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Stem Cells in Drug Discovery | Technology Networks – Technology Networks

Early efforts to harness the potential of stem cells for treating disease were largely focused on regeneration and the ability to repair tissues in the body through cell therapies. However, as technologies have advanced, the focus is shifting to using stem cells in drug discovery applications, such as compound screening, toxicity testing, target identification, and disease modelling. Professor Christine Mummery, from the University of Leiden tells us more and explains why stem cells are particularly suited to these applications.

Why use stem cells?

What is it that makes stem cells such an attractive option for drug discovery studies? One of the main reasons is that they make a much better model of human disease and drug reactions than animal models. As Professor Christine Mummery explains, many commonly used animal models such as mice do not accurately reflect some of the workings of cells and processes in the human body, having different immune systems and characteristics, such as heart rate, for example. This can result in problems with drugs falling down in clinical trials after showing promising results in earlier animal studies.

Using more relevant models provides not only financial savings by highlighting issues earlier in the drug discovery pipeline, but also helps efforts to reduce the number of animals used in research.

Stem cells in toxicity testing

A vital part of determining a drugs safety is assessing its cardiac toxicity. This refers to the side effects a drug can have on the functioning of the heart, such as causing arrhythmias and sudden death. As well as ensuring the safety of a drug, however, there is also a need to not unduly constrain drug development. Improvements in assay design and the implementation of the Comprehensive in Vitro Proarrhythmia Assays (CiPA) are helping to find a balance in this area.

Professor Christine Mummery tells us more about the problem of cardiotoxicity and how stem cell models and CiPA can help.

Stem cells can also play a role in testing the systemic toxicity of drugs. As Dr Glyn Stacey from NIBSC explains, pluripotent stem cell lines are increasingly being used to develop new assays that enable earlier identification of drugs that can have chronic effects on the body.

Endogenous activation of stem cells A novel and promising area of currently developing research is the ability to drive regeneration endogenously using small molecules. As Professor Angela Russell from the University of Oxford describes in the following video, we might not need to rely on using stem cells themselves, but rather small molecule therapeutics that can promote repair in damaged tissues. Circumventing the need for cells could have huge benefits for both the patient and drug developers.

What are some of the hurdles?

Stem cells certainly provide numerous opportunities to accelerate the drug discovery field, but challenges do remain.

A fundamental issue faced by all researchers in this field is ensuring the quality of the cells used. As Dr Glyn Stacey explains, a good level of quality control needs to be maintained throughout, to ensure that cells have not been contaminated or mixed up with another cell line.

Understanding signalling pathways and knowing which growth factors to add to push cells to develop into progenitor cells can also present challenges to researchers developing stem cell based screening assays. Producing sufficient numbers of relevant cell types to conduct a screen is another problem commonly faced.

The final hurdle is translation to the clinic, which relies on proving the safety of a treatment, and ensuring that it does not give rise to secondary conditions. In the case of Professor Angela Russells work, this involves taking careful steps to select compounds that act through correct pathways that wont increase the risk of cancer developing.

What does the future hold?

The roles that stem cells play in the drug discovery process are likely to continue to increase, as developments in technology enable the creation of a wider range of cells and assays. A move towards using cells with greater maturity and models that incorporate a combination of different cell types, enabling the study of interactions between cells is on the horizon. These combinations of cells will teach us a lot about drug discovery and disease, says Professor Christine Mummery.

All interviews from Stem Cells in Drug Discovery 2017 can be found here.

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Stem Cells: Viable Option for CHF or Pipe Dream? | Medpage …

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By pooling all available results from trials of bone-marrow-derived stem cells (BMSCs) in patients with ischemic heart disease or congestive heart failure, a Cochrane review found slight evidence to suggest a benefit for stem-cell therapy in those populations.

In pooled results from smaller randomized trials, BMSC treatment was associated with reductions in mortality (RR 0.28, 95% CI 0.14-0.53) and rehospitalization for heart failure (RR 0.26, 95% CI 0.07-0.94) at follow-up exceeding 1 year, Enca Martin-Rendon, PhD, of NHS Blood and Transplant in Oxford, England, and colleagues reported.

But the quality of the evidence was considered low, and no significant differences were seen in those outcomes with shorter follow-up.

Multiple measures of cardiac function — including left ventricular ejection fraction, left ventricular end-systolic volume, and stroke volume index — and New York Heart Association class showed improvements with BMSC treatment, with moderate-quality evidence.

“At present, these results provide some evidence that stem-cell treatment may be of benefit in people both with chronic ischemic heart disease and with heart failure. Adverse events are rare, with no long-term adverse events reported,” the authors wrote.

“However, the quality of the evidence is relatively low because there were few deaths and hospital readmissions in the studies, and individual study results varied,” they added. “Although BMSC treatment has the potential to be used in clinical practice for people with heart failure and for those with no other treatment option, the results of this review warrant larger clinical trials to confirm the present findings.”

Clyde Yancy, MD, of the Northwestern University Feinberg School of Medicine, expressed disappointment about the results because of the low numbers of patients included in the reviewed trials, which spanned several years.

“I know these studies are difficult — and I’ve been directly involved in several — but at a certain point in time we have to call the question and say, ‘Do we know anything more now, are we any closer to the clinical application of these technologies than we were a decade ago?'” he told MedPage Today. “The answer in a very disappointing way is ‘No.'”

“It doesn’t mean we shouldn’t continue the pursuit, but it at least points out how difficult it is, and it points out … how unrewarding it has been up until this time,” he said, adding that he remains hopeful that regenerative therapies will gain a clinical application in his lifetime.

A previous Cochrane review published in 2012 examined the use of stem-cell therapy following acute MI and showed that despite some improvements in left ventricular ejection fraction, there did not appear to be any effects on major clinical outcomes, including mortality.

But many randomized trials also have examined the potential for stem-cell treatments to improve outcomes in patients with chronic ischemic heart disease or congestive heart failure, with conflicting results.

To review the overall body of evidence, Martin-Rendon and colleagues collected data from randomized trials conducted through March 2013 that compared the use of autologous adult stem/progenitor cells with no cells/placebo. They identified 23 trials with a total of 1,137 participants diagnosed with ischemic heart disease or congestive heart failure, after excluding those with acute MI.

The average age of the patients ranged from 53 to 70, and the duration of follow-up ranged from 3 months to 5 years.

During follow-up lasting less than a year, there were no significant differences between the BMSC and control groups in mortality (RR 0.68, 95% CI 0.32-1.41) or rehospitalization for heart failure (RR 0.36, 95% CI 0.12-1.06), although an advantage for BMSC therapy did emerge over the longer term.

According to moderate-quality evidence, BMSC therapy also improved various other endpoints relative to control:

Subgroup analyses showed that the way the stem cells were administered, baseline ejection fraction, cell type, and the clinical status of the patients — but not cell dose — all influenced the observed effects, according to the authors.

Only 19 of the trials reported adverse events, and in those, only four patients had one — one hematoma related to bone marrow harvest and three cases of pulmonary edema during injection of the cells.

But even though BMSC treatment appears to be safe and effective, the review was limited by the small size of the included studies, the low numbers of events, possible publication bias, and the large number of comparisons performed, which might have led to false-positive results.

“There is a clear need for large-scale, adequately powered studies with well-defined participant cohorts and long-term follow-up to confirm the beneficial effects of BMSC in terms of reduced mortality and rehospitalization, and improved cardiac function,” the authors wrote.

They acknowledged, however, that “the potential for a large, funded clinical trial is limited, as there are no intellectual property rights associated with this procedure in its current form, rendering it unattractive to private company funding.”

The review received internal support from NHS Blood and Transplant, Research and Development, and the William Harvey Research Institute, and external support from the National Institute for Health Research and the Oxford Biomedical Research Center Program — all in the U.K.

Martin-Rendon disclosed working at the Stem Cell Research Laboratory, NHS Blood and Transplant, at John Radcliffe Hospital in Oxford, England. One of the other authors disclosed being the lead investigator of the ongoing BAMI trial, which is a European phase III trial to test the clinical efficacy of stem-cell therapy for acute myocardial infarction.

1969-12-31T19:00:00-0500

last updated 04.29.2014

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Stem Cells: Viable Option for CHF or Pipe Dream? | Medpage …

Therapeutic microparticles functionalized with biomimetic …

Junnan Tang Deliang Shen Thomas George Caranasos Zegen Wang Adam C Vandergriff Tyler A Allen Michael Taylor Hensley Phuong-Uyen Dinh Jhon Cores Tao-Sheng Li Jinying Zhang Quancheng Kan Ke Cheng PubMedID: 28045024

Tang J, Shen D, Caranasos TG, Wang Z, Vandergriff AC, Allen TA, Hensley MT, Dinh PU, Cores J, Li TS, Zhang J, Kan Q, Cheng K. Therapeutic microparticles functionalized with biomimetic cardiac stem cell membranes and secretome. Nat Commun. 2017;813724.

Stem cell therapy represents a promising strategy in regenerative medicine. However, cells need to be carefully preserved and processed before usage. In addition, cell transplantation carries immunogenicity and/or tumourigenicity risks. Mounting lines of evidence indicate that stem cells exert their beneficial effects mainly through secretion (of regenerative factors) and membrane-based cell-cell interaction with the injured cells. Here, we fabricate a synthetic cell-mimicking microparticle (CMMP) that recapitulates stem cell functions in tissue repair. CMMPs carry similar secreted proteins and membranes as genuine cardiac stem cells do. In a mouse model of myocardial infarction, injection of CMMPs leads to the preservation of viable myocardium and augmentation of cardiac functions similar to cardiac stem cell therapy. CMMPs (derived from human cells) do not stimulate T-cell infiltration in immuno-competent mice. In conclusion, CMMPs act as ‘synthetic stem cells’ which mimic the paracrine and biointerfacing activities of natural stem cells in therapeutic cardiac regeneration.

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Cardiac Stem Cells Offer New Ways to Prevent and Treat …

Stem cells under a microscope.

A newly published study shows for the first time that if cardiac stem cells are eliminated, the heart is unable to repair itself after damage.

Researchers at Kings College London have for the first time highlighted the natural regenerative capacity of a group of stem cells that reside in the heart. This new study shows that these cells are responsible for repairing and regenerating muscle tissue damaged by a heart attack which leads to heart failure.

The study, published in the journal Cell, shows that if the stem cells are eliminated, the heart is unable to repair after damage. If the cardiac stem cells are replaced the heart repairs itself, leading to complete cellular, anatomical and functional heart recovery, with the heart returning to normal and pumping at a regular rate.

Also, if the cardiac stem cells are removed and re-injected, they naturally home to and repair the damaged heart, a discovery that could lead to less-invasive treatments and even early prevention of heart failure in the future.

The study, funded by the European Commission Seventh Framework Program (FP7), set out to establish the role of cardiac stem cells (eCSCs) by first removing the cells from the hearts of rodents with heart failure. This stopped regeneration and recovery of the heart, demonstrating the intrinsic regenerative capacity of these cells for repairing the heart in response to heart failure.

Heart failure when the heart is unable to pump blood around the body adequately affects more than 750,000 people in the UK, causing breathlessness and impeding daily activities. Current treatments are aimed at treating the underlying causes, such as coronary heart disease, heart attack and blood pressure through lifestyle changes, medicines and in severe cases, surgery. These treatments are sometimes successful in preventing or delaying heart failure. However, once heart failure develops the only curative treatment is heart transplantation.

By revealing this robust homing mechanism, which causes cardiac stem cells to home to and repair the hearts damaged muscle, the findings could lead to less invasive treatments or even preventative measures aimed at maintaining or increasing the activity of the hearts own cardiac stem cells.

Dr Georgina Ellison, the first author of the paper and Professor Bernardo Nadal-Ginard, the studys corresponding author, both from the Center of Human & Aerospace Physiological Sciences and the Center for Stem Cells and Regenerative Medicine at Kings, said: In a healthy heart the quantity of cardiac stem cells is sufficient to repair muscle tissue in the heart. However, in damaged hearts many of these cells cannot multiply or produce new muscle tissue. In these cases it could be possible to replace the damaged cardiac stem cells or add new ones by growing them in the laboratory and administering them intravenously.

Dr Ellison added: Understanding the role and potential of cardiac stems cells could pave the way for a variety of new ways to prevent and treat heart failure. These new approaches involve maintaining or increasing the activity of cardiac stem cells so that muscle tissue in the heart can be renewed with new heart cells, replacing old cells or those damaged by wear and tear.

The cardiac stem cells naturally home to the heart because the heart is their home they know to go there. Current practices involve major operations such as injection through the hearts muscle wall (intramyocardial) or coronary vessels (intracoronary). The homing mechanism shown by our research could lead to a less invasive treatment whereby cardiac stem cells are injected through a vein in the skin (intravenously).

Professor Nadal-Ginard added: Although an early study, our findings are very promising. Next steps include clinical trials, due to start early 2014, aimed at assessing the effectiveness of cardiac stem cells for preventing and treating heart failure in humans.

Publication: Georgina M. Ellison, et al., Adult c-kitpos Cardiac Stem Cells Are Necessary and Sufficient for Functional Cardiac Regeneration and Repair, Cell, Volume 154, Issue 4, 827-842, 2013; doi:10.1016/j.cell.2013.07.039

Source: Kings College London

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VistaGen Therapeutics Receives European Patent Office Notice of Intention to Grant European Patent for AV-101 – Yahoo Finance

SOUTH SAN FRANCISCO, CA–(Marketwired – March 29, 2017) – VistaGen Therapeutics Inc. (VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, announced today that the European Patent Office (EPO) has issued a Notice of Intention to Grant the Company’s European Patent Application for AV-101, its oral CNS prodrug candidate in Phase 2 development for major depressive disorder (MDD). The granted claims covering multiple dosage forms of AV-101, treatment of depression and reduction of dyskinesias associated with L-DOPA treatment of Parkinson’s disease will be in effect until at least January 2034.

“We are extremely pleased to receive the EPO’s notice of intention to grant significant CNS-related patent claims for AV-101, another substantial step forward in our plan to secure a broad spectrum of intellectual property protection for AV-101 covering multiple CNS indications,” stated Shawn Singh, Chief Executive Officer of VistaGen.

About AV-101

AV-101 (4-CI-KYN) is an oral CNS prodrug candidate in Phase 2 development in the U.S. as a new generation treatment for major depressive disorder (MDD). AV-101 also has broad potential utility in several other CNS disorders, including chronic neuropathic pain and epilepsy, as well as neurodegenerative diseases, such as Parkinson’s disease and Huntington’s disease.

AV-101 is currently being evaluated in a Phase 2 monotherapy study in MDD, a study being fully funded by the U.S. National Institute of Mental Health (NIMH) and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH, as Principal Investigator.

VistaGen is preparing to advance AV-101 into a 180-patient, U.S. multi-center, Phase 2 adjunctive treatment study in MDD patients with an inadequate response to standard FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator.

About VistaGen

VistaGen Therapeutics, Inc. (VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen’s lead CNS product candidate, AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development for major depressive disorder (MDD). AV-101’s mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH) in a Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressants. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Company’s Phase 2 adjunctive treatment study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including chronic neuropathic pain, epilepsy, Parkinson’s disease and Huntington’s disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit.

VistaStem Therapeutics is VistaGen’s wholly owned subsidiary focused on applying human pluripotent stem cell technology, internally and with collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities (NCEs), including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. In December 2016, VistaGen exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.

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For more information, please visit http://www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

Forward-Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the successful launch, continuation and results of the NIMH’s Phase 2 (monotherapy) and/or the Company’s planned Phase 2 (adjunctive therapy) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at http://www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

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VistaGen Therapeutics Receives European Patent Office Notice of Intention to Grant European Patent for AV-101 – Yahoo Finance

Researchers Turn Spinach Leaves Into Beating Heart Tissues – Smithsonian

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smithsonian.com March 27, 2017 1:36PM

Researchers have gotten pretty good at growing human tissues from stem cellsfrom heart cellsin a Petri dish to 3-D printingfull ears. But assembling the complex vascularity of heart tissue is no small feat. Even the most sophisticated 3-D printers can’t fabricate the structure. However, asBen Guarinowrites for The Washington Post, researchers at Worcester Polytechnic Institute might have a solution: use spinach leaves as the backbone for the heart tissue.

The study, recently published in the journalBiomaterials, offers an innovative wayto solve a common problem in tissue engineering by looking towardthe plant world. Though plants and animals transport fluids in very different ways,their vascular structuresare similar, according to apress release.

Take a plant leaf and hold it up to the light. “What do you see?”Tanja Dominko, an author of the study, asksCyrusMoultonat theWorcester Telegram. “You see a plant vascular system that is very, very similar to a human system and serves an identical purpose, she says.

But to use that structure, researchers had to first remove the plant cells, leaving its vascular system intact. To accomplish such a feat, the team washes the leaves through using a type of detergent, turning the leaf from transparent green to translucent white. The remaining cellulose structure is compatible with human tissue.

As Guarino reports,the researchers then seeded the spinach with cardiac tissue, which began to grow inside the leaf. After five days, they witnessed some of the tissue contracting on the microscopic level. In other words, the spinach leaf began to beat. They passed liquids and microbeads the size of human blood cells through the leaves to show they could potentially transport blood.

Though the team wasn’t aiming to grow a fullheart from spinach,they hope the methodcould be used to help patients after suffering from heart attack or other heart problem. Long term, were definitely envisioning implanting a graft in damaged heart tissue, Glenn Gaudette, a bioengineer and co-author of the study, tells Guarino. They hope to make a patch as thick and strong as natural heart tissue.

Spinach is not the only superfood the team is working with. According to the press release, they have also successfully removed the cells from leaves of parsley, sweet wormwood and hairy peanut root. In the future, different plants could be used as scaffolding to grow different patches and replacement parts. For instance, the hollow stem of jewelweed could be sued to create arteries and wood or bamboo could be used to engineer bone. When you think of the wide array of plants out there, theres almost nothing that plants can’t do, Gaudette tells Moulton.

The Worcester team isnt the only group working on this idea either. Andrew Pelling at the University of Ottawa is using the cellulose in apple slicesto grow (slightly scary-looking) human ears.

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Jason Daley is a Madison, Wisconsin-based writer specializing in natural history, science, travel, and the environment. His work has appeared in Discover, Popular Science, Outside, Mens Journal, and other magazines.

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Human heart muscle made from stem cells – Free Press Journal

By FPJ Bureau|Mar 20, 2017 06:26 pm

Melbourne: Scientists have created a functional beating human heart muscle from stem cells, a significant step forward in cardiac disease research. Researchers at The University of Queensland (UQ) in Australia developed models of human heart tissue in the laboratory so they can study cardiac biology and diseases in a dish.

The patented technology enables us to now perform experiments on human heart tissue in the lab, said James Hudson from the UQ School of Biomedical Sciences. This provides scientists with viable, functioning human heart muscle to work on, to model disease, screen new drugs and investigate heart repair, said Hudson.

In the laboratory we used dry ice to kill part of the tissue while leaving the surrounding muscle healthy and viable, Hudson said. We found those tissues fully recovered because they were immature and the cells could regenerate in contrast to what happens normally in the adult heart where you get a dead patch. Our goal is to use this model to potentially find new therapeutic targets to enhance or induce cardiac regeneration in people with heart failure, he said.

Studying regeneration of these damaged, immature cells will enable us to figure out the biochemical events behind this process. Hopefully we can determine how to replicate this process in adult hearts for cardiovascular patients, said Hudson.

Each year, about 54,000 Australians suffer a heart attack, with an average of about 23 deaths every day, researchers said. Heart Foundation Queensland CEO Stephen Vines said the charity was excited to fund such an important research project.

Heart attack survivors who have had permanent damage to their heart tissue are essentially trying to live on half an engine, Vines said. The research will help unlock the key to regenerating damaged heart tissue, which will have a huge impact on the quality of life for heart attack survivors, he added.

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Measuring Heart Toxicity of Cancer Drugs | Technology Networks – Technology Networks

A stem cell-derived heart muscle cell. Proteins that are important for muscle cell contraction are highlighted in red and green, and cell nuclei are blue. Credit: Joseph C. Wu, M.D., Ph.D., Stanford Cardiovascular Institute

Using human heart cells generated from adult stem cells, researchers have developed an index that may be used to determine how toxic a group of cancer drugs, called tyrosine kinase inhibitors (TKIs), are to human cells. While 26 TKIs are currently used to treat a variety of cancers, some can severely damage patients hearts, causing problems such as an irregular heartbeat or heart failure.

For the study, reported February 15 in Science Translational Medicine, the researchers used stem cell-derived heart cells from 13 volunteers to develop a cardiac safety index that measures the extent to which TKIs kill or alter the function of heart cells. They found that the TKIs’ toxicity score on the index was generally consistent with what is known about each drug’s heart-related side effects.

This work follows on the heels of an earlier study from the same research team, published in Nature Medicine, in which they assessed the heart cell toxicity of doxorubicin, a chemotherapy drug that also causes heart-related side effects, including heart failure. In that study, the researchers used stem cell-derived heart cells from women with breast cancer to correctly predict how sensitive each womans heart cells were to doxorubicin.

Such tests could ultimately help the pharmaceutical industry identify drugs that cause heart-related side effects earlier in the drug development process and help the Food and Drug Administration (FDA) during the drug review and approval process, said the study’s senior author Joseph C. Wu, M.D., Ph.D., director of the Stanford Cardiovascular Institute.

I hope this research will be helpful for individual patients, once we further implement precision medicine approaches, he added.

Ranking Heart Toxicity

To assess the potential risk of heart toxicity for drugs in development, pharmaceutical companies use laboratory tests involving animals (usually rats or mice) or cells from animals or humans that are engineered to artificially express heart-related genes. Drug candidates that appear to have an acceptable balance of benefits and risks typically proceed to testing in human clinical trials.

But there can be biological differences between these existing models and humans, so non-clinical lab tests can have significant limitations, explained Dr. Wu.

Currently, the first time humans are exposed to a new drug is during clinical trials, he said. We think it would be great if you could actually expose patients heart, brain, liver, or kidney cells to a drug in the lab, prior to clinical treatment, allowing researchers to determine whether the drug has any toxic effects.

Dr. Wu, a cardiologist by training, studies toxicities cancer drugs cause in heart cells. Human heart muscle cells (called cardiomyocytes), however, are hard to obtainrequiring risky heart surgery that may be of no direct benefit to the patientand are notoriously difficult to grow in the lab.

As an alternative, researchers have developed a method to produce heart cells from human induced pluripotent stem cells (hiPSCs). hiPSCs are created by genetically engineering normal human skin or blood cells to express four specific genes that induce them to act like stem cells. Chemical treatments can prompt hiPSCs to develop into mature cell types, such as heart muscle cells.

A large body of research has established that human adult stem cell-derived heart cells, which function and grow in cell culture, can be used as an initial model to screen drug compounds for toxic effects on the heart, said Myrtle Davis, Ph.D., chief of the Toxicology and Pharmacology Branch of NCIs Division of Cancer Treatment and Diagnosis, who was not involved in the studies.

For the Science Translational Medicine study, Dr. Wu and his colleagues set out to determine if a panel of human stem cell-derived heart cells could be used to evaluate the heart toxicity of 21 different FDA-approved TKIs.

They generated hiPSC-derived heart endothelial, fibroblast, and muscle cells from 13 volunteers: 11 healthy individuals and 2 people with kidney cancer who were being treated with a TKI. Using drug concentrations equivalent to what patients receive, the investigators next determined how lethal each TKI was to the heart cells.

They found that several TKIs were very lethal to endothelial, fibroblast, and heart muscle cells from all 13 individuals, while others were more benign.

Stem cell-derived heart muscle cells grown in a dish spontaneously contract as a beating heart does, so the researchers also analyzed the effects of TKIs on the cells beat rate, or contractility. They found that several TKIs altered the cells beat rate before they were killed by the drug treatment. If severe enough, an irregular heartbeat (called an arrhythmia), can disrupt normal heart function.

From these lethality and contractility experiments, the team developed a cardiac safety index, a 0-to-1 scale that identifies how toxic a TKI is to heart cells (with 0 being the most toxic). They then used the index to rank the 21 TKIs. The control treatment scored a 1, while a few TKIs that are labeled by the FDA with boxed warnings for severe heart toxicity scored close to 0.

Safety indices like this one can be very useful during drug discovery, said Dr. Davis, and the applicability of the index developed by Dr. Wu and his colleagues will become clear when they evaluate its performance with more compounds.

And for the safety index to be applicable to more patients, the panel of cells used to develop it would need to be gathered from a sufficiently representative population of people reflecting different ages, races/ethnicities, health statuses, and other characteristics, said Lori Minasian, M.D., deputy director of NCIs Division of Cancer Prevention, who was not involved in either study.

For example, the study did not include cells derived from patients with [pre-existing] cardiac disease, said Dr. Davis.

A Personalized Approach

In addition to their potential application during drug development, Dr. Wu believes that stem cell-derived heart cells could potentially be used to predict toxicity risk for individual patients. He and his colleagues explored this possibility in their Nature Medicine study.

Doxorubicin, used on its own or in combination with other drugs, is an effective treatment for breast cancer and several other types of cancer. Like TKIs, however, it is known to cause heart toxicities, such as arrhythmias and heart failure, in a small proportion of patients. But there has been no way to predict which patients will experience these side effects.

The researchers developed stem cell-derived heart cells from eight women with breast cancer who had been treated with doxorubicinhalf of whom experienced cardiotoxicity from the treatment and half who did not.

In several different lab tests, the heart cells from women who had experienced cardiotoxicity were more sensitive to doxorubicin than those from women who had not. More specifically, in heart cells from women who had experienced cardiotoxicity, doxorubicin treatment caused more severe irregularities in cell contractility, and even low concentrations of the drug killed the cells.

An Improved Model

While the stem cell-derived heart cell model may be an improvement over the current [drug testing] system, its not perfect, said Dr. Minasian. For example, the model does not capture contributions of other organs and cells to the toxic effects of a drug, she explained. The drug may be broken down in the liver, for instance, and side products (called metabolites) may also cause toxic effects.

In addition, the lab-grown stem cell-derived version of someones heart cells are not going to be exactly the same as the cells found in that persons heart, Dr. Wu noted. Nevertheless, they reflect the same genetics and they are pretty good at predicting drug response, he said.

Looking forward, Dr. Minasian said, figuring out how to best use this approach is going to take more work, but being able to better predict human response [to cancer drugs] is important.

The research teams next steps include conducting prospective studies to determine whether they can use a patients stem cell-derived heart cells to potentially predict if that person will develop heart toxicity before they actually receive cancer treatment.

This article has been republished frommaterialsprovided byNCI. Note: material may have been edited for length and content. For further information, please contact the cited source.

Reference

Sharma, A., Burridge, P. W., McKeithan, W. L., Serrano, R., Shukla, P., Sayed, N., … & Matsa, E. (2017). High-throughput screening of tyrosine kinase inhibitor cardiotoxicity with human induced pluripotent stem cells. Science translational medicine, 9(377), eaaf2584.

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Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific … – DARKDaily.com – Laboratory…

Published: March 22 2017

Stanford University School of Medicine researchers grew heart muscle cells and used them, along with CRISPR, to predict whether a patient would benefit or experience bad side effects to specific therapeutic drugs

What would it mean to pathology groups if they could grow heart cells that mimicked a cardiac patients own cells? What if clinical laboratories could determine in vitro, using grown cells, if specific patients would have positive or negative reactions to specific heart drugs before they were prescribed the drug? How would that impact the pathology and medical laboratory industries?

We may soon know. Researchers at Stanford University School of Medicine (Stanford) have begun to answer these questions.

May Be Feasible for Clinical Laboratories to Use Pluripotent Stem Cells for Assays

In a Stanford press release, researchers stated that induced pluripotent stem cells (iPS cells), coupled with CRISPRtechnology, could be used to determine:

1) Whether a patient would benefit from a specific therapeutic drug; and

2) The likelihood that the patient might have a negative reaction or bad side effect from that drug.

Thirty percent of drugs in clinical trials are eventually withdrawn due to safety concerns, which often involve adverse cardiac effects. This study shows that these cells serve as a functional readout to predict how a patients heart might respond to particular drug treatments and identify those who should avoid certain treatments, said Joseph Wu, MD, PhD, in the Stanford press release. Wu is Director of Stanfords Cardiovascular Institute and a Professor of Cardiovascular Medicine and Radiology.

The researchers believe their discovery could become a form of diagnostic and prognostic testing performed by pathologists and clinical laboratories if it passes further clinical trials.

Heart Muscle Made from Stem Cells, Study Advances Precision Medicine

The iPS cells are stem cells created in a lab, usually from a persons skin sample, and then induced into becoming cells from other parts of the body. Heart muscle cells made from iPS cells mirror the expression patterns of key genes in the donors native heart tissue. This means the cells can be leveraged to predict a patients likelihood of experiencing drug-related heart damage, according to the Stanford release.

The Stanford study also advanced precision medicine. It combined genetics, large-scale data research, and individualized testing to determine the best treatments for patients, noted an article in United Press International (UPI).

Researchers were motivated by a need to understand individual susceptibility to drug-induced cardiotoxicity, to improve patient safety, and to prevent drug attrition, according to the Stanford study, which was published in the research journal Cell Stem Cell.

Human iPS cells enable the study of pharmacological and toxicological responses in patient-specific cardiomyocytes and may serve as preclinical platforms for precision medicine, the authors noted in the study summary.

Furthermore, the researchers idea could have implications for medical conditions beyond cardiomyopathy, noted an article in LabRoots.

Cardiomyopathy is a disease of the heart muscle that affects millions of people worldwide each year.

Joseph Wu, MD, PhD (above left), and Elena Matsa, PhD (above right), both with Stanford University School of Medicine, led a team of researchers who published a study involving CRISPR that suggests heart muscle cells made from induced pluripotent stem cells (iPS cells) could be used to identify cardiac patients who could benefit from or who could be damaged by certain cardiac medications. (Photo credits: Stanford University.)

Testing Tissues in the Stanford University Research Lab

Heres how the research progressed, according to the Stanford press release:

Matsa, Wu, and their colleagues created heart muscle cells, or cardiomyocytes, from iPS cells taken from seven people not known to be genetically predisposed to cardiac problems;

They sequenced the RNA molecules made by the heart muscle cells to learn which proteins the cells were making, and by how much;

They then compared the results within individualslooking at the gene expression patterns of cardiomyocytes derived from several batches of iPS cells from each personas well as among all seven study subjects.

They also investigated how the cardiomyocytes from each person responded to increasing amounts of two drugs: Rosiglitazone (marketed as Avandia by GlaxoSmithKline), which is sometimes used to treat Type 2 diabetes; and Tacrolimus (marketed as Prograf by Astellas Pharma), which serves as an immunosuppressant to inhibit the rejection of transplanted organs. Each of the two drugs has been associated with adverse cardiac effects in some people, but it has not been possible to predict which patients will experience heart damage.

Gene expression patterns of the iPS cell-derived cardiomyocytes from each individual patient correlated very well, said Elena Matsa, PhD, Stanford Instructor, Cardiovascular Institute, and the studys lead author. But there was marked variability among the seven people, particularly in genes involved in metabolism and stress responses. In fact, one of our subjects exhibited a very abnormal expression of genes in a key metabolic pathway.

Gene Editing Reveals Drug Response Information

Enter the Clustered Regularly Interspaced Short Palindromic Repeats, or CRISPR (pronounced crisper), gene editing technology. CRISPR technology has advanced the study and practice of genetic medicine.

Researchers could not pinpoint a specific gene mutation responsible for abnormal cardiomyocyte response. But they did identify a metabolic pathway that influenced Rosiglitazones response.

They corrected the abnormality using CRISPR-Cas9 (a simplified version of the CRISPR/Cas system). This genome editing technique enables researchers to edit parts of the genome by removing or changing in some manner the DNAsequence, according to yourgenome, an information website dedicated solely to DNA, genes, and genomes.

The results? The Stanford researchers reported boosting a gene expression in the pathway, restoring normal function, and prompting a response to Rosiglitazone that was consistent to that of the other subjects cardiomyocytes.

Clinical Laboratories Become Even More Integral to Cardiac Diagnosis and Treatment

Can iPS-derived cardiomyocytes reliably replicate human heart tissue? Researchers were not sure. So, they created iPS cells from another three people who had heart biopsies or transplants. They then compared the cells made in the clinical laboratory with the gene native cells and found that they were similar in many significant ways.

In the end, cardiomyocytes derived from human iPS cells correlated with patient participants in the Stanford study. And, most importantly, the study revealed a potential ability to test drugs for adverse reactions and improve treatment for millions of people with cardiomyopathy. Should additional research confirm these findings, it could provide medical laboratories with a new approach to improving diagnosis and therapeutic selection for patients with heart disease.

Donna Marie Pocius

Related Information:

Heart Muscle Grown from Stem Cells May Help Doctors Test Treatments

Heart Muscle Made from Stem Cells Aids Precision Cardiovascular Medicine

Transcriptome Profiling of Patient-Specific Human iPSC-Cardiomyocytes Predicts Individual Drug Safety and Efficacy Responses in Vitro

Heart Stem Cells for Individualized Medicine in Cardiology

Stem Cells Create Faithful Replicas of Native Tissues, According to Stanford Study

CRISPR/Cas9 and Targeted Genome Editing: A New Era in Molecular Biology

Read the original:
Pathologists and Clinical Laboratories May Soon Have a Test for Identifying Cardiac Patients at Risk from Specific … – DARKDaily.com – Laboratory…

‘Beating’ Heart Created from Stem Cells – Technology Networks

Scientists at The University of Queensland have taken a significant step forward in cardiac disease research by creating a functional beating human heart muscle from stem cells.

Dr James Hudson and Dr Enzo Porrello from the UQ School of Biomedical Sciences collaborated with German researchers to create models of human heart tissue in the laboratory so they can study cardiac biology and diseases in a dish.

The patented technology enables us to now perform experiments on human heart tissue in the lab, Dr Hudson said.

This provides scientists with viable, functioning human heart muscle to work on, to model disease, screen new drugs and investigate heart repair.

The UQ Cardiac Regeneration Laboratory co-leaders have also extended this research and shown that the immature tissues have the capacity to regenerate following injury.

In the laboratory we used dry ice to kill part of the tissue while leaving the surrounding muscle healthy and viable, Dr Hudson said.

We found those tissues fully recovered because they were immature and the cells could regenerate in contrast to what happens normally in the adult heart where you get a dead patch.

Our goal is to use this model to potentially find new therapeutic targets to enhance or induce cardiac regeneration in people with heart failure.

Studying regeneration of these damaged, immature cells will enable us to figure out the biochemical events behind this process.

Hopefully we can determine how to replicate this process in adult hearts for cardiovascular patients.

Each year, about 54,000 Australians suffer a heart attack, with an average of about 23 deaths every day.

The UQ research has been supported by the National Health and Medical Research Council (NHMRC) and the National Heart Foundation.

Heart Foundation Queensland CEO Stephen Vines said the charity was excited to fund such an important research project.

Heart attack survivors who have had permanent damage to their heart tissue are essentially trying to live on half an engine, Mr Vines said.

The research by Dr Hudson and Dr Porello will help unlock the key to regenerating damaged heart tissue, which will have a huge impact on the quality of life for heart attack survivors.

Dr Hudson and Dr Porello are deserved recipients of our highest national research accolade the Future Leader Fellowship Award.

Reference:

Tiburcy, M., Hudson, J. E., Balfanz, P., Schlick, S. F., Meyer, T., Liao, M. C., . . . Zimmermann, W. (2017). Defined Engineered Human Myocardium with Advanced Maturation for Applications in Heart Failure Modelling and Repair. Circulation. doi:10.1161/circulationaha.116.024145

This article has been republished frommaterialsprovided by University of Queensland. Note: material may have been edited for length and content. For further information, please contact the cited source.

More here:
‘Beating’ Heart Created from Stem Cells – Technology Networks

Stem Cell Cardiac Toxicity Model for Testing Chemotherapy Agents – Technology Networks

A team of scientists has developed a new safety index for a common group of chemotherapy drugs, by using a stem cell model to screen such therapies for their potential to damage patients hearts.

The study, published in Science Translational Medicine, was co-authored by Paul Burridge, PhD, assistant professor of Pharmacology.

Tyrosine kinase inhibitors (TKIs), a class of chemotherapy drugs, have become increasingly important in treating many types of cancer. But almost all TKIs are also associated with cardiovascular side effects ranging from arrhythmias to heart failure and there has not yet been an effective tool to predict this cardiotoxicity.

In the current study, the scientists demonstrated that human-induced pluripotent stem cells can be used to model how TKIs might affect the hearts of patients receiving chemotherapy.

To do so, the scientists took stem cells from both a control group and patients with cancer and reprogrammed them to become cardiomyocytes, or heart muscle cells. Using high-throughput screening, they then evaluated how the heart cells responded to treatment with 21 different FDA-approved TKIs, looking at factors like cell survival, signaling and alterations in their ability to beat properly.

With the stem-cell data, the scientists were able to create a cardiac safety index, which ranks the TKIs on their likelihood of inflicting heart damage. That index correlates with the toxicity that has been observed in patients clinically a validation that suggests the screening system might be a powerful tool in predicting toxicity before therapies are ever administered to patients.

Future research could establish even more specific predictions, by comparing the genomes of patients who might experience a certain drug side effect, such as atherosclerosis, with those who dont. Long-term, what my lab is interested in is taking a patients whole genome and, based on the work weve done in the past, being able to predict whether a patient will have an adverse drug event, said Burridge, also a member of the Robert H. Lurie Comprehensive Cancer Center of Northwestern University. This is the whole idea of pharmacogenomics, or precision medicine: Everyone is going to have a different response to a drug, and that response good or bad is already encoded in all of us.

In the study, the scientists also discovered that administering insulin or insulin-like growth factor 1 alongside TKIs seemed to protect against some of the heart damage associated with the drugs. While its still early, this is the first step toward opening up a whole new field of identifying cardioprotectants to reduce the toxicity of these drugs, Burridge said.

This article has been republished frommaterialsprovided byNorthwestern University, Feinberg School of Medicine. Note: material may have been edited for length and content. For further information, please contact the cited source.

Excerpt from:
Stem Cell Cardiac Toxicity Model for Testing Chemotherapy Agents – Technology Networks

Self-repairing heart tissue breakthrough brings hope for cardiac patients – ABC Online

Updated March 17, 2017 13:31:00

Queensland researchers have used stem cells to create a beating human heart muscle, as well as heart tissue that is able to repair itself.

Doctors James Hudson and Enzo Porello from the University of Queensland worked with German researchers to create the samples in a laboratory, and will use them to study cardiac biology and diseases.

“The patented technology enables us to now perform experiments on human heart tissue,” Dr Hudson said.

Up until now researchers have had no “living” tissue to study, but now scientists have a viable, functioning heart muscle to work on.

Dr Hudson said it would help them model the cardiovascular disease, screen new drugs and investigate heart repair.

“Immature tissues were found to have the ability to regenerate following injury something that did not occur naturally for adults,” he said.

“In the laboratory we used dry ice to kill part of the tissue while leaving the surrounding muscle healthy and viable.

“We found that when we injured those tissues in contrast to what happens normally in the heart where you get a ‘dead’ patch muscle function fully recovered because the cells regenerate.

“Our goal is to use this model to potentially find new therapeutic targets to enhance or induce cardiac regeneration in people with heart failure.”

While the researchers have grown samples of beating heart tissue, they are not full size.

Dr Hudson said they were about 1 centimetre long and 1 millimetre wide.

He said about 54,000 Australians had heart attacks each year, with an average of about 23 deaths a day.

“Current pharmaceuticals can help those people in the shorter term, however some of those patients still progress to heart failure,” Dr Hudson said.

“The holy grail goal of all this is to come up with new regenerative therapeutics to cure those patients.”

The research team hopes to commercialise the technology, which it believes will help save lives.

The project has been supported by the National Health and Medical Research Council (NHMRC) and the National Heart Foundation.

Topics: medical-research, health, diseases-and-disorders, heart-disease, science-and-technology, research, qld, university-of-queensland-4072, australia

First posted March 17, 2017 13:11:06

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Self-repairing heart tissue breakthrough brings hope for cardiac patients – ABC Online

Scientists create ‘beating’ human heart muscle for cardiac research – UQ News

Scientists at The University of Queensland have taken a significant step forward in cardiac disease research by creating a functional beating human heart muscle from stem cells.

Dr James Hudson and Dr Enzo Porrello from the UQ School of Biomedical Sciences collaborated with German researchers to create models of human heart tissue in the laboratory so they can study cardiac biology and diseases in a dish.

The patented technology enables us to now perform experiments on human heart tissue in the lab, Dr Hudson said.

This provides scientists with viable, functioning human heart muscle to work on, to model disease, screen new drugs and investigate heart repair.

The UQCardiac Regeneration Laboratoryco-leaders have also extended this research and shown that the immature tissues have the capacity to regenerate following injury.

In the laboratory we used dry ice to kill part of the tissue while leaving the surrounding muscle healthy and viable, Dr Hudson said.

We found those tissues fully recovered because they were immature and the cells could regenerate in contrast to what happens normally in the adult heart where you get a dead patch.

Our goal is to use this model to potentially find new therapeutic targets to enhance or induce cardiac regeneration in people with heart failure.

Studying regeneration of these damaged, immature cells will enable us to figure out the biochemical events behind this process.

Hopefully we can determine how to replicate this process in adult hearts for cardiovascular patients.

UQ scientists create beating human heart muscle from The University of Queensland on Vimeo.

Each year, about 54,000 Australians suffer a heart attack, with an average of about 23 deaths every day.

The UQ research has been supported by the National Health and Medical Research Council (NHMRC) and the National Heart Foundation.

Heart Foundation Queensland CEO Stephen Vines said the charity was excited to fund such an important research project.

Heart attack survivors who have had permanent damage to their heart tissue are essentially trying to live on half an engine, Mr Vines said.

The research by Dr Hudson and Dr Porello will help unlock the key to regenerating damaged heart tissue, which will have a huge impact on the quality of life for heart attack survivors.

Dr Hudson and Dr Porello are deserved recipients of our highest national research accolade the Future Leader Fellowship Award.

The research is published in Circulation and Development.

Media: Dr James Hudson, j.hudson@uq.edu.au; Kim Lyell, k.lyell@uq.edu.au, 0427 530 647.

More here:
Scientists create ‘beating’ human heart muscle for cardiac research – UQ News

Belgium’s Tigenix says heart attack stem cell trial successful – Reuters

BRUSSELS Belgian biotech group Tigenix said on Monday its medical trial with a novel treatment for patients at risk of heart failure after a coronary attack was successful.

The group said patients treated in its PhaseI/II trial of donor-derived expanded cardiac stem cells (AlloCSC) showed no side-effects and all of them continued to live after 30 days, six months and a year.

Tigenix added that in one subgroup of trial patients associated with a poor long-term outlook, there was a larger reduction in the size of infarction, tissue death due to inadequate blood supply.

“This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree,” one of the doctors in the trial said.

The group said it would now analyze the data from the trial and decide on how to proceed with its research.

(Reporting by Robert-Jan Bartunek; editing by Philip Blenkinsop)

A South Dakota state judge has ordered ABC Broadcasting to face a potential $5.7 billion defamation lawsuit claiming it damaged Beef Products Inc by referring in a series of reports to a meat product it sold as “pink slime.”

ZURICH Novartis has won U.S. Food and Drug Administration approval for Kisqali to treat postmenopausal women who have a difficult-to-treat form of breast cancer, challenging U.S. rival Pfizer’s Ibrance.

Employees of Monsanto Co ghostwrote scientific reports that U.S. regulators relied on to determine that a chemical in its Roundup weed killer does not cause cancer, farmers and others suing the company claimed in court filings.

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Belgium’s Tigenix says heart attack stem cell trial successful – Reuters

Cardiac researcher Milica Radisic to present keynote address at Libin Institute’s Cardiac Research Day – UCalgary News

Milica Radisic, PhD,knew she’d found her scientific niche when she read about tissue engineering as an undergrad. This year’s Libin InstituteTine Haworth Cardiovascular Research Day keynote speaker hopes her work will guide healing and tissue regeneration in the body and works to help her students become successful in their careers.

Radisic is a professor at the University of Toronto and Canada Research Chair in Functional Cardiovascular Tissue Engineering (Tier 2). She will be presenting the Dr. E.R. Smith Lecture in Cardiovascular Research April 6, on bioengineering functional tissues for drug discovery and therapy.

Q: How did you become interested in research as a career?

A: I have been interested in science since I was a child, probably since I was in elementary school. It was just the question about what exactly in science I would do. At the end of my undergraduate degree at McMaster, I read an article in the Scientific American about tissue engineering, an emerging field at that time. It was clear to me at that moment that I had found the area I would like to work in as a scientist.

Q: Tell us about your research.

A: The long-term objective of my research is to enable cardiovascular regeneration through tissue engineering and development of new biomaterials. We are working with human-induced pluripotent stem cells (iPSC) as a source of beating heart cells for our engineered tissues. We are designing new biomaterials to guide cellular response, and we are investigating methods to make both cardiac muscle and vasculature. This work relies heavily on controlling cell environment through microfabrication. My research interests also include microfluidic cell separation and development of in vitro models for drug testing.

Q: Your current research focuses on tissue engineering. How will it help people?

A:It is not possible to take a biopsy from a human heart and make more beating heart cells from the biopsy. This is a big problem in drug discovery, as pharma uses cell lines and animal models that are not fully predictive of the human heart muscle response. Using the methods developed in my lab, it is now possible to make a human heart tissue starting from iPSC for drug discovery and safety testing. These models are already being used by pharma companies through our startup company TARA Biosystems.

Q:What are your ultimate career/research goals?

A:My goals are to provide better healthy and diseased human tissue models for discovery, as well as to develop new biomaterials that can guide healing and regeneration in the body.

Q:What is your favourite thing about being with students?

A:Working with grad students is the best part of my job. As my former chair, Dr. Doug Reeve, said, You are surrounded by young people who are focused on self-improvement. This is really unique to an academic position. Our students are young, energetic, creative, they have outstanding ideas and they want to succeed. It is really fantastic to be surrounded by them. They keep me young, and it is really for them that I work as hard as possible to enable their career success.

Q:What is the best piece of advice you would give to up-and-coming researchers?

A:To work on really important (and hard) problems that have not been solved. I think those projects give us the best returns.

Getmore information on the Libin Institutes Cardiovascular Research Day and register for a free ticket. Milica Radisics presentation will be on bioengineering functional tissues for drug discovery and therapy.

The Libin Institutes Tine Haworth Cardiovascular Research Day is an annual event thatshowcases cutting-edge cardiovascular research presentations from external and internal speakers.The day also consists of a poster competition, TOD talks from Libin Institute trainees andspeakers, and the Dr. E.R. Smith Lecture in Cardiovascular Research, named in honour of the former dean of the Cumming School of Medicine, Dr. Eldon Smith.

Original post:
Cardiac researcher Milica Radisic to present keynote address at Libin Institute’s Cardiac Research Day – UCalgary News

Woodrose Ventures Corporation Announces Proposed Acquisition … – Marketwired (press release)

VANCOUVER, BRITISH COLUMBIA–(Marketwired – March 13, 2017) –

NOT FOR DISSEMINATION IN THE UNITED STATES

Editors Note: There is a photo associated with this press release.

Woodrose Ventures Corporation (TSX VENTURE:WRS.H) (“Woodrose” or the “Company”) is pleased to announce that it has entered into an agreement (the “Agreement”) dated March 10, 2017 to acquire all of the shares of Novoheart Holdings Ltd. (“Novoheart”), a global stem cell biotechnology company dedicated to human heart engineering (the “Transaction”). Novoheart develops products and provides services focused on engineering prototypes of bio-artificial human heart tissues and chambers for drug discovery, cardiotoxicity screening, disease modelling and therapeutic applications.

The Transaction will constitute a “reverse-takeover” of Woodrose in accordance with the policies of the TSX Venture Exchange (the “TSXV”) and the reactivation of Woodrose, which is currently a NEX-listed issuer.

About Novoheart

Novoheart is a global stem cell biotechnology company headquartered in Hong Kong with R&D Innovation Centres being set up in the United States. Novoheart’s mission is to revolutionize drug discovery and the development of heart therapeutics with its range of proprietary bioengineered human heart constructs, collectively known as the MyHeart platform, and to further develop them into transplantable heart grafts for cell-based regenerative therapies with superior safety and efficacy. Its scientific team has pioneered a range of best-in-class bioengineering technologies and constructed the world’s first human mini-heart “novoHeart” with which the Novoheart team intends to revolutionize:

1) Pre-clinical drug discovery, cardiotoxicity screening and heart disease modelling;

2) Post-discovery, clinical development of novel therapeutics; and

3) Pre-clinical and clinical development of cell-based cardiac regenerative therapies.

Novoheart’s immediate focus is to innovate and accelerate the lengthy, expensive and inefficient drug development process. The development of a new drug candidate typically costs US$2-4bn and takes 10+ years (Tufts Centre for the Study of Drug Development, Tufts CSDD R&D Cost Study 2014) with extremely poor success rates of

Novoheart’s intellectual property portfolio, including the human “heart-in-a-jar” (novoHeart) and other related next-generation technologies of the MyHeart platform (see figure below) are unique solutions that help bridge the gap between pre-clinical and clinical drug trials. The MyHeart platform provides advanced human heart surrogates for pre-screening of drug formulas and the elimination of toxic compounds early on in the drug development process, minimizing the risk towards patients. Significantly, the MyHeart Platform provides real time data on the effects of drug formulations enabling drug development companies to undertake “on-the-fly” reformulation of drug candidates to optimize efficacy and toxicological profiles. With Novoheart’s technologies, we aim to significantly reduce pre-clinical R&D time and costs, and importantly, improve trial successes. It is anticipated that drug screening results using Novoheart’s human engineered tissues would be accepted as reliable indicators for toxicity and efficacy, thereby qualifying the test compounds for accelerated drug development.

Novoheart adopts a hybrid business model by:

These products and services are designed to significantly reduce the time, cost, and use of animal models, as well as improve patient safety, and facilitate pharmaceutical discovery and development. Novoheart is currently working with leading academic and pharmaceutical partners to innovate drug discovery and toxicity screening protocols. Our targeted clients are pharmaceutical companies, government units, and research institutions.

Novoheart was incorporated in 2014 pursuant to the laws of British Virgin Islands (BVI) and its controlling shareholder is Medera Group Limited, a BVI entity. Novoheart has one wholly owned Hong Kong subsidiary “Novoheart Limited” (“Novoheart Hong Kong”) which is the group operating entity.

Novoheart Hong Kong was incorporated in January 2014 by founder and CEO Prof. Ronald Li, with scientific co-founders Prof. Kevin Costa and Prof. Michelle Khine.

Novoheart’s foundational technologies are the direct outcome of over 15 years of research effort supported by R&D investments amounting to approximately USD30MM. These research efforts, performed at Johns Hopkins University, Icahn School of Medicine at Mount Sinai, University of California Irvine, University of California Davis, and the University of Hong Kong by our scientific founders, have received major recognitions such as American Heart Association’s Best Study of 2005, Ground-breaking Study of 2006, and Late-breaking Studies of 2002, 2003, 2005 and 2007, and the Spirit of Hong Kong Innovating for Good Award in 2015. The “human-heart-in-a-jar” technology was selected by Google’s Solve For X as a Moonshot Project in 2015.

Novoheart’s scientific founders and advisors are renowned pioneering leaders in the stem cell and cardiac space, with a successful track record in developing and commercializing ground-breaking technologies. In September 2014, Novoheart established its R&D base and office in the Hong Kong Science Park, where it continues to innovate solutions for drug discovery and human heart tissue engineering.

In December 2014, Novoheart signed a strategic partnership with a major global pharmaceutical company (the “Global Pharma Partner”) headquartered in New York City to validate the MyHeart platform. The success of this validation process has resulted in follow on income-generating projects.

In January 2015, Novoheart’s R&D proposal to develop bio-artificial heart tissues for drug screening received 50/50 matched funding from the Innovation & Technology Commission (ITC) of the Government of Hong Kong, with a total project cost of over HK$21MM over 2 years. It was also the largest biotech project granted by ITC for that year. Novoheart owns all of the intellectual property generated from this project, and as a result of the R&D, Novoheart has applied or is in the application process for 3 new patents covering newly developed technology, including the human ventricular cardiac anisotropic sheet (hvCAS) as a powerful tool for detecting drug-induced arrhythmias with the results published in the prestigious international peer-reviewed bioengineering journal Advanced Materials (Shum et al. 2017, Advanced Materials, 29). Additionally, Novoheart holds exclusive worldwide licenses or options to acquire the same for technologies that constitute its MyHeart platform and future developments.

In December 2015, Novoheart signed a second contract with the Global Pharma Partner to build disease-specific engineered human heart tissues and chambers for drug discovery. The total project cost is US$726,000 over 1.5 years.

In February 2017, the Corporate Venture Fund (CVF) of the Hong Kong Science and Technology Parks Corporation (HKSTPC) completed an equity investment of approximately US$250,000 into Novoheart and an additional investment would be made at the Transaction.

Novoheart Financial Information

The following table includes a summary of certain financial information of Novoheart and is derived from its financial statements for the years ended June 30, 2016 and June 30, 2015.

Summary of the Transaction

Under the terms of the Agreement, the shareholders of Novoheart will receive an aggregate of 66,086,600 common shares of Woodrose on a post-Consolidation basis (see below) (“Woodrose Post-Consolidation Shares”). In addition, a finder’s fee of 2,313,038 Woodrose Post-Consolidation Shares will be paid to Cynosure Private Equity Limited in connection with the Transaction.

In connection with the Transaction, Woodrose intends to complete a consolidation of all its outstanding common shares on the basis of 3.56878449 old common shares for each one new common share (the “Consolidation”). In addition, Woodrose intends to complete a non-brokered private placement (the “Private Placement”) of 11,700,000 subscription receipts (“Subscription Receipts”) at a price of CDN$0.50 per Subscription Receipt to raise gross proceeds of CDN$5,850,000, which will be held in escrow in accordance with the terms of a subscription receipt agreement (the “Subscription Receipt Agreement”). It is anticipated that the Subscription Receipt Agreement will provide that, upon completion of the Transaction, each Subscription Receipt will automatically convert into one Woodrose Post-Consolidation Share. The Subscription Receipt Agreement will also provide that, in the event the Transaction is terminated or does not complete within an agreed timeframe, the Subscription Receipts will be cancelled and the funds will be returned to the holders. Woodrose may pay cash fees in an amount not to exceed 7% of the gross proceeds (to a maximum of $364,000) to certain finders involved in the Private Placement and may issue finder’s warrants (“Finder’s Warrants”), in an amount not to exceed 7% of the number of Subscription Receipts issued (to a maximum of 728,000 Finders Warrants) each of which would entitle the holder to acquire one Woodrose Post-Consolidation Share at a price of CDN$0.50 for a period of two years following closing of the Private Placement. All securities issued pursuant to the Private Placement will be subject to a statutory hold period of four months and one day.

The Company intends to use the net proceeds of the offering to finance investment in drug discovery and screening, establish commercial partnerships, expand the current laboratory, hire additional research and development team members and for working capital and general corporate purposes.

Upon completion of the Transaction, it is anticipated that the Company will be classified as a Tier 2 Technology Issuer on the TSXV and will change its name to “Novoheart Holdings (BC) Limited” or such other name as is acceptable to the Board of Directors. Closing of the Transaction (“Closing”) is subject to conditions precedent, that include, but are not limited to, the following:

The Transaction is an “arm’s length” transaction (as defined by the policies of the TSXV). Woodrose intends to rely an exemption from the sponsorship requirements of the policies of the TSXV.

Proposed Management Team

Upon closing of the Transaction, the following directors and senior officers are anticipated to be appointed in replacement of Woodrose’s current board and management:

Prof. Ronald Li, B.Sc. (Hons), Ph.D. (Proposed President, Chief Executive Officer and Director)

Prof. Ronald Li is a co-founder of Novoheart, and has been serving as the CEO since 2016. He is concurrently Director of Ming-Wai Lau Centre for Reparative Medicine, HK node, Karolinska Institutet (KI), Sweden, with a professorial cross appointment at the Dr. Li Dak-Sum Research Centre, The University of Hong Kong (HKU)-KI Collaboration in Regenerative Medicine of HKU. Prof. Li has been an advocate of stem cell technology for many years, starting from his career as Assistant Professor of Cardiology, and Cellular and Molecular Medicine at the Johns Hopkins University (JHU) School of Medicine. He founded and led the Human Embryonic Stem Cell Consortium when he was recruited in 2005 to become a tenured Associate Professor at the University of California, Davis, in light of state’s USD3-billion stem cell initiative Proposition 71. Prof. Li was the Founding Director of the Stem Cell & Regenerative Medicine Consortium (SCRMC) at the University of Hong Kong (HKU) from 2010 to 2015. He also co-directed the Section of Cardiovascular Cell & Tissue Engineering in Icahn School of Medicine at Mount Sinai with Prof. Kevin Costa. Prof. Li has received multiple accolades and recognitions during his career, including the Spirit of Hong Kong Innovating for Good Award by the South China Morning Post (2015), the Top Young Faculty Award (2002, 2004), the Top Prize for the Young Investigator Basic Research (2001) and Top Postdoctoral Fellow Helen Taussig Award (2001) of JHU School of Medicine, Young Investigator Award 1st Prize from the Heart Rhythm Society (2002), and the Career Development Award from the Cardiac Arrhythmias Research & Education Foundation (2001).

Prof. Li graduated with his B.S. with honors in Biotechnology from University of Waterloo, Ontario, on Dean’s List and his Ph.D. in Cardiology/Physiology at the University of Toronto.

Dr. Camie Chan, B.Sc. (Hons), M.Sc., Ph.D. (Proposed Chief Operating Officer and Director)

Dr. Camie Chan joined Novoheart Hong Kong as the Chief Operating Officer in 2016, after having served at HKU as the Deputy Director of the Faculty of Medicine Core Facility, a founding member of the Management Committee of the Stem Cell & Regenerative Medicine Consortium (SCRMC), and Assistant Professor in the Department of Anatomy, between 2010 and 2016. She has had extensive experience managing laboratory operations in her capacity at HKU, and her prior career as Assistant Professor at the University of California, Davis, and Assistant Investigator at the Shriners Hospital for Children. Dr. Chan is also a co-inventor of technology allowing mass production of human ventricular heart cells from pluripotent stem cells.

Dr. Chan graduated with her B.Sc. with honors at the University of Waterloo, followed by obtaining her M.Sc. degree in Medical Sciences and Ph.D. degree in Immunology at the University of Toronto, Canada. She then received postdoctoral training at the Sydney Kimmel Cancer Research Center at the Johns Hopkins University. She has garnered numerous awards in her career, including the prestigious National Institute of Allergy and Infectious Diseases (NIAID) Developmental Research Grant Award.

Prof. Kevin Costa, B.S., Ph.D. (Proposed Chief Scientific Officer)

Prof. Costa is Director of the Section of Cardiovascular Cell and Tissue Engineering at the Icahn School of Medicine at Mount Sinai in New York City. Prof. Costa was previously trained at the Johns Hopkins University and on the faculty as Associate Professor of Biomedical Engineering at Columbia University. As a “blue-blood” biomedical engineering (BME) expert (B.S. and M.S. in BME from Boston University, Ph.D. in BME from UC San Diego, and postdoc in BME from JHU and University of Washington) in cell and tissue biomechanics and cardiac tissue engineering, he has developed one of the first engineered cardiac tissue systems. Since 2009, he has been working with Prof. Ronald Li to translate such systems into human cells. Prof. Costa has received research funding from the Whitaker Foundation, the National Science Foundation (NSF) and the National Institutes of Health (NIH; NHLBI, NIBIB, and NIGMS). He was also a recipient of the prestigious Faculty Early Career Development (CAREER) Award from the NSF. Prof. Costa is an inventor of several cardiac tissue engineering technologies and one of the scientific co-founders of Novoheart Hong Kong.

Ms. Iris Lo, B. Comm. (Hons), CPA, CA (Proposed Chief Financial Officer)

Ms. Lo is a seasoned professional with expertise in corporate finance, mergers and acquisitions, accounting, and finance. Prior to joining Novoheart, Ms. Lo was the Director of Corporate Development & Analysis at Cardiome Pharma Corp., a Canadian public company dually listed on the TSX and NASDAQ (TSX: COM, NASDAQ: CRME). At Cardiome, she held responsibilities in equity and debt financing, corporate mergers and acquisitions, product licensing and distributions, financial planning and analysis, as well as regulatory and risk management. During her tenure at Cardiome, Ms. Lo participated in transactions totaling over US$240 million as Cardiome grew from a company with a market capitalization of US$25 million to over US$150 million at its peak. She brings with her valuable experience from the life sciences and pharmaceutical sector, as well as expertise in dealing with the complexities of operating and financing public corporations. Ms. Lo was also previously a Manager in the Transaction Services team at PwC Hong Kong and began her career articling with KPMG Vancouver. She is a Chartered Professional Accountant and holds a Bachelor of Commerce (Honours) from the Sauder School of Business at the University of British Columbia.

Mr. Victor Chang (Proposed Director)

Mr. Chang is a seasoned investor who has lately become focused on start-ups. Mr. Chang started his career with Lippo Securities Limited in 1996 and became a Director of Grand International Holdings Limited in 1999, which was engaged in general investments. During the period from 2007 to 2009, he was a Director and Responsible Officer for Astrum Capital Management Limited carrying out regulated activities under the Securities and Futures Ordinance (“SFO”, Cap. 571, Laws of Hong Kong) and with Murtsa Capital Partners Limited as well. During the period from 2007 to 2012, he was also a compliance consultant for Astrum Capital Management Limited. As co-founder and Managing Director of Zebra Strategic Outsource Solution, he has over 16 years of experience in recruitment process outsourcing, executive search as well as and private investment management. In Apil 2013, he successfully brought Zebra Strategic Holdings Limited which offers holistic HR solutions to IPO on the HK GEM board (Stock Code: 8260) and was re-designated as and is currently a Non-Executive Director with the company. He is currently a Director and Responsible Officer of Dakin Financial Group, a corporation licensed to carry out type 1, 2 & 9 regulated activity under the Hong Kong Securities and Futures Ordinance.

Mr. Tong Ricky Chiu (Proposed Director)

As a key founder and visionary for Grand Power Logistics Group Inc., which was listed on the TSX Venture Exchange (GPW.V) before its privatization in 2016, and Baoshinn International Express Ltd., Mr. Chiu adds value with his immense corporate development and growth skills. He received his education in Oxford University, England, and Beijing University, and began his career in Australia. He has a diversified background in a wide range of industries with roles in finance, audit, real estate, merchandise trading and travel, as well as logistics.

Mr. James Topham (Proposed Director)

Mr. Topham is an experienced executive with expertise in finance, accounting, auditing and entrepreneurial technology companies. He was an audit partner leading KPMG’s Technology Group in the Vancouver office for 20 years where he worked with many fast growing public companies and was involved in many M&A and IPO transactions in Canada, the US and Europe. Mr. Topham founded Social Venture Partners Vancouver in 2001 with a mission to strengthen the organizational capacity of innovative non-profits serving children in-need and youth at-risk. It has funded several million dollars and provided thousands of hours of executive time mentoring these local non-profits. Since retiring at KPMG 7 years ago, Mr. Topham has worked on several Boards of both public and private technology companies. He received a lifetime achievement award from the BC Technology Industry Association and was awarded the designation of Fellow Chartered Public Accountant (FCPA) from the Chartered Public Accountants of BC for his career achievements in the profession and community. He was a founder and Board member for 9 years of the BC Technology Industry Association that represents the technology industry in BC. Mr. Topham is a CPA and has a Bachelor of Commerce degree with Honours from the University of Saskatchewan graduating as the most distinguished graduate in the College of Commerce.

Mr. Allen Ma (Proposed Director)

As a 30-year technology industry veteran, Mr. Ma was the CEO of Hong Kong Science & Technology Parks before he retired in July 2016. He held senior executive positions within the information and communications technology sector. His past roles include president for Asia-Pacific at British Telecom, vice-president for Asia at the global telecom solutions sector of Motorola, executive director of Hong Kong Telecommunications – subsequently called Cable & Wireless HKT – and managing director of Hong Kong Telecom CSL. Ma holds an MBA from the University of Toronto and is a fellow member of both the Chartered Institute of Management Accountants, UK and the Association of Chartered Certified Accountants, UK. He is also a Certified Management Accountant of Canada.

Proposed Advisory Team

Novoheart is supported by a Scientific Advisory Board whose proposed composition consists of eminent scientists renowned in the fields of stem cells, cardiac biology and physiology, tissue engineering, and clinical cardiology including clinical trials research, from top academic research institutes in the U.S.A. Their technical expertise will guide the development of Novoheart as a forerunner in the application of cutting-edge technologies to develop new and better treatments for heart disease and beyond.

Further Details

Both the Company and Novoheart intend to work diligently to complete the conditions precedent to Closing and anticipate completion of the Transaction in the second quarter of 2017. The Company will update its shareholders with further details as they become available.

ON BEHALF OF WOODROSE VENTURES CORPORATION

Darren Devine, President, CEO and Director

NEITHER THE TSX VENTURE EXCHANGE NOR ITS REGULATION SERVICES PROVIDER (AS THAT TERM IS DEFINED IN THE POLICIES OF THE TSX VENTURE EXCHANGE) ACCEPTS RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

Completion of the Transaction is subject to a number of conditions, including but not limited to, Exchange acceptance and if applicable pursuant to Exchange requirements, majority shareholder approval. Where applicable, the Transaction cannot close until the required shareholder approval is obtained. There can be no assurance that the Transaction will be completed as proposed or at all.

Investors are cautioned that, except as disclosed in the Filing Statement to be prepared in connection with the Transaction, any information with respect to the Transaction may not be accurate or complete and should not be relied on. Trading in securities of the Company should be considered highly speculative.

The TSX Venture Exchange has in no way passed upon the merits of the Transaction and has neither approved nor disproved the contents of this news release.

Cautionary Note Regarding Forward-Looking Statements

Information set forth in this news release may involve forward-looking statements under applicable securities laws. Forward-looking statements are statements that relate to future, not past, events. In this context, forward-looking statements often address expected future business and financial performance, and often contain words such as “anticipate”, “believe”, “plan”, “estimate”, “expect”, and “intend”, statements that an action or event “may”, “might”, “could”, “should”, or “will” be taken or occur, or other similar expressions. All statements, other than statements of historical fact, included herein including, without limitation; statements about the terms and completion of the Transaction are forward-looking statements. By their nature, forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements, or other future events, to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following risks: failure to satisfy all conditions precedent to the Transaction, including shareholder approval, approval of the TSX Venture Exchange and completion of the necessary financings and the additional risks identified in the management discussion and analysis section of Woodrose Corporation’s interim and most recent annual financial statement or other reports and filings with the TSX Venture Exchange and applicable Canadian securities regulators. Forward-looking statements are made based on management’s beliefs, estimates and opinions on the date that statements are made and the respective companies undertakes no obligation to update forward-looking statements if these beliefs, estimates and opinions or other circumstances should change, except as required by applicable securities laws. Investors are cautioned against attributing undue certainty to forward-looking statements.

To view the photo associated with this press release, please visit the following link: http://www.marketwire.com/library/20170312-1088577_MyHeart_800.jpg

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Woodrose Ventures Corporation Announces Proposed Acquisition … – Marketwired (press release)

Daiichi Sankyo forges $12M pact for GPCR pain program with Heptares; Incyte shares jump on latest takeover chatter – Endpoints News

Heptares struck a $12 million deal to partner with Daiichi Sankyo on a new GPCR pain drug. The UK biotech gets $4 million upfront and $8 million in research support along with an unspecified set of milestones for the deal, in which the Sosei subsidiary will search for new drugs that can be developed for pain. Said CEO Malcolm Weir: We are confident that the unique structural insights of the receptor that our technologies can deliver combined with expertise on its role in pain from the Neurosciences team at Daiichi Sankyo will yield new, differentiated molecules that can be advanced into development.

Everybody loves a good takeover rumor. On Friday, it was Incytes turn again. The biotechs shares jumped Friday on buzz that Gilead was interested in acquiring the company, fast on the heels of an analysts report insisting that Gilead needed to do a deal, fast.

Belgiums TiGenix says that it gained some positive data in a Phase I/II cardiac stem cell study. Investigators say that a pre-specified subset of patients demonstrated a larger reduction in infarct size. This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left ventricular dysfunction, commented Professor Fernndez-Avils, head of the Department of Cardiology at the Hospital General Universitario Gregorio Maran.

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Daiichi Sankyo forges $12M pact for GPCR pain program with Heptares; Incyte shares jump on latest takeover chatter – Endpoints News

TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction – GlobeNewswire (press release)

March 13, 2017 02:00 ET | Source: TiGenix NV

multilang-release

PRESS RELEASE REGULATED INFORMATION INSIDE INFORMATION

TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction

Leuven (BELGIUM) – March 13, 2017, 07:00h CET – TiGenix NV (Euronext Brussels and Nasdaq: TIG), an advanced biopharmaceutical company focused on developing novel therapeutics from its two proprietary platforms of donor-derived expanded adipose derived stem cells (eASC) and donor-derived expanded cardiac stem cells (AlloCSCs), today announced top-line one-year results from the CAREMI clinical trial, an exploratory Phase I/II study of AlloCSCs in acute myocardial infarction (AMI).

CAREMI is the first-in-human clinical trial with the primary objective being safety and evaluating the feasibility of an intracoronary infusion of 35 million of AlloCSCs in patients with AMI and left ventricular dysfunction treated within the first week post-AMI. Importantly, the trial is the first cardiac stem cell study to integrate a highly discriminatory magnetic resonance imaging (MRI) strategy to select patients at increased risk of heart failure and late adverse outcomes. CAREMI was not powered to establish efficacy therefore no conclusion can be drawn on the secondary efficacy end-points.

The main findings of this study are:

“This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left ventricular dysfunction,” commented Professor Fernndez-Avils, Head of the Department of Cardiology at the Hospital General Universitario Gregorio Maran in Madrid (Spain), principal investigator on the trial in Spain. “It is especially encouraging that no cardiac or immunological side effects were observed.”

“This is the first study in which we have used a state of the art comprehensive MRI analysis to include patients with a large myocardial infarction in an innovative cell therapy protocol,” said Professor Janssens, Head of the Department of Cardiovascular Diseases, University Hospital, Leuven (Belgium), and principal investigator on the trial in Belgium. “Serial MRI analysis and extensive immunological profiling will allow us to further explore the encouraging signals we observed in cell treated patients with the worst MRI signature. These findings offer an exciting prospect for targeted follow-up studies in these high-risk patients.”

“Besides confirming the long term safety of the treatment these results suggest interesting opportunities in populations with high unmet medical need,” said Dr. Marie Paule Richard, Chief Medical Officer at TiGenix. “We look forward to working with our advisors to analyze the data in depth and determine the best way forward with AlloCSC-01 during the second half of this year.”

Full data results from the CAREMI study will be presented at an upcoming medical congress.

###

For more information

Claudia D’Augusta Chief Financial Officer

T: +34 91 804 92 64

claudia.daugusta@tigenix.com

About TiGenix

TiGenix NV (Euronext Brussels and Nasdaq: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived stem cell technology platform are currently in clinical development: Cx601 in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients; Cx611 which has completed a Phase I sepsis challenge trial and a Phase I/II trial in rheumatoid arthritis. Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product, AlloCSC-01, has concluded a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem cell-based platform acquired from Coretherapix, AlloCSC-02, is being developed in a chronic indication. On July 4, 2016, TiGenix entered into a licensing agreement with Takeda, a large pharmaceutical company active in gastroenterology, under which Takeda acquired the exclusive right to commercialize Cx601 for complex perianal fistulas outside the United States. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain). For more information, please visit http://www.tigenix.com.

About AlloCSC-01

AlloCSC-01 is a cellular product consisting of adult expanded allogeneic cardiac stem cells isolated from the right atrial appendages of donors, and expanded in vitro. Pre-clinical data has shown evidence of the strong cardio-protective and immune-regulatory activity of AlloCSC-01. In vivo studies suggest that AlloCSC-01 has cardio-reparative potential by activating endogenous regenerative pathways and by promoting the formation of new cardiac tissue. In addition, AlloCSC-01 has displayed a strong tropism for the heart enabling a high retention of cells in the myocardium after intracoronary administration.

About CAREMI

The CAREMI trial comprised two consecutive phases: an open-label dose-escalation phase (n=6) and a 2:1 randomized, double-blind, placebo-controlled phase (n=49). The objective of this clinical trial is to evaluate the safety and the efficacy of the cardiac stem cells product AlloCSC-01 in the acute phase of ischemic heart disease. The primary safety endpoint are all-cause mortality within 30 days and percentage of patients with major adverse cardiac events (MACE) within 30 days after treatment. MACE is a broader safety endpoint that covers all-cause mortality as well as new AMI, hospitalization due to heart failure, sustained ventricular tachycardia, ventricular fibrillation and stroke. Secondary safety endpoints include percentage of patients with MACE at 6 and 12 months after treatment, all-cause mortality at 12 months after treatment and percentage of patients with AE during the study. Secondary efficacy include MRI parameters (evolution of infarct size and evolution of biomechanical parameters) and clinical parameters (including the 6 minute walking test and the New York Heart Association scale). The CAREMI study has been conducted at the Hospital General Universitario Gregorio Maraon, Madrid, UZ Leuven, Hospital de Navarra, Hospital Clnico Universitario de Valladolid, Hospital Universitario de Donostia, Hospital Universitario de Salamanca, Hospital Clnico Universitario de Valencia, and Hospital Virgen de la Victoria de Mlaga. The CAREMI trial has benefitted from the support of the CARE-MI consortium (Grant Number 242038, http://www.caremiproject.eu/) funded by the Seventh Framework Programme of the European Commission under the coordination of the Centro Nacional the Investigaciones Cardiovasculares (CNIC) and the participation of research institutions and companies from nine EU countries.

Forward-looking information

This press release may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, “believes”, “anticipates”, “expects”, “intends”, “plans”, “seeks”, “estimates”, “may”, “will” and “continue” and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond the Company’s control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this press release. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in the Company’s expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.

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TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction – GlobeNewswire (press release)

Belgium’s Tigenix says heart attack stem cell trial successful – KFGO

Monday, March 13, 2017 3 a.m. CDT

BRUSSELS (Reuters) – Belgian biotech group Tigenix said on Monday its medical trial with a novel treatment for patients at risk of heart failure after a coronary attack was successful.

The group said patients treated in its PhaseI/II trial of donor-derived expanded cardiac stem cells (AlloCSC) showed no side-effects and all of them continued to live after 30 days, six months and a year.

Tigenix added that in one subgroup of trial patients associated with a poor long-term outlook, there was a larger reduction in the size of infarction, tissue death due to inadequate blood supply.

“This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree,” one of the doctors in the trial said.

The group said it would now analyze the data from the trial and decide on how to proceed with its research.

(Reporting by Robert-Jan Bartunek; editing by Philip Blenkinsop)

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TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction – P&T Community

TiGenix Announces Top-Line Phase I/II Results of AlloCSC-01 in Acute Myocardial Infarction
P&T Community
"This is the first trial in which it has been demonstrated that allogeneic cardiac stem cells can be transplanted safely through the coronary tree, and in the worst possible setting represented by patients with an acute heart attack with left

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VistaGen Therapeutics Inc. (Nasdaq: VTGN) to Ring The Nasdaq … – GlobeNewswire (press release)

March 10, 2017 15:16 ET | Source: NASDAQ, Inc.

ADVISORY, March 10, 2017 (GLOBE NEWSWIRE) —

What:VistaGen Therapeutics Inc. (Nasdaq:VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, will visit the Nasdaq MarketSite in Times Square.

In honor of the occasion, Shawn K. Singh, CEO & Director, will ring the Closing Bell.

Where:Nasdaq MarketSite 4 Times Square 43rd & Broadway Broadcast Studio

When:Monday, March 13, 2017 3:45 p.m. to 4:00 p.m. ET

VistaGen Contact:Mark A. McPartland (650) 577-3600 IR@vistagen.com

Nasdaq MarketSite:Emily Pan (646) 441-5120 emily.pan@nasdaq.com

Feed Information:Fiber Line (Encompass Waterfront): 4463

Gal 3C/06C 95.05 degrees West 18 mhz Lower DL 3811 Vertical FEC 3/4 SR 13.235 DR 18.295411 MOD 4:2:0 DVBS QPSK

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Webcast: A live stream of the Nasdaq Closing Bell will be available at: https://new.livestream.com/nasdaq/live or http://www.nasdaq.com/about/marketsitetowervideo.asx

Photos: To obtain a hi-resolution photograph of the Market Close, please go to http://business.nasdaq.com/discover/market-bell-ceremonies and click on the market close of your choice.

About VistaGenVistaGen Therapeutics, Inc.(NASDAQ:VTGN), is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders. VistaGen’s lead CNS product candidate, AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development. AV-101’s mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the U.S. National Institute of Mental Health (NIMH)in a Phase 2a monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 280-patient Phase 2b study of AV-101 as an adjunctive treatment for MDD patients with inadequate response to standard, FDA-approved antidepressant therapies. Dr. Maurizio Fava of Harvard University will be the Principal Investigator of the Phase 2b study. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including chronic neuropathic pain, epilepsy, Parkinson’s disease and Huntington’s disease, where modulation of the NMDAR, AMPA pathway and/or key active metabolites of AV-101 may achieve therapeutic benefit.

VistaStem Therapeutics is VistaGen’s wholly owned subsidiary focused on applying human pluripotent stem cell(hPSC)technology, internally and with third-party collaborators, to discover, rescue, develop and commercialize proprietary new chemical entities(NCEs),including small molecule NCEs with regenerative potential, for CNS and other diseases, and cellular therapies involving stem cell-derived blood, cartilage, heart and liver cells. In December 2016, VistaGen exclusively sublicensed to BlueRock Therapeutics LP, a next generation regenerative medicine company established by Bayer AG and Versant Ventures, rights to certain proprietary technologies relating to the production of cardiac stem cells for the treatment of heart disease.

For more information, please visitwww.vistagen.comand connect with VistaGen onTwitter,LinkedInandFacebook.

About NasdaqNasdaq (Nasdaq:NDAQ) is a leading provider of trading, clearing, exchange technology, listing, information and public company services across six continents. Through its diverse portfolio of solutions, Nasdaq enables clients to plan, optimize and execute their business vision with confidence, using proven technologies that provide transparency and insight for navigating today’s global capital markets.As the creator of the world’s first electronic stock market, its technology powers more than 85 marketplaces in 50 countries, and 1 in 10 of the world’s securities transactions. Nasdaq is home to approximately 3,800 listed companies with a market value of $10.1 trillion and nearly 18,000 corporate clients. To learn more, visit: business.nasdaq.com.

-NDAQA-

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VistaGen Therapeutics Inc. (Nasdaq: VTGN) to Ring The Nasdaq … – GlobeNewswire (press release)

Cardiac research nets Holly Mewhort prestigious heart association award – UCalgary News

Numerous people may say they want to grow up to be a heart surgeon, but very few actually achieve that goal. Holly Mewhort, MD, PhD, is one who has done so. And thats not the only thing Mewhort, who is part of the Libin Cardiovascular Institute of Albertas cardiac surgical residency program, has accomplished.

She has also excelled in basic and translational research. She recently received international recognition for her work in cardiac research, winning the Vivien Thomas Young Investigator Award from the American Heart Association, a prestige award given to early investigators who are focusing on fundamental and applied surgical research.

That research was done as part of her PhD program, which she completed in June 2016 under the supervision of Libin Institutes Paul Fedak, MD, PhD. Fedak is a cardiac surgeon and basic/translational researcher who directs the Marlene and Don Campbell Family Cardiac Research Laboratory at the Cumming School of Medicine.

Research shows biomaterial can trigger healing in damaged heart muscle

Mewhorts research investigates the use of biomaterial in regenerating and restoring heart tissue in patients who had previously suffered a heart attack. The material, CorMatrix-ECM, is a connective tissue matrix surgically applied to damaged heart tissue to trigger healing.Mewhort describes the material as providing the scaffolding that holds cells together and influences their behaviour and survival.

Her research in this area began four years ago in the lab and has had great success. In preclinical trials, the project has shown that this bio-material can restore function to damaged heart muscle by promoting the formation of new blood vessel networks a process called vasculogenesis.

The investigators have completed a pilot clinical trial, which saw the patch applied to the heart tissue of a handful of patients during coronary bypass surgery. The results havent been published yet, but the data looks promising.

Mewhort is thrilled to be part of a research project that has been successfully translated from bench to bedside. If it works at the clinical trial level, this could be a game-changer for patients who have suffered a heart attack, she says, noting until now, there hasnt been a way of restoring function to damaged heart tissue in those patients.

Cardiac surgery research program is ‘cutting edge’

Its also exciting for Mewhort to win the same award her mentor, Dr. Paul Fedak, received 14 years ago. He was also a cardiac surgery trainee pursuing a PhD, investigating stem cell regeneration of heart tissue. The fact that two researchers connected with the University of Calgary earned the same international award is impressive, as competition is stiff. Past winners have studied at such institutions as the University of Toronto, Duke and Stanford.

Fedak, who studied at the University of Toronto, was recruited to come to Calgary about a decade ago and has since set up a cutting-edge cardiac surgery research program. Mewhort is the first PhD graduate of his laboratory. As her mentor, Fedak, who, besides being an academic researcher is a full-time clinical heart surgeon, is pleased to see the program turning out well-respected young academic surgical scientists.

He says Mewhorts award fulfils another career goal, explaining that when he won the Vivien Thomas Young Investigator Award his desire became to see one of his students do the same. For Fedak, the award signifies the coming-of-age of academic cardiac surgeon training in Calgary.

This shows us how far we have come with our program, he says.

Receiving her mentors praise is a big deal for Mewhort, as Fedak was one of the reasons she chose to pursue her surgery training and PhD in Calgary. Mewhorts future looks bright as she continues her residency in cardiac surgery on campus with the ultimate goal of having an active surgical and research career, much like her mentor.

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Cardiac research nets Holly Mewhort prestigious heart association award – UCalgary News

TiGenix Announces Positive Topline Week-104 Data for Cx601 ADMIRE-CD Trial – P&T Community

TiGenix Announces Positive Topline Week-104 Data for Cx601 ADMIRE-CD Trial
P&T Community
Effective July 31, 2015, TiGenix acquired Coretherapix, whose lead cellular product candidate, AlloCSC-01, is currently in a Phase II clinical trial in Acute Myocardial Infarction (AMI). In addition, the second product candidate from the cardiac stem

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Robert Clayton Robbins Top Choice for UA President – Arizona Public Media

Robert Clayton Robbins, head of the Texas Medical Center, was named Tuesday as top choice for president of the University of Arizona.

The Board of Regents selected Robbins in Phoenix following interviews with him and one other candidate Monday.

Robbins will meet the campus community and the public at a forum Wednesday afternoon. The regents will vote next week formally to make him an offer, and contract negotiations will begin. A final vote on the contract is expected April 6, based on a timeline the regents released last week.

Robbins, who serves as president and chief executive officer at the Texas Medical Center, said at a press conference Tuesday he was eager to get on the road to Tucson. He said his top priority will be the UA’s students.

“I look forward to meeting them, working with them, and helping them be prepared for this new world that were living in now,” he said. “Its changing rapidly, and as the university family weve got to treat each one of them like our own children and help them be prepared for not just the four years they spend on campus, but the next 40 years of their life.”

The announcement was delayed by more than an hour late Tuesday afternoon as members of the Board of Regents met privately to select their top candidate. Regent Bill Ridenour, who headed the search committee, said the delay was not a sign of disagreement.

“We just wanted to be very thorough,” Ridenour said. “When you get nine people in a room that have differing thoughts, you want to make sure that you give those people every opportunity because its important, we think, that we be unanimous. So we are, and we are, and were excited.”

Robbins is a cardiac surgeon who joined the Texas Medical Center as its president and CEO in 2012. In that time, he introduced five research initiatives centered on innovation, genomics, regenerative medicine, health policy and clinical research. The Texas Medical Center is the largest medical complex in the world, a press release said.

Dr. Robbins comprehensive experience as both a visionary leader and highly-respected physician, as well as his evident talent for advancing research, innovation, entrepreneurship and economic development will serve the University of Arizona and our state well, regents’ President Eileen Klein said in a press release.

As a surgeon, Robbins has focused on acquired cardiac diseases with a special expertise in the surgical treatment of congestive heart failure and cardiothoracic transplantation. His research work includes the investigation of stem cells for cardiac regeneration.

The other finalist was Sethuraman Panch Panchanathan, executive vice president and chief research and innovation officer at Arizona State University.

Current UA President Ann Weaver Hart will step down after her successor is chosen. Hart will take a one-year sabbatical leave and return to the UA as a professor in the College of Education.

She became the university’s first female president in 2012 and announced last year she would not seek renewal of her contract in 2018.

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Robert Clayton Robbins Top Choice for UA President – Arizona Public Media

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