Enzolytics Announces Preliminary Results of GLP Toxicology Study for its anti-HIV Therapeutic ITV-1 and Production of ITV-1 for Initiation of Registration in Africa

COLLEGE STATION, TX / ACCESSWIRE / February 8, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).

Enzolytics, Inc. announced today the preliminary results of Toxicology studies of the Company's ITV-1 anti-HIV therapeutic confirming that the therapy is non-toxic and demonstrating the safety of administration of this patented proprietary immunotherapy. Establishing this result is essential to permitting under the European Medicines Agency (EMA) and the acceptance for administration of ITV-1 to HIV-infected patients in Africa.

The tests and protocol being conducted are a GLP-Compliant Intramuscular Dose (~28-Day) Study, followed by a 4-Week Recovery Period of ITV-1 in Sprague-Dawley Rats. The objective of the study is to characterize any toxicity of ITV-1 when administered intramuscularly (IM) into Sprague-Dawley rats twice per week (Days 0, 1, 7, 8, 14, 15, 21, and 22) for 4 weeks (8 total doses) followed by a 4‑week observation period for selected animals. Based on all clinical parameters, analysis, and observations of the studies completed, ITV-1 was well tolerated, up to 2.5 mg per intramuscular injection.

With the preliminary results of the Toxicology study, Enzolytics is anticipating entry into the markets of Rwanda, DR Congo, Botswana, and Kenya. Enzolytics' Chief Science Officer, Harry Zhabilov, manages the manufacture of ITV-1 and will travel to Africa in late March to confer with principals regarding the administration of the therapeutic to patients.

The World Health Organization estimates a population of over 4,000,000 HIV infected individuals living with HIV in the four African countries where the Company will register the therapy. It is estimated that the hospitals will administer the treatment to 40,000 - 50,000 patients in the first year after the initial product production is completed.

At this projected level of penetration (1% of the infected population), the expected gross revenue would exceed USD 45 Million in the first year. The World Health Organization reported "Sub-Saharan Africa remains most severely affected, with nearly 1 in every 25 adults (3.4%) living with HIV and accounting for two-thirds of the people living with HIV worldwide" making the African market the largest potential market for ITV-1. Forty percent (40%) of those in Africa infected with HIV have no access to any treatment for the virus. In addition, 91% of the world's HIV-positive children live in Africa. Every day, over 300 children worldwide die from HIV-related causes, and most of these deaths are in Africa. The introduction of ITV-1 in Africa represents the Company's desire to take all steps possible to address this pandemic, which has existed for 40 years. One of the Company's long-term plans is to offer effective, affordable treatment to the 69% of the world's HIV patients who live in Africa.