This Day On The Street
Continue to site right-arrow
This account is pending registration confirmation. Please click on the link within the confirmation email previously sent you to complete registration.
Need a new registration confirmation email? Click here
Stocks Under $10 with 50-100% upside potential - 14 days FREE!

Overview Of Aastrom RESTORE-CLI And IMPACT-DCM Clinical Results Presented Today At The Conference On Cell Therapy For Cardiovascular Disease

ANN ARBOR, Mich., Jan. 20, 2011 (GLOBE NEWSWIRE) -- Amit N. Patel, MD, MS, associate professor of surgery at the University of Utah School of Medicine and national principal investigator in Aastrom's U.S. Phase 2 IMPACT-DCM clinical trial, and Sharon Watling, Pharm.D., Aastrom's vice president of clinical and regulatory, today reviewed findings from the company's IMPACT-DCM and RESTORE-CLI clinical studies in presentations at The Sixth International Conference on Cell Therapy for Cardiovascular Disease in New York City.

Dr. Patel reviewed six-month interim results from the Phase 2 IMPACT-DCM clinical trial investigating the surgical administration of the company's expanded autologous mixed-cell therapy in patients with dilated cardiomyopathy (DCM). Dr. Patel reviewed previously reported results indicating that treatment is safe and showing that adverse events were minor and associated only with the surgical procedure. No AEs were reported associated with the therapy and AEs were similar in the treatment and control groups. Dr. Patel also reviewed findings showing consistent and positive trends in quality of life, functional and structural parameters in the treatment group. Aastrom expects to report 12-month data from the IMPACT-DCM clinical study in the second quarter of 2011 and six-month results from the DCM catheter Phase 2 clinical study in the third quarter of 2011.  

Dr. Watling provided a summary of previously reported interim results from the company's U.S. Phase 2b RESTORE-CLI clinical trial investigating treatment with the company's expanded autologous mixed-cell therapy in patients with critical limb ischemia (CLI). Aastrom plans to conduct two Phase 3 clinical studies of its expanded autologous therapy in patients with CLI and has received Fast Track designation from the FDA for this program. The company has received initial responses from the FDA regarding the special protocol assessments for the two Phase 3 studies, which were submitted in October 2010.

"We are pleased with the initial responses from the FDA, especially for the no-option CLI study. We look forward to continuing to work with the FDA to finalize both special protocol assessments for the Phase 3 CLI program in the months ahead," said Tim Mayleben, president and CEO of Aastrom Biosciences. The Company expects to initiate the no-option Phase 3 trial by mid-2011.

1 of 2

Select the service that is right for you!

Action Alerts PLUS
Try it NOW

Jim Cramer and Stephanie Link actively manage a real portfolio and reveal their money management tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
  • Weekly roundups
TheStreet Quant Ratings
Try it NOW
Only $49.95/yr

Access the tool that DOMINATES the Russell 2000 and the S&P 500.

Product Features:
  • Buy, hold, or sell recommendations for over 4,300 stocks
  • Unlimited research reports on your favorite stocks
  • A custom stock screener
  • Upgrade/downgrade alerts
Stocks Under $10
Try it NOW

David Peltier, uncovers low dollar stocks with extraordinary upside potential that are flying under Wall Street's radar.

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
  • Weekly roundups
Dividend Stock Advisor
Try it NOW

Jim Cramer's protege, David Peltier, identifies the best of breed dividend stocks that will pay a reliable AND significant income stream.

Product Features:
  • Diversified model portfolio of dividend stocks
  • Alerts when market news affect the portfolio
  • Bi-weekly updates with exact steps to take - BUY, HOLD, SELL
Real Money Pro
Try it NOW

All of Real Money, plus 15 more of Wall Street's sharpest minds delivering actionable trading ideas, a comprehensive look at the market, and fundamental and technical analysis.

Product Features:
  • Real Money + Doug Kass Plus 15 more Wall Street Pros
  • Intraday commentary & news
  • Ultra-actionable trading ideas
Options Profits
Try it NOW

Our options trading pros provide daily market commentary and over 100 monthly option trading ideas and strategies to help you become a well-seasoned trader.

Product Features:
  • 100+ monthly options trading ideas
  • Actionable options commentary & news
  • Real-time trading community
  • Options TV
To begin commenting right away, you can log in below using your Disqus, Facebook, Twitter, OpenID or Yahoo login credentials. Alternatively, you can post a comment as a "guest" just by entering an email address. Your use of the commenting tool is subject to multiple terms of service/use and privacy policies - see here for more details.
Submit an article to us!


DOW 17,959.44 +154.64 0.87%
S&P 500 2,078.54 +7.89 0.38%
NASDAQ 4,781.4240 +16.0440 0.34%

Brokerage Partners

Rates from

  • Mortgage
  • Credit Cards
  • Auto

Free Newsletters from TheStreet

My Subscriptions:

After the Bell

Before the Bell

Booyah! Newsletter

Midday Bell

TheStreet Top 10 Stories

Winners & Losers

Register for Newsletters
Top Rated Stocks Top Rated Funds Top Rated ETFs