Bangalore: Stempeutics Research Pvt. Lab., a spin-off from the Manipal Education & Medical Group, has set up a subsidiary in Malaysia, becoming the first international company to obtain the bionexus status, which entitles it to special tax benefits and obtain grants there.
Manipal will spend $6-10 million (Rs23.6-39.4 crore) on Stempeutics Research Malaysia Sdn Bhd in the next three years even as it expects seed investments and grants from the Malaysian government to spur an ambitious growth plan. The group , which has invested more than $7 million in Stempeutics since its inception in January 2006, intends to use its Malaysian subsidiary to provide stem cell therapy in neighbouring South-East Asian countries.
“To begin with, we will tap Taiwan and Singapore for research and as well as for commercializing our stem cell therapies,” said Stempeutics’ chief scientific officer Satish Totey, who has steered the start-up to undertake India’s first formal adult stem cell trials for treating myocardial infarction, multiple sclerosis, limb ischemia and cerebral stroke.
After encouraging results from pilot studies with autologous (from one’s own body) adult stem cells derived from bone marrow, Stempeutics is now conducting experimental stem cell transplants for a variety of diseases at Manipal Hospital in Bangalore, which it intends to extend to hospitals in the four metros.
“We are awaiting approval from the Drug Controller General of India for allogeneic (stem cells derived from non-related donor cells) stem cell trials,” said B.N. Manohar, president of Stempeutics.
Allogeneic stem cells are shown to provide long-term, disease-free survival, but they also have greater risks of infection or graft-versus-host disease similar to organ transplants. However, standard, commercial stem therapies can use only allogeneic cells as these can be produced on a large scale.
The group will invest another $5 million over the next two years in building a cell manufacturing facility in Manipal and in conducting clinical trials. “Globally, companies have either launched allogeneic products, or are conducting late stage trials. We’ve not even begun allogeneic trials here,” said Totey.
According to Vasantha Muthuswamy, a deputy director at the Indian Council of Medical Research (ICMR), New Delhi, all the on-going trials in India are autologous, except the one at Deccan College of Medical Sciences in Hyderabad, which is for chronic liver failure. “It’s a phase III trial for an allogeneic product, which is already approved by the US food and drug administration, and a US company is conducting simultaneous trials in India,” she added.
After five years of deliberations and public debate, ICMR and the department of biotechnology finally submitted their draft guidelines for stem cell research to the Union ministry of health on 8 November. “Mere guidelines are not sufficient. We need legislation,” said Muthuswamy, hinting that it’s anybody’s guess how long before the legislation comes into force.
“The private sector cannot wait endlessly for approvals. If we don’t get it on time, we’d move to Malaysia for allogeneic trials, though ideally we’d like our data to come from India,” said Totey. Stempeutics plans to be the first Indian company to bring “off-the-shelf, standard stem cell therapies” to the market by December 2009 and is talking to pharma companies for marketing its products.