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Enzolytics Announces Its Progress Toward Completion of Clinical Trials for Its Anti-HIV ITV-1 Therapeutic and Plans for Its Distribution Throughout Europe
Enzolytics Announces Its Progress Toward Completion of Clinical Trials for Its Anti-HIV ITV-1 Therapeutic and Plans for Its Distribution Throughout Europe.
About this update from Enzolytics Inc.
[{"type":"text","content":"COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.The Company's ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA) but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company total confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.The steps now in place to accomplish the Company's goal of bringing its anti-HIV ITV-1 therapeutic to patients are:The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.IMPL is owned equally by the Company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania.The Company has engaged the Contract Manufacturing Company (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.The Company has engaged the Contract Research Organization (CRO) Clinical Design Ltd. in cooperation with PharmaLex to prepare and establish a drug development programme concerning creation of protocols for human clinical trials that will lead to the licensing of the Company's ITV-1 therapeutic under the European Medicine Agency (EMA).The production at Danhson Ltd. will produce initial quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinical Designs, Ltd.IMBL is contracting with PharmaLex, a leading EU regulatory consulting company to manage document review of the product compliance with EMA requirements.The clinical trials will be f...