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Synchroneuron Featured in BioWorld Insight Article on Tardive Dyskinesia

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By Brian Orelli, Contributing Writer

August 18, 2014

Companies in Race to Bring Tardive Dyskinesia Therapy to Market

Nearly 60 years after tardive dyskinesia (TD) was recognized as a disease, patients may soon have a drug approved to treat their involuntary movements. In fact, there could potentially be as many as three drugs approved. Synchroneuron Inc., Neurocrine Biosciences Inc. and Auspex Pharmaceuticals Inc. all have drugs in pivotal trials to treat TD.

The disease manifests itself in a variety of involuntary movements, typically of the lower face. Depending on the severity of the disease, it can cause problems eating and potentially interfere with employment.

“This isn’t simply a cosmetic issue. It can be a very debilitating neurologic condition,” Pratik Shah, CEO of Auspex, told BioWorld Insight.

LHS Gains Coverage for Tyrogenex in Premier Financial, Biotech Pubs

Xcovery Tyrogenex LHS

LaVoieHealthScience helped Tyrogenex, an Xcovery Group company based in West Palm Beach, Fla., announce a $15M Series D fund raise. As the investor in the round, Brace Pharma, which is the U.S.-based investment arm of EMS S/A - the largest drug developer in Brazil and the second-largest drug company in Latin America, became the first institutional investor in the Xcovery companies. The news gained coverage from DowJones VentureWire, the Sun Sentinel daily newspaper of South Florida, BioWorld and BioCentury, reaching the company’s local business community as well as premier financial and biotech pubs.

DowJones VentureWire (subscription service) covered the news, saying, “Brace is looking toDow Jones Venture Wire back therapies that are targeted at unmet medical needs, and address a potential annual market of $200 million.” The funding supports Tyrogenex’ planned Phase II trials for X-82, a small-molecule therapeutic that can inhibit kinases related to cancer and age-related macular degeneration. “X-82, could one day be offered as an oral alternative to drugs like Avastin and Lucentis, which today are taken by injection,” Tyogenex VP Cheryl Calhoun told DowJones.

describe the imageThe Sun-Sentinel detailed how X-82 is better tolerated by patients at higher doses than existing drugs for wet age-related macular degeneration. “At higher doses, researchers found dramatic reductions in fluid in the retina,” the daily newspaper reported. The paper quoted: "It would eliminate those painful monthly injections." 

Synchroneuron Nets $20M to Combat Drug-Induced Movement Disorder

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Ben Fidler7/2/14Follow @benthefidler

With a few tweaks, Synchroneuron believes it’s been able to turn an old, flawed drug for alcoholism into a new one for a completely different disorder. Now the Waltham, MA-based startup has just banked a big round of cash to go prove it in clinical trials.

Synchroneuron is announcing today that it’s raised a $20 million Series B round of equity financing, all from its sole backer, Hong Kong investment firm Morningside Technology Ventures. The cash will help Synchroneuron get to a key point in its development. SNC-102—the souped-up formulation of the alcoholism drug acamprosate calcium the company is developing to treat a debilitating movement disorder called tardive dyskinesia (TD)—is currently in a Phase 2 study.

By the time that study produces results in the first quarter of 2015, Synchroneuron will have a good read on whether or not it has a potential drug—and where it stands compared to San Diego-based Neurocrine Biosciences (NASDAQ: NBIX), which is developing a rival treatment for the diseaseand is further along in development.

“We think [there’s] going to be good news, but the question is how good,” says scientific founder Barry Fogel, of the mid-stage trial. “We’d be quite surprised if we see no benefit, and we’d be shocked if we saw adverse effects because the safety record for this drug is so impressive.”

The winner gets the first crack at an FDA-approved drug for TD, a debilitating disorder characterized by involuntary, repetitive movements—primarily of the lips, tongue, or jaw— tied to the chronic use of certain antipsychotic drugs that block dopamine. For most people, the disorder is irreversible. Around 300,000 people in the U.S. are affected with severe forms of TD, and they’re typically treated either with preventative measures—like lowering the doses of their antipsychotics—or with other drugs like calcium channel blockers or benzodiazepines that at times have worked to help certain patients.

“Nothing has emerged, though, as a standard of pharmacologic practice,” Fogel says. “[TD] is a disabling, stigmatizing thing.”

Synchroneuron is based on the work of Fogel, a neuropsychiatrist and professor of neurology at Harvard Medical School who began searching for a treatment for TD in the 1990s. Fogel determined that modulating the brain chemical glutamate could relieve the symptoms of TD, so he began using approved drugs that affect glutamate to treat his patients. That led him to acamprosate, a decades-old drug that works by essentially balancing out the glutamate and GABA neurotransmitters in the brain, as a potential treatment. Fogel found that certain patients responded particularly well to acamprosate, but the problem was the drug couldn’t be given chronically because its pharmacokinetic properties were poor—it doesn’t absorb into the blood particularly well. So while acamprosate has been approved for some 25 years to reduce the withdrawal symptoms alcoholics get when they stop drinking, it isn’t widely prescribed for alcoholism because it’s not very effective, according to Fogel; patients have to take a very high dose for it to work well (Fogel says upwards of nine pills per day), and if they take those doses, the drug often irritates the stomach and produces side effects like nausea, vomiting, and diarrhea.

The concept behind Synchroneuron is to essentially fix those flaws by making a version of acamprosate with better pharmacokinetic properties—as in, it can produce a bigger effect at a smaller dose, while limiting the GI side effects. Fogel co-founded the company in February 2012 with the help of drug development consulting firm Accellient Partners, and then raised $6 million in VC backing from Morningside to carry out that plan. Synchroneuron has since done the formulation work to create SNC-102 and test it in an early-stage clinical trial of healthy volunteers.

Chief executive William Kerns says that the company has seen positive signs so far: it’s beenWilliam Kearns able to significantly reduce the daily dose of acamprosate through the formulation work, and is testing a regimen of one or two pills per day.

Ultimately, the company’s big plan is not just to target TD, but potentially other related diseases like Tourette’s syndrome and post-traumatic stress disorder. Synchroneuron will use some of the cash, for instance, to begin an exploratory study in Tourette’s patients later this year, according to Fogel.

All of these disorders “may have an underlying problem with the regulation of glutamate transmission,” he says.

The reality, however, is that Synchroneuron has much to prove in the clinic before it can succeed—like whether its drug, which would be taken chronically either once or twice a day, can really prove much more effective and tolerable than the approved acamprosate formulation. It’s also got some catching up to do, as its competitor Neurocrine has already finished a Phase 2 trial for its own candidate, a new chemical entity called NBI-98854.

For its part, Synchroneuron is pointing to the fact that SNC-102 is based on a well-studied, approved drug. That means safety wouldn’t be a primary study endpoint— the company could theoretically run shorter, smaller Phase 3 studies testing solely for efficacy, rather than waiting longer to guard for safety signals, according to Kerns. That also means Synchroneuron might have an opportunity to catch up to Neurocrine if things break right, since the San Diego company is testing a new chemical compound for TD.

The big test is now underway. Synchroneuron is enrolling 90 patients in a Phase 2 study in 12 sites across the U.S, which should give the company the chance to prove, in a placebo-controlled study, if SNC-102 can reduce the number of abnormal tics patients experience. By that point, it’ll have a better read on whether its formulation work is producing a meaningful clinical effect.

“The challenge is to determine whether our delivery system—our formulation—is delivering enough drug in a once-a-day or twice-a-day form,” Kerns says. “I think that’s an area of risk, and we’ll know soon.”

Save the Date - FDA Social Media Guidance Panel

Save the date banner

Social media has exploded over the last decade, yet the biotech and pharmaceutical sectors have been reluctant to harness the full power of platforms like Linked In, Facebook and Twitter. But now we have draft guidances from the FDA providing some clarity on how to communicate over social media channels and engage with patients, physicians and caregivers in a fair and balanced way.

LaVoieHealthScience and Burns & Levinson are getting lawyers and communications and marketing professionals together to discuss these new guidelines and how we should move forward with fewer than 140 characters (too late), likes and status updates.

Save the date below and stay tuned for more details:

Date:    Tuesday, September 9, 2014
Time:    8:30 -11:00 am ET
Where:  Burns & Levinson LLP
            125 Summer Street
            Boston MA 02110

LHS Helps DARA BioSciences Launch Patient Smartphone App, Gain Targeted Media Coverage

Opportunity: DARA BioSciences launched a smartphone app to provide cancer patients an educational resource to help patients diagnosed with cancer improve oral care and management of oral mucositis in support of Gelclair®, a bioadherent oral rinse gel.

LHS Solution: In an effort to maximize exposure for this announcement, LHS developed and released “Top 10 Oral Hygiene Tips for Patients with Cancer“ with images in a movie format and worked with the Oral Cancer Foundation to gain a quote in the press release supporting the Oral Mucositis Care app. 

Results: LHS was successful in gaining media coverage in targeted publications and news outlets, including Oral Cancer Foundation news page, Dental Product Review, DentistryIQ.com and Oncology Business Review with interviews pending at two additional outlets. Dental Product Review, a new site with more than 500,000 unique visitors in its first few months online, embedded the Top 10 Oral Hygiene Tips for Patients with Cancer video.

Our multimedia release more than 3,000 views and the “Top 10 Oral Hygiene Tips for Patients with Cancer” video has been viewed more than 300 times, not counting Business Wire plays.

Traffic to Gelclair.com was up 300 percent the week of the announcement.

To download the app, visit the iTunes Store or Google Play and search for “Oral Mucositis Care.”

Synchroneuron Nets $20M to Combat Drug-Induced Movement Disorder

 

describe the image                Xconomy resized 600

Ben Fidler July 2, 2014

With a few tweaks, Synchroneuron believes it’s been able to turn an old, flawed drug for alcoholism into a new one for a completely different disorder. Now the Waltham, MA-based startup has just banked a big round of cash to go prove it in clinical trials.

Synchroneuron is announcing today that it’s raised a $20 million Series B round of equity financing, all from its sole backer, Hong Kong investment firm Morningside Technology Ventures. The cash will help Synchroneuron get to a key point in its development. SNC-102—the souped-up formulation of the alcoholism drug acamprosate calcium the company is developing to treat a debilitating movement disorder called tardive dyskinesia (TD)—is currently in a Phase 2 study.

By the time that study produces results in the first quarter of 2015, Synchroneuron will have a good read on whether or not it has a potential drug—and where it stands compared to San Diego-based Neurocrine Biosciences (NASDAQ: NBIX), which is developing a rival treatment for the diseaseand is further along in development.

“We think [there’s] going to be good news, but the question is how good,” says scientific founder Barry Fogel, of the mid-stage trial. “We’d be quite surprised if we see no benefit, and we’d be shocked if we saw adverse effects because the safety record for this drug is so impressive.”

The winner gets the first crack at an FDA-approved drug for TD, a debilitating disorder characterized by involuntary, repetitive movements—primarily of the lips, tongue, or jaw— tied to the chronic use of certain antipsychotic drugs that block dopamine. For most people, the disorder is irreversible. Around 300,000 people in the U.S. are affected with severe forms of TD, and they’re typically treated either with preventative measures—like lowering the doses of their antipsychotics—or with other drugs like calcium channel blockers or benzodiazepines that at times have worked to help certain patients.

“Nothing has emerged, though, as a standard of pharmacologic practice,” Fogel says. “[TD] is a disabling, stigmatizing thing.”

Synchroneuron is based on the work of Fogel, a neuropsychiatrist and professor of neurology at Harvard Medical School who began searching for a treatment for TD in the 1990s. Fogel determined that modulating the brain chemical glutamate could relieve the symptoms of TD, so he began using approved drugs that affect glutamate to treat his patients. That led him to acamprosate, a decades-old drug that works by essentially balancing out the glutamate and GABA neurotransmitters in the brain, as a potential treatment. Fogel found that certain patients responded particularly well to acamprosate, but the problem was the drug couldn’t be given chronically because its pharmacokinetic properties were poor—it doesn’t absorb into the blood particularly well. So while acamprosate has been approved for some 25 years to reduce the withdrawal symptoms alcoholics get when they stop drinking, it isn’t widely prescribed for alcoholism because it’s not very effective, according to Fogel; patients have to take a very high dose for it to work well (Fogel says upwards of nine pills per day), and if they take those doses, the drug often irritates the stomach and produces side effects like nausea, vomiting, and diarrhea.

The concept behind Synchroneuron is to essentially fix those flaws by making a version of acamprosate with better pharmacokinetic properties—as in, it can produce a bigger effect at a smaller dose, while limiting the GI side effects. Fogel co-founded the company in February 2012 with the help of drug development consulting firm Accellient Partners, and then raised $6 million in VC backing from Morningside to carry out that plan. Synchroneuron has since done the formulation work to create SNC-102 and test it in an early-stage clinical trial of healthy volunteers.

Chief executive William Kerns says that the company has seen positive signs so far: it’s been able to significantly reduce the daily dose of acamprosate through the formulation work, and is testing a regimen of one or two pills per day.

Ultimately, the company’s big plan is not just to target TD, but potentially other related diseases like Tourette’s syndrome and post-traumatic stress disorder. Synchroneuron will use some of the cash, for instance, to begin an exploratory study in Tourette’s patients later this year, according to Fogel.

All of these disorders “may have an underlying problem with the regulation of glutamate transmission,” he says.

The reality, however, is that Synchroneuron has much to prove in the clinic before it can succeed—like whether its drug, which would be taken chronically either once or twice a day, can really prove much more effective and tolerable than the approved acamprosate formulation. It’s also got some catching up to do, as its competitor Neurocrine has already finished a Phase 2 trial for its own candidate, a new chemical entity called NBI-98854.

For its part, Synchroneuron is pointing to the fact that SNC-102 is based on a well-studied, approved drug. That means safety wouldn’t be a primary study endpoint— the company could theoretically run shorter, smaller Phase 3 studies testing solely for efficacy, rather than waiting longer to guard for safety signals, according to Kerns. That also means Synchroneuron might have an opportunity to catch up to Neurocrine if things break right, since the San Diego company is testing a new chemical compound for TD.

The big test is now underway. Synchroneuron is enrolling 90 patients in a Phase 2 study in 12 sites across the U.S, which should give the company the chance to prove, in a placebo-controlled study, if SNC-102 can reduce the number of abnormal tics patients experience. By that point, it’ll have a better read on whether its formulation work is producing a meaningful clinical effect.

“The challenge is to determine whether our delivery system—our formulation—is delivering enough drug in a once-a-day or twice-a-day form,” Kerns says. “I think that’s an area of risk, and we’ll know soon.”

LaVoieHealthScience Wins Three Awards for Work with Mass. Department of Public Health and Chelsea Therapeutics

LaVoieHealthScience
LHS Wins Bronze Bell Ringer for DPH ‘Together We’re Ready’ Emergency Preparedness Campaign
 
Communications Program for Chelsea FDA Approval Process Nets LACP’s Impact Award and Bell Ringer Honors

Boston, MA, June 11, 2014 – LaVoieHealthScience, Inc., (LHS) provider of strategic communications programs that integrate public and investor relations, marketing and communications to engage target stakeholders to create behavioral change, won multiple awards from the 2013 LACP Impact Awards and the 2013 Bell Ringer Awards. LaVoieHealthScience this week received the Bronze Bell Ringer Award and a merit award in the Product/Service Launch: Healthcare Campaign category for their work with Chelsea Therapeutics. LHS also received a best program award for its communications plan for Chelsea Therapeutics in the 2013 League of American Communications Professionals (LACP) Impact Awards.

The Publicity Club of New England recognized LHS’ Massachusetts Department of Public Health, “Together We’re Ready” campaign with a Bronze Bell Ringer in the Community and Consumer Affairs Category. The campaign increased awareness of emergency preparedness efforts for individuals, families and communities, promoted easy to understand messaging, branding collateral, videos, social media content and a media buy all illustrating the importance of emergency preparedness. LHS developed this campaign in partnership with Carroll Communications and NewTV. Since being implemented last year, the campaign has earned Platinum at the 2013 MarCom Awards, Top 25 Communications Campaigns, Platinum, and Best on a Limited Budget at the Magellan Awards.

Judges for the Impact Awards recognized LaVoieHealthScience’s Chelsea Therapeutics NORTHERA Plan as the Best Sales Communications Program in this year’s competition. The plan, developed to support Chelsea’s application for new drug approval to the FDA for NORTHERA™, consisted of comprehensive messaging and strategic external communications to media, patients and stakeholders.

“We are honored to have worked with both organizations on these campaigns and are pleased to be recognized in both award competitions,” said Donna L. LaVoie president and chief executive officer of LaVoieHealthScience. “I am proud of the team for developing and executing on these complex communications plans and getting results for our clients.”

The Publicity Club of New England prestigious Bell Ringer Awards recognize excellence in communications and public relations work in every field and industry, across all forms of media. The awards honor the communications and PR professionals who leverage unique and creative strategy, tactics, and tools to achieve meaningful results for their clients, companies, organizations, and institutions. 

The League of American Communications Professionals (LACP) was established in 2001 in order to create a forum within the public relations industry that facilitates discussion of best-in-class practices within the profession while also recognizing those who demonstrate exemplary communications capabilities.  This year the Impact Awards debuted nearly 100 entries, from some of the most recognized organizations throughout the world, creating exceptional competition.

About LaVoieHealthScience

LaVoieHealthScience partners with leading life sciences brands to build value for their companies, attract capital, and reach key stakeholders through integrated communications and marketing. The firm provides strategy consulting and integrated communications programs designed to properly position, create visibility and drive value. The agency has received 25 awards over the past four years in recognition of the work it has done for its many clients.

LaVoieHealthScience is ranked by O'Dwyer's PR Report as one of the leading independent healthcare PR firms in the U.S. and has been honored for the past four years by the LACP for best agency awards, including the 2011 "Best Small Agency."

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Media contact:
David Connolly
Vice President, LaVoieHealthScience
dconnolly@lavoiehealthscience.com

LaVoieHealthScience's Client Ocugen Featured in BioWorld Today

ocugen     bioworld logo

 

New LaVoieHealthScience client, Ocugen, which recently licensed two development assets in ophthalmology from the University of Colorado and gained orphan status from the FDA for one of them, is featured in BioWorld Today.  See the press release.

LaVoieHealthScience's Aurora Krause Wins NIRI Individual Leadership Award

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NIRI Announces 2013-2014 Individual Leadership Award Winners

LAS VEGAS – The National Investor Relations Institute (NIRI) today announced its  annual Individual Leadership Award winners. 

NIRI Chairman John Chevalier, Director of Global Investor Relations, The Procter & Gamble Company, said, “These individuals represent the best ideals of NIRI membership. NIRI relies on the tireless efforts of these volunteers, and many more like them, to drive its success. I applaud their spirit of volunteerism, and thank them for their devotion to NIRI’s mission.”

The 2013-2014 NIRI Individual Leadership Award winners and associated NIRI chapters are:

Aurora Krause, Boston; David Dixon, Capital Area; Matthew Schlarb, Central Ohio; Roy Granato, Charlotte; Christine Hanneman, Chicago; Kenneth Lovik, Cincinnati Tri State; Shannon Gaycheck, Cleveland/Northern Ohio; Liz Kline, Dallas*Ft. Worth; Kim Pinyopusarerk, Houston; Debbie Hagen, Kansas City; Scott Cunningham, Los Angeles; Theresa Molloy, New York; Cynthia Skoglund, Orange County; John Demming, Philadelphia; Kathleen Marvin, Rocky Mountain; Pete De Spain, San Diego; Brenda Ropoulos, Silicon Valley; Howard Goldman, South Florida; John Hastings, St. Louis; Justin Vieira, Triangle; and Bernadette McCormick, Virtual.

Theresa Molloy, Director, Governance and Shareholder Services, Prudential Financial, received the NIRI National Volunteer of the Year Award. This award, introduced in 2009, honors a NIRI member who best exemplifies the NIRI mission of “advancing the practice of investor relations and professional competency and stature NIRI members” at the national level. An active volunteer at both the national and chapter levels, Ms. Molloy has:  spoken at NIRI national programs and webinars; contributed to IR Update magazine; appeared as a guest on NIRI video programs; served as a member of the IR Certification Subject Matter Expert Committee; participated as a member of the NIRI Annual Conference Committee; and served as a Vice President of Programs for the New York chapter.  

The awards were presented at the NIRI Volunteer Appreciation Dinner in Las Vegas, site of the 2014 NIRI Annual Conference (www.niri.org/conference), the world’s largest and most comprehensive investor relations education and networking event.

About the National Investor Relations Institute (NIRI)

Founded in 1969, NIRI (www.NIRI.org) is the professional association of corporate officers and investor relations consultants responsible for communication among corporate management, shareholders, securities analysts and other financial community constituents.  NIRI is the largest professional investor relations association in the world with more than 3,300 members representing over 1,600 publicly held companies and $9 trillion in stock market capitalization.

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Local Biotech's Heart Failure Treatment Shows Promise; Juventas to Launch Phase 3 Study Next Year

juventas logoThe Plain Dealer

Plain Dealer Doctor
Dr. Marc Penn studies a slide of mouse heart tissue in this 2012 photo taken in Rootstown. Penn and his team at Juventas have been working on JVS-100, a method of treating damaged heart muscle that recruits the body's innate healing abilities, for the past decade. The company was a Cleveland Clinic spinoff formed in 2007 when Penn still worked for the hospital system; he is now Director of Cardiovascular Research at Summa Health System in Akron. (Thomas Ondrey/ The Plain Dealer)
 

 

 

By Brie Zeltner, The Plain Dealer
May 28, 2014 at 8:00 AM, updated May 28, 2014 at 8:18 AM

CLEVELAND, Ohio— A potential new treatment for heart failure developed by Cleveland Clinic spinoff Juventas Therapeutics has shown new promise in a Phase 2 trial, according to data recently released by the company.

The treatment, a gene therapy called JVS-100 that recruits the body's own stem cells to repair damaged areas of the heart, was safe and improved cardiac function in patients with advanced heart failure who had heart attacks more than a decade ago.

In the trial, called STOP-HF, 93 participants received either a single treatment of a low dose of JVS-100, a high dose of JVS-100, or placebo. They were then followed and evaluated at two points -- four months and one year later -- to test their heart function.

"We're very excited by the results," said Dr. Marc Penn, a former Cleveland Clinic doctor and founder and Chief Medical Officer for Juventas, who is now Director of Cardiovascular Research at Summa Health System in Akron. "This is a high risk population probably approaching most cancer mortalities."

About 6 million Americans suffer from heart failure, which happens when the heart can no longer keep up with its workload. About half of people diagnosed with heart failure die within five years, according to the Centers for Disease Control and Prevention.

Penn estimates that about 1.5 million people with heart failure do not benefit from current treatments, and still suffer daily symptoms, which include shortness of breath, fatigue and swelling from fluid buildup in the limbs. As the heart muscle weakens over time, the heart grows larger to compensate and becomes less efficient, pumping less blood (a measure referred to as ejection fraction) per heartbeat.

In the STOP-HF trial, JVS-100 reduced the size of the heart by about 8 percent and improved ejection fraction by about 2 percent overall, and higher doses of the treatment worked better. Participants in the trial had symptomatic heart failure, were about 65 years old on average, and had suffered a heart attack an average of 11 years prior to enrolling in the trial. JVS-100 was delivered via catheter to 15 spots in the heart muscle that showed signs of damage from a previous heart attack.

In a subgroup of high-risk patients within the trial who had more advanced heart failure, there was a decrease in a key heart function measure called end systolic volume, which indicates the size of the heart after it finishes its squeeze. Smaller values correlate with better heart function.

"This level of reduction correlates with a greater than 80 percent chance of us having a meaningful mortality benefit over two years -- at least a 20 percent reduction in mortality," Penn said.

STOP-HF was not designed to measure the impact of the drug on the risk of dying from heart failure over time, so these interim Phase 2 results can only give a suggestion of how the therapy may affect a patient's survival. A definitive test of the drug, in a Phase 3 trial, is set to launch next summer and should enroll several hundred heart failure patients.

Participants in the STOP-HF trial are still being followed and the company will report final results by the end of this year.

Juventas, which was spun out of the Cleveland Clinic in July 2007, has since attracted $32 million in private investment and grants. The company is also testing JVS-100 for people with critical limb ischemia, a severe blockage of blood flow in the legs that causes pain, blood clots and amputations.

The company believes the treatment works by stimulating the patient's stem cells to heal and regenerate tissue that has been damaged, reduce the amount of scarring, and block any ongoing cell damage caused by the chronic disease.

"This repair mechanism isn't just about the heart, it's really about any organ in the body and having a specific drug that activates this repair pathway that allows us now to attack disease in a new and fundamentally novel way," Penn said.

"It's very exciting to be working on this for so many years and to see this pathway become so important."

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