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Histogenics Reports Positive Phase 2 Data for NeoCart Autologous Cartilage Tissue Implant for the Treatment of Knee Cartilage Injury
Data at Two Years Post-Op Met Primary Endpoints
WALTHAM, Mass. – July 27, 2011 – 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 prospective 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.
About the Phase 2 Trial
The Phase 2 study of NeoCart evaluated 30 subjects, with a 2:1 randomization ratio of NeoCart treatment to MF treatment. Efficacy outcome measures applied included the Knee Injury and Osteoarthritis Outcome Score (KOOS) and the International Knee Documentation Committee (IKDC) Score.
According to results from the study, there were no serious adverse events related to treatment with NeoCart. Both cohorts demonstrated improvements in a measure of general health status at six, 12 and 24 months. NeoCart-treated patients demonstrated significant improvement for all outcome measures included in the study at 12 and 24 months, including knee function, pain (including maximum pain), activities of daily living, and sport and knee quality of life.
Surgeons who contributed to the Phase 2 trial include: Thomas Debarardino, M.D.; Aki Kusanagi, D.V.M., Ph.D.; CT Mooreman, M.D.; Suichi Mizuno, Ph.D.; Brad Nelson, M.D.; Hollis Potter, M.D.; Lane Smith, Ph.D.; Dean Taylor, M.D.; and Riley J. Williams, IIII, M.D.
Histogenics is a leading regenerative medicine company that combines cell therapy and tissue engineering technologies to develop highly innovative products for tissue repair and regeneration. In May of 2011, Histogenics acquired Israeli cell-therapy company Prochon BioTech. Histogenics’ flagship products focus on the treatment of active patients suffering from articular cartilage derived pain and immobility. The Company takes an interdisciplinary approach to engineering neocartilage that looks, acts, and lasts like hyaline cartilage. It is developing new treatments for sports injuries and other orthopedic conditions, where demand is growing for long-term alternatives to joint replacement. Histogenics has successfully completed Phase 1 and Phase 2 clinical trials in which the NeoCart autologous tissue implant’s effectiveness is compared to that of standard microfracture surgery. Based in Waltham, Massachusetts, the company is privately held. For more information, visit www.histogenics.com.