|Investors buy ASTM on rumor, sell on news that study met main safety and efficacy goal|
|By Staff and Wire Reports|
|Thursday, 18 November 2010 14:30|
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.
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.
BioMedReports subscribers may download ASTM's latest investors presentation from our research section: http://biomedreports.com/Download-document/143-ASTM-Investors-Presentation.html