This Day On The Street
Continue to site
ADVERTISEMENT
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

BioMimetic Therapeutics, Inc. Initiates Enrollment In Augment™ Chronic Tendinopathy Clinical Trial

BioMimetic Therapeutics, Inc. (NASDAQ: BMTI) today announced it initiated enrollment in a Phase II clinical trial to assess the safety and efficacy of Augment™ Chronic Tendinopathy (ACT) as a treatment for lateral epicondylitis, commonly known as tennis elbow. The randomized, controlled trial is expected to enroll up to 100 patients at seven clinical sites in the U.S. and will evaluate the safety and therapeutic potential of escalating doses of a one-time injection of pure recombinant human platelet-derived growth factor (rhPDGF-BB) homodimer solution into the extensor carpi radialis brevis (ECRB), the tendon in the elbow that is generally the source of pain in tennis elbow. The product candidate is aimed at the large tendinosis market for which there is significant unmet clinical need with limited effective long-term treatments currently available.

“We have seen promising pre-clinical data with ACT and believe the initiation of this Phase II dose finding clinical trial is the logical next step in the development of our sports medicine program,” said Dr. Samuel Lynch, BioMimetic president and CEO. “ACT has the potential to help millions of patients suffering from painful inflammation of the tendon at the outer border of the elbow resulting from overuse of lower arm muscles or trauma.”

Study Design

The Phase II trial is designed as a randomized, ascending dose, double-blinded, placebo controlled, multi-center study. The trial is expected to enroll up to 100 patients ranging from 21 – 80 years of age, who will receive a single injection into the ECRB. The injection will consist of either a placebo or one of four different doses of rhPDGF-BB.

The primary efficacy endpoints will be derived from a combination of pain and disability assessments as measured by the Visual Analog Scale (VAS), Disabilities of the Arm, Shoulder and Hand (DASH) Score and the Patient Rated Tennis Elbow Evaluation (PRTEE), along with sincerity of effort measured by grip strength testing. These clinical outcome measures will be used to detect changes in pain and function up to 24 weeks from baseline. Adverse event reporting, including incidence, relationship with treatment and severity will be recorded throughout the study to evaluate safety of the drug. The product candidate will be reviewed by the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), which regulates over-the-counter and prescription drugs, including biological therapeutics and generic drugs.

1 of 4

Check Out Our Best Services for Investors

Action Alerts PLUS

Portfolio Manager Jim Cramer and Director of Research Jack Mohr reveal their investment tactics while giving advanced notice before every trade.

Product Features:
  • $2.5+ million portfolio
  • Large-cap and dividend focus
  • Intraday trade alerts from Cramer
Quant Ratings

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
Stocks Under $10

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

Product Features:
  • Model portfolio
  • Stocks trading below $10
  • Intraday trade alerts
14-Days Free
Only $9.95
14-Days Free
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!
SYM TRADE IT LAST %CHG

Markets

DOW 18,080.14 +21.45 0.12%
S&P 500 2,117.69 +4.76 0.23%
NASDAQ 5,092.0850 +36.0220 0.71%

Partners Compare Online Brokers

Free Reports

Top Rated Stocks Top Rated Funds Top Rated ETFs