Heberprot-P

Heberprot-P is the brand name of a drug developed by scientists at the Center for Genetic Engineering and Biotechnology (CIGB) in Cuba as a cure for diabetic foot ulcer.^[1] The product contains epidermal growth factor (EGF) to be applied by intra-lesional injections directly in the wound site.^[2][3][4] It has been found to "promote granulation and healing in advanced diabetic foot ulcers".^[5] Heberprot-P is indicated for the treatment of poor prognosis of deep, extensive, and terminal DFU not responding to comprehensive and/or extensive conventional methods, particularly in grades 3, 4 and 5 of Wagner's Classification with average ulcer size bigger than 20 cm²,^[1] of both neuropathic and ischemic etiology with high risk amputation. Clinical studies in 344 patients with advanced diabetic foot ulcers (Wagner´s grade 3 or 4, median size >20 cm², ischemic ulcers not excluded) have shown that injected recombinant EGF has the potential to promote complete granulation in more than 80%, with complete wound healing (re-epithelialization) in more than 50% of subjects usually unresponsive to other treatments. Injected recombinant EGF has the potential to reduce amputation rates, with a considerable personal and public health improvement, including longer survival.^[1]

Clinical trials and use

The drug is currently in use in Cuba (since 2007^[6]), Argentina, Colombia, Costa Rica, Ecuador,^[7] Guatemala, Mexico,^[8] Panama,^[9] Paraguay, Peru, Uruguay, Venezuela,^[10] Russia, Turkey^[11] and in the Domenican Republic, Kuwait,^[12] Vietnam, and the Philippines. Heberprot-P is protected by World patent WO PCT/CU2002/000011.^[13] As of July 2012, China has started advanced stage-three tests of the drug, along with colleagues at 100 hospitals throughout the European Union. These trials are the first time Cuban scientists have undertaken advanced clinical trials in developed countries.^[14]

The drug has seen successful use in Algeria where at least 700 patients with diabetes could avoid amputation and another 3000 cases of gangrene have been treated. A local firm is manufacturing the drug in Algeria.^[15] In South-east Asian countries such as Vietnam and the Philippines, the drug is being used as an advanced wound care healing drug and may be accessed through wound care clinics or wound care specialists among hospitals.

In a retrospective analysis in Argentina it has been shown that, in patients with severe diabetic foot ulcers (Wagner 3 and 4), local administration of Heberprot-P® during a brief period, was effective to induce healing of ulcers in a high percentage of patients. Granulation response was shown in 91% of patients. The complete granulation response rate obtained was 70.3%, with a complete ulcer closure in 69.2% of the patients. Mean wound healing time was 13 weeks.The recurrence rate was low, thus, further amputations were avoided and, as a consequence,patient’s quality of life improved.^[16]

Scientists presented the successful results of Heberprot-P in two forums held in the United States: Pan-American Health Organization in Washington, and the meeting at the Conference on the Management of Diabetic Foot Ulcers (DFCON, Los Angeles, 2014).^[17]

References