidemic is the symptom[T]hey have all these treatments for it, and weve been spending all this money on it, but there seems to be a reluctance to take a look and say that the core issue is really a low magnesium intake that happens chronically, and its happening to the entire population, she adds. What we are doing is treating the symptoms of what is in fact a nutritional deficiency in most casesnot all cases. In 2016, CMER was instrumental in the submission of a qualified health claim petition to FDA linking magnesium to lowering blood pressure. The petition is still in review.

Stress management is also an evolving market for magnesium, reflecting consumers growing search for stress aids. And while the mental health research on magnesium is nowhere as robust as it is for heart health, Rosanoff says that magnesium is crucial to optimizing how you face stress. Because magnesium is involved in so many bodily reactions and even up to 80% of metabolism, if you get low in magnesium, your reactions just cant go as well as they optimally could, she says.

This is how basic magnesium is to life, she points out, and in some of these basic cellular metabolic reactions that make life run smoothly.

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Magnesium saw huge cross-channel sales growth last year. Here's what's driving the ingredient in 2020: 2020 Ingredient trends to watch for foods,...

We are such stuff as dreams are made on, and our little life is rounded with a sleep. William Shakespeare

Life is indeed little. Englands bard must have sat beside many rivers and sacred places with wise souls to speak and write the way he did. His words emulate the teachings of my deman (grandparents) and mentors. They taught me that each time we see a falling star we know a new life is forming from an old soul, eventually returning to the sky when that life is rounded by sleep, and that all things in life are circular. I think of myself as a life extension of an old soul that has been loaned to me. I have always longed to be in the company of people older than me and wiser than me to learn, to grow and to be inspired by their lifes performance.

There are so many stories that need to be told and remembered. We all want to go forward. We need to respect the elements. Roma Yibiyung Winmar

We Noongar of the south-west of Western Australia constitute one of Australias largest Aboriginal cultural blocs, both in terms of population and a vast estate of lands and waters which includes Perth, Albany and Esperance. We share a common ancestral language with various regional dialects. As the first Aboriginal group in Western Australia to experience sustained foreign contact and British invasion, Noongar bore the brunt of land theft, frontier violence, and the dislocation from homelands and family resulting from successive government policies of segregation and assimilation.

Despite staggering odds, we Noongar find ways to continue to sing and speak the way our ancestors did. Noongar language is all around us in the names of local towns, suburbs, flora and fauna. Over 30,000 people identify as Noongar, and while Australian census data suggests that less than 2% of them speak the language at home, this number has grown exponentially in every census since 1996 as a result of continued efforts since the 1980s.

One of the most fulfilling things I have ever done in my life was sit with my grandmothers to learn our ancient Noongar language. The time spent with them and my everlasting connection with language is dear to my heart. Nine years ago, my cousin and modern theatre visionary Kyle J Morrison revealed his dream idea to develop a full Shakespeare work in Noongar language. Although initially surprised by the audacity of the idea, I jumped at the chance to collaborate and pay homage to the survival of our language.

We held a series of sporadic workshops over six years in which Noongar actors could reclaim the sounds of their mother tongue together in a safe, trusting and empowering environment. This process led to the formation of an ensemble of nine actors who have performed a 90-minute adaptation of Shakespeares Macbeth, titled Hecate, in this years Perth festival. I ended up with the responsibility to adapt and direct Hecate, co-translating it with my husband. The production is receiving critical acclaim, standing ovations and full houses. Still, the real achievement is supporting the emergence of more than nine Noongar people who can speak Noongar language now and into the future.

Hecate is indebted to broader longstanding efforts in our community to share, revitalise and maintain our language. Under the guidance of our editor, Roma Yibiyung Winmar, and with the encouragement of other senior language speakers, we have worked together to craft Hecate with the utmost care and attention to detail. Noongar words and philosophy are the true hero in Hecate the way we communicate, signal, celebrate, sing and cry our language has always been, and will always be, powerful. Why? Because we value truth in storytelling. Noongar people have always had the heart and organic ability to hold an audience captivated on story alone. Hecate celebrates the true strength of Noongar language expression, away from societys stereotypes, tropes and confinements of us. In this production, we have not eased into simply fulfilling the ways theatre audiences expect us to look and sound as Aboriginal performers. Hecate pays tribute to boodjar (mother earth) and all her wonders including us!

The courageous Noongar actors who bring these words to life on stage are truly inspirational and pave the way for a stronger Noongar speaking community.

Twelve Noongar words spoken in Hecate:

Kylie Bracknell [Kaarljilba Kaardn] is an actress, voice-over artist, television presenter, writer, dramaturg and theatre director from the south west of Western Australia, the Noongar nation

Comments on this piece are premoderated to ensure discussion remains on topics raised by the writer. Please be aware there may be a short delay in comments appearing

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Noongar words and philosophy are the true hero in our Macbeth adaptation Hecate - The Guardian

WASHINGTON The U.S. Army released its top 10 programs it intends to cancel or reduce in fiscal 2021 on Feb. 13, which accounts for $1.13 billion of the $2.4 billion the service plans to shift to higher priority modernization efforts.

Through a second round of night court an effort to find and shift funding from programs that dont align with the Armys modernization priorities or the National Defense Strategy the Army plans to eliminate 41 programs and reduce or delay another 39 programs across the five-year budget plan from FY21 through FY25, according to FY21 budget documents released Feb. 10.

That would allow $13.5 billion in funds to be moved toward the Armys top six modernization priorities.

During a budget briefing with the Pentagon press on Feb. 11, the Army said it would produce its list of the top 10 cuts and reductions. But when asked for more details, the service could not explain why it was unable to produce the entire list to the media, but noted it was provided to Congress.

In addition to a few programs the Army already revealed when asked specifically on Feb. 10 such as its plan to cancel the Advanced Precision Kill Weapon System (APKWS) and a delayed Joint Light Tactical Vehicle (JLTV) buy the service is also cutting from missile, vehicle, communications and electronic warfare programs.

The Army revealed in the list that its cancellation of the APKWS program frees up $122 million in FY21.

The service also plans to cancel an FY20 new start program in FY21 the Mobile Intermediate Range Missile, or MIRM, which will save $90 million.

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The Army had planned over the next five budget cycles in FY20 to spend nearly $1 billion on MIRM, which is essentially a land-based cruise missile eyed for operations in the Indo-Pacific region to address the medium-range (1,000-kilometer) gap in capability there.

The service was going to move into a technology-maturation and risk-reduction phase in FY21 for the effort.

Plans to fund a service life extension program for the Guided Multiple Launch Rocket System are also canceled, according to the list, and will save the Army $42.5 million.

The Army is also canceling the Explosive Hazard Roller, Vehicle Optics Sensor System, freeing up $21.6 million as well as the High Mobility Engineer Excavator program worth $16.4 million in FY21.

The cancellation of a Heavy Equipment Transporter variant dubbed EHET in the list frees up another $7.8 million to be used for higher priority programs.

An electronic warfare system called the DOD Manager Controlled Improvised Explosive Device Electronic Warfare system is also being canceled valued at $4.3 million.

The service is also eliminating the Route Clearance Interrogation System ($3.5 million), the Light Engineer Utility Trailer ($3.3 million), and the Tactical Electronic Power research and development program ($3.2 million).

Overall, the top 10 canceled programs amount to $314.8 million.

The Army will reduce Bradley Infantry Fighting Vehicle modifications further after cutting future upgrades beyond its A4 variant in FY20. The service is working to replace the Bradley down the road with an Optionally Manned Fighting Vehicle program, which is currently fraught with uncertainty.

The reduction amounts to $222.2 million in FY21 to cover other modernization efforts. The Army intended to spend $715.3 million in FY21, according to the FY20 budget justification documents.

The Army will now spend $493.1 million which supports procurement of multiple modifications to the Bradley vehicles including the following: procurement and installation of the Track and Suspension [engineering change proposal], procurement and fielding of M2A4 vehicles, upgrades to the Bradley Fire Support Team vehicle, procurement of training devices and procurement of safety upgrades, according to FY21 budget documents.

The service notes that current projects indicate the Bradley and its fire support vehicle will remain in armored brigade combat team formations until the 2050s.

Some of the funding reduction comes from the elimination of production and fielding of an active protection system, according to the budget books. The Army is still working toward an APS for the vehicle but has run into a few issues that must be worked through, including changes to the APS itself. And the service needs the Bradley A4 to properly run the system, as A3 power capabilities cant support it.

The Army is freeing up $201.6 million by delaying procurement of the JLTV by three years, but that wont affect the services overall procurement objective. According to Pentagon budget documents, the Army is requesting $894.4 million in FY21 for 1,920 JLTVs of various configurations as well as 1,334 JLTV-T companion trailers.

If funding levels remain consistent with the [FY21] funding profile, the Army anticipates reaching the [acquisition program objective] in FY41, the service said in a statement providing clarity to the newly released budget documents.

The Joint Assault Bridge is also taking a $126.2 million hit. The JAB program is delayed a year due to difficulty with the hydraulics system, which has since been fixed. The program will go for another initial operational test this year after struggling through its first attempt in April 2019.

According to FY20 budget documents, the Army planned to spend $164.3 million in FY21, but will now only spend $72.2 million on the program in that fiscal year.

The Army is also reducing its Close Terrain Shaping Obstacle program, which are munitions used to create obstacles on the battlefield, by $92.9 million. It will also cut $36.6 million out of its Lightweight Laser Designated Rangefinder program.

As the service prepares to procure a new precision strike missile, or PrSM, it has reduced its plans to conduct a service life extension program for the Army Tactical Missile, or ATACMS, which PrSM will ultimately replace. The Army will save $35.6 million in FY21 for that decision.

Additionally, while the service had funded the ATACMS service life extension program across the five-year defense plan in its FY20 budget documents, the FY21 documents show no funding in its five-year plan past FY21.

The Army is also reducing funding for the Distributed Common Ground System-Army, a data analytics capability for intelligence analysis, by $30.6 million due to savings, the list indicates.

And the service is cutting out $25.5 million from PROPHET, a signals intelligence program.

While the Army did not specify what mortars will be cut, it plans to reduce mortar procurement by $22.7 million, and the service will cut from its Total Army Munitions Requirement by $21.9 million.

Through all of the top 10 reductions, the Army will move $815.8 million into priority programs.

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Here's the US Army's top 10 canceled and reduced programs in FY21 - DefenseNews.com

Kellstrom Defense Aerospace (KDA) has announced a partnership with Lynden Air Cargo to install the first Digital Fuel Quantity Measurement Solution (DFQMS) on 382G (L-100) aircraft.

DFQMS is KDAs latest aircraft life extension product (LEP) and a modern active capacitance system.

Under the partnership, Lynden will also complete the supplemental type certificate (STC) for the L-100 aircraft type. The modernisation solution will support legacy C-130 and L-100 aircraft.

Kellstrom Defense said in a statement: The engineered product operating segment has invested to bring in a full-scale development programme for this technology, supported by our partners at the AMETEK SFMS and PDS divisions and the system engineering team at Cascade Aerospace, a Lockheed Martin service and engineering centre.

The DFQMS system improves system reliability, lowers material cost and increases mission readiness by replacing legacy fuel quantity measurement systems and aircraft wiring harnesses.

The Lynden installation is expected to clear the way for global fleet retrofit of this technology.

Kellstrom Defense Aerospace LEP vice-president Michael Farmer said: We are excited to work closely with Lynden on their fleet of 382G (L-100) aircraft to complete STC development and ensure that this critical technology reaches maturity.

It has been a team effort with AMETEK, Cascade Aerospace, Lynden, and KDA committing investment, resources, and technical know-how to achieve this milestone.

Kellstrom Defense develops and deploys aircraft upgrades that include the SHORT-POD APU and E2H ECS upgrades for C-130 and L-100 aircraft.

In October 2018, Cascade Aerospace signed an exclusive agreement with Kellstrom Defense to support the upgrade installation for the C-130 Hercules military transport aircraft.

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Kellstrom Defense and Lynden partner to install DFQMS on L-100 aircraft - Airforce Technology

Kellstrom Defense Aerospace (KDA) has partnered with Lynden Air Cargo (Lynden) to be the launch customer for the first installation and entry into service for the latest aircraft life extension product (LEP), KDAs Digital Fuel Quantity Measurement Solution (DFQMS). Lynden will also complete the Supplemental Type Certificate (STC) for the 382G (L-100) aircraft type for this modernization solution to support legacy C-130 and L-100 aircraft.

The Engineered Product operating segment has invested to bring in a full-scale development program for this technology, supported by our partners at the AMETEK PDS and Thermal divisions and the system engineering team at Cascade Aerospace, a Lockheed Martin service and engineering center.

The DFQMS is a modern active capacitance system that replaces legacy fuel quantity measurement systems and aircraft wiring harnesses to improve system reliability, lower material cost, and increase mission readiness. The Lynden installation will clear the way for global fleet retrofit of this technology and will drive operator value by increasing mission availability and ensuring accurate fuel measurement ensuring mission duration.

Michael Farmer, KDAs LEP Vice President, comments, "We are excited to work closely with Lynden on their fleet of 382G (L-100) aircraft to complete STC development and ensure that this critical technology reaches maturity. It has been a team effort with AMETEK, Cascade Aerospace, Lynden, and KDA committing investment, resources, and technical know-how to achieve this milestone."

Kellstrom Defense is recognized as the global leader for military aircraft support and sustainment, with a long history of developing and deploying aircraft upgrades, that include the SHORT-POD APU and E2H ECS upgrades for legacy C-130 and L-100 aircraft.

About Kellstrom Defense Aerospace, Inc.

Kellstrom Defense Aerospace, Inc. (KDA) is a respected global leader for defense aircraft sustainment, deploying an experienced team and complete capabilities to solve customer challenges through OEM strategic distribution, component repair services, engineered products, and logistics solutions for military transporters, fighters, and rotary wing platforms. With operations in Camarillo, CA; Miramar, FL; Macon, GA; Chula Vista, CA; Cambridge, UK; South Windsor, AU; Singapore, and Abu Dhabi, United Arab Emirates, the KDA team provides support to the United States military and over 60 partnering nations. KDA is committed to compliance, with hundreds of active export licenses and dedicated contract, export, and security personnel.

For more information: http://www.kellstromdefense.com, http://www.c130.com, and http://www.wam-inc.com. Follow @kellstromdef on Twitter.

About Lynden Air Cargo

Lynden Air Cargo operates the largest fleet of L-382 (L-100) in the world and is part of the Lynden family of transportation companies primarily serving Alaska and the Pacific Northwest with service extending throughout the U.S. and internationally. Our fleet of L-382 Hercules aircraft transports everything from groceries to cars within Alaska through scheduled weekly service and oversized cargo worldwide through charter flights. Lynden Air Cargo carries materials and supplies to remote and challenging destinations in the Alaskan Bush and beyond and has been called upon to fly relief missions for some of the world's most devastating disasters. We support customers in the mining, construction and energy industries and have mobilized operations to support startup projects around the globe. Lynden Air Cargo has been a subcontractor for the Department of Defense and is a member of the Civil Reserve Air Fleet (CRAF) program since 1999. Lynden Air Cargo has successfully flown thousands of missions to locations around the world while providing a reliability rating among the top of any CRAF carrier. Over the years, Lynden Air Cargo has had aircraft contracted for weekly scheduled flights, based at Air Force Bases in Yokota, Japan; Ramstein, Germany; and Trenton, New Jersey. In addition, Lynden Air Cargo has operated Department of Defense Air Mobility Command (AMC) expansion missions as needed on an ad hoc trip basis. Our pilots have thousands of hours of flight time, and all of our employees - in the air or on the ground - pride themselves on providing safe, reliable and friendly air cargo service year-round.

For more information please visit http://www.lynden.com/lac or http://www.facebook.com/LyndenInc. Contact: Adam Murray, Vice President of Commercial Operations, charters@lynden.com.

2019 Kellstrom Defense Aerospace, Inc.; All Rights Reserved.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200213005103/en/

Contacts

Kellstrom Defense Aerospace, Inc.Ruth GarciaDirector, Marketing & CommunicationsPR@kellstromdefense.com

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Kellstrom Defense Partners With Lynden Air Cargo to Install the First DFQMS on the L-100 Aircraft - Yahoo Finance

By Chris Forrester

February 14, 2020

A report from Northern Sky Research (NSR) forecasts that over $3.1 billion in cumulative revenues could be generated by 2029 for applications such as satellite life extension, relocation, de-orbiting, salvage, robotics, and space situational awareness. NSRs analysis shows progress of this much-anticipated technology and business as launches of satellite constellations continue, and there is growing concerns and opportunity to service in-orbit infrastructure to more accurately and efficiently manage orbital assets.

The in-orbit servicing (IoS) market stands ready to develop quickly, as Northrop Grummans Mission Extension Vehicle launch in late 2019 kick-starts a flurry of life extension and space tugs in-orbit service technologies. Meanwhile, increasing partnerships between players and future-proofing of satellites, such as OneWebs recent announcement to install a grappling handle on its satellites to help with future de-orbiting, are aiding the commencement of services and their sustainability, said NSR.

GEO satellites were once isolated, but missions once one and done are no longer the only available option, noted Dallas Kasaboski, NSR Senior Analyst and report lead author. Space as the next frontier is increasingly becoming a service environment where demand for greater control of orbital infrastructure, from beginning through end of life, is a reality, he adds.

NSRs analysis of the risks, challenges, players, and opportunity of IoS technology & services, finds that non-GEO satellites will drive 75 per cent of demand. However, Geostationary [demand] will control over 66 per cent of those cumulative revenues generated by 2029, due to higher complexity missions in higher orbits.

BSR said: Once in-orbit demonstration of life extension missions are successful, NSR notes that more complicated applications, such as robotic manipulation and salvage will follow. At the same time, Space Situational Awareness (SSA), newly represented and forecasted in NSRs report, is becoming even more globally recognized and supported.

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Report: Space tugs will develop rapidly | - Advanced Television

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Is the Trump administration interested in authorizing the development of a new nuclear warhead? The U.S. Department of Energys fiscal year 2021 budget request, revealed on Monday, outlines, among other things, a new warhead program known as the W93.

As part of the budget request highlights published by the National Nuclear Security Administration (NNSA), which is the U.S. Department of Energy agency charged with maintaining the U.S. nuclear arsenal, the W93 warhead program is identified alongside four other older programs as part of the weapons activities budget request. The total budget request for this category of NNSA activities for fiscal year 2021 is $15.6 billion, a 25.2 percent increase over the fiscal year 2020 amount.

The funds will sustain and modernize the U.S. nuclear weapons stockpile with five weapons programs, including the B61-12 Life Extension Program, W80-4 Life Extension Program, W88 Alteration 370, W87-1 Modification Program, and the W93 warhead program, the NNSA noted.

The NNSAs budget release describe the W93 warhead program for the first time in its budget release in a single sentence: The W93 warhead program was recently endorsed by the Nuclear Weapons Council and the Deputy Secretary of Defense to support the U.S. Strategic Command-required replacement for the Navys Trident II D5 submarine launched ballistic missile (SLBM).

Analysts like the Federation of American Scientists Hans Kristensen (disclosure: I am affiliated with FAS) have pointed out that the W93 name, which is now public, is likely a new moniker for what was previously known as the Interoperable Warhead-2 and the Next Navy Warhead in the NNSAs July 2019 Stockpile Stewardship and Management Plan (SSMP).

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In the SSMP, the Next Navy Warhead was slated to enter the studies and engineering phase of development in fiscal year 2024. If the W93 is the same warhead that was envisioned previously, it will deploy on the U.S. Navys next-generation ballistic missile submarines, the Columbia-class, for the entirety of that platforms lifetime.

Whats unclear for now is what kind of warhead the W93 will actually end up being. The United States has not designed any warheads from scratch since the W88, which is the highest-yield option on board the U.S. Navys currently operational Trident II D5 submarine-launched ballistic missiles. The development of the W88 was completed in 1989.

One concern with the W93 designation is that the designation itself suggests something grander than a modification, or mod, like the recently fielded W76-2, which is a primary-only, lower-yield derivative of the W76-1 warhead. Calling the new warhead the W93 may imply an all-new design.

As a corollary of developing a new design, calls to resume nuclear testing might resurface in the United States. The fiscal year 2021 budget is silent on this matter and the Trump administration has not officially suggested that any new warheads might need to be tested, but this would be a major concern.

The United States ceased nuclear testing and entered a self-imposed moratorium on September 23, 1992. The only country to have tested any nuclear weapons in the 21st century is North Korea, which has been heavily criticized by the United States and other countries for doing so.

The Trump administration published a Nuclear Posture Review in 2018 that called for two new nuclear capabilities. The first of these, the W76-2, has been developed and fielded by the U.S. Navy. The second was a sea-launched cruise missile, which has yet to enter production.

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Will the United States Develop a New Type of Nuclear Warhead? - The Diplomat

WASHINGTON The Army will reduce its Joint Light Tactical Vehicle (JLTV) buy in the fiscal 2021 budget and cancel procurement of specific precision-guided rockets in order to fund modernization priorities, according to Maj. Gen. Paul Chamberlain, the Armys budget director.

Through a second round of night court an effort to find and shift funding from programs that dont align with the Armys modernization priorities or the National Defense Strategy the service found an additional $2.4 billion to move from lower priority programs.

And the Army found a total of $13.5 billion across the five-year budget plan in savings, with $7.2 billion of that coming from a legacy system review.

Chamberlain said the JLTV procurement would be reduced in FY21. The reductions wont affect the Armys overall procurement requirement but will extend the process to buy the vehicles out by additional years.

According to Pentagon budget documents, the Army is requesting $894.4 million in FY21 for 1,920 JLTVs of various configurations as well as 1,334 JLTV-T companion trailers.

The number of JLTVs under contract totals 10,760. The services forecasted quantities total across the five-year budget plan is 8,829 vehicles. If funding levels remain consistent with the [FY21] funding profile, the Army anticipates reaching the [Acquisition Program Objective] in FY41, the service said in a statement providing clarity to the newly released budget documents.

The Army cut its procurement of the JLTV in its FY20 budget request by 863 vehicles as well. The service procured 3,393 vehicles in FY19 in low-rate initial production, but only planned to buy 2,530 vehicles in FY20. The Army originally planned in its FY19 request to buy 3,035 vehicles in FY20.

The service also struggled to reach full-rate production due to several changes to the vehicle. The Army originally planned to make an FRP decision in December 2018 but didnt reach the milestone until May 2019.

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Defense Secretary Mark Esper, while serving as Army secretary in the spring of 2019, said that the vehicle was designed and procured in the context of Afghanistan and Iraq, and hence was just not as relevant anymore when applied to the fresh NDS guiding Army investment.

We are certainly cutting the total number," Esper said of the vehicles, at the time.

The Army is also canceling the Advanced Precision Kill Weapon System (APKS) procurement, which are guided rockets, Chamberlain said.

And the Army is also canceling the High Mobility Engineer Excavator and research and development of tactical electric power, he added.

The service is also planning to reduce the service life extension program for the Army Tactical Missile System (ATACMS) and some mortar procurement, Chamberlain said.

The Army is planning to replace ATACMS with its new Precision Strike Missile (PrSM). Raytheon and Lockheed Martin are competing to build the new missile for the Army.

As far as the bigger programs that saw reductions or cancellations last year in order to find funding for top priorities, the Army is not walking back on those decisions.

For example, the service is still continuing to upgrade Bradley Infantry Fighting Vehicles in advance of procuring its replacement, the Optionally Manned Fighting Vehicle, which is currently in a tactical pause. But its not adding back cuts it made to upgrades to pay for OMFV, despite its unclear future.

And the Army is still not planning on funding any CH-47F Block II Chinook cargo helicopters for the active force, which it cut last year, despite Congress injecting funds in FY20 to jump start advanced procurement for aircraft for the active force.

Chamberlain said the service is still planning to fund the development and procurement of the Block II variant for Army Special Operations.

The Army plans to revisit its decision to cut the CH-47F Block II procurement for conventional forces in FY23, according to a service statement. The options include buying the Block II variant for the active component or recapitalizing the Block I variant, the statement details.

Original post:
Army sacrifices JLTV and guided rockets to pay for Army modernization in FY21 - DefenseNews.com

Maintenance team attends to Minuteman III

A significant portion of Americas nuclear deterrent force currently relies on intercontinental ballistic missiles (ICBMs) that were fielded over forty years ago. This mission, which represents the bedrock of U.S. security, demands modern technology. The time for a replacement is now.

Since the dawn of the nuclear age, nuclear deterrence has been an enduring tenet of U.S. defense strategy.It is fundamental to checking threats from Russia and China who possess sufficient numbers of nuclear weapons to pose an existential threat to the U.S. The U.S. nuclear triadcomprised of air, sea, and ground launched nuclear weapons, each with unique characteristics and advantages that collectively compensate for the disadvantages of the othersremains the cornerstone of effective U.S. nuclear deterrence. Yet, over the past three decades, every leg of the U.S. triad has been allowed to age, if not atrophy.

The LGM-30 Minuteman III, is the ICBM land leg of the U.S. nuclear triadand is complemented by theTridentsubmarine-launched ballistic missile(SLBM), and nuclear weapons carried by long-range bombers. The first Minuteman was developed in the late 1950s and the current Minuteman III entered service with the Air Force in the 1970s.Originally intended for a service life of just a decade, the Air Force invested in a series of service life extension programs (SLEPs) through the 1990s and early 2000s in order to maintain the Minuteman III force through 2030. The deferment of a new ICBM system meant that any replacement would likely be fielded at thenear endof the Minutemans existing service life.

Russia and China, meanwhile, developed and deployed a wide variety of new ICBMsto include rail and road mobile variants. Russias newest ICBM, theRS-28 Sarmat, was publicly unveiled by Russian President Putinin 2018. China has developed several long-range ICBMs, most notably theDF-31and theDF-41 capable ofcarrying 10 independently targetable nuclear warheads. China has also recently tested an SLBMsignaling their intent to deploy a full-fledged triad themselves.

While the number of nuclear weapons Russia and the U.S. possesses is determined in part by arms control agreements, there are only bilateral treaties between the U.S. and Russia. China was not a party to any of the Cold War era arms control agreements and is not a party to any similar treaty today.

In 2014, the Air Force determined that a new ICBM system would be required to maintain effective U.S. nuclear deterrence and assurance beyond 2030. This was largely due to concerns about flexibility of the missile system as new threats emerged over time and ever escalating maintenance costs on the aging Minuteman III system. The Air Force then ran a series of competitions among industry leaders to design and produce this new system. In the end, after three years of competition, only one contractor submitted a bid. This fact affords the Air Force an opportunity to accelerate the new ICBM program now called the ground based strategic deterrent (GBSD). The Air Forces original acquisition schedule anticipated the need to review multiple 1000+ page proposals. Now that this is unnecessary given the single bid, the Air Force is in a position to accelerate the GBSD acquisition process because it can avoid the multitude of time-consuming elements of the source selection process required when there is more than one bidder. This acceleration would provide some slack in the program schedule and meet U.S. Strategic Commands imperative to go fast.

It is not uncommon for the Defense Department to receive only one bid on major programs: the global positioning satellite (GPS) III, Presidential helicopter, armored multi-purpose vehicle, and the optionally manned fighting vehicle are just some of the solicitations that received a single bid. There are regulations for the government to follow in these situations that yield transparency and insight into the bidders pricing.

One of the challenges of this program is the strict schedule. Through age and attrition, the size of the Minuteman III missile force will dwindle dramatically after 2030. That means the program must meet its critical milestones on timelike first flight and full functional test. Time is of the essence to design, develop, and test all the sub-systems that need to be integrated for first flight. Every month that the engineers spend focused on this program is an investment in risk reduction and schedule certainty.

While no one could have predicted the dynamics in the aerospace industry landscape when this program was first authorized, a series of unusual circumstances have gifted the Air Force the opportunity to accelerate the GBSD program. Deploying our new ICBM leg of the triad ahead of schedule and with considerable savings would be a big win for all Americans.

Go here to see the original:
The Opportunity Exists To Move Faster On Nuclear Modernization - Forbes

The study on the Male Hypogonadism Market Research delivers a profound comprehension of the market dynamics like drivers, the challenges, trends, and opportunities. The analysis further elaborates on the micro and macro-economic facets which can be predicted to shape the increase of the Male Hypogonadism Market through the forecast period (2019-2029).

The study elucidates the crucial indexes of Male Hypogonadism Market expansion which contains a comprehensive analysis of CAGR development this value series, and Porters Five Forces Analysis. This data may enable readers to realize the growth parameters of this industry that is Male Hypogonadism .

Analytical Insights Contained from the Male Hypogonadism Market Report

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Male Hypogonadism Market Segmentation Assessment

The increase prospects of this marketplace in several Regions are examined in the report together with details like political, the regulatory frame, and financial prognosis of each region.

Trends and Opportunities

The top driver of the male hypogonadism market includes rising prevalence of testosterone deficiency among men, increasing infertility rates, and increasing awareness among individuals about hypogonadism treatment due to awareness drives organized by several governments across the world. Moreover, high risk of hypogonadism among the geriatric population with obesity and diabetes, and increasing prevalence of chronic disorders among the geriatrics are further expected to boost the markets growth.

However, factors such as high side effects of testosterone products are challenging the growth of testosterone replacement therapy market. Top players in the market are focused on research and development to introduce newer products with fewer or negligible side effects and improved results. For example, LPCN 1111, a product which is under development from Lipocine Inc., is a newer testosterone prodrug that utilizes Lipral technology for enhanced systemic absorption and for enhanced solubility of testosterone. Nevertheless, technological advancements are anticipated to extend new opportunities to the markets growth.

Global Male Hypogonadism Market: Regional Overview

The global male Hypogonadism market can be analyzed with respect to the regional segments of North America, Asia Pacific, Europe, Latin America, and the Middle East and Africa. North America held the majority share of the global market in the recent past and is expected to retain its dominant position in the near future. This is mainly due to the rise in the number of individuals suffering from primary and secondary conditions of hypogonadism, and rising awareness among individuals about treatment options for the condition. Moreover, the presence of ultra-modern healthcare infrastructure and increasing popularity of technologically advanced products are expected to offer new opportunities for top players in this market. The region is closely followed by Europe.

Asia Pacific is expected to offer lucrative opportunities to this market due to the modernization of the healthcare infrastructure in the emerging economies of India and China and the increasing awareness about the treatment for the condition. In Asia Pacific, the increasing prevalence of hypogonadism and infertility rates along with the rising geriatric population base with diabetes and obesity are propelling the growth of this market. China, Taiwan, and Malaysia are some of the countries that display the highest rate of male hypogonadism.

Major Companies Mentioned in Report

Some of the key players in the male Hypogonadism market include AbbVie Inc., Astrazeneca plc, Eli Lilly and Company Ltd., Merck & Co. Inc., SA, Finox Biotech, Laboratories Genevrier, Teva Pharmaceutical Industries Ltd., Allergan plc, Bayer AG, Endo International plc, IBSA Institut Biochimque, and Ferring.

Key players are focused on product approval for growth considerations and to cater to the changing demand of the industry. The introduction of innovative and technologically advanced products is also the focus of key players to increase their market share and for serving patients in a better manner.

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Male Hypogonadism to Witness Growth Acceleration During 2018 2028 - Redhill Local Councillors

The incidence of cancer has increased tremendously in the past few years. With advancements in science and technology, the treatment for cancer has become efficient and affordable. However, there are some rare and complicated forms of cancer that require better treatments to increase success rates. Recently, cancer gene therapy has showed promising results in preclinical trials. This is a promising trend for the global cancer gene therapy market.

Gene therapy is a method of adding or replacing a gene in an organisms DNA. In some forms of cancer, there is a defective or malfunctioning gene. Nucleic acid is administered to an individual like a drug to correct the gene sequence. Globally, there is a huge thrust on gene therapy research, and it is boosting the growth in the cancer gene therapy market.

Key driving factors of the global cancer gene therapy market

Chemotherapy and radiation, along with surgery are some of the prominent treatments available for cancer today. In cases of early detection, doctors recommend surgery along with chemotherapy or radiation. But, if the cancer has metastasized (spread to other organs), then surgery is difficult. This calls for advanced treatments, a positive factor for the global cancer gene therapy market

While chemotherapy has its own advantages, it has several side effects on the patients. It causes weight loss, vomiting, hair loss, nausea, and other complications in the body. That is the reason why doctors are better treatment options. This is a boost for the global cancer gene therapy market

Radiation also has severe impact on the body. It may cause hair loss, nausea, vomiting, fatigue and skin problems depending on the area of radiation. It also results in lung and heart problems. These factors are favorable for the global cancer gene therapy market

The survival rate of some cancers like lung, pancreatic, and liver is very less. Their chemotherapy treatments have severe side effects. Researchers feel that cancer gene therapy can improve the quality of the treatment. These findings are pushing the demand in the global cancer gene therapy market

With promising in vivo (laboratory) results, many pharmaceutical companies have embarked upon research to develop cancer gene therapy. Investments in R&D have soared in the past few years, a welcoming trend for the global cancer gene therapy market

Cancer has become more prevalent than ever today. With rising number of people seeking treatment for this disease, the demand for quality treatment is expected to grow in the coming years. This is a prime growth factor for the global cancer gene therapy market

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Global Cancer Gene Therapy Market: Key Segments

Based on type, the cancer gene therapy market is segmented into gene transfer immunotherapy and oncolytic virotherapy. Immunotherapy uses genetically modified cells and viral particles to stimulate the immune system to destroy cancer cells. Immunotherapy include treatment with either cytokine gene delivery or tumor antigen gene delivery.

Oncolytic virotherapy uses viral particles, which replicate within the cancer cell causing the death of the cell. It is an emerging treatment modality that is expected to shows great promise, particularly in metastatic cancer treatment. It includes treatment with adenovirus, retrovirus, lentivirus, herpes simplex virus, adeno-associated virus, simian virus, alphavirus, and vaccinia virus.

Gene transfer is the newest treatment modality that is expected to introduce new modified genes into cancerous cell or associated tissue for destruction of cell or to slow down cancer growth. This technique is flexible as a wide variety of vectors and genes are used for clinical trials with positive outcomes. As gene therapy advance, they could be used alone or in combination with other treatments to control the disease. Gene transfer or gene replacement is performed using naked/plasmid vectors, electroporation, sonoporation, magnetofection, and gene gun.

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Global Cancer Gene Therapy Market: Regional Analysis

Based on region, the global cancer gene therapy market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa. North America is anticipated to hold the largest market share. The U.S. dominates the cancer gene therapy market owing to its increase in funding for research & development and other government initiatives.

Key players in the biotech industry are engaging in research & development of gene therapy products. Moreover, rising demand for DNA vaccines and growing interest of venture capitalists to investment in commercialization of gene-based cancer therapies are likely to propel the market. The cancer gene therapy market in Asia Pacific is anticipated to expand at a rapid pace as in China cancer gene therapy is anticipated to attribute for largest revenue, due to the recent launch of Gendicine and rising healthcare expenditure with strong R&D facilities.

Global Cancer Gene Therapy Market: Key Players

Key players operating in the global cancer gene therapy market are Adaptimmune, ZioPharm Oncology Altor Bioscience, MolMed, bluebird bio, Shanghai Sunway Biotech Company limited, MultiVir, Shenzhen SiBiono GeneTech, and Corporation.

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Original post:
Promising In Vitro Results to Fillip Global Cancer Gene Therapy Market - BioSpace

Researchers at the University of Pennsylvania and Childrens National Hospital in Washington, DC utilized a hybrid approach that combined gene therapy with gene editing to treat a rare genetic disease in animal models, making it convert into a milder, more treatable form of the disease. The disease was ornithine transcarbamylase deficiency (OTCD), which is the most common type of a family of illnesses called urea cycle disorders.

Urea cycle disorders affect about 1 in 30,000 individuals. It causes problems in how the body metabolizes proteins in food. Normally, proteins are broken into individual amino acids. The body then recycles those amino acids to create new proteins for the body to use. Extra proteins are metabolized for energy, which requires a chemical category called amines to be removed, which are converted into ammonia. Ammonia is toxic to cells. In healthy people, urea cycle enzymes from the liver convert ammonia into urea, which is harmlessly excreted in urine.

When people have urea cycle disorders, ammonia builds up, causing vomiting and lethargy. If untreated, it can cause coma and death.

The various urea cycle disorders are caused by various genetic mutations. The researchers, led by James M. Wilson at the University of Pennsylvania and Mark L. Batshaw at Childrens National, originally attempted a typical form of gene therapy in animal models, inserting a properly functioning version of the OTC gene into a virus that carries the code for the missing enzyme, ornithine transcarbamylase.

This approach worked in older animals but did not last long in newborn animals because of rapid liver growth. CRISPR/Cas9 gene editing, on the other hand, can be used to modify the genes. Alone, this is a problem for OTCD because there are more than 400 different known mutations that cause it.

For their new approach, which they described in the journal Science Advances, they developed a viral vector that carried an enzyme that creates a targeted break in DNA. This step is typical in standard gene editing. But, instead of correcting the mistake, a second vector that carried a copy of the correct OTC gene sequence was used simultaneously.

In their experimental animal models of newborn animals, the gene integrated into cells and spread in patches in the animals livers as they grew. They produced more and more of the necessary detoxifying enzyme as they grew. They then tested nitrogen loads on the animals, and the ones who had been treated with the combined strategy had approximately 60% lower ammonia levels in their blood compared to untreated animals. All of the treated animals survived a seven-day test, while only a quarter of the untreated animals survived.

Theoretically, this could be a curative approach for OTCD, Batshaw said. And if it worked for that, we could create similar templates to treat other related disorders.

Currently, treatment for the disease includes a very low protein diet, drugs that scavenge nitrogen from the blood or a liver transplant in the most serious cases. Through these therapies, weve turned this fatal disease into a chronic one for most patients, Batshaw said. But theres still no curative approach other than liver transplantation.

The research isnt quite ready for human studies, but it is promising.

Read the original post:
Hybrid Gene Therapy Approach Shows Promise in Treating Metabolic Diseases - BioSpace

Abstract / Synopsis:

AAV8-RPGR gene therapy for X-linked retinitis pigmentosa showed early responses to treatment at one month with increased retinal sensitivity with retinal toxicity.

This article was reviewed by Paulo E. Stanga, MD

The results of treatment of X-linked retinitis pigmentosa (XLRP) with AAV8-RPGR gene therapy proved to be early and effective with durable improvements in vision occurring as early as one month following treatment.

XLRP, a rare disease that comprises 10% to 20% of RP worldwide, affects mostly males, and 70% of the cases are caused by RPGR gene mutations and 60% of those are caused by gene mutations in RPGR-ORF15. In this form of RP, the median age of blindness is 45 years, which is younger than the other forms.

Disease progression occurs in stages, with nyctalopia manifesting in the early stage, peripheral visual field constriction in the middle stage, and central visual deterioration and visual loss in the end stage, according to Paulo E. Stanga, MD, professor of Ophthalmology and Retinal Regeneration, Manchester Royal Eye Hospital and University of Manchester, London, UK.

Related: Gene therapy offering hope for retinal, corneal patients

The RPGR mutations cause abnormal transport across the cilium, where RPGR is located, and this abnormal transport results in photoreceptor death.

Obviously, this leads to loss of retinal sensitivity across the visual field and loss of visual acuity, he said.

The treatment that Dr. Stanga and colleagues devised has the goal of correcting the full length of the RPGR-ORF15 mRNA.

We aim for yields of high expression levels that are four times higher than the expression levels of the wild-type RPGR, he explained.

Related: Research targets precision data for gene, cell therapy

Six-month Phase I resultsDr. Stanga and colleagues are currently conducting a two-year dose-escalation clinical trial. The study included men who were 18 years and older with genetically confirmed XLRP. All patients had active disease that was visible bilaterally in the maculas. The study included six cohorts, with the following levels of affect vision: 1, better than light perception; 2 and 3, 34 to 73 Early Treatment Diabetic Retinopathy Study (ETDRS) letters; and 4, 5, and 6, greater than 34 ETDRS letters.

The primary endpoint was the incidence of dose-limiting toxicities and treatment-emergent adverse events. The secondary endpoints were the changes in microperimetry, visual stability, and changes in the ellipsoidal zone on spectral-domain optical coherence tomography, Dr. Stanga recounted.

The patients underwent a surgical procedure that included creation of a bleb followed by injection of the virus vector within the bleb.

Related: New vitreoretinal tools advancing surgical outcomes

The investigators evaluated the early effects of changes in the retinal sensitivity in the central retina using microperimetry (Maia, Centervue). The central 16 retinal loci represent 8 degrees of vision; an improvement of five of the central 16 loci equals a 30% improvement in the central visual field. An improvement of 7 dB represents five times greater light sensitivity, he explained.

One month after treatment, Dr. Stanga reported that there was a significant improvement in microperimetry in six of the 12 treated eyes in cohorts 3 to 6 that occurred at one month after vector injection; these cohorts received therapeutic doses. Cohorts 1 and 2, which received subtherapeutic doses, showed no changes.

Cohort 3 showed a mean improvement in the mean retinal sensitivity of 5 to 6 dB in the central 16 retinal loci between the treated and untreated eyes. The improvement became apparent at one month and remained relatively stable at three and six months, Dr. Stanga reported.

According to Dr. Stanga, these changes in retinal sensitivity differed from those observed in untreated eyes in the central 16 retinal loci. The untreated eyes showed decreases in retinal sensitivity over time.

Related: Surgeons provides pearls for handling retinal tears

The microperimetry heat maps also reflected the changes in the treated eyes with enlargement of the sensitive areas.

The investigators also reported that they also determined that the gene therapy with AAV8-RPGR gene therapy for XLRP was generally well tolerated.

No patients left the study and no dose-limiting toxicities were readily apparent.

Transient inflammation developed in the higher cohorts that responded to systemic steroid therapy. Two ocular adverse effects were related to the procedure or drug.

ConclusionsWe demonstrated proof of concept with durable dose-related improvements that appeared as early as one month after treatment across multiple microperimetry analyses, Dr. Stanga concluded. The preliminary efficacy signals were exhibited in cohorts 3 to 6, which responded to the highest doses.

Read more by Lynda Charters

Paulo E. Stanga, MDE: [emailprotected]This article is based on Dr. Stanga's presentation at the American Academy of Ophthalmology 2019 annual meeting. Dr. Stanga has no financial interest in this subject matter.

Excerpt from:
Gene therapy offers treatment for X-linked retinitis pigmentosa - Modern Retina

AUSTIN, Texas & CAMBRIDGE, Mass. (Feb. 11, 2020) Genprex, Inc. ("Genprex" or the "Company") (NASDAQ: GNPX), a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases, today announced that it signed an exclusive license agreement with the University of Pittsburgh for a diabetes gene therapy that may have the potential to cure Type 1 and Type 2 diabetes, which together currently affect approximately 30.3 million people in the U.S, or 9 percent of the U.S. population.

The diabetes gene therapy, which was developed by lead researcher and Harvard graduate, Dr. George Gittes, at the Rangos Research Center at UPMC Children's Hospital of Pittsburgh, works by reprogramming beta cells in the pancreas to restore their function, thereby replenishing levels of insulin. The novel infusion process uses an endoscope and an adeno-associated virus (AAV) vector to deliver Pdx1 and MafA genes to the pancreas. The proteins these genes express transform alpha cells in the pancreas into functional beta-like cells, which can produce insulin but are distinct enough from beta cells to evade the body's immune system.

The diabetes gene therapy has been tested in vivo in mice and nonhuman primates. In studies of diabetic mice, the gene therapy approach restored normal blood glucose levels for an extended period of time, typically around four months. According to Dr. Gittes, the duration of restored blood glucose levels in mice could translate to decades in humans. Following preclinical studies, Dr. Gittes and his team plan to begin a Phase I clinical trial in diabetic patients, which could be the first-ever gene therapy tested in humans for diabetes.

"One of the biggest advantages of this gene therapy is that it could eliminate the need for insulin replacement therapy for diabetic patients," said Dr. Gittes. "Lifting this huge burden for the millions of patients who must continuously monitor blood glucose levels and inject insulin daily would be a breakthrough in modern medicine. This therapy has the potential to truly disrupt the diabetes market."

Genprex will add this exciting technology to its research and development pipeline, diversifying its portfolio and expanding its clinical development programs. The company will continue its focus on developing its immunogene therapies for cancer, including Oncoprex immunogene therapy, its lead drug candidate for non-small cell lung cancer, in parallel with development of the new diabetes gene therapy.

"We are excited to announce the licensing agreement with The University of Pittsburgh, and we look forward to working with Dr. Gittes and his team to develop this groundbreaking treatment for diabetes," said Rodney Varner, Genprex's Chairman and Chief Executive Officer. "At Genprex, we have always put patient needs first, focusing on ways to bring new treatment options to patient populations who have large unmet medical needs. We believe this diabetes gene therapy may potentially become a new treatment option for the millions of diabetes patients who now must take insulin replacement therapy, and it may be effective for patients who do not benefit sufficiently from that therapy. Even more moving, the diabetes gene therapy could hold the potential to provide long term effectiveness, or even be a cure, for diabetes patients."

Genprex plans to pursue potential partnerships for the development of this therapy globally and in the U.S.

According to the American Diabetes Association, more than 30 million Americans have diabetes, and approximately 1.5 million Americans are diagnosed with diabetes every year. Diabetes patients have the continuous burden of checking and monitoring their blood glucose levels and injecting insulin on a daily basis. Without effective management of diabetes, patients are at risk of stroke, hyperglycemia, cardiovascular disease, diabetic ketoacidosis and extremity amputation. Diabetes is the seventh leading cause of death in the U.S.

About Genprex, Inc.

Genprex, Inc. is a clinical-stage gene therapy company developing potentially life-changing technologies for patients with cancer and other serious diseases. Genprex's technologies are designed to administer disease-fighting genes to provide new treatment options for large patient populations with cancer and other serious diseases who currently have limited treatment options. Genprex works with world-class institutions and collaborators to in-license and develop drug candidates to further its pipeline of gene therapies in order to provide novel treatment approaches for patients with cancer and other serious diseases. The company's lead product candidate, Oncoprex immunogene therapy for non-small cell lung cancer (NSCLC), uses the company's unique, proprietary platform which delivers cancer-fighting genes by encapsulating them into nanoscale hollow spheres called nanovesicles, which are then administered intravenously and taken up by tumor cells where they express proteins that are missing or found in low quantities. In January 2020, the FDA granted Fast Track Designation for Oncoprex in combination with AstraZeneca's Tagrisso for the treatment of NSCLC. For more information, please visit the company's website at http://www.genprex.com or follow Genprex on Twitter, Facebook and LinkedIn.

Forward-Looking Statements

Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the effects of the licensed gene therapy on diabetes and the effect of Genprex's other product candidates, alone and in combination with other therapies, on cancer, as well as Genprex's ongoing and planned preclinical and clinical studies and potential partnerships. Risks that contribute to the uncertain nature of the forward-looking statements include risks relating to the effects of the safety and effectiveness of the licensed gene therapy and of Genprex's other product candidates, alone and in combination with other therapies, as well as the success of Genprex's ongoing and planned preclinical and clinical studies and the success of Genprex's efforts in concluding potential partnering arrangements for product development and commercialization. Other risks and uncertainties associated with Genprex and its product candidates are described more fully under the caption "Risk Factors" and elsewhere in Genprex's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Genprex undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Read more here:
Genprex and University of Pittsburgh Sign License Agreement - Patch.com

Neurocognitive development of young MPS IIIA patients preserved up to two years post ABO-102 treatment

Dose-dependent and sustained reductions in disease-specific biomarkers denotes clear biologic effects of ABO-102 and ABO-101

First patient treated in cohort 3 of ABO-101 MPS IIIB trial; total enrollment eight patients

Favorable safety profile observed in both studies

NEW YORK and CLEVELAND, Feb. 12, 2020 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, today announced that researchers from the Abigail Wexner Research Institute (AWRI) at Nationwide Childrens Hospital presented positive interim data from two ongoing Phase I/II clinical trials evaluating ABO-102 and ABO-101, the Companys investigational gene therapies for MPS IIIA and MPS IIIB, respectively, at WORLDSymposium. Results from the Transpher A study demonstrated that MPS IIIA patients younger than 30 months treated with ABO-102 in dose cohort 3 continue to show neurocognitive development 18 months to two years after treatment. Reductions in cerebrospinal fluid (CSF) heparan sulfate (HS), denoting enzyme activity in the central nervous system, and liver volume reductions remain stable two years after treatment. Results from the Transpher B study showed that ABO-101 also improved multiple disease biomarkers providing clear evidence of a biologic effect in patients with MPS IIIB. Dosing in cohort 2 is complete and the first patient in cohort 3 was treated in late January, with a total of 8 patients treated to date. Both therapies have been well-tolerated to date. Abeona licensed the AAV9-based gene therapy technology underpinning ABO-102 and ABO-101 from AWRI at Nationwide Childrens where it was developed.

Todays presentations are available on abeonatherapeutics.com by following this link:https://investors.abeonatherapeutics.com/news-events

In total, the new results continue to show that early treatment with ABO-102 can help preserve neurodevelopment in children with MPS IIIA. These data will inform our ongoing discussions with the FDA and EMA, as we work towards providing a regulatory update in the second quarter, said Joo Siffert, M.D., Chief Executive Officer. For ABO-101, the reductions in disease-specific biomarkers are encouraging and demonstrate a clear biologic effect, which parallels that seen in the MPS IIIA study. We look forward to enrolling the Transpher B study as expeditiously as possible.

Results from the Transpher A study, an ongoing Phase I/II clinical trial with ABO-102 showed that:

The interim results presented today add to evidence suggesting a single intravenous dose of ABO-102 AAV9-based gene therapy has the potential to help MPS IIIA patients sustain neurocognitive development when they are treated at a young age, said Kevin Flanigan, M.D., Director, Center for Gene Therapy at AWRI at Nationwide Children's and Transpher A study investigator. These data showed that ABO-102 can deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs, as evidenced by the clinical benefits in neurocognition and biophysical measures and improvements in disease-specific biomarkers.

Sites in the U.S., Spain, and Australia continue to enroll eligible patients into the Transpher A study. Additional information about the trial is available at AbeonaTrials.com and ClinicalTrials.gov.

Results from cohorts 1 and 2 (n=7) of the Transpher B study, an ongoing Phase I/II clinical trial showed that ABO-101 treatment demonstrated biologic effect in patients with MPS IIIB, as evidenced by initial improvements in multiple disease biomarkers associated with abnormal accumulation of glycosaminoglycans (GAGs) in the brain and throughout the body:

The Transpher B study provides hope that we may one day alter the course of this devastating disease, said Kim McBride, M.D., Principal Investigator at AWRI at Nationwide Children's and co-investigator for the Transpher B study. The impact on disease biomarkers in the early stages of follow up suggest the potential of ABO-101 gene therapy to break down the accumulation of glycosaminoglycans that underlie MPS IIIB pathology. I look forward to working with fellow investigators to gather more data from the study, including results from high-dose cohort 3.

Dose cohort 2 has been completed and dosing is underway in cohort 3 (n=1). Sites in the U.S., Spain, and France continue to enroll eligible patients into the Transpher B study. Additional information about the trial is available at abeonatherapeutics.com/clinical-trials and ClinicalTrials.gov.

About The Transpher A StudyThe Transpher A Study (NCT02716246) is an ongoing, two-year, open-label, dose-escalation, Phase I/II global clinical trial assessing ABO-102 for the treatment of patients with Sanfilippo syndrome type A (MPS IIIA). The study, also known as ABT-001, is intended for patients 6 months to 2 years of age, or patients older than 2 years with a cognitive Developmental Quotient of 60% or above. The study has enrolled 14 patients to date across three dose-escalating cohorts (N=3, N=3, N=8) and remains open for enrollment. The gene therapy ABO-102 is delivered using AAV9 technology via a single-dose intravenous infusion. The study primary endpoints are neurodevelopment and safety, with secondary endpoints including behavior evaluations, quality of life, enzyme activity in cerebrospinal fluid (CSF) and plasma, heparan sulfate levels in CSF, plasma and urine, and brain and liver volume.

About The Transpher B StudyThe Transpher B Study (NCT03315182) is an ongoing, two-year, open-label, dose-escalation, Phase I/II global clinical trial assessing ABO-101 for the treatment of patients with Sanfilippo syndrome type B (MPS IIIB). The study, also known as ABT-002, is intended for patients 6 months to 2 years of age, or patients older than 2 years with a cognitive Developmental Quotient of 60% or above. The study has enrolled 8 patients to date across three dose-escalating cohorts (N=2, N=5, N=1) and remains open for enrollment. The gene therapy ABO-101 is delivered using AAV9 technology via a single-dose intravenous infusion. The study primary endpoints are neurodevelopment and safety, with secondary endpoints including behavior evaluations, quality of life, enzyme activity in cerebrospinal fluid (CSF) and plasma, heparan sulfate levels in CSF, plasma and urine, and brain and liver volume.

About ABO-102ABO-102 is a novel gene therapy in Phase I/II development for Sanfilippo syndrome type A (MPS IIIA), a rare lysosomal storage disease with no approved treatment that primarily affects the central nervous system (CNS). ABO-102 is dosed in a one-time intravenous infusion using a self-complementary AAV9 vector to deliver a functional copy of the SGSH gene to cells of the CNS and peripheral organs. The therapy is designed to address the underlying SGSH enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. In the U.S., Abeona holds Regenerative Medicine Advanced Therapy, Fast Track, Rare Pediatric Disease, and Orphan Drug designations for the ABO-102 clinical program. In the EU, the Company holds PRIME and Orphan medicinal product designations.

About ABO-101ABO-101 is a novel gene therapy in Phase I/II development for Sanfilippo syndrome type B (MPS IIIB), a rare lysosomal storage disease with no approved therapy that primarily affects the central nervous system (CNS). ABO-101 is dosed in a one-time intravenous infusion using a self-complementary AAV9 vector to deliver a functional copy of the NAGLU gene to cells of the CNS and peripheral tissues. The therapy is designed to address the underlying NAGLU enzyme deficiency responsible for abnormal accumulation of glycosaminoglycans in the brain and throughout the body that results in progressive cell damage and neurodevelopmental and physical decline. In the U.S., Abeona holds Fast Track and Rare Pediatric Disease designations for ABO-101 and Orphan Drug designation in both the U.S. and EU.

About Sanfilippo Syndrome Type A (MPS IIIA)Sanfilippo syndrome type A (MPS IIIA) is a rare, fatal lysosomal storage disease with no approved treatment that primarily affects the CNS and is characterized by rapid neurodevelopmental and physical decline. Children with MPS IIIA present with progressive language and cognitive decline and behavioral abnormalities. Other symptoms include sleep problems and frequent ear infections. Additionally, distinctive facial features with thick eyebrows or a unibrow, full lips and excessive body hair for ones age, and liver/spleen enlargement are also present in early childhood. MPS IIIA is caused by genetic mutations that lead to a deficiency in the SGSH enzyme responsible for breaking down glycosaminoglycans, which accumulate in cells throughout the body resulting in rapid health decline associated with the disorder.

About Sanfilippo syndrome type B (MPS IIIB)Sanfilippo syndrome type B (MPS IIIB) is a rare and fatal lysosomal storage disease with no approved therapy that primarily affects the central nervous system and is characterized by rapid neurodevelopmental and physical decline. Children with MPS IIIB present with progressive language and cognitive decline and behavioral abnormalities. Other symptoms include sleep problems and frequent ear infections. Additionally, distinctive signs such as facial features with thick eyebrows or a unibrow, full lips and excessive body hair for ones age and liver/spleen enlargement are also present. The underlying cause of MPS IIIB is a deficiency in the NAGLU enzyme responsible for breaking down glycosaminoglycans, which accumulate throughout the body resulting in rapid decline associated with the disorder.

About Abeona TherapeuticsAbeona Therapeutics Inc. is a clinical-stage biopharmaceutical company developing gene and cell therapies for serious diseases. The Companys clinical programs include EB-101, its autologous, gene-corrected cell therapy for recessive dystrophic epidermolysis bullosa, as well as ABO-102 and ABO-101, novel AAV9-based gene therapies for Sanfilippo syndrome types A and B (MPS IIIA and MPS IIIB), respectively. The Companys portfolio of AAV9-based gene therapies also features ABO-202 and ABO-201 for CLN1 disease and CLN3 disease, respectively. Abeona has received numerous regulatory designations from the FDA and EMA for its pipeline candidates, including Regenerative Medicine Advanced Therapy designation for two candidates (EB-101 and ABO-102). http://www.abeonatherapeutics.com

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Abeona Therapeutics Announces Positive Interim Data from MPS III Gene Therapy Programs Presented at WORLDSymposium - PharmiWeb.com

North Carolina is home to one of the most dynamic life sciences clusters in the United States, with more than 600 life science companies, 75 percent in the Research Triangle, according to the Life Sciences 2020 report from Cushman and Wakefield,

Cushman and Wakefields numbers differ from those cited by the NC Biotech Center, which says there are more than 735 life sciences companies in the state.

Among other metrics cited: life sciences companies employ 6.9 thousand employees, up 84 percent since 2010; a 10.7 percent vacancy for office/lab space; the $20.1 billion in National Institute of Health funding for UNC-CH, $2 billion at Duke; and $160 million for the Research Triangle Institute. NC State, which also lands significant NIH funding, is not listed.

The report notes that Research Triangle Park is centrally located between Raleigh and Durham and is the largest research park in North America. It is home to industry giants such as GlaxoSmithKline, IQVIA, PPD, and Biogen. It also includes university spinouts and startups among Fortune 100 international corporations on its sprawling 7,000 acre campus.

The report points out that Forbes ranked NC as number one among the best states for business in 2017 and 2018. Key factors, it says, are extremely low cost of doing business, minimal regulations, impressive growth statistics, and a high quality of life.

Most notably, the report states, is home to three separate research universities (Duke, the University of North Carolina at Chapel Hill, and NC State University) which graduate 53,000 students annually. This provides life science companies with a pool of top talent.

The report lists top life science companies, top venture-funded companies, inventory growth projections, notable lease transactions and notable real estate sales transactions.

Other biotech hubs examined in the report are: Baltimore, Boston, Chicago, Montreal, New York City, New Jersey, Oakland/East Bay, Philadelphia, San Diego, San Francisco, Seattle, Toronto, and Washington DC.

Doug Edgeton, president and CEO of the NC Biotech Center, had this response to the report:

Were always pleased to be among the nations leaders in the annual Cushman & Wakefield life science report. It is, of course, quite specific in its focus on real estate, its always useful to see how we compare with other major life science hubs.

It also serves as a reminder of the importance of some recently announced projects that arent reflected in this survey, including Eli Lillys January announcement of a $474 million, 462-employee pharma manufacturing facility its building in RTP Lillys first in the state.

NC Biotechnology Center CEO Doug Edgeton

That followed Mercks announcement of a $680 million, 425-employee vaccine production expansion thatll add 225,000 square feet to its existing and already impressive Durham campus.

Fresenius Kabi is adding a $100 million 445-employee expansion of its pharmaceutical factory in Wilson. And Seqirus is constantly expanding its huge cell-based flu vaccine factory in Holly Springs, where its about to occupy a $140 million, 120-employee addition to give it 475,000 square feet of space the size of eight football fields at its 185-acre site.

And Pfizer has just embarked on a build-out of a $600 million, 340-employee gene therapy research and manufacturing facility at its 230-acre campus in Sanford, plus a $19 million investment in a 60,000-square-foot building on a 16-acre site in Durham. Pfizer already employs about 3,600 people in North Carolina at sites in Chapel Hill, Sanford and Morrisville.

And there are more announcements on the near horizon, because North Carolina is a great place to do business, especially in the life sciences. In fact, Forbes named us the best state for business in both 2017 and 2018.

Those same years, Site Selection Magazine has named us the top competitive state. And just last month The Boyd Company released a study comparing the top 25 global biopharma hubs for cost of operating a biomanufacturing plant.

We came in at number three, beaten only by Bangalore, India and Tel Aviv, Israel. We beat Austin, Texas; Denver; Pittsburgh; St. Louis; Seattle; Montgomery County, Maryland; and of course, San Diego, Philadelphia and Chicago.

We can never become complacent, because the life science world is extremely competitive, very rewarding, and necessary for global health and well-being. And were glad to be among the leaders of the pack.

Excerpt from:
Report says: North Carolina home to one of the most dynamic life science clusters in the US - WRAL Tech Wire

An emergency room physician, initially unable to diagnose a disoriented patient, finds on the patient a wallet-sized card providing access to his genome, or all his DNA. The physician quickly searches the genome, diagnoses the problem and sends the patient off for a gene-therapy cure. Thats what a Pulitzer prize-winningjournalist imagined2020 would look like when she reported on the Human Genome Project back in 1996.

The Human Genome Project was an international scientific collaboration that successfully mapped, sequenced and made publicly available the genetic content of human chromosomes or all human DNA. Taking place between 1990 and 2003, the project caused many to speculate about the future of medicine. In 1996, Walter Gilbert, a Nobel laureate,said, The results of the Human Genome Project will produce a tremendous shift in the way we can do medicine and attack problems of human disease. In 2000, Francis Collins, then head of the HGP at the National Institutes of Health,predicted, Perhaps in another 15 or 20 years, you will see a complete transformation in therapeutic medicine. The same year, President Bill Clintonstatedthe Human Genome Project would revolutionize the diagnosis, prevention and treatment of most, if not all, human diseases.

It is now 2020 and no one carries a genome card. Physicians typically do not examine your DNA to diagnose or treat you. Why not? As I explain in a recentarticle in the Journal of Neurogenetics, the causes of common debilitating diseases are complex, so they typically are not amenable to simple genetic treatments, despite the hope and hype to the contrary.

The idea that a single gene can cause common diseases has been around for several decades. In the late 1980s and early 1990s, high-profile scientific journals, including Nature and JAMA, announced single-gene causation ofbipolar disorder,schizophreniaandalcoholism, among other conditions and behaviors. These articles drewmassive attentionin thepopular media, but weresoonretractedorfailedattemptsatreplication. These reevaluations completely undermined the initial conclusions, which often had relied onmisguided statistical tests. Biologists were generally aware of these developments, though the follow-up studies received little attention in popular media.

There are indeed individual gene mutations that cause devastating disorders, such asHuntingtons disease. But most common debilitating diseases are not caused by a mutation of a single gene. This is because people who have a debilitating genetic disease, on average, do not survive long enough to have numerous healthy children. In other words, there is strong evolutionary pressure against such mutations. Huntingtons disease is an exception that endures because it typically does not produce symptoms until a patient is beyond their reproductive years. Although new mutations for many other disabling conditions occur by chance, they dont become frequent in the population.

Instead, most common debilitating diseases are caused by combinations of mutations in many genes, each having a very small effect. They interact with one another and with environmental factors, modifying the production of proteins from genes. The many kinds of microbes that live within the human body can play a role, too.

A silver bullet genetic fix is still elusive for most diseases. (Credit: drpnncpptak/Shutterstock)

Since common serious diseases are rarely caused by single-gene mutations, they cannot be cured by replacing the mutated gene with a normal copy, the premise for gene therapy.Gene therapyhas gradually progressed in research along a very bumpy path, which has included accidentally causingleukemiaandat least one death, but doctors recently have been successful treatingsome rare diseasesin which a single-gene mutation has had a large effect. Gene therapy for rare single-gene disorders is likely to succeed, but must be tailored to each individual condition. The enormous cost and the relatively small number of patients who can be helped by such a treatment may create insurmountable financial barriers in these cases. For many diseases, gene therapy may never be useful.

The Human Genome Project has had an enormous impact on almost every field of biological research, by spurring technical advances that facilitate fast, precise and relatively inexpensive sequencing and manipulation of DNA. But these advances in research methods have not led to dramatic improvements in treatment of common debilitating diseases.

Although you cannot bring your genome card to your next doctors appointment, perhaps you can bring a more nuanced understanding of the relationship between genes and disease. A more accurate understanding of disease causation may insulate patients against unrealistic stories and false promises.

This article is republished from The Conversation under a Creative Commons license. Read the original article. This opinions expressed in this article belong solely to the author.

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We've Sequenced the Human Genome. So Why Haven't We Cured More Diseases? - Discover Magazine

IRVINE, Calif., Feb. 14, 2020 (GLOBE NEWSWIRE) -- ClearPoint Neuro, Inc. (Nasdaq: CLPT) (the Company), a leading platform neurosurgery company, today announced a strategic agreement with PTC Therapeutics, Inc. (PTC). The scope of the agreement includes hardware, software, clinical case and market development services for gene therapy cases in the United States and Europe to support PTCs potential commercialization in gene therapy globally upon regulatory approval. In addition to the announcement of this agreement, ClearPoint Neuro today announces the following 2020 Outlook for the companys performance:

We have put a tremendous amount of thought and effort into redefining our Company over the past two years, commented Joe Burnett, President and CEO of ClearPoint Neuro, Inc. This has included the vision, the team, the partnerships, and even the name of our company which officially changed this week to ClearPoint Neuro from MRI Interventions. We are thrilled by the evolution our Company has already undergone and believe we have only scratched the surface of the significant potential ahead.

We have evolved to become two companies in one, continued Burnett. On one side, we are a platform medical device company, consistently delivering double digit growth, and continuing to expand our installed base of neurosurgery centers in the U.S. Every year more surgeons and more patients gain access to the ClearPoint system and compatible disposable devices. On the other side of the business, we are a gene therapy and biologics enabling company, providing navigation, drug delivery, and case support to more than 20 companies in this exciting and growing space. Here we currently support pre-clinical and clinical efforts, but we believe that we are on the precipice of potentially explosive growth as these therapies progress through the regulatory process toward commercial launch. We feel that our company represents both scale and purpose through a unique combination of predictable device growth and a potential biologics opportunity, all supported under a common team dedicated to treating the most debilitating neurological disorders.

ClearPoint Neuros revenue outlook for 2020 includes an expectation that approximately 33% of total revenue will be derived from biologics and drug delivery products and services, up from approximately 20% in 2019, and reflecting the growth of this part of the business.

When planning for the development and potential commercialization of gene therapy globally, safety, consistency and predictability are crucial constructs that all must be included, commented Marcio Souza, Chief Operating Officer of PTC Therapeutics and ClearPoint Neuro Board Member. Our agreement with ClearPoint Neuro is designed to provide standardization across all of our centers of excellence as we can maintain consistency in navigation, delivery and clinical support. The more variables we can control, the more successful we believe the outcomes for patients will be.

As part of our Companys duality in devices and biologics, we are thrilled to deepen our partnership with PTC, commented Jacqueline Keller, Vice President and Program Manager at ClearPoint Neuro for the PTC Partnership. This new agreement with PTC highlights a turn-key solution for our gene therapy partners, whereby our commercial organization, with deep relationships in the neurosurgery community, can take on the burden of sales and clinical activities in the surgical suite, and allow our partners who are commonly small-molecule focused companies to continue to prioritize their efforts with neurologists, patients and reimbursement administrators. With the capacity to support thousands of cases each year, our team plans to provide this service across multiple companies and indications in neuro.

About the Company

The Companys mission is to improve and restore quality of life to patients and their families by enabling therapies for the most complex neurological disorders with pinpoint accuracy. Applications of the Companys current product portfolio include deep-brain stimulation, laser ablation, biopsy, neuro-aspiration, and delivery of drugs, biologics and gene therapy to the brain. The ClearPoint Neuro Navigation System has FDA clearance, is CE-marked, and installed in 60 active clinical sites in the United States. The Companys SmartFlow cannula is being used in partnership or evaluation with more than 20 individual biologics and drug delivery companies in various stages from preclinical research to late stage regulatory trials. To date, more than 3,500 cases have been performed and supported by the Companys field-based clinical specialist team which offers support and services for our partners. For more information, please visit http://www.clearpointneuro.com.

Note on Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 regarding the planned offering. Additionally, all statements relating to any closing(s) of, and the amount or use of any proceeds from, the transactions described in this press release are considered to be forward-looking statements. Other forward-looking statements may be identified by the words guidance, plan, anticipate, believe, estimate, expect, intend, may, target, potential, will, would, could, should, continue, and similar expressions. Forward-looking statements are subject to risks and uncertainties, and the Companys actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of such risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of closing conditions related to the transactions described in this press release. There can be no assurance that the parties will be able to complete the transactions described in this press release on the terms described herein or in a timely manner, if at all. More detailed information on these and additional factors that could affect the Companys actual results are described in the Risk Factors section of the Companys Annual Report on Form 10-K for the year ended December 31, 2018, and the Companys Quarterly Reports on Form 10-Q for the periods ended March 31, 2019, June 30, 2019 and September 30, 2019, all of which have been filed with the SEC, as well as the Companys Annual Report on Form 10-K for the year ended December 31, 2019, which the Company intends to file with the Securities and Exchange Commission on or before March 30, 2020. You are urged to carefully consider all such factors. Copies of these and other documents are available from the Company. The forward-looking statements contained herein represent the Companys views only as of the date of this press release the Company does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

For More Information

ClearPoint Neuro, Inc.Matt KrepsDarrow Associates Investor Relations(214) 597-8200mkreps@darrowir.com

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