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 that the NeoCart will be regulated as a regenerative medical product in the country. The company said it would also engage in minor, non-clinical safety studies, including short-term general toxicity and in vitro tumorigenicity studies to “reflect current standards” and augment pre-clinical data.
“We are very pleased with the formal feedback we received from the PMDA regarding the relatively expeditious approval pathway for NeoCart in Japan, and appreciate the thoughtful, rapid and collaborative approach provided by Japan regulators. These successful consultations and meetings are evidence of our execution of a broadening global regulatory strategy launched only seven months ago where we initiated efforts to leverage the robust U.S. clinical, preclinical and cGMP data for NeoCart into international markets. We believe the clarity on this efficient regulatory pathway for full Marketing Authorization will be important to our efforts to seek a development and commercialization partner for NeoCart in Japan and other markets in Asia,” Histogenics prez & CEO Adam Gridley said in a press release.
Last October, Histogenics said it raised $30 million in a private placement. The round of equity, convertible stock and warrants was led by new institutional investors and some of its existing backers.