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Enzolytics Reports Its Progress Toward Completion Of Clinical Trials for Its ITV-1 ANTI-HIV Therapeutic and Securing Use Authorization Under the European Medicines Agency
Enzolytics Reports Its Progress Toward Completion Of Clinical Trials for Its ITV-1 ANTI-HIV Therapeutic and Securing Use Authorization Under the European Medicines Agency.
About this update from Enzolytics Inc.
[{"type":"text","content":"COLLEGE STATION, TX / ACCESSWIRE / July 29, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has completed arrangements and agreements with Danhson (https://danhson.bg/en/) and Clinic Design (https://clinicdesign.eu/) to advance its anti-HIV therapeutic ITV-1 to production and clinical trials. These steps are prefatory to approval by the European Medicines Agency (EMA), leading to patient use authorization.Production of the therapeutic will be accomplished at Danhson pharmaceutical company facilities, to be followed by clinical trials conducted by Clinic Design. Production of the therapeutics is expected to be completed in the next few months followed by clinical trials to be conducted immediately thereafter. The protocol of the trials will be guided by Pharmalex (https://www.pharmalex.com/), an EU regulatory consulting company.Earlier in the year, the Company announced the formation of International Medical Partners ("IMPL"), a Bulgarian Limited Liability Company, of which the Company is 50% owner. Pursuant to that formation, the Company will fund the initial production of the ITV-1 therapeutic and the Company's partners in IMBL will fund the cost of the clinical trials and cost of EMA permitting.IMBL will be the exclusive distributor of the ITV-1 therapeutic in the European Medicines Agency member countries (namely all 27 European Union member states and Iceland, Liechtenstein and Norway) as well as the countries of Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania. IMBL may distribute the ITV-1 therapeutic outside of its exclusive territory where an exclusive license does not otherwise exist.All documentation for registration of IMPL has been filed with the Registry Office in Sofia. The initial funding of IMBL, by Enzolytics and its partners, has been provided by the partners.The Company's two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as completed. The audit is proceeding as planned without any unanswered issues.Harry Zhabilov, CSO of Enzolytics, stated, "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 EM...