Heberprot-P to Begin Clinical Evaluation Stage in USA

The Cuban medicine Heberprot-P will begin a clinical evaluation stage in the United States with the aim of reducing the risks of amputation due to diabetic foot ulcer (DFU), business group BioCubaFarma reported today.

Following the procedures of the U.S. authority for the use of drugs (the Food and Drug Administration, FDA), once this stage has concluded, and that agency has approved it, the distribution and application in that country would begin, the entity exclusively told Prensa Latina.

According to BioCubaFarma president, Eduardo Martinez, the fulfillment of that purpose responds to the agreement signed on March 14 between the Cuban company Heber Biotec and U.S.-based Mercury Biotec.

According to Martinez, recent figures from the Centers for Disease Control and Prevention (CDC) state that there are more than 30 million diabetic patients, representing 9.4 percent of the population of that territory.

He also said that another 84.1 million pre-diabetic patients could become diabetics within a period of no more than five years for that disease, which was ranked seventh cause of death in the United States in 2015.

One of the main complications of this disease is the DFU, and amputations of lower limbs for this disease exceed 80,000 people affected annually in that country, he said.

The Heberprot-P, which has benefited about 300,000 patients worldwide, is registered in 23 countries, including Russia, Kuwait, Ukraine, Argentina, Turkey, Vietnam, Colombia, he said.

Specifically in Cuba, more than 77,300 DFU patients have been treated with Heberprot-P since 2007, which has led to reduce amputation by 70 percent, Martinez said.