Shares were halted this afternoon for Aastrom Biosciences, Inc. (Nasdaq:ASTM), the regenerative medicine company engaged in the development of autologous cell products for treatment of severe, chronic cardiovascular diseases as the company announced that an interim analysis of all 86 patients enrolled in the company's Phase 2b RESTORE-CLI clinical trial shows that the study achieved both its primary safety endpoint and primary efficacy endpoint of time to first occurrence of treatment failure.

The findings were statistically significant (p=0.0132) and close analyses showed a clinically meaningful reduction of 56% in treatment failure events. The RESTORE-CLI trial is the largest fully controlled cell-therapy study ever conducted in critical limb ischemia (CLI)- a severe blockage in the arteries of the lower extremities, which markedly reduces blood-flow. It is a serious form of peripheral arterial disease. The most prominent features of critical limb ischemia are severe pain in the legs and feet while a person is not moving, or non-healing sores on the feet or legs. ASTM is the first company to make it this far in clinical trials with such positive results. 

Shares had climbed significantly in advance of today's news presentation but most investors chose to take profits off the table upon release of the data when Reuters reported that the study failed to meet a key secondary goal- something which the study was not designed to demonstrate. That data showed a clinically meaningful reduction in event rates (amputation) of 24% but did not show statistical significance. Phase III will be designed to focus on that secondary data, but at least momentarily the article panicked investors and sent shares tumbling. Others swooped in for the suddenly discounted shares and took them back from $2.86 to the $3.85 range. Moments later, shares continued a slow decline as investors began to digest the news and try to decide how to best intrepret the study data over the next few days.

Aastrom Biosciences has become is a strong stem cell play, but fear of dillution has also impacted shares after a mid-November registration with the U.S. Securities and Exchange Commission to sell, from time to time, up to $75 million of Common Stock, Preferred Stock, Debt Securities, Warrants, Units, or any combination thereof. It appears that the fear that the company could sell shares on the good news played a role in the mass exodus.

Reuters news story on Aastrom Biosciences Flash Player 9 or higher is required to view the chart Click here to download Flash Player now

• Phase 2 Surgical-DCM 6-month results in January,
• SPA negotiations for Phase 3 in CLI with FDA between now and early 2011
• Phase 2b CLI 12-month results in Q2
• Phase 2 Surgical-DCM 12 month results in Q2/Q3

The value of Aastrom’s pipeline will be more clear going forward, as these results and other news start to trickle in. Success in CLI has set ASTM apart from other stem cell companies as other pharmaceutical and biotechnology firms have recently abandoned programs aiming to treat CLI.

In February 2010, Aastrom had reported results from an interim analysis of data from this trial that showed a statistically significant clinical benefit favoring Aastrom's autologous cellular therapy for the first 46 patients enrolled in the trial, in both time to first occurrence of treatment failure (a composite endpoint consisting of major amputation of treated leg, all-cause mortality, doubling of total wound surface area from baseline and de novo gangrene; p=0.005) and amputation-free survival (p=0.038).

Results of the second interim analysis were presented today in a non-CME satellite session of the VEITHsymposium(TM) in New York City by principal investigator Richard Powell, M.D., chief of vascular surgery at Dartmouth-Hitchcock Medical Center in Lebanon, NH. An archived webcast of the presentation will be available at www.aastrom.com/investor.cfm.

"I am very optimistic about the treatment response rates we have seen in patients in this trial so far. These interim data suggest that there is a clear and clinically meaningful therapeutic effect at work in treated patients. I look forward to examining the benefits of this treatment in the context of a larger Phase 3 study," said Dr. Powell.

The two interim analyses were done to provide information to support the design and execution of Aastrom's Phase 3 CLI program. In October, Aastrom announced plans to initiate a Phase 3 CLI clinical development program under special protocol assessments (SPA) with a Fast Track designation by the FDA.

"We believe these interim results provide further evidence supporting the use of our autologous cell therapy to treat patients with this devastating disease," said Tim Mayleben, president and CEO of Aastrom Biosciences. "As expected, these data provide essential guidance as we refine and finalize the sample sizes and patient selection criteria for our Phase 3 program."

BioMedReports subscribers may download ASTM's latest investors presentation from our research section: http://biomedreports.com/Download-document/143-ASTM-Investors-Presentation.html

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

---

Add this page to your favorite Social Bookmarking websites