Stempeutics Research, a group company of Manipal Education & Medical Group, plans to launch and market its product Stempeucel in the Indian market by mid-2015. The product which is currently undergoing the last stage of phase 2 clinical trial across the country for the indication of critical limb ischemia (CLI), osteoarthritis (OA) and liver sclerosis is expected to enter phase 3 trial by early 2013.
Three trials are currently in progress for Stempeucel at multiple sites for the above indications, wherein patients are enrolled from all over the country for better results. As of now, 16 patients have been enrolled in the CLI trials, 45 patients in OA trail and 2 patients in LC trial. All the 45 patients enrolled for OA study in India have already cleared the trials successfully without any adverse drug reactions (ADR's) showing a positive future for the drug. A senior company official informed that it will take another six months to the get the preliminary efficacy data of the phase 2 trials for OA and CLI indications.
According to Manohar, CEO, Stempeutics Research, the aim of the company is to launch the product at the earliest in the market with requisite regulatory approvals and trial results so that it can be beneficial for the patients as soon as possible. He informed, “We are very happy with the way the trials are going and have high hopes on Stempeucel product as it will be able to cater to the needs of many people from the sub continent. Based on the results till now, we plan to officially launch this product into the Indian and Malaysian market by the end of 2014 or latest by mid 2015 based on their clinical outcomes.”
Like in India, Stempeucel is also undergoing phase 2 clinical trial for the OA indication in Malaysia with the permission of the Malaysian regulatory authority and has already completed the recruitment of 72 patients in the country. Manohar states that Malaysia is also one of the important market along with other south East Asian countries that the company is aiming to strengthen its hold in.
He added, “Once we complete the CLI trial in India, we will contemplate over launching the product line in other South East Asian countries as well, depending on their regulatory requirements and clinical trial requirements. But right now our main focus is on India and Malaysia only.”
The company informed that the product will be launched in the market at a very affordable rate and it will be comparable or cheaper to the current available medication in the country. “Our main aim is to ensure availability of safe and efficacious stem cell products to all the patients at an affordable rate. We believe that our treatment option will be affordable to the patients compared to the current treatment available for the knee replacement therapy.”
'Stempeucel' product is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics proprietary technology. In CLI trial Stempeucel may possibly address the issues related to these diseases among others. When injected by the intramuscular route in the affected limb, it can lead to formation of new blood vessels or neo-angiogenesis. This in turn may relieve the rest pain, heal the ulcers and prevent amputation.