Press Release

CITOPROT-P®: a new alternative for end-stage diabetic foot ulcer José A. Acosta, Ernesto L. Mola, Ricardo S. Rodríguez, Boris E. Acevedo, Luis H. Martínez

Havana . July 1 - Scientists working at the Centre for Genetic Engineering and Biotec hnology (CIGB), Havana , Cuba ,have developed a new product for preventing lower-limb amputation in patients suffering diabetic foot ulcerations. The new product CITOPROT-P ®, with more than 80% efficacy, is to be introduced in hospitals throughout the country, in a national multi-centric Phase III clinical trial, due to start before the end of 2005.

Researchers, medical doctors and patients know the meaning of CITOPROT-P® for those people living without a solution other than amputation. This product is an attractive alternative for end-stage diabetic foot ulcer patients, either ischemic and/or neuropathic, where amputation is the only available choice.

Medical data allow understanding the significant contribution of CITOPROT-P® to improve life condition of people suffering diabetic foot. The prevalence of Diabetes mellitus is between 174 and 194 million of people worldwide. Foot ulcers develop in approximately 15% of patients with diabetes and foot disorders are a leading cause of hospitalization among such patients; 85% of lower-limb amputations in patients with diabetes are preceded by foot ulceration. The annual incidence of foot ulceration is slightly more than 2% among all patients with diabetes and between 5 to 7.5% among diabetic patients with peripheral neuropathy.

In Cuba , the prevalence of diabetes is around 3% of the total population and 3 000 patients may suffer amputations if CITOPROT-P® were not available. At the present, products in the market are only restricted to prescriptions for neuropathic foot ulcers.

CITOPROT-P® is the result of more than 10 years of research at the CIGB and two well designed clinical trials performed in Cuba . After preclinical results showing that CITOPROT-P® stimulates granulation and epithelization, and reduces surgical treatment, thus limiting more invasive surgery due to relapses, the CIGB and the National Institute of Angiology and Vascular Surgery performed the first clinical trial with CITOPROT-P® in 29 type-II diabetic patients with micro and/or macro angiophathy. As a first result, 55% of patients were saved from amputations. Then, a Phase II clinical trial was conducted in 41 patients and the results were even better: more than 80% patients were saved from amputations.

CITOPROT-P® has already been patented in Cuba and patent requests have been made in Europe , Japan , the US , Canada and some countries of Latin America , among others. The patent application claims for use of a pharmaceutical composition containing epidermal growth factor (EGF) in a parenteral formulation, which is administered by infiltration for preventing diabetic foot amputations. The product is offered for out-license as an orphan designation for diabetic lower-limb amputation prevention, which remains an unmet medical need.