Heberprot-P, the only drug in the world that has reduced the amputation rate by up to 75 percent in patients with diabetic foot ulcers, has been approved by the US Food and Drug Administration (FDA) for the biotechnology company Discovery Therapeutics Caribe (DTC) to conduct the said study.
It is a phase-three protocol for a randomized, double-blind, placebo-controlled trial of the company’s leading product, according to a press release from the Biotechnological and Pharmaceutical Industries Business Group (BioCubaFarma).
According to its description, Heberprot-P contains recombinant human epidermal growth factor (rhEGF) to heal deep and complex neuropathic and ischemic diabetic foot ulcers, speeds up progressive and sustained healing, and reduces the risk of amputation.
Cuba’s Center for Genetic Engineering and Biotechnology (CIGB) is credited with developing Heberprot-P, the only therapy included in the comprehensive care program for Cuban diabetic patients, and the Good Diabetic Living Program in Venezuela for more than ten years.
Heberprot-P is also available in more than 20 countries and is the first time that it will be tested in US patients. It will be a leading option in the therapeutic arsenal for the severe condition of the diabetic foot.
In statements to Prensa Latina early this year, CIGB General Director Marta Ayala said that Heberprot-P is administered in Colombia, Türkiye, and Russia, has sanitary registrations in Arab countries, and Cuba is also working so that people from other nations can have access to it, considering that diabetes is a chronic disease present across the world.
She noted that more than 400,000 patients with diabetic foot ulcers have benefited from Heberprot-P since its initial approval by the Cuban regulatory agency in June 2006.
Ayala said that research into other formulations, including nanotechnology, will make it possible to administer Heberprot-P to treat other complex ulcers, such as pressure ulcers and venous ulcers caused by vascular disorders.
Dr. David Armstrong, a distinguished podiatric surgeon at the University of Southern California and a world-renowned diabetic foot ulcer researcher, emphasized the critical need for innovative therapies.
“There is an urgent need for treatments that can halt the progression of diabetic foot ulcers before amputation becomes the inevitable solution. Historically, treatment options have been limited, but we have hope with the introduction of advanced therapies such as intralesional rhEGF.”
DTC Co-founder and President Lee Weingart commented, “We are pleased to start the next stage of intralesional rhEGF’s global journey in the United States, which will help understand the clinical profile of this biologic product within the regulatory framework, and use the extensive international clinical experience.
It is estimated that more than 37 million US citizens have diabetes; up to 34 percent of them will suffer from diabetic foot ulcers, and about 154,000 patients with non-healing ulcers undergo amputation.
In addition, nearly half of patients who undergo lower extremity amputations related to diabetic foot ulcers do not survive more than five years, Charles Zelen, a doctor of Podiatric Medicine, explained.
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