Strong data should continue to propel ASTM |
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By Patrick Crutcher | |
Wednesday, 17 November 2010 10:50 | |
With results on their pipeline set to be delivered on Thursday, we want to cover some important points and provide our readers with a more in-depth look at Aastrom. We continue to believe the results will be significant for the future of their CLI program and potentially indicative of success in DCM. Aastrom will present data from an interim analysis of its Phase 2b RESTORE-CLI clinical trial at the VEITHsymposium™ on November 18, 2010 @ 1:00 pm (ET). First, we want to review the Phase 2b RESTORE-CLI trial, including the initial interim data. The data set will be comprised of 86 patients, with 46 patients at 6 months and 40 patients at 12 months. National Securities biotechnology analyst, Jason Kolbert, “expects the 12 month data to continue to show a strong separation between the active and control arms, and that the 6 months data set will confirm the earlier data sets reported.” The interim study results in CLI showed a statistically significant improvement of the composite endpoint assessing time to treatment failure (including major amputations, doubling wound size and new gangrene)(p-value=0.005). Most importantly, results showed a statistically significant improvement in amputation free survival, the FDA’s gold-standard endpoint for Phase 3 CLI studies(p-value=0.038). We also saw beneficial improvements in wound healing and fewer amputations.
ASTM has made great strides in their pipeline and over the next 6 months they will be showing their cards. As you can see below, ASTM has a lot in store for investors. Specifically, there are 5 catalysts that investors should be watching closely for: 1. Phase 2b CLI 6-month results on November 18th 2. Phase 2 Surgical-DCM 6-month results in January, 3. SPA negotiations for Phase 3 in CLI with FDA between now and early 2011 4. Phase 2b CLI 12-month results in Q2, 5. Phase 2 Surgical-DCM 12 month results in Q2/Q3, The value of Aastrom’s pipeline will be more clear going forward, as results start to trickle in. Success in CLI or DCM would set them apart from other stem cell companies. After a recent meeting with Aastrom’s management, Zack’s Managing Director & Sr. Biotechnology Analyst, Jason Napodano, had this to say about Aastrom Biosciences: "ASTM is the premier stem cell play for CV(cardiovascular) disease, and may be the premier stem cell play period. My meeting with ASTM today really did a lot to convince me that they are a solid team with a real shot at big things one day." Critical Limb Ischemia or CLI is a severe obstruction of the arteries which seriously decreases blood flow to the extremities (hands, feet and legs) and has progressed to the point of severe pain and even skin ulcers or sores. Critical Limb Ischemia (CLI) is often present in individuals with severe peripheral arterial disease (PAD). CLI is very severe condition that needs comprehensive treatment by a vascular surgeon or vascular specialist as it will not improve on its own. A break-through treatment from ASTM would present the opportunity to serve a multi-billion dollar market. Disclosure: Long ASTM "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 ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() ![]() |