Of the total number of citizens living in the United States with diabetes, about 34 percent could suffer from a diabetic foot ulcer.
The Cuban drug was developed two decades ago and its use was already authorized in 26 countries.
Regulatory authorities of the United States Government authorized the final stage of clinical trials of a medicine manufactured in Cuba, offering hope for more than 37 million people who today suffer from diabetes in this country.
The biotechnology company Discovery Therapeutics Caribe (DTC), based in Cleveland, received permission from the United States Food and Drug Administration (FDA) to begin phase 3 of those clinical studies.
DTC, which is dedicated to improving health outcomes for Americans by developing regenerative therapies for serious and life-threatening diseases, in making the announcement said it achieved an important milestone reflecting progress in its clinical program.
Of the total citizens living here with diabetes, about 34 percent could suffer from Diabetic Foot Ulcer (DFU), according to researchers.
“There is a pressing need for treatments that can stop the progression of diabetic foot ulcers before amputation becomes the inevitable solution,” said Dr. David Armstrong, distinguished podiatric surgeon at the University of Southern California.
Armstrong, a renowned diabetic foot ulcer researcher, emphasized that historically, treatment options have been limited, but with the introduction of advanced therapies such as intralesional rhEGF, which “I have seen used effectively overseas, we are hopeful.”
The upcoming Phase 3 trial in the United States will rigorously evaluate its efficacy in patients with DFU.
This study “represents exciting potential to change the current paradigm and provide new hope to those who desperately need it,” he stressed.
For his part, Lee Weingart, co-founder and president of DTC, said the sold phase 3 clinical trial stage “will help us understand the clinical profile of this biological product within the FDA regulatory framework and take advantage of the extensive international clinical experience of the rhEGF».
While Dr. Charles Zelen, president of the Professional Education and Research Institute (PERI), warned that “preventing the serious outcomes associated with diabetic foot ulcers is critical to saving limbs and lives of Americans.”
Based on clinical efficacy and safety data collected from international studies, DTC management believes they are on track to initiate this pivotal trial with intralesional rhEGF, marketed globally as Heberprot-P, by the end of 2024 in the United States, the study said. text.
Alarmingly, nearly half of patients who undergo DFU-related lower extremity amputation do not survive more than five years.
The statement noted that among U.S. veterans, the prognosis is even bleaker, as survival after two years is rare for patients who develop gangrene.
Additionally, particularly concerning is the disproportionate impact on African American communities, they are nearly twice as likely to suffer a lower limb amputation within one year of DFU diagnosis compared to their non-Hispanic white counterparts.
Innovative therapeutic options for severe diabetic foot ulcers are not only necessary: patients have long needed them, they noted.
The Cuban drug, which helps close wounds that are difficult to heal in diabetic patients, was developed two decades ago and its use was already authorized in 26 countries.
