OrthoTrophix Completed Patient Treatments in Part A of the Phase 2 Clinical Trial of a New Cartilage Repair Therapeutic for Knee Osteoarthritis and Initiated Patient Enrollment for Part B
Oakland, Calif., November 17, 2014—OrthoTrophix, Inc., a privately held biopharmaceutical company, announced today the completion of the dose-finding (Part A) portion of the Phase 2 clinical study of TPX-100 in subjects with osteoarthritis (OA) of the knee. The Company initiated the study in early 2014 (Press Release on February 20, 2014). All 27 subjects in the four dosing cohorts have completed all scheduled intra-articular injections. There have been no severe or serious AEs, and no subjects have withdrawn from the trial. Based on review by the Safety Review Committee, a dosing regimen has been selected and Part B has been initiated.
The Phase 2 clinical trial is entitled, “A Randomized, Double-blind, Placebo-controlled, Multi-dose Phase 2 Study Evaluating the Safety and Efficacy of Intra-articular Injections of TPX-100 in Subjects with Mild to Moderate Patello-Femoral Osteoarthritis Involving Both Knees.” The study is designed to obtain proof of principle of safety and efficacy of TPX-100 for knee cartilage repair and regeneration compared to placebo among subjects with mild to moderate osteoarthritis. The study outline is posted at the ClinicalTrials.gov site.
OrthoTrophix is developing TPX-100 as the first disease modifying osteoarthritis drug (DMOAD). Osteoarthritis (OA) is among the most common of all disabling diseases. In the US, it is estimated that more than 27 million people suffer from osteoarthritis, including more than half of individuals 65 years of age or older. The knee is the joint most affected by symptomatic OA, and is one of the most important causes of poor quality of life in the aging population.
The Company’s Chief Medical Officer, Dawn McGuire, M.D., FAAN stated, “It is encouraging that all subjects completed all scheduled TPX-100 administrations uneventfully, with no withdrawals or serious adverse events. Safety and tolerability of TPX-100 has been excellent at all four doses administered. We look forward to acquiring further safety and efficacy data on TPX-100 for the indication of articular cartilage repair and regeneration in patients afflicted by OA.”
About OrthoTrophix, Inc.
OrthoTrophix, Inc., based in Oakland, Calif., is a privately held biopharmaceutical company focused on the development and commercialization of revolutionary therapeutics for the treatment of diseases and conditions involving the hard tissues. Founded by three co-founders in 2011, the primary focus of OrthoTrophix has been regeneration and repair of cartilage in the knee and other joints with its novel proprietary compounds which promote formation of new cartilage and bone tissues thereby repairing the respective defects. OrthoTrophix has received over $14 million from its Series A preferred stock financing and research and development revenues since its inception.
This press release contains “forward-looking” statements. These statements involve risks and uncertainties, which may cause results to differ materially from those set forth in the statements. The forward-looking statements include statements regarding product development and cannot be guaranteed. OrthoTrophix undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect OrthoTrophix’ business.
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