Seeking Alpha

MissionIR's  Instablog

MissionIR
Send Message
We know our reputation is based on the integrity of our clients and go to great lengths to ensure the companies represented adhere to sound business practices. It is our unwavering commitment to connect the investment community with companies that have great potential and a strong dedication to... More
My company:
MissionIR
My blog:
MissionIR Blog
  • Aastrom Biosciences Inc. (ASTM), FDA Reach Protocol Agreement for Phase 3 Clinical Trial of Multicellular Therapy 0 comments
    Jul 26, 2011 3:09 PM | about stocks: VCEL
    Aastrom Biosciences Inc., leading developer of patient-specific, expanded multicellular therapies for the treatment of severe, chronic cardiovascular diseases, has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding the Special Protocol Assessment (NYSE:SPA) for the design of the company’s phase 3 REVIVE-CLI clinical trial of ixmyelocel-T.
     
    Ixmyelocel-T is the company’s expanded multicellular therapy, designed to treat patients with critical limb ischemia (NYSE:CLI) who have no other treatment options. CLI leads to more than 160,000 limb amputations each year in the United States, making it the most severe form of peripheral artery disease. CLI is also fatal; approximately 25 percent of patients diagnosed with CLI will die within the 12 months of diagnosis, while fewer than 25 percent of patients survive more than four years following diagnosis.
     
    Aastrom’s will enroll up to 594 no-option patients at approximately 80 clinical sites across the U.S. This phase 3 clinical trial will be a randomized, double-blind, placebo-controlled study that will include only CLI patients with existing tissue loss, such as ulcerations and gangrene.
     
    “We greatly appreciate the guidance and support of the FDA staff, our phase 2 investigators and our phase 3 steering committee who have helped us reach final agreement on the SPA, a critical component to advancing ixmyelocel-T into phase 3 clinical testing,” Tim Mayleben, president and CEO of Aastrom stated in the press release.
     
    Mayleben said the SPA confirms the company’s confidence that the design of the phase 3 trial, also supported by positive results from the previously conducted RESTORE-CLI phase 2b trial, which was the largest fully controlled cell-therapy study ever conducted in CLI, in patients who received treatment with ixmyelocel-T.
     
    The therapy demonstrated a favorable safety profile and clinically meaningful and statistically significant benefit in time to treatment failure events. Aastrom will present the data for the phase 2b trial at a major medical meeting in November.
     
    For more information visit aastrom.com
     
    Please see disclaimer on the MissionIR website www.missionir.com/disclaimer.html ;
     
    Stocks: VCEL
Back To MissionIR's Instablog HomePage »

Instablogs are blogs which are instantly set up and networked within the Seeking Alpha community. Instablog posts are not selected, edited or screened by Seeking Alpha editors, in contrast to contributors' articles.

Comments (0)
Track new comments
Be the first to comment
Full index of posts »
Latest Followers

StockTalks

More »
Instablogs are Seeking Alpha's free blogging platform customized for finance, with instant set up and exposure to millions of readers interested in the financial markets. Publish your own instablog in minutes.