Enzolytics Inc. (OTCMKTS: ENZC) has finalized an agreement and arrangements with Danhason and Clinic Design to advance its Anti-HIV treatment ITV—1 into clinical trials and production. These processes are necessary before the European Medicines Agency (EMA) approves a product for patient use.
Danhson to manufacturer Enzolytics’ ITV-1 treatment
The medication will be manufactured at Danhson Pharmaceutical Company facilities, and Clinic Design will undertake clinical studies. The medicines’ production is due to be completed within the next six months, with clinical trials following soon after. Pharmalex, an EU regulatory consultancy firm, will oversee the trial’s protocol.
The company announced earlier this year the formation of International Medical Partners (“IMPL”), a Limited Liability Company in Bulgaria in which it owns a 50% stake. Enzolytics will fund the initial ITV-1 therapeutic production with its partners in IMPL, funding the clinical trials and EMA licensing costs.
IMPL to supply ITV-1 therapeutics to 27 EU states
IMPL will be the sole distributor of the ITV-1 treatment in all 27 EU member nations, including Liechtenstein, Iceland, and Norway, as well as Georgia, Russia, Ukraine, Belarus, Moldova, Armenia, Azerbaijan, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Latvia, Estonia, and Lithuania. In addition, IMBL could distribute the ITV-1 treatment outside of its exclusive jurisdiction where an exclusive license is not available. The Registry Office in Sofia has received all of the papers required for IMPL registration.
CSO of Enzolytics Harry Zhabilov said, “We are excited about the progress we have made with the assistance of our IMBL partners. Contracting with Danhson, Clinic Design and PharmaLex is integral to the success of the EMA permitting process. As this is the second time our ITV-1 therapeutic has progressed through clinical trials and the first trials were successful, we are fully confident that we will succeed in the permitting process. With the reciprocal treaty between the EMA and FDA, we believe that the EMA approval with lead to further advancement of our ITV-1 as a successful therapy.”