• 25% people with Diabetes develop a Diabetic Foot Ulcer • 1 in 5 people developing severe infection undergo foot amputation • Developed with German technology partner – CytoTools AG • Will help save millions of foot amputating happening in India and the world-over Mumbai, [India] : Centaur Pharmaceuticals announced the launch of a New Chemical Entity (NCE) – WOXheal® – for the first time in the world. With its dual mechanism of action, WOXheal® is a unique product in the treatment of Diabetic Foot ulcers, and it will save millions of Diabetics who have to undergo foot amputation globally.
WHO predicts that there will be 10 crore Indians with Diabetes in the next 10 years. Amongst other complications of Diabetes; Diabetic foot ulcer is the most common complication seen in India. Apart from the fact that diabetic foot ulcers are non-healing, they not only hamper the Quality of life of the patient, but may also lead to complications such as wet gangrene, cellulitis, abscess and necrotizing fasciitis all leading to a total or partial foot amputation. Data indicates that 25% of people with Diabetes, will develop a Diabetic Foot Ulcer in their lifetime. 1 in 5 Diabetics who are hospitalised due to severe foot infection, undergo a foot amputation affecting the livelihood of the family.
Speaking on this occasion, Mr. S. D. Sawant, Chairman and MD of Centaur Pharmaceuticals, said, “We, at Centaur Pharmaceuticals, were deeply concerned with the alarming rate of foot amputations in India, and wanted to discover a drug to prevent it. Fifteen years ago, we collaborated with CytoTools AG, Germany, who had this promising molecule for the treatment of Diabetic foot ulcers. We are very happy to offer this ray of hope to people with Diabetic foot ulcer in India.” A globally patented product, WOXheal®topical solution, is effective in treating Diabetic foot ulcers. WOXheal® contains the NCE, Diperoxochloric acid, also called as DPOCL. WOXheal® has dual mechanism of action, i.e. it has functional antibacterial action against Gram positive and Gram-negative bacteria and it also promotes growth of fibroblast cells, thereby yielding complete wound closure.
Randomized clinical trials conducted across India in over 15 clinical trial centres on WOXheal® elucidated that over 90% patients with non-healing diabetic foot ulcer showed reduction in the size of the ulcer, and 75% out of these patients achieved complete healing within 6-8 weeks without any safety issue. The data and outcomes of the trial were submitted to the Indian Regulatory Authority and a manufacturing and marketing approval was granted to Centaur Pharmaceuticals for WOXheal®.
Dr. Mark-Andre Freyberg, the co-innovator of WOXheal® and the Chief Executive Officer of CytoTools AG, Germany said ' WOXheal® has completed Phase III clinical trials in India and demonstrated rapid and effective wound healing in patients with Diabetic foot ulcers, a condition that is notoriously difficult to treat.' Dr Dirk Kaiser, the co-innovator of WOXheal® and the Chief Scientific Officer of CytoTools AG, Germany said “WOXheal® is a novel drug born out of Indo-German collaboration and it will change the way Diabetic Foot Ulcer management is done and will help prevent amputation.” Dr Kaiser also added that phase III clinical trials were ongoing in Europe and the results from phase II clinical trials were similar to Indian clinical trials.
This pioneering effort by Centaur Pharmaceuticals, for an unmet medical need, enhances India’s stature as a self-reliant nation and a Pharma super-power. WOXheal® will be readily available in the entire country by the end of the month.