TissueGene, Inc. Completes Enrollment in U.S. Phase II Study of TG-C in Patients With Knee Osteoarthritis
Published: Nov 14, 2012
ROCKVILLE, Md., Nov. 14, 2012 /PRNewswire/ -- TissueGene, Inc. announced today that it has completed patient enrollment for a U.S. Phase II clinical trial of TG-C in patients suffering from severe osteoarthritis of the knee. TG-C is a therapy that involves human allogeneic chondrocytes developed to produce the therapeutic protein TGF-beta1 to regenerate cartilage.
The randomized, double-blind, placebo-controlled study has been designed to evaluate the safety and efficacy of TG-C in patients with Grade 3 chronic degenerative joint disease (DJD) of the knee. This multi-center study has been conducted at five hospitals and clinical research centers across the country specializing in orthopedics. Patients have received an intra-articular injection of either TG-C or placebo to the damaged joint area. Patients in this study are being followed for two years with the primary efficacy endpoint analysis being conducted once all patients have reached their one year follow-up. In conjunction with this milestone, TissueGene's licensing partner, Kolon Life Science, Inc. has completed patient enrollment for a Phase IIb study of TG -C in Korea.
"We are very pleased with the clinical progress of TG-C in both the US and Korea and look forward to reporting our Phase II data in 2013," stated Dr. Kwan Hee Lee, Chief Medical Officer of TissueGene.
About TissueGene, Inc.
TissueGene, Inc. is a Maryland-based biopharmaceutical company focused on developing novel regenerative therapies for the treatment of various orthopedic diseases. TissueGene's proprietary 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 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.
SOURCE TissueGene, Inc.