Positive data from Histogenics' NeoCart Phase 2 study on knee cartilage injury

Histogenics Corporation, a privately held regenerative medicine company, today announced the presentation of positive Phase 2 data for the NeoCart Autologous Cartilage Tissue Implant (ACTI). The perspective, randomized, controlled study, which was presented by Dennis Crawford, M.D., Ph.D. at the American Orthopaedic Society for Sports Medicine (AOSSM) Annual Meeting, compared NeoCart to microfracture (MF) for knee cartilage injury treatment at two years post-operation. NeoCart is a bio-engineered neo-cartilage implant containing an autologous chondrocyte population matured in a biodegradable collagen matrix. The Phase 2 results showed that ACTI treatment using NeoCart is associated with statistically significant improvements in knee and general health outcomes scores by six months, at the primary endpoint of twelve months, and that are then sustained for at least two years, and that NeoCart had a higher proportion of therapeutic responders in comparison to MF at one and two years. In addition, the study confirmed a favorable safety profile for NeoCart.

"These Phase 2 results demonstrate Histogenics' continued progress with this product as we build a leading regenerative medicine company," said Patrick O'Donnell, President and Chief Executive Officer of Histogenics. "Building on these results, Histogenics has advanced this program into a Phase 3 trial under a Special Protocol Assessment (SPA) with the FDA, moving us closer to addressing a significant opportunity - pain associated with cartilage injury - in the large and fast-growing global sports medicine market."

Dennis Crawford, M.D., Ph.D., who led the Phase 2 trial and presented the results at AOSSM, stated, "Cartilage has a poor ability to repair itself, and, as a result, these injuries can persist indefinitely and often lead to pain and compromised joint function. These results strongly support the continued clinical development of NeoCart." Dr. Crawford is Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University.

Source: Histogenics