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Stempeutics banks on stem cells as cure for chronic diseases

Company stands a good chance of finding cure, but it may be a while before that happens

Joe C Mathew  |  New Delhi 

This Bangalore-based startup, backed by the and seed-funded by Cipla, is on fire and hopes to devise cures for at least eight such as Alzheimer’s and diabetes, though it may be a while before that happens.

A Kidney donor can save one life. A blood donor perhaps, will save several dozens in one’s life time. But what about a technology that allows one healthy donor provide treatment to thousands? Seems impossible? Not really, if the claims made by a Bangalore based start-up Ltd, is any indication. The company is in the process of devising medicines for at least eight including heart problems and cerebral strokes, through a patented technique that uses a particular type of stem cell taken from a healthy donor’s bone marrow for the production of around 20,000 units of a potential medicine. This could cure diseases that were previously untreatable, and potentially revolutionise the world of medicine.

Stem cells are biological cells found in all multicellular organisms, that can divide (through mitosis) and self-renew to produce more stem cells. In many tissues they serve as a sort of internal repair system. The most important potential application of human stem cells is the generation of cells and tissues that could be used for cell-based therapies. Today, donated organs and tissues are often used to replace ailing or destroyed tissue, but the need for transplantable tissues and organs far outweighs the available supply. Stem cells offer the possibility of a renewable source of replacement cells to treat diseases including Alzheimer’s disease, spinal cord injury, stroke, burns, heart disease, diabetes, osteoarthritis, and rheumatoid arthritis. These treatments are on the cutting edge of medicine and have the potential to be nothing short of revolutionary as a treatment.

What Stempeutics does is this: the company takes out the mesenchymal stem cell (a particular type of multipotent cell that can differentiate into a variety of cell types suitable to the bone, heart, brain etc) from the bone marrow of a healthy donor and culture more such cells in a lab setting. The product thus derived is expected to replace or regenerate the affected cells in the patients who are not ethnically or genetically related to the donor and cure, in a naturally way, without side effects.

Early this month, Stempeutics got Indian drug regulator’s approval to conduct the Phase II of clinical trials on its drug candidate “Stempeucel” in patients with (CLI) due to Buerger’s disease (a problem common among heavy smokers).

Globally, the incidence of CLI is estimated to be approximately 50 to 100 patients per lakh per year where 10-40 per cent of them are at risk of primary amputation. It is expected that when “stempeucel” is injected in the affected limb, it can lead to formation of new blood vessels, which in turn may relieve the pain, heal the ulcers and prevent amputation. “Through Phase I trial we could establish the safety of stempeucel for CLI patients and through this Phase II trial we hope to prove the efficacy and the optimum dose. Upon successful outcome, the company will be filing for Phase III approval in early 2013” BN Manohar, CEO, Stempeutics said.

The CLI drug trial is one among the two most advanced research programmes of the company. The other one is to see if “Stempeucel” can regenerate cells that get damaged in heart attack cases. In addition, clinical trial approvals are expected for various indications including chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and mellitus.

Manohar said the company hopes to commence its commercial operations by using imported “stempeucels” and then setting up a manufacturing facility on the outskirts of Bangalore once volumes begin to build up. “We should be looking at a facility with a capacity to manufacture 20,000 to 50,000 units a day”, he explained.

According to Manohar, the market potential of the drug candidates they are working on is immense. “India is the global capital of and of several illnesses related to lungs, heart etc. Even if we decide to put a price tag of Rs 1,000 a unit, it will run into several billions of dollars in a country of 1.2 billion people” he said, adding that it is too early to talk about marketing strategy or revenues. According to industry estimates, the global market for stem cell therapy will become $16 billion (approximately Rs 84,600 crore) in the next two years.

Company details:
* Bangalore-based company promoted by the Manipal Hospital Group
* Been given approval for Phase II of clinical trials for treatment that looks to help patients with Critical Limb Ischemia 
* Upon successful outcome, the company will be filing for Phase III approval in early 2013
* Also, clinical trial approvals expected for various treatments of chronic obstructive pulmonary disease, dilated cardiomyopathy, liver cirrhosis, osteoarthritis and mellitus amongst others
* Mumbai-based has seed—funded the company’s research programmes to the tune of Rs 50 crore in return for marketing rights of just Indian version of drug
* The caveat is that experts say that it is still too early to accurately predict the promises that stem cell research offers 
How its stem cells work:
* Stem cells are taken from bone marrow of donor
* Multiplied in thousands in laboratory setting
* Each such unit gets injected into the patient
* Replaces affected cells with healthy cells
* Could cure diseases by this repeated process
* Patient need not be ethnically or genetically related to the donor 
* The cure is essentially natural without side effects

How promising is Stempeutics’ proposed treatments? Enough to convince Mumbai-based Cipla—one among the top three domestic pharmaceutical and a leading provider of low cost generic medicines across the globe—to tie up with the and seed fund the company’s research programmes to the tune of Rs 50 crore in return for marketing rights of just the Indian version of a global drug. “We believe that stem cell therapy will be a huge opportunity in times to come, and hence Cipla’s investment in this segment. Stempeutics has a robust pipeline of products at a very advanced stage of development and (marketing) registration”, a senior official said.

To get an understanding of what kind of future awaits Stempeutics, one can size up the fortunes of Osiris, a US stem cell company which essentially claims to have recognised the potential of medical applications of the same type of stem cell that Stempeutics has zeroed in on. “Mesenchymal stem cells, intuitive, natural, requiring no typing or matching, and can be used with any patient, in any setting at any time. Understanding the implications of such a far reaching treatment, Osiris has developed a method of production where one healthy donor can provide treatment for thousands”, Osiris claims on its website. Three years ago, Osiris had entered into a $1.2 billion (Rs 6,300 crore) collaboration with global biotechnology major Genzyme whereby, the research programmes of Osiris will get Genzyme funding in return of marketing rights in specified countries.

Similarly, Israeli stem cell firm Gamida Cell, teamed up with the world’s largest generic drug company Teva (of Israel), signing a joint research and marketing collaboration with the company. Teva also has a similar tie-up through its subsidiary Cephalon with Australian stem cell company Mesoblast.

Stempeutics is not alone in the stem cell arena in India. The country’s clinical trial registry indicates that there are over 40 stem cell-related clinical trials (including that of Stempeutics) going on in over two dozen hospitals across the country. In addition to the efforts of individual hospital based researchers, there are contract research happening on behalf of overseas firms and trials carried out by a few other Indian Reliance Life Sciences is another serious player in this segment. “There is definitely lot of excitement around anything related to stem cells and regenerative medicine. As a business model, several people have noticed this opportunity to build organisations. Stempeutics is one of them. There are three of four other players in this segment in India”, Vijay Chandru, President of Associaiton of Biotechnology Led Enterprises (ABLE) said.

Starting off as an in-house lab of South India’s leading private healthcare provider Manipal Group, Stempeutics got incorporated as a standalone entity in 2006. In addition to its research lab in the group’s Bangalore hospital, the company has an R&D unit inside Manipal University (also in Manipal, Karnataka) campus and a third one in Malaysia. “We want to be known as a leading Asian (stem cell therapy) company”, Manohar says, adding that the long-term objective (of the company) is to market its products in the European and North American markets. The company has the approval of Malaysia’s Ministry of Health for cerebral stroke and Osteo Arthritis clinical trials and enjoys a Bionexus status in that country. Bionexus status provides Stempeutics 100 per cent income tax exemption for 10 years commencing from the first year the company derives profit.

A BE graduate from Regional Engineering College – Trichy, in 1977 and a ME graduate from Guindy Engineering College, University of Madras in 1979, Manohar first joined the Manipal Education & Medical Group (MEMG) as Chief Executive Officer—Manipal Infocom—a BPO organisation of MEMG, and went on to various other roles including acting as CEO of Manipal Universal Learning, before becoming CEO of Stempeutics.

Though remains the key promoter of Stempeutics, there are several others, apart from Cipla, who are finding Stempeutics’ research programmes worthy of funding support. Last month, the Department of Biotechnology (DBT) agreed to fund Stempeutics up to Rs 3.5 crore for conducting clinical trials to see whether “stempeucel” can help patients with alcoholic liver cirrhosis. Company claims this is the first ever occasion where DBT agreed to support a private firm for conducting stem cell clinical trials.

Still, the world of stem cell therapy comes with a host of caveats. In all these global tie-ups, the targeted stem cell products are still in the realm of clinical research. According to an Indian representative of a global life science consultancy firm, it is too early to predict the promises that stem cell research offers. “are putting in investments, promises are there, but it’s still long way to go”, the Mumbai based expert, who did not wished to be named said.

That said, if there’s any one company in India who stands a chance in finding a cutting edge cure for diseases that have confounded the global medical industry to date, it may well be Stempeutics.

First Published: Wed, December 28 2011. 00:13 IST