WALTHAM, Mass., Dec. 21, 2015 (GLOBE NEWSWIRE) — Histogenics Corporation (Histogenics) (Nasdaq:HSGX), a regenerative medicine company focused on developing and commercializing products in the musculoskeletal space, announced that the United States Food and Drug Administration (FDA) has accepted the Company’s amendment filed in November 2015 to the NeoCart Phase 3 clinical trial protocol to expand the eligible patient population. The approved protocol amendment was submitted, and the clinical trial is being conducted under, a Special Protocol Assessment (SPA) with the FDA.
“We are pleased that the FDA agreed with our proposed changes to the study protocol, and believe this may enhance our ability to attract qualified patient candidates while maintaining the integrity of the clinical evaluation of NeoCart, our product candidate for knee cartilage repair,” stated Dr. Gloria Matthews, Chief Medical Officer of Histogenics. “We continue to be pleased with the recent momentum we have seen in trial enrollment and we remain on track to complete enrollment by the end of the second quarter of 2017,” concluded Dr. Matthews.
Revisions to the NeoCart Phase 3 clinical trial protocol include:
- Patients with trochlear lesions will now be included in the trial.
- The upper age limit of patients eligible to participate in the trial will be increased from 55 years to 59 years.
- The time between a prior procedure, such as ligament reconstruction and meniscal tears, and a patient’s participation in the study will be reduced from six months prior to arthroscopy, which is the final step prior to enrollment, to three months prior to arthroscopy.
- Patients with asymptomatic lesions in non-study locations that are larger than the study lesion will no longer be excluded from the trial.
About Histogenics Corporation
Histogenics is a regenerative medicine company focused on developing and commercializing products in the musculoskeletal segment of the marketplace. Histogenics’ regenerative medicine platform combines expertise in cell processing, scaffolding, tissue engineering, bioadhesives and growth factors to provide solutions that can be utilized individually or in concert to treat musculoskeletal-related conditions. Histogenics’ first investigational product candidate, NeoCart, leverages its platform to provide an innovative treatment in the orthopedic space, specifically cartilage damage in the knee.