WALTHAM, Mass.--(BUSINESS WIRE)--Regenerative medicine company Histogenics Corporation, announced today the presentation of intermediate term data supporting the clinical efficacy of the Company’s NeoCart Autologous Cartilage Tissue Implant (ACTI) for periods of up to five years with no evidence of severe treatment-related adverse events in patients with grade III chondral injury to the femur (cartilage damage in the knee). Dennis Crawford, M.D., Ph.D., Assistant Professor and Surgical Director of Sports Medicine Programs in the Department of Orthopedics and Rehabilitation at Oregon Health Science University presented the findings “An Autologous Cartilage Tissue Implant (ACTI) NeoCart® for Treatment Grade III Chondral Injury to the Femur. Intermediate Term Results from Initial FDA Trials.” at the International Cartilage Repair Society (ICRS) 2012 Annual Meeting in Montreal Canada on Sunday, May 13, 2012. NeoCart is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the repair of full thickness cartilage lesions.
“These results suggest that NeoCart has significant potential to act as a first-line surgical treatment option for focal cartilage repair or replacement and, as such, may provide an alternative to microfracture type procedures,” said Dr. Crawford. “For the patients in this cohort with knee cartilage injuries treated with NeoCart, we reported improvement in all patient reported outcomes as soon as six months following surgery, as patients were released to full activity, and these therapeutic gains were sustained throughout a median study period of 48 months. The first patients treated with NeoCart have had similar gains for five years. These improvements are seen across a spectrum of validated, ICRS-recommended outcome measures, including pain, function and associated activity of daily living performance.”
“This analysis continues to add to an already impressive NeoCart data set and further supports our ongoing Phase 3 study,” said Patrick O’Donnell, President and Chief Executive Officer of Histogenics. “There is clearly a need in the market for longer-term, effective solutions for cartilage injury and we are hopeful that NeoCart may be able to play a role in filling this treatment void.”
The primary purpose of the analysis was to summarize the safety and efficacy experience of all patients treated with NeoCart up to five years using ICRS-recommended patient reported scores, as well as general health assessments. Subjects were pooled from previously-completed, Company-sponsored Phase 1 and 2 multi-center clinical trials. Eligible patients were between the ages of 18-55 years of age and had one or two symptomatic ICRS grade III chondral lesion(s) on the femoral condyle. Validated and ICRS-recommended patient reported outcome measures were obtained at each follow up visit. These included the following: Knee Injury and Osteoarthritis Outcome Score, Visual Analog Scale, Short Form Health Survey, and International Knee Documentation Committee subjective. Serious and adverse events were recorded for all patients. Data on twenty-nine patients was reported in the cohort, including eight patients through 60 months and 20 patients at a minimum of 36 months; one patient was lost to follow up after 12 months. The median follow up time period was 48 months.
Significant improvement (p<0.0001) was seen in the mean measures of all patient reported outcomes across all time points up to four years and at final follow up for each patient. Measures included the International Knee Documentation Committee, Short Form Health Survey, all five domains of the Knee injury and Osteoarthritis Outcome Score and the Visual Analog Scale (VAS) average and highest. Significant decreases from baseline (p<0.05) were reported for average VAS pain scores (17±18, p=0.031) at six weeks and for highest VAS pain scores at three months (23±31, p=0.004), and sustained through final visit (p<0.0001) for both. Range of motion did not decrease in any patient and, in fact, improved with a mean change from baseline of 6±8 degrees at final follow-up (p<0.001). Serious adverse events were limited to four and not related to the implant.
NeoCart® is an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions. NeoCart recently entered a Phase 3 clinical trial after reporting positive Phase 2 data, in which all primary endpoints were met and a favorable safety profile was demonstrated.
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, including lead candidates NeoCart®, an autologous bioengineered neocartilage grown outside the body using the patient’s own cells for the regeneration of cartilage lesions, and VeriCart™, a three-dimensional cartilage matrix designed to stimulate cartilage repair in a simple, one-step procedure. 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.