FIRST: Alkem Labs secures DCGI nod for launch of StemOne in India

The product has been developed by Stempeutics, a group company of Manipal Education and Medical Group, over a period of twelve years. More than one million doses can be produced from a single set of master cell banks, which is unique in regenerative medicine, thus providing consistent product to patients.

Knee OA is one of the most common debilitating diseases experienced within an ageing population and constitutes an urgent medical need. Also, obesity, a major risk factor, is increasing in prevalence leading to increased occurrence of osteoarthritis. The estimated OA population in India alone is approximately 35 million. Presently, treatment options available include NSAIDs, glucosamine & chondroitin sulphate, Diacerin (IL-1 inhibitor), Hyaluronic Acid injections ("HA"), steroid injections, PRP injection and, ultimately, total knee replacement. Existing treatment options focus on providing temporary pain relief and reducing inflammation during the early stages of the disease without affecting the course of the disease.

StemOne has anti-inflammatory & immunosuppressive properties which reduce inflammation in the knee joint. StemOne may initiate the repair process by differentiating into chondrocytes or by inducing proliferation and differentiation of endogenous chondro-progenitors into mature chondrocytes or both.

Mr. Sunil Pathak - Senior Vice President & Cluster Head at Alkem said, "Our focus on innovation is guided by our strong sense of responsibility to address unmet patient needs and alleviate suffering. Knee OA is a serious and painful condition that impacts patients worldwide and we are happy that we are able to introduce this stem cell therapy in the country at an affordable cost. Current Knee OA treatments are more symptomatic in nature whereas StemOne™ drug has potential to address the root cause of the disease. StemOne™ offers a novel treatment approach to the physicians in India to treat Knee OA and will substantially improve the quality of life of millions of patients suffering from this painful disease".

Commenting on the DCGI approval, Mr. Manohar BN, MD & CEO of Stempeutics said, "Obtaining DCGI approval for StemOne™ is an important and historic milestone for Stempeutics. It is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work and underscores our global leadership in allogeneic, pooled MSC technology. We believe that the StemOne™ product is a game-changer, offering an advanced therapeutic treatment for millions of patients suffering from this painful disease."

Dr Pawan Gupta, Sr. Vice President, Medical & Regulatory Affairs, Stempeutics said, "StemOne™ product is developed from Bone Marrow Derived, Cultured Pooled, Allogeneic Mesenchymal Stromal Cells. Our Phase III trial is a double blind, randomised, placebo-controlled trial. We have administered StemOne™ using ultrasound guidance and used new MRI techniques called T2 mapping to assess the quality of articular cartilage. We are extremely happy to see statistically significant data on our primary end point i.e., the change from baseline to one year in WOMAC (Western Ontario and McMaster Universities Osteoarthritis) Osteoarthritis Composite Index score as compared to the placebo arm. Also, statistical significance was observed in WOMAC OA Pain Index/ Stiffness Index / Physical function Index".