The novelty covers the method of preparing master cell banks, working cell banks and the final therapeutic product Stempeucel based on the novel pooling technology. Stempeucel will initially be used for the treatment of critical limb ischemia (CLI).
The firm’s proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product to patients at an affordable cost. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine.
“The new patent strengthens our position in Japan, which has created an accelerated development path for stem cell therapies. The new regenerative medicine law implemented in Japan allows conditional approval of stem cell products, thereby enabling more rapid entry into the Japanese market. We are actively evaluating the potential for accelerated development of Stempeucel product for Critical Limb Ischemia and osteoarthritis indications in Japan with strategic collaborations,” said B.N. Manohar, CEO of Stempeutics.
“Japan is showing great leadership in innovating a regulatory framework for regenerative medicine thereby addressing major unmet medical needs faster,” said Chandru Chawla, head of Cipla New Ventures.
Drug authorities in the European Union granted the so-called orphan drug status to Stempeucel and the company wants to get a conditional licence to sell the drug in India to help it raise money to complete the drug’s late-stage trials.
Currently three Phase 2 clinical trials are in progress in India which are approved by DCGI i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Liver Cirrhosis (LC). Stempeutics is planning to complete OA & CLI Phase 2 trial by middle of 2013 and likely to file for Phase 3 by end of 2013 based on the outcomes of Phase 2 trial. Stempeutics has also received approval from DCGI to conduct Phase 2 clinical trials for Chronic Obstructive Pulmonary Disorders (COPD) and Diabetes Mellitus Type-II (DM). These two trials are yet to start. In Malaysia, Stempeutics is currently conducting OA Phase 2 trial. Stempeutics has also received NPCB approval for Phase 1/2 Ischemic Cerebral Stroke (CS) trial. This trial is yet to start.
With three Phase 2 trials in progress, Stempeutics aims to bring out their first product into the Indian and Malaysian markets in 2015. Stempeutics long-term objective is to market “stempeucel®” in the Asian, European and North American markets.