teleSUR – The Cuban drug Heberprot-p received authorization for the development of a clinical trial in the U.S. . At the end of the year, the Biocubafarma Business Group announced on its Facebook page.
Biocubafarma explained that Discovery Therapeutics Caribe (DTC), an American company specialized in biotechnology, will be in charge of conducting clinical trials with this novel Cuban medicine to treat diabetic foot.
As the Granma newspaper details “In the first quarter of 2024, DTC filed an application for a new investigational drug with the US Food and Drug Administration. USA. (FDA) , which included a Phase III protocol for a randomized, double-blind, placebo-controlled trial of Biocubafarma’s leading product.”
Granma also points out that although rhegf (rhegf) is already available in more than 20 countries, this is the first time it will be studied in American patients suffering from diabetic foot ulcers (UPD).
The Pan American Health Organization (PAHO) highlights that Heberprot-P is indicated, along with other conventional therapies, for the management of diabetic foot in patients with neuropathic and ischemic ulcers, in stages 3 and 4 of the Wagner classification.
“Some 426 232 patients have already used it in other nations after it was approved by Cuban authorities in 2006. But the US blockade against Cuba and the requirements to obtain commercial licenses have delayed the introduction of this drug in the US,” said the digital media Cubadebate.
The process of obtaining Heberprot-p is carried out by the Center for Genetic Engineering and Biotechnology (CIGB), and it is estimated that more than 400,000 patients with UPD have been administered this drug worldwide, since its commercial authorization in June 2006.