Heberprot-P remains the only pharmacological treatment option in the world for high-grade lesions in the lower limbs of diabetic patients, and reduces the risk of amputation of these limbs by around 75%. This is supported by the favourable results of its application for 24 years.
This was stated to Granma by Dr. Jorge Berlanga Acosta, scientific leader of the Healing Research project, of the Center for Genetic Engineering and Biotechnology (CIGB), belonging to the BioCubaFarma Business Group.
“According to the conclusions of recent research published by our team of specialists in refereed academic journals of high international impact, Heberprot-P also continues to be the only product capable of preventing short-term recurrences of this type of ulcers.”
The doctor explained that the value of treatment with the Cuban injectable medicine lies not only in healing the injury, but also in maintaining its integrity over time.
«Famous drugs approved by the Food and Drug Administration (FDA) of the United States show recurrences of up to 40%, three months after epithelialization or recovery of damaged tissue has occurred.
“In the case of Heberprot-P, pharmacovigilance studies report recurrence rates of only 5% 12 months after the end of its application, experiences that we have also made known in some of the most recognized scientific publications on the subject,” he stressed.
«To date, and following the trail of potential competing drugs, it is possible to infer, according to what has been publicly reported, that the rest of the products existing on the international market, or candidates to obtain that status in the clinical trial phase, are focused on low-grade lesions, and all conceive treatment by topical route.»
He mentioned, among them, the so-called inflammation modulators, through the reprogramming of macrophages, angiogenic inducers, as well as the development of special dressings for the absorption of proteases and cellular skin substitutes with human fibroblasts and keratinocytes.
None of them considers advanced stage ulcers of diabetic foot within their therapeutic indication niches, stressed Dr. Berlanga Acosta.
«With the experience accumulated with Heberprot-P, we can affirm that we have sufficient evidence on its therapeutic effect at a systemic level, by attenuating or correcting a group of altered biochemical indicators in diabetic patients, due to sustained hyperglycemia.»
He gave as an example the results of two studies that demonstrated its effectiveness in reducing inflammatory, apoptogenic (programmed cell death or caused by the body itself), and oxidative markers, which is a key factor in preventing lesion recurrences.
The scientist stressed that the CIGB is currently working on identifying new uses of the drug in other ailments, while developing new formulations of the product, based on nanotechnology, aimed at reducing the number of applications, making the therapeutic procedure less invasive and promoting its use in other very complex ulcers, such as bedsores and venous ulcers caused by vascular disorders.
CREDENTIALS
Leading product of Cuban biotechnology, Heberprot-P contains as an active pharmaceutical ingredient recombinant human epidermal growth factor, a 53-amino acid peptide that, when coupled to its receptor, activates anabolic metabolism, promotes the synthesis of amino acids and proteins, resulting in cell division.
In 2001, permission to test it on humans was requested from the Cuban regulatory authority. After the request was accepted by the Center for State Control of Medicines, Equipment and Medical Devices (Cecmed), the 1st. June 2001, it was used for the first time in a Cuban patient, admitted to the Institute of Angiology and Vascular Surgery, as part of the beginning of a Phase I clinical trial conducted by Dr. José Ignacio Fernández Montequín, then director of that institution.
The aforementioned study covered another 28 national patients with complex ulcers in their lower extremities, who presented a high criterion for amputation. After the trial, approximately 59% of them managed to heal their wounds.
Registered in Cuba in 2006, since then and to date Heberprot-P has been used in more than 450,000 Cuban and foreign patients suffering, mostly, from diabetic foot ulcers in advanced stages, showing notable effectiveness in closing and rapid healing of the lesions, which prevented the majority of those treated with the drug from ending up with one of their two lower limbs amputated.
In 2011 he was awarded the Gold Medal from the World Intellectual Property Organization (WIPO) for providing an original and effective therapeutic solution against an ailment that, until then, had no favorable treatment options.
During 2024, the Cuban medicine continued to attract attention in different scenarios around the world. Thus, at the beginning of last May, the BioCubaFarma Business Group reported that Heberprot-P received authorization from the FDA to carry out a clinical trial in the United States.
The research will be carried out by the American company Discovery Therapeutics Caribe (DTC), which specialises in biotechnology.
Likewise, in the month of February, the Ministry of Science, Technology and Environment notified that Heberprot-P will be one of the first Cuban biotechnology medications that will arrive in the United Arab Emirates to begin marketing, following the agreements signed between both countries. in that sphere.
