|View printer-friendly version|
|Histogenics Announces Publication of MRI Data From NeoCart® Phase 1 and Phase 2 Clinical Trials in the American Journal of Sports Medicine|
– Data demonstrate significant improvement in cartilage quality over first 24 months after treatment, with stabilization and maturation thereafter out to 60 months –
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
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
“We believe the data from these two clinical trials are compelling and provide further evidence that NeoCart implants may provide an improved alternative for patients with knee cartilage defects,” stated, Dr.
The full publication is hosted on the
NeoCart is a cartilage-like, tissue engineered implant created from a patient’s own cartilage cells. The patient’s cells are multiplied in Histogenics’ laboratory and then infused into a proprietary scaffold to allow them to organize and function like cartilage cells. Before NeoCart is shipped to the surgeon for implantation, the cell and scaffold construct undergoes a bioengineering process that is designed to mimic a joint so that the implant, upon placement in the knee with a proprietary bioadhesive, is primed to begin functioning like healthy cartilage. NeoCart is currently in a Phase 3 clinical trial that is designed to evaluate the safety and efficacy of NeoCart as a first-line therapy for full thickness knee cartilage defects in skeletally mature adults ages 18 to 59 and to show superiority of NeoCart against the current standard of care, microfracture.
Various statements in this release are “forward-looking statements” under the securities laws. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties.
Important factors that could cause actual results to differ materially from those reflected in Histogenics’ forward-looking statements include, among others: the timing and success of Histogenics’ NeoCart Phase 3 clinical trial, including, without limitation, possible delays in enrolling the NeoCart Phase 3 clinical trial; the ability to obtain and maintain regulatory approval of NeoCart or any product candidates, and the labeling for any approved products; the scope, progress, expansion, and costs of developing and commercializing Histogenics’ product candidates; the ability to obtain and maintain regulatory approval regarding the comparability of critical NeoCart raw materials following our technology transfer and manufacturing location transition; the size and growth of the potential markets for Histogenics’ product candidates and the ability to serve those markets; Histogenics’ expectations regarding its expenses and revenue; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Histogenics’ Annual Report on Form 10-K for the year ended
There can be no assurance that the actual results or developments anticipated by
All written and verbal forward-looking statements attributable to
Contact: Investor Relations Tel: +1 (781) 547-7909 InvestorRelations@histogenics.com