April 10, 2018 8:50am
CLBS closed at $5.31 and is UP +$0.77 or +15.84%
The SAKIGAKE designation is part of Japan’s effort to accelerate the development and approval of regenerative medicines.
The strategy of SAKIGAKE includes a system for designating products for which prominent effectiveness (i.e. radical improvement compared to existing therapy) can be expected.
CLBS has received SAKIGAKE designation from the Japan Ministry of Health, Labor and Welfare (MHLW) for CLBS12 for the treatment of critical limb ischemia (CLI). CLBS12 is currently in a P2 trial in Japan for the treatment of no-option CLI, a severe obstruction of arterial blood flow to the extremities in patients that results in severe pain at rest and/or non-healing ulcers, which carry a risk of amputation.
The Pharmaceutical and Medical Devices Act (“PMDA”) enables an expedited path to conditional approval for regenerative medicine products that show sufficient safety evidence and signals of efficacy in P2 study and is similar to the Breakthrough Therapy Designation in the United States.
The CLBS12 P2 trial is a 35-patient prospective, randomized, controlled, multicenter study in no-option CLI patients in Japan. No-option CLI means that pharmacotherapy is unable to provide satisfactory treatment and that amputation of a limb or limbs is the next step in treatment for these patients. Patients randomized to treatment will be dosed with autologous G-CSF-mobilized peripheral blood-derived CD34 cells (CLBS12) through intramuscular injection, in addition to receiving standard of care pharmacotherapy. Patients randomized to the control arm will receive standard of care pharmacotherapy alone.
The primary endpoint is time to continuous CLI-free status.