Cipla to market India’s stem cell drug Stempeucel for leg ischemia by Stempeutics

India’s domestic pharma market leader Cipla will market Stempeutics’ stem cell therapy for leg ischemia drug Stempeucel, reports said.

Stempeucel, which is claimed to be the first stem therapy in India, is expected to be launched in India by 2013.

Cipla Ltd has already invested Rs 50 crore into Stempeutics Research Pvt Ltd (SRPL), a part of the Manipal Education & Research Group for R&D and marketing of Stempeucel for treating Critical Leg Ischemia (CLI).

Stempeutics is expected to undergo phase-III study on 120 patients at hospitals across the country.

Stempeutics has completed pre-clinical studies demonstrating the appropriate safety profile of human bone marrow-derived ex vivo cultured adult mesenchymal stem cells in allogenic settings.

Stempeutics is currently doing clinical research to establish the efficacy of the stem cell therapy in acute myocardial infarction (heart attack) and critical limb ischemia.

The injected cells have the potential to induce formation of new blood vessels (neoangiogenesis) in the ischemic limb and by improving circulation, they increase pain free walking distance (PFWD), relieve rest pain, heal ischemic ulcer and prevent or decrease rate of amputation.

Drug Controller General of India (DCGI) and Indian Council for Medical Research (ICMR) – the apex body regulating medical research in India –and the Department of Biotechnology (DBT) under the ministry of science and technology, government of India gave approval to Stempeutics last year to start clinical trials using allogenic mesenchymal stem cells from the bone marrow for these two indications.

Stempeutics’ is considered the first DCGI and ICMR approved clinical trial using adult allogenic mesenchymal stem cells from the bone marrow in India.

A phase 3 study using adult allogenic mesenchymal stem cells is planned to be conducted in India in 2011

Stempeutics is also planning to conduct another phase III study outside India. This second phase 3 is likely to be supportive for the registration of the product in ASEAN countries.

Stempeutics is planning to file new drug application (NDA) in India in the coming years.

The clinical trials are being spearheaded by Manipal Acunova, a Bangalore based CRO.

The multi centre, double blind, randomised and placebo controlled studies are being conducted at various hospitals in India including Bhagawan Mahaveer Jain Heart Centre, Bangalore; Amrita Institute of Medical Sciences, Kochi; Care Hospital, Hyderabad; S A L Hospital and Medical Institute, Ahmedabad; and M S Ramaiah Memorial Hospital, Bangalore ASir Ganga Ram Hospital, New Delhi; M S Ramaiah Memorial Hospital, Bangalore and in Bhagawan Mahaveer Jain Heart Centre, Bangalore.

Stempeutics Research Private Limited is a stem cell company developing stem cell based medicinal products, with facilities in Bangalore and Manipal (India) as well as in Kuala Lumpur (Malaysia).

Cipla, which plans to support Stempeutics Research Pvt Ltd for research and development of stem cell based products, could consider boosting the investment further in coming years, reports said quoting senior officials.

Stempeutics has a pipeline of stem cell therapies for various indications including chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and diabetes mellitus.

Stempeuties has obtained MoH, Malaysia approval for cerebral stroke clinical trails.

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