Heberprot-P® is a novel and unique medicine indicated for diabetic foot ulcer treatment (DFU). This innovative product contains epithermal growth factor (EGF) as active pharmaceutical ingredient (APhI) to be applied by intra-lesional infiltration directly in the wound site. The therapy with Heberprot-P® fills the gap of an urgent unmet medical need for the treatment of complex DFU. There is a growing interest on the use of growing factors for treatment of DFUs. Therefore, a research program has been developed at the Center for Genetic Engineering and Biotechnology (CIGB), Havana, Cuba, from the 90s to study the biological effects of repeated parentheral application of human recombinant epithermal growth factor (hr-EGF) in wounds.
Pre-clinical experience on the pharmacologic effect of the hr-EGF in terms of tissue restoration and cito-protection, the technology expertise of the hr-EGF manufacturing staff, the design of a suitable parentheral pharmaceutical formulation, and a commercial vision focused to the development of research projects were the main active components that gave rise to the product Heberprot-P®. This medicine is an injectable formulation for intralesional infiltration, which constitutes a treatment for accelerating the healing process of deep and complex ulcers, including ischemic and neuropathic ulcers, derived from Diabetis mellitus (DM).
Characteristics and advantages of the treatment with Heberprot-P®
- Accelerates healing of deep and complex DFU.
- Reduces amputation risk in DFU patients. 3 weeks of treatment have been enough to observe granulation in more than 80% of DFU patients with wound areas between 1 and 80 cm2.
- Constitutes a significant contribution to improve the patient’s life condition, since it reduces the number and extension of surgical debridement or removal of necrotic tissue, and prevents recidives.
- Reduces the healing time, diabetes related complications such as gangrene, and infections, allowing re-positioning of medical resources to patients with a poorer prognosis.