Courtesy of Benzinga.
Aastrom Biosciences (NASDAQ: ASTM) recently announced that results from its RESTORE Phase 2 clinical trial were positive, and met all primary safety and efficacy endpoints. The trial studied the company’s ixmyelocel-T cellular therapy treatment which helps to restore damaged tissue in patients with critical limb ischemia. The study showed a 62% reduction in treatment failure compared to a placebo group and lessened the number of adverse events such as death, increase in surface wound area, or new gangrene. “The trial results provide compelling clinical evidence that ixmyelocel-T could represent a major advance in the treatment of patients with CLI who have no option for revascularization,” said CEO Tim Mayleben. “We look forward to initiating our pivotal Phase 3 clinical trial this quarter.”
Critical limb ischemia occurs when a patient suffers from pain, gangrene, or ulcers attributed to inadequate blood flow or blocked arteries in the legs. Patients can also experience pale or cold feet, as well as develop ulcers in the area. They typically suffer pain at night while sleeping and it can last several hours at a time. The symptoms generally develop over several months or years. If not treated properly, patients could be forced to have the affected limb amputated.
During the Phase 2 trial, 72 patients were treated with ixmyelocel-T injections. By the middle of the study, Aastrom cut the risk of death or amputation by 32%, although this was not shown to be statistically significant. “We were one event away from reaching statistical significance,” said Mayleben.
The success of the Phase 2 trial means that Aastrom will proceed with the initiation of a Phase 3 trial. Aastrom has collaborated with the FDA and reached a Special Protocol Agreement on how the trial will be run. Aastrom will use a committee of vascular surgeons to observe disease progression and amputation criteria. The primary endpoint of the study will be amputation free survival after one year of treatment, as well as secondary endpoints regarding wound size, gangrene, and major amputation.
Aastrom’s stock has moved sideways over the past year, but fell after the results of the Phase 2 trial were announced. Investors are concerned that the Phase 3 trial could cost up to $25 million. The company reported that it had about $12M on hand at the end of the third quarter and it is very likely they will have to do an equity offering to raise more. “The data looked impressive, but people may be selling after the results in anticipation of an upcoming financing event,” said Brian Lian, a Global Hunter securities analyst.
ACTION ITEMS
Bullish: Traders who believe Aastrom Biosciences will successfully market their CLI treatment should consider purchasing shares. The stock is trading well off its 52 week highs, but FDA approval may be too far off to consider playing options.
Bearish: Traders who are bearish may want to short the stock. Aastrom may dilute the stock with an equity offering to pay for the Phase 3 trial, which would drive the price down.
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