- Diabetic foot is one of the most significant and devastating complications of diabetes
- Out of approx. 70 million diabetics in India, 25% develop DFUs, of which 50% contact infection and require hospitalization while 20% undergo amputation
- Evidence from published literature shows 100,000 leg amputations/year due to diabetes related problems & an expense of approx. Rs 1.40 Lakhs for complete treatment of DFUs
- Stempeucel-DFU – a stem cell therapy product, promises significant therapeutic effect due to its strong angiogenic and anti-inflammatory properties
- DCGI has approved the conduct of Phase 3 clinical trial
Bengaluru, September 18, 2019: Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced today that it has signed an out-licensing deal with Cipla for Stempeucel-DFU product for Diabetic Foot Ulcer indication. Out-licensing deal comprises of upfront payment and various milestones based payments. Under this agreement, Cipla will get the exclusive marketing rights for five years in India for DFU product with Stempeutics manufacturing & supplying the product to Cipla. The product is expected to be available in Indian market in the beginning of 2021 after undergoing the Phase 3 Clinical trial in India, which is expected to commence in October 2019.
Commenting on the tie up with Stempeutics Mr Nikhil Chopra, Head, Cipla India Business said, “We are pleased to partner with Stempeutics in bringing the next generation of biologics to address unmet medical needs in India. DFU is a serious condition that requires immediate treatment to re-establish blood-flow to the affected area to prevent the leg from amputation. Stempeucel-DFU offers a novel treatment approach to the physicians in India to treat DFU and will substantially improve the quality of life of thousands of patients suffering from this painful disease.”
Mr BN Manohar, CEO of Stempeutics said, “We are extremely happy to collaborate with Cipla in developing cell therapy product for non-healing DFU. DCGI approved Phase 3 clinical trial is a placebo controlled, double blind study consisting of 84 patients. Study will be conducted across India consisting of 17 hospitals. To show the effect of Stempeucel-DFU product, only patients not getting cured with the existing standard of care will be included in the clinical trial. Stempeucel-DFU will be injected in and around the wound bed, in order to accentuate the healing process.”
Speaking on the Stempeucel-DFU product, Dr Pawan Gupta, Senior Vice President, Medical and Regulatory Affairs, Stempeutics, said “Current standard of care for treating non-healing diabetic ulcer includes local wound care with sterile dressings, repeated debridement of necrotic tissues, and pressure off- loading. However, most results are far from satisfactory, and about 20% of patients with DFU undergo limb amputation. Since DFU is a complex clinical condition, current approaches endeavour to address one single approach, which leads to the failure of complete healing. Cell therapy-based approaches have several advantages compared to others, as it allows therapeutic targeting of different phases of wound healing. Multiple mechanisms of action of these cells can address both cellular and growth factor defects in the non-healing wounds.”
Corporate Comm India (CCI Newswire)
