Histogenics finishes trial planning in pursuit of Japanese NeoCart approval

Histogenics (NSDQ:HSGX) said today it completed all formal consultations with the Japanese Pharmaceuticals and Medical Devices Agency’s Office of Cellular and Tissue-based Products as it seeks regulatory clearance for its NeoCart in Japan. NeoCart is designed to stimulate the body’s ability to regenerate cartilage in the knee, using neocartilagenous tissue developed from patients’ chondrocyte cells, the Waltham, Mass.-based company said. Histogenics said that it is nearing enrollment completion in the 245-patient Phase 3 clinical trial of its NeoCart under a Special Protocol Assessment as it seeks FDA clearance. The company said that it came to an agreement with the PMDA that its ongoing Phase 3 clinical trial with a 1-year primary endpoint “could be appropriate and provide sufficient evidence of safety and effectiveness for the full Marketing and Manufacturing Authorization in Japan,” according to a press release. The company will also engage in a 30-patient, 1-year confirmatory clinical trial in Japan as it seeks full authorization in the country. “We are thankful for the leadership and partnership with the PMDA. We have been working collaboratively for nearly 20 years to provide substantial supportive basic science and non-clinical data as well as novel cell culture technology to guide the development of this important innovative therapy for cartilage defects,” co-founder Dr. Shuichi Mizuno said in a prepared statement. Histogenics said...
Source: Mass Device - Category: Medical Equipment Authors: Tags: Regenerative Medicine Regulatory/Compliance Histogenics Source Type: news