Manipal group-owned Stempeutics Research has received the green signal from the Malaysian regulator for conducting Phase I and II clinical trials of its novel candidate drug to treat osteoarthritis and cerebral stroke.

Depending on the outcome of the studies, Stempeutics said it expected to launch the first stem cell-based drug off the shelf in Malaysia in 2014.

This is the first Indian stem cell product to be tested in Malaysia, the Bangalore-based Stempeutics, funded by Manipal Education & Medical Group and Cipla Ltd, said in a release.

According to Mr B.N. Manohar, CEO, Stempeutics Research, “We have also planned for a large-scale upscaling of mesenchymal stem cells facility in Malaysia and we expect that it will be the most cost-effective product globally.” Apart from large facilities in Bangalore and Manipal, the company had set up Stempeutics Malaysia in 2007 and a large facility to produce mesenchymal stem cells from donated bone marrow. It has filed six patents in Malaysia.

Mr Dato' Iskandar Mizal Mahmood, CEO of Malaysian Biotechnology Corp (BiotechCorp), was quoted as saying the global market for stem cell therapy was expected to be $16 billion in 2014; in Malaysia this market was around $157 million.

Mr Madhu Kumar, Country Manager, Stempeutics Research Malaysia, said, “While the initial foray of Stempeutics is in bone marrow-derived mesenchymal stem cells, Stempeutics is investing heavily on R&D to bring out some innovative products in the near future based on adult stem cells. We want to become an undisputed leader in the stem cell area in this part of the world.”

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