BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

TissueGene, Inc. Initiates Patient Enrollment for a Phase II Study of TG-C for Osteoarthritis of the Knee


5/19/2011 10:02:11 AM

ROCKVILLE, Md., May 19, 2011 /PRNewswire/ -- TissueGene, Inc. announced today that it has initiated patient enrollment for a U.S. Phase II clinical trial of its lead product candidate TG-C. TG-C involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 for the regeneration of cartilage in patients suffering from severe osteoarthritis of the knee.

The randomized, double-blind, placebo-controlled Phase II study will evaluate the safety and efficacy of TG-C in patients with chronic degenerative joint disease (DJD) of the knee. Patients will receive an intra-articular injection of either TG-C or placebo to the damaged joint area with primary and secondary endpoints involving evidence of symptomatic improvement and cartilage regeneration, respectively. This multi-center study will be conducted at hospitals and clinical research centers across the United States specializing in orthopedic research and is expected to include 100 patients. In conjunction with these efforts, TissueGene's licensing partner, Kolon Life Science, Inc. (KOSDAQ: 102940) anticipates the initiation of a Phase IIb single-dose study for TG-C in Korea by 3Q 2011, having previously received regulatory allowance by the Korean FDA to proceed.

"We are pleased to have reached another significant milestone with the start of our U.S. Phase II study of TG-C," stated Dr. Kwan Hee Lee, Chief Medical Officer of TissueGene. "We believe that TG-C has the potential to become the first noninvasive treatment for osteoarthritis by regenerating cartilage through a simple injection into the knee."

About TissueGene, Inc.

TissueGene, Inc. is a Maryland-based biopharmaceutical company with a pipeline of noninvasive regenerative medicine therapies in the field of cell therapy. TissueGene's core technology employs a form of cell-mediated therapy to deliver therapeutic proteins to localized areas of damaged tissue. The company is currently developing four product candidates for the regeneration of cartilage (TG-C), bone (TG-B), disc (TG-D), and nerve tissue (TG-N) for the treatment of various orthopedic diseases. For more information, please visit http://www.TissueGene.com.

About Kolon Life Science, Inc.

Kolon Life Science, Inc. (KOSDAQ: 102940), a subsidiary company of Kolon Group, is a leading Korean-based biochemical company focused on pharmaceutical ingredients and environmental biochemicals. Its pharmaceutical business division provides active pharmaceutical ingredients and pharmaceutical intermediates ranging from zaltoprofen and flurbiprofen to argatroban and voglibose. For more information, please visit http://www.kolonls.co.kr.

Media Contact: Joy Limpuangthip, Director of Business Development, +1-301-921-6000, joy@tissuegene.com

SOURCE TissueGene, Inc.



Read at BioSpace.com

   

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES