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 4week 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.
In addition, with the initial results of the ITV-1 Toxicology, the Company is moving forward with Pharmacokinetic Analysis necessary for advancing the therapeutic for use in European countries under the EMA. The completion of toxicology studies is necessary for EMA registration. Approval under the EMA will allow use of the therapeutic in the EU, followed by seeking FDA approval for use in North America.
The Company anticipates raising additional funds to complete EMA registration of ITV-1, production and testing of its Immunotherapy and Monoclonal Antibody treatments as well as advancing its AI (Artificial Intelligence) technology platform for use in developing therapeutics against targeted viruses. With these funds, the Company will advance its therapeutics that are at the forefront of modern medicine. In 2021, the global market for Monoclonal Antibody therapies was valued at USD 186 Billion. This market is projected to increase at an annual growth rate of 12% between 2022 and 2032, reaching a total value of USD 647 Billion in 2032. The significance of the role that Monoclonal Antibodies will play in world health can be seen to be rapidly accelerating. Enzolytics believes its technology in the field of Monoclonal Antibodies production will play a major role in this future of medicine.
Additional raised funds will also be used for the promotion of the Company’s IPF Immune nutritional supplement which is now on the market in the U.S. The product enters the North American market as nutritional supplement annual sales reached USD 50.11 Billion. With funding for communicating the significant benefit provided by IPF Immune, the Company expects significant sales and profit. Enzolytics is also proceeding with the registration of IPF Immune for sale in the European Market.
The Company CSO, Harry Zhabilov, said, “The successful results of the toxicology study for ITV-1 are a testament to the safety of ITV-1. Effectiveness has been demonstrated in earlier trials. It also marks a major milestone as the Company embarks on allowing access to a significant number of patients with limited access to safe, affordable therapy for HIV. Strategically, this allows Enzolytics to build a strong revenue-generating asset.”
The Company COO, Dr. Gaurav Chandra, said, “The Company has made significant progress on its multiple therapeutic platforms. These platforms include the Company’s ongoing development of multiple Monoclonal Antibodies for the treatment of various infectious diseases, an AI platform that makes possible rapid production of effective multiple Monoclonal Antibodies, including those targeting both human and animal viruses, and an effective nutritional supplement, IPF Immune, that is currently on the market. With several therapeutic platforms providing significant value to the Company and its shareholders, we are confident in our future. The Company’s strengths are its multiple technologies that will individually provide effective therapies and treatments for patients and consumers.”
Safe Harbor Statement: This news release contains forward-looking statements that involve risks and uncertainties associated with financial projections, budgets, milestone timelines, clinical development, regulatory approvals, and other risks described by Enzolytics, Inc. from time to time in its periodic reports filed with the SEC. ITV-1 is not approved by the U.S. Food and Drug Administration or by any comparable regulatory agencies elsewhere in the world.
While Enzolytics, Inc. believes that the forward-looking statements and underlying assumptions contained therein are reasonable, any of the assumptions could be inaccurate, including, but not limited to, the ability of Enzolytics to establish the efficacy of its therapeutics in the treatment of any disease or health condition, the development of studies and strategies leading to commercialization of its therapeutics in the United States, the obtaining of funding required to carry out the development plan, the completion of studies and tests on time or at all, and the successful outcome of such studies or tests. Therefore, there can be no assurance that the forward-looking statements included in this release will prove to be accurate.
Such forward-looking statements are based on current expectations. They involve inherent risks and uncertainties, including factors that could delay, divert or change any of the statements made, and cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. These forward-looking statements are made as of the date of this press release. The Company expressly disclaims any intention or obligation to update the forward-looking statements or update the reasons why actual results could differ from those projected in the forward-looking statements.
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SOURCE: Enzolytics, Inc.
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