Preclinical Results

Heberprot-P® is a pharmaceutical composition for parenteral use, containing epidermal growth factor as the active pharmaceutical ingredient (EGF).  A research project on the biological effects of the repeated parenteral administration of EGF has been developed at the Centre for Genetic Engineering and Biotechnology from the 90s. A set of experiments to evaluate the effect of repeated injections of EGF on the morphological and functional restoration of an important peripherals nerve after sever damage.

The experiments consisted in repeated injection of EGF next to the nerve section region in a group of rats, while the other group of animals received physiologic saline solution. Deferent experimental methodologies allowed demonstrate that animals receiving EGF injections improved the nerve condition, motility and sensitivity of the affected limb. These results suggested that the EGF favored survival of cell producing myelin, located next to the section of the nerve. Electron microscopy studies evidenced the citoprotection effect of the EGF on different nerve structures.

The observations that the debut of sole ulcer and other forms of dead of limb soft tissues were delayed for more than 10 days in animals receiving EGF injections were highly valuable results. An experiment performed three times consisted on denervating the back feet of the rats. A protection effect of the EGF on the soft tissues of the denervated limb was observed as an invariant pattern. Opposed to data obtained from animals injected with EGF, ulcers appeared in the group of animals receiving saline solution, loosing part of the denervated limb after no more than 48 to 72 hours.

The prevention of hair lost in the denervated limb was maybe the earliest response to the treatment with EGF, which allowed taking the risk to forecast the magnitude of the effect in terms of nerve restoration and prevention of finger necrosis. The finding that the EGF showed an anti-necrotic effect into the assayed experimental context, suggested an unusual citoprotection capacity with a high potential for therapeutic applications, according to the physiopathologic relevance of the implemented lesion model.

The section of the sciatic nerve represented a sudden deterioration of the vascular neurotone, and the vasomotor reserve, which undoubtedly will imply negative consequences on the oxygenated blood irrigation in the skin, as such as its venous return. In other words, the possibility of implementing the pharmacological management of an ischemic process or tisular hypoperfusion from neurogenic causes started to become rational.