Discovery Therapeutics Caribe (DTC) is a clinical-stage biotechnology company dedicated to improving the health outcomes of Americans through the development of regenerative therapies for serious and life-threatening diseases.
DTC’s lead product is an intralesional recombinant human Epidermal Growth Factor (rhEGF) for the treatment of complex and complicated refractory neuropathic, ischemic, and neuroischemic diabetic foot ulcers (DFU).
The clinical grades of complex and complicated refractory DFUs are comparable to Wagner’s classification system grades 3 and 4; University of Texas classification system grades 2 and 3; and Wound/Ischemia/Foot Infection (WIfI) classification system stages 3 and 4. These severe ulcers exhibit an elevated risk of amputation and death. Although treatments exist, there is substantial need for improved DFU therapies.
While intralesional rhEGF, globally marketed under the brand name Heberprot-P®, is available to patients in twenty-six countries, DTC’s Phase 3 clinical trial will be the first time this treatment has be studied in the United States DFU patient population. The primary objective of this Phase 3 study is to assess the efficacy and safety of Heberprot-P, 75 µg, administered by direct intralesional injection plus Standard of Care Wound Treatment (SOC) in the treatment of DFUs compared to Placebo plus SOC.
Further clinical development of Heberprot-P® in the United States would provide an opportunity to assess the product’s potential to heal chronic wounds. This treatment is expected to induce granulation, tissue formation, and complete closure (i.e. re-epithelization) of the DFU.
Heberprot-P® was developed by the Center for Genetic Engineering and Biotechnology (Spanish: Centro de Ingeniería Genética y Biotecnología, [CIGB]) in Havana, Cuba. The drug product is a lyophilized formulation of rhEGF provided in a single use vial for parenteral administration.
DTC is developing Heberprot-P in the United States under a research and collaboration agreement with CIGB. DTC also has an exclusive license agreement to market Heberprot-P in the United States and other territories. DTC is following the Biologics License Application (BLA) licensure pathway, under the provisions of 351(a) of the Public Health Service (PHS) Act. This initiative adheres to the provisions of Section § 515.547 of the Cuban Assets Control Regulations (CACR).
Intralesional rhEGF is a well-established therapeutic agent with a solid foundation of more than three decades of research and development
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