Date: 2015-04-08
Type of information: Clinical trial autorization
phase: 3
Announcement:
Company: Mesoblast (Australia)
Product: rexlemestrocel-L (MPC-06-ID)
Action
mechanism: stem cell therapy
Disease: chronic low back pain due to degenerative disc disease
Therapeutic area: CNS diseases - Bone diseases
Country:
Trial details:
Latest
news: * On April 8, 2015, Mesoblast announced that following positive feedback from its recent meeting with the European Medicines Agency (EMA), it intends to expand the Phase 3 clinical program of its product candidate MPC-06-ID in the treatment of chronic low back pain due to degenerative disc disease to include sites in the European Union (EU).
Mesoblast\'s Phase 3 program for this product candidate is currently enrolling patients in the United States under an Investigational New Drug (IND) application filed with the FDA. Having received general agreement from EMA on the target patient population, trial size, primary composite endpoint, and comparators in the control population, the Company now intends to additionally enroll patients across multiple European sites.
The discussions with EMA occurred as part of combined scientific and reimbursement advice under an EU pilot program known as Shaping European Early Dialogues (SEED). The SEED pilot program was established to facilitate early dialogue between EMA, European Health Technology Assessment (HTA) reimbursement bodies, and selected companies with late-stage clinical development
programs. Mesoblast\'s product candidate MPC-06-ID is one of only seven medicines accepted for the SEED program.
Mesoblast and SEED representatives discussed key clinical trial aspects of the development of MPC-06-ID including the safety database, mechanisms of action, patient population and trial size, composite endpoints, and comparators. The discussions also focused on access to EU markets and pharmacoeconomic endpoints that may lead to reimbursement.
The guidance from the meeting with SEED representatives may result in a final comprehensive EU development and commercialization program that has an increased likelihood of producing data that will be acceptable for both registration and reimbursement review in multiple European countries.
