Firm Claims TPX-100 Modifies Osteoarthritis!!

OrthoTrophix, Inc., a privately held biopharmaceutical company based in Oakland, California, has started a Phase 2 clinical trial of a cartilage repair therapeutic agent. Called TPX-100, the substance is designed to be used with knee osteoarthritis patients in the U.S.

The purpose of the clinical trial is to demonstrate proof of principle of the safety and knee cartilage repair efficacy of TPX-100 in cases of mild to moderate knee osteoarthritis (DMOAD). The outline of the study is posted at the ClinicalTrials.gov site.

OrthoTrophix reports that it plans to develop TPX-100 as the first disease modifying osteoarthritis or DMOAD drug. Osteoarthritis, a degenerative joint disease, is the most common disease of the joints, and one of the most widespread of all chronic diseases. The company estimates that, in the U.S. more than 27 million people suffer from osteoarthritis with more than half of those individuals being 65 years of age or older.

The joint most affected by osteoarthritis is the knee. Doctors have identified the main cause of the disease to be the degeneration of articular cartilage in the joints by aging, mechanical stress, or both and that repair of such damaged cartilage with new articular cartilage tissue would mitigate such symptoms. While its mortality is low, osteoarthritis presents one of the most critical quality of life problems in all generation with much higher prevalence in the aged population, say OrthoTrophix officials.

Company researchers discovered TPX-100 to be a tissue-specific hard tissue regeneration molecule. They say that TPX-100 has demonstrated the ability to repair cartilage and bone by regenerating the respective tissues without affecting soft tissues, and without forming non-relevant tissues in the target site. It forms only cartilage in the cartilage defects without forming bone or other tissues there.

Company officials claim that TPX-100 has demonstrated the ability to promote regeneration of new articular cartilage in the cartilage defects in the knee joints and delay advancement of cartilage damage in multiple cartilage trauma and osteoarthritis models. Company officials have tested TPX-100 in one Phase 1 and two Phase 2 clinical trials to date, and claim that it exhibited an excellent safety profile.

Chief Medical Officer Dawn McGuire, M.D., stated, “A novel DMOAD that promotes articular cartilage formation by simple intraarticular injections would be a revolutionary advance for OA. Current treatments require invasive surgeries or else address only symptoms. We expect to modify the root cause of disability in OA.”