Join        Login             Stock Quote

Biomimetic Therapeutics (BMTI) Begins Augment Chronic Tendinopathy Trial For Tennis Elbow

 January 03, 2013 11:47 AM

(By Balaseshan) BioMimetic Therapeutics Inc. (NASDAQ: BMTI), which develops products to heal musculoskeletal injuries and diseases, said it has began a phase 2 Augment Chronic Tendinopathy clinical trial to treat tennis elbow.

The company initiated enrollment in a phase 2 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.

Augment Chronic Tendinopathy (ACT) is being developed to treat chronic tendon injuries, or tendinosis. The target indication for this clinical trial is lateral epicondylitis, commonly referred to as tennis elbow.

[Related -Stocks Jump Over 1 Pct On Budget Deal Optimism; Apple (AAPL) Surges]

Lateral Epicondylitis is an inflammation of the tendons that join the forearm muscles on the outside of the elbow. The forearm muscles and tendons become damaged from overuse, or in some cases trauma, leading to pain and tenderness on the outside of the elbow.

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.

The trial 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.

[Related -Biomimetic Therapeutics (BMTI) Jumps After Business Combination With Wright Medical (WMGI)]

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.

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.

BMTI is trading up 2.01% at $7.60 on Thursday. The stock has been trading between $1.87 and $7.85 for the past 52 weeks.

iOnTheMarket Premium


Post Comment -- Login is required to post message
Alert for new comments:
Your email:
Your Website:

rss feed

Latest Stories

article imageGreek Government Theatrics and Other Reruns

Greece has a new anti-austerity government, but a disorderly euro exit is as unlikely as read on...

article imageHedge Market Volatility: Buy This Dividend Aristocrat

When uncertainty reigns in the global economy, you can count on stocks to be even more read on...

article imageCanadian Banks Hesitate to Follow the Bank of Canada's Rate Cut

The Bank of Canadasurprised markets last week when they lowered the overnight rate 0.75% on Wednesday. The read on...

article image3 Stocks With 100% Upside

Biotech stocks had a banner year in 2014. Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), Avanir read on...

Popular Articles

Daily Sector Scan
Partner Center

Related Articles:

Stellar Day For Stocks
More Articles on: Medical

Fundamental data is provided by Zacks Investment Research, and Commentary, news and Press Releases provided by YellowBrix and Quotemedia.
All information provided "as is" for informational purposes only, not intended for trading purposes or advice. iStockAnalyst.com is not an investment adviser and does not provide, endorse or review any information or data contained herein.
The blog articles are opinions by respective blogger. By using this site you are agreeing to terms and conditions posted on respective bloggers' website.
The postings/comments on the site may or may not be from reliable sources. Neither iStockAnalyst nor any of its independent providers is liable for any informational errors, incompleteness, or delays, or for any actions taken in reliance on information contained herein. You are solely responsible for the investment decisions made by you and the consequences resulting therefrom. By accessing the iStockAnalyst.com site, you agree not to redistribute the information found therein.
The sector scan is based on 15-30 minutes delayed data. The Pattern scan is based on EOD data.