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Capricor hit as J&J bails on stem cell heart med

July 9, 2017

Johnson & Johnson (JNJ)’s Janssen Biotech (JNJ) has opted out of its licensing deal with Los Angeles-based Capricor Therapeutics for CAP-1002 (allogeneic cardiosphere-derived cells).

In 2014, J&J and Capricor signed a licensing deal for CAP-1002. J&J paid Capricor $12.5 million upfront and the company was eligible for up to another $325 million.

Janssen’s decision followed an announcement in May that Capricor’s Phase II trial of CAP-1002 in adults who had a large heart attack with residual cardiac dysfunction, had a low probability of statistically-significant different in effectiveness. Capricor noted that analysis “showed a low probability that CAP-1002 would achieve the primary endpoint of scar size reduction, as measured by late gadolinium-enhanced magnetic resonance imaging, at 12 months.”

However, Capricor on April 25 indicated CAP-1002 had positive top-line results from a safety and exploratory efficacy analysis in Duchenne’s muscular dystrophy. At the time, Linda Marban, Capricor’s president and chief executive officer, said in a statement, “These initial positive clinical results build upon a large body of preclinical data which illustrate CAP-1002’s potential to broadly improve the condition of those afflicted by DMD, as they show that cardiosphere-derived cells exert salutary effects on cardiac and skeletal muscle.”

But apparently not enough to interest J&J. John Carroll, writing for Endpoints Newssaid, “Thursday evening, two months after the biotech noted that their 142-patient study was headed to failure, J&J said they weren’t interested. They washed their hands of the partnership, handed back full rights, and walked away from the deal.”

Some of this is likely due to what Carroll describes as “a waning interest in stem cells. Once the subject of intense speculation, stem cells and the companies that develop them have been shunted aside as repeated studies fell far short of expectations—particularly in heart repair.”

Capricor plans to shift its efforts, energies and resources toward DMD. Duchenne’s muscular dystrophy (DMD) is a muscle-wasting disease caused by mutations in the dystrophin gene. It is a progressive disease and generally results in death in early adulthood. Serious complications include heart or respiratory-related problems. It affects mostly boys, about 1 in every 3,500 to 5,000 male children.

CAP-1002 is made up of allogeneic cardiosphere-drived cells (CDCs), a type of cardiac stem cell. It is in clinical development for heart disease associated with DMD in addition to two adult cardiology indications, postmyocardial infarction, currently in Phase II trials, and advanced heart failure, currently in Phase I trials.

As a result of today’s news, Capricor stock has gotten slammed, and is currently trading for $0.68.

Carroll writes, “Capricor is left with a stock that has been hammered down to penny stock size, looking to rally investors around a plan to shift focus to Duchenne muscular dystrophy with a plan to use their stem cell tech to tamp down on the inflammation that wreaks havoc on boys. LA-based Capricor—which initially set out to test the potential of technology Linda Marban’s husband, Eduardo Marban, developed at Johns Hopkins—noted in May that it would be cutting its work force.”

Marban said in a statement, “Following our announcement of positive results from our Phase I/II HOPE clinical trial in April, we have focused our efforts toward the clinical development of CAP-1002 for DMD. We discussed potential product registration strategies for this indication at our recent meeting with the U.S. Food and Drug Administration, and we look forward to providing an update on our clinical development plans in DMD very shortly.”

The company hopes to begin a clinical trial of repeat doses of IV CAP-1002 in boys and young men with DMD in the second half of this year if the FDA gives the go-ahead.

http://bit.ly/2tEGYUp

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