Ohio company gets greenlight from FDA to test Cuban drug for diabetic foot ulcers
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CLEVELAND, Ohio— Cleveland-based biotechnology company Discovery Therapeutics Caribe will soon be studying a treatment for diabetic ulcers that was developed in Cuba.
The drug, which helps close hard-to-heal wounds in diabetic patients, was developed two decades ago and is authorized for use in 26 countries around the world to heal large ulcers in the feet of patients with poor circulation due to diabetes.
After applying to the U.S. Food and Drug Administration in February of 2024, Discovery Therapeutics Caribe received the greenlight to proceed with a Phase III clinical trial which it hopes will establish the drug’s efficacy as a treatment for diabetic foot ulcers here in the United States.
The drug will be marketed commercially under the name Heberprot-P. It is what’s known as a recombinant human epidermal growth factor (rhEGF), a genetically engineered version of a naturally occurring substance in the human body. Genetically modified yeast are used to produce the growth factor from human DNA.
The company says other therapies currently available in the United States that use growth factors for treating diabetic foot ulcers are applied directly to the surface of wounds. However, Heberprot-P is an injection that delivers the active ingredient under the skin, past the chronic wound environment that can otherwise degrade the drug and reduce the effectiveness of the treatment.
Naturally occurring human epidermal growth factor plays a crucial role in the body’s healing process. It works by activating a receptor on the surface of cells that stimulates them to grow, migrate where they are needed, and differentiate into the different cell types in wound healing such as those that form the skin (keratinocytes), connective tissue (fibroblasts), and blood vessels (vascular endothelial cells).
Epidermal growth factor aids in guiding these cells to the wound site, helps them develop into mature cells, and promotes the formation of new blood vessels. Together, these actions accelerate the formation of new tissue and help wounds heal effectively.
There is a pressing need for treatments that can halt the progression of diabetic foot ulcers before amputation becomes the inevitable solution, explained Dr. David Armstrong, a podiatric surgeon at the University of Southern California who studies diabetic foot ulcers, in a statement from the company.
Nearly half of patients who undergo lower extremity amputation resulting from diabetic foot ulcers do not survive beyond five years.
Among U.S. veterans, the prognosis is even more grim. Roughly two-thirds of veterans die following a diabetic foot amputation. In fact, in the past two decades, nearly 800,000 U.S. veterans have died from diabetic foot ulcers and lower limb amputation, more than all the soldiers killed in U.S. wars since the beginning of World War I (623,982).
In addition, Black patients are nearly twice as likely to undergo lower limb amputation within a year of a diabetic foot ulcers diagnosis compared to their white counterparts.
“Historically, treatment options have been limited, but with the introduction of advanced therapies like intralesional rhEGF, which I have seen used electively abroad, we are hopeful … ,” Armstrong said. “This trial represents an exciting potential to shift the current paradigm and provide new hope for those who desperately need it.”
The company says they are hoping to conduct the clinical trial in the Cleveland area. Diabetes is the 8th largest cause of death in Ohio.
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