Updated 6:31 p.m.
While guarding against making too much of a small Phase 1 study, Athersys Inc. (NASDAQ: ATHX) leaders hinted late Wednesday that their adult stem cell therapy MultiStem eventually could change the way people are treated for heart attacks.
The Cleveland, Ohio, biopharmaceutical company reported early results from an ongoing Phase 1 trial to determine the safety and maximum dose of MultiStem for heart attack patients. MultiStem is an off-the-shelf stem cell treatment derived from the bone marrow of adults.
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Three escalating doses of the therapy (20 million, 50 million and 100 million cells) were well-tolerated by patients, who received the cells through a micro-infusion catheter system. Patients who received medium and high doses of MultiStem had significantly improved heart function.
Analysts on a conference call with Athersys leaders called the results “good” and “surprising.” One even called it a potential “paradigm shift in the treatment of heart attacks.”
“Yes, we think so,” said Gil Van Bokkelen, chairman and chief executive of Athersys, which has yet to market its first commercial product.
Highlights of the open label, multicenter dose escalation trial at institutions including the Cleveland Clinic:
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— MultiStem was well-tolerated at all dose levels.
— No clinically significant changes in vital signs, allergic reactions or infusion-related toxicities were associated with the therapy.
— Each dose group showed improvement in left ventricular ejection fraction, a measure of heart function, compared to baseline heart function and a registry group.
— Patients in the medium dose group had a statistically significant improvement in heart function.
— Patients with more severe heart attacks demonstrated better than 25 percent improvement in heart function when given the medium and high doses of MultiStem.
“We are encouraged by the results of this Phase I study, and based on these results, will work with our partner, Angiotech Pharmaceuticals, on plans for a phase II trial to further evaluate safety and assess improvement in cardiac function,” Van Bokkelen said in a release.
“This study is an important step and provides additional validation of the clinical potential and therapeutic profile of MultiStem as an off-the-shelf, allogeneic
stem cell therapy, and we look forward to building off these results,” Van Bokkelen said.
Past stem cell studies have been criticized for producing far less benefit for humans than for animals.
“This is the first clinical trial that gives the (same) degree of results that we saw in the animals,” said Dr. Marc Penn, co-principal investigator on the trial, and director of Cardiovascular Cell Therapy at the Cleveland Clinic, as well as the Clinic’s Skirball Laboratory for Cardiovascular Cellular Therapeutics.
“An absolute improvement of 10 percent in left ventricular ejection fraction in patients who are having a myocardial infarction is a very significant benefit,” said cardiologist Penn. “It’s a greater benefit than any medication short of opening the artery that we currently use.”
Penn noted that MultiStem was used on top of medical therapies like beta blockers, and interventional therapies like balloon angioplasties and stents. “So the size of the infarction is key,” he said. “This would suggest the infarction is smaller, and certainly the function of the heart is much better,” when using MultiStem.
Athersys announced its trial results after the close of stock markets Wednesday. Interesting. The company’s shares had fallen 30 cents, or nearly 10 percent, to $2.76 by the closing bell. But the shares gained that back in after-hours trading, rising 29 cents to $3.05 by 6:11 p.m. EDT.
