India's Stempeutics seeks partner as projects advance
This article was originally published in Scrip
Stempeutics Research, an Indian stem cell company, is hoping to rope in a strategic partner to finance its R&D, even as it remains upbeat about the prospects of ongoing trials to develop potential treatments for acute myocardial infarction and critical limb ischaemia.
Stempeutics' president, B N Manohar, told Scrip that the company was keen on a partner to fund "ongoing and future" clinical trials and R&D activities.
"We have invested nearly Rs1 billion ($22.3 million) in R&D across our centres in India and Malaysia. Though we conduct research on both adult and embryonic stem cells, we believe that adult stem cells, especially the stem cells from the bone marrow, are closer to the market and have invested heavily in this area," Mr Manohar said. Stempeutics has labs in Bangalore and Manipal in India and in Malaysia.
On the company's potential treatments for myocardial infarction and critical limb ischaemia, Mr Manohar said that Phase I/II trials in both areas were showing encouraging results and that data were expected to be provided to the Drugs Controller General of India (DCGI) within the next few months.
"This is the first DCGI and Indian Council of Medical Research (ICMR)-approved clinical trial using adult allogeneic mesenchymal stem cells from healthy bone marrow. Our investments in the last three years [in] R&D have clearly put us ahead of [the] rest of the players," Mr Manohar claimed.
The company has contracted Acunova, a Bangalore-based CRO, to conduct clinical trials in India and Malaysia. The trials for acute myocardial infarction are being undertaken in hospitals in Bangalore, Hyderabad and Ahmedabad. The critical limb ischaemia study is being done in Kochi, New Delhi and Bangalore.
Stempeutics, which is financed by the Manipal Education and Medical Group, has also received approval from Malaysia's ministry of health for trials in cerebral stroke patients. The studies expect to explore the safety and efficacy of allogeneic mesenchymal stem cells in cerebral stroke patients by assessing their potential in the formation of new blood vessels in ischaemic cerebral tissue to improve blood circulation.
Details on the trials in Malaysia are expected to be announced shortly once the entire approval process is completed, Mr Manohar said, adding that the Malaysian operation was key to the company's growth plans in Southeast Asia.
orphan status
Stempeutics believes that India needs to consider fast-tracking the approval process for stem cell-based studies. "The government needs to think of a fast-track approval process, considering it as 'orphan' drug status – like what the FDA is doing in the US," Mr Manohar said.
He also suggested the need for a separate task force on stem cell research and therapy to see how India can leverage its intellectual talent and become a global leader in the area. Some industry analysts believe that Indian stem cell companies could possibly mirror the success of domestic firms in the area of outsourcing.
Mr Manohar said that such opportunities were immense and that the cost of production of the clinical grade stem cells for trials was nearly 50% less than that in developed countries.
Stempeutics also wants the Indian government to back the industry with financial incentives. Mr Manohar referred to the "excellent" support provided by the Malaysian Biotechnology Corporation, which provides seed, R&D and export funding for start up companies. "It also provides 10-year tax benefits from the year the company starts making profit, duty exemptions and other benefits for promoting stem cell companies. The Indian government should provide these benefits to stem cell companies based on certain evaluation," he said.
The ICMR and India's Department of Biotechnology jointly formulated guidelines for stem cell research and therapy in 2007, providing ethical and scientific direction to scientists and clinicians in the field. Recent media reports suggest that there are now plans to set up a National Apex Committee to review stem cell research. ICMR is currently holding public consultations across India to generate consensus among various stakeholders and interest groups.