Enzolytics Inc (ENZC)

[bigtalan]

Virogentics, Inc. Receives Permit for Export to Africa of the ITV-1 Immunotherapy Solidifying the Scheduled Administration of the Treatment
ALLEN, TX / ACCESSWIRE / August 8, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/)

Virogentics, Inc. ("VIRO") a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today the receipt of an export permit for the delivery of the treatments to be administered to the volunteer HIV/AIDS patients at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. The results of this African pilot clinical trial will be used in the development of the European Medicine Authority (EMA) clinical trials expected to begin in late 2023/early 2024.

so what are we missing we were told in 2021 clinical trials according to this PR

for Its ITV-1 ANTI-HIV Therapeutic and Securing Use Authorization Under the European Medicines Agency
PUBLISHED
JUL 29, 2021 7:30AM EDT
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 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."