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Manipal group-owned Stempeutics Research said its stem-cell-based candidate drug has been cleared for phase-II trials for four diseases.
Stempeutics expects to introduce by the end of 2013 the first stem-cell-based drug that would be available off-the-shelf in India, it said on Thursday.
Following the clearance of the Drug-Controller General of India, Stempeucel, the experimental drug, will be tested on patients with type-2 diabetes, osteoarthritis, liver cirrhosis and chronic obstructive pulmonary disease.
The drug was cleared for phase I/II clinical trials on acute myocardial infarction (heart attack) and critical limb ischemia in March 2009.
Stempeutics, formed in 2006, is funded by the Manipal Education & Medical Group and drug company Cipla Ltd.
Mr B.N. Manohar, CEO, Stempeutics Research, said, “We are the only company in India [to have] achieved this significant milestone. Our team is working towards hitting the first off-the-shelf stem-cell product in the Indian market by the end of 2013. We have pioneered large-scale upscaling of mesenchymal stem cells, and we expect that it will be the most cost-effective product globally.”
“The DCGI's clearance of Stempeucel for four debilitating diseases is one of Stempeutics's significant accomplishments towards its goal of bringing safe, effective and affordable stem-cell-based products in India in the near future. India becomes one of the leading countries after the US to enter this phase of stem-cell research,” the company said.
The company said it took 15 months to get the regulator's approval. The drug controller referred Stempeucel to the Indian Council for Medical Research, which in turn set up an expert committee to study the proposal.
The allogenic Stempeucel product — that is not derived from the patient — is developed from mesenchymal stem cells of a donated bone marrow.
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