Histogenics Announces Publication of MRI Data From NeoCart® Phase 1 and Phase 2 Clinical Trials in the American Journal of Sports Medicine
WALTHAM, Mass., Jan. 11, 2017 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, today announced the online publication in the January 2017 issue of the American Journal of Sports Medicine of a peer-reviewed publication entitled Magnetic Resonance Imaging Characterization and Clinical Outcomes After NeoCart Surgical Therapy as a Primary Reparative Treatment for Knee Cartilage Injuries. The lead investigator is Dr. Dennis Crawford MD, PhD with support from other investigators including Devon E. Anderson, PhD, Riley J. Williams III, MD, Thomas M. DeBerardino, MD, Dean C. Taylor, MD, C. Benjamin Ma, MD, and Marie S. Kane, MS. The publication analyzes magnetic resonance imaging (MRI) data through 60 months follow up from the Phase 1 and 2 clinical trials of NeoCart for the repair of articular cartilage injuries in the knee.
29 patients with symptomatic full thickness cartilage lesions of the distal femoral condyle were treated with NeoCart in the Phase 1 and Phase 2 clinical trials and pooled for this analysis. Safety and efficacy were evaluated prospectively by MRI and patient reported outcomes (PROs) through a 60-month follow-up period, with 21 patients evaluable at the final time point. Qualitative MRI metrics were quantified according to modified magnetic resonance observation of cartilage repair tissue (MOCART) criteria, with an additional evaluation of repair tissue signal intensity. The NeoCart patients were followed over 52 ± 15.5 (median=60) months.
MOCART analyses indicated significant improvement (p<0.001) in the cartilage quality from 3 to 24 months, with stabilization and maturation from 24 to 60 months. In addition, longitudinal MRI analysis demonstrated NeoCart repair tissue to be durable and evolve over time. Changes in imaging measures over time corresponded with improvement in clinical measures, with maximum benefits experienced at 24-months. Results from the two studies indicate that NeoCart is a safe and effective treatment for articular cartilage lesions through 5-year follow-up. In addition, the Phase 1 and 2 NeoCart PROs when compared to baseline demonstrated statistically significant improvements on virtually all of the pain and functional endpoints, as early as 3 to 6 months, with sustained outcomes through 5 years.
“We are very pleased with the results of the clinical trials conducted to date and want to thank our investigators and patients for their participation. We believe this is an area in need of a better alternative for patients who are seeking new options to repair cartilage defects that potentially offer both a more rapid recovery and durable response over time with fewer repeat surgeries,” stated Gloria Matthews, Chief Medical Officer of Histogenics. “We believe the MRI data, while limited in the number of patients, provide additional confirmatory evidence of previously reported clinical efficacy outcomes, and demonstrate the potential benefits to patients with cartilage defects. We are looking forward to the availability of additional data from the continuing development of this promising treatment alternative,” continued Dr. Matthews.
The demonstrated rapid maturation of cartilage as evidenced by the MRI data from the Phase 1 and Phase 2 clinical trials is consistent with biomechanical data recently presented by Histogenics and Cornell University that showed that in vitro cartilage constructs, or tissue implants, produced using a process that is designed to mimic that of NeoCart exhibited mechanical properties prior to implantation that were similar to that of native cartilage. These results suggest that the maturation of tissue-engineered cartilage implants, such as NeoCart, leads to improved mechanical properties prior to implantation and may result in a more rapid recovery and return to function for patients suffering from cartilage defects.
