Enzolytics, Inc.'s Wholly Owned Subsidiary Virogentics, Inc. Reports Progress on the Delivery of its ITV-1 Anti-HIV Therapeutic for Use by Patients in African Regions

Rhea-AI Summary

Enzolytics, Inc. (ENZC) recently reported advancements by its subsidiary, Virogentics, in the production of its ITV-1 anti-HIV immunotherapy for distribution in Central and Eastern Africa. The company is conducting toxicology studies prerequisite for clinical trials and EMA approval. Initial production commitments are in place for two hospitals, with potential future treatment for up to 30,000 patients. The HIV market remains significant, with over 16 million infected globally, highlighting the critical need for effective therapies, especially in regions lacking access to current treatments.

Positive

• Progress in production and delivery of ITV-1 anti-HIV therapy in Africa.
• Initial commitments for production to treat HIV/AIDS patients.
• Potential to scale treatment to 30,000 patients in the future.
• Strong market opportunity in the HIV space with projected growth.

Negative

• None.

COLLEGE STATION, TX / ACCESSWIRE / March 14, 2022 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/) Enzolytics' ("ENZC") wholly-owned subsidiary Virogentics, Inc. (the "Subsidiary") today announced its progress toward the production and use of its ITV-1, anti-HIV immunotherapy treatment in the Central and Eastern regions of Africa for patients with HIV/AIDS.

The steps necessary for the production and delivery of the Company's anti-HIV therapy in these regions are in progress. Toxicology, pharmacodynamic and pharmacokinetic studies (toxicology studies) of the immunotherapy are planned, a prerequisite to use of the immunotherapy in certain African countries where the therapies will be used. These toxicology studies will also be used in the Company's progress toward clinical trials necessary for EMA approval. The ITV-1 therapeutic has succeeded in clinical trials earlier and the Company is planning additional trials leading to EMA approval. As that approval is underway, the ITV-1 therapeutic will be provided to the Central and Eastern regions of Africa once toxicology studies are completed.

The Company, led by its CSO Harry Zhabilov and advisor Professor Dr. Luchezar Ivanov, is guiding the production in Eastern Europe using the Company's patented proprietary technology and production process. The Company has commitments for the production of an initial quantity for use in two African hospitals. A follow-on production will be provided to treat a larger group of HIV/AIDS patients followed by a much larger commitment, potentially to treat 30,000 patients,

While the healthcare focus for the last 2 years has been on the COVID-19 pandemic, the HIV pandemic has continued unabated. Over 16 million people are infected with HIV, with approximately 10% being children. There are 1.7 Million new cases each year and approximately 1 Million deaths. Over 50% of the worldwide patients with HIV/AIDS are located in Africa.

The only therapy for treating infected patients is antirational (ARV) drugs, but these drugs are not available to 27% of those infected. The ARV therapies which are available cause substantial side effects and are expensive. The ARV therapy Biktarvy produced by Gilead costs $42,635 per year. The global HIV market is estimated to be over $30 billion this year and is expected to grow to over $36 billion globally by 2027.

The Company sees this as a massive market opportunity with room for improved therapies and recognizing that 27% of those infected with HIV do not have access to any ARV therapy.

Harry Zhabilov, the Chief Science Officer of ENZC, stated, "We continue to move forward methodically in our efforts to bring our ITV-1 immunotherapy treatment to market as well as the IPF Immune™ modulator. The Company is moving forward with preparation for clinical trials in Europe and approval under the EMA. At the same time, the Company plans to follow the approval process for FDA approval. Our partners, especially Dr. Ivanov, have been invaluable in these efforts."

About Enzolytics, Inc.

Enzolytics, Inc. is a drug development company committed to commercializing its proprietary proteins and monoclonal antibodies to treat debilitating infectious diseases. The Company is advancing multiple therapeutics targeting numerous infectious diseases. One patented and clinically tested compound, ITV-1 (Immune Therapeutic Vaccine-1), is a suspension of Inactivated Pepsin Fraction (IPF), covered by U.S. Patent Nos. 8,066,982 and 7,479,538. Studies have shown it to be effective in treating HIV/AIDS. ITV-1 has also been shown to modulate the immune system.

The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. In addition, its proprietary methodology, covered in its pending U.S. Patent Application for producing fully human monoclonal antibodies, is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the CoronaVirus (SARS-CoV-2) and HTLV-1.

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.

I.R. contact:
TEN Associates, LLC
Tom Nelson, CEO
(480) 326-8577

Company Contact:
Enzolytics, Inc.
2000 North Central Expressway
Plano, Texas 75074
Texas A&M Institute for Preclinical Studies

Enzolytics, Inc.
800 Raymond Stotzer Parkway
College Station, Texas 77843-4478

SOURCE: Enzolytics, Inc.

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FAQ

What recent progress has Enzolytics (ENZC) made with its ITV-1 therapy?

Enzolytics has made progress in its ITV-1 anti-HIV therapy, moving towards production and delivery in Africa, with commitments for initial treatments.

What is the target market for Enzolytics' ITV-1 therapy?

The target market includes patients in Central and Eastern Africa suffering from HIV/AIDS, with plans to potentially treat up to 30,000 patients.

What studies are necessary before Enzolytics can proceed with clinical trials for ITV-1?

Toxicology studies are required as a prerequisite for the clinical trials and EMA approval of the ITV-1 immunotherapy.

How many people are currently infected with HIV globally?

Over 16 million people are infected with HIV globally, with a significant portion located in Africa.

What is the significance of the HIV market for Enzolytics?

The global HIV market is estimated to exceed $30 billion this year, providing a substantial opportunity for Enzolytics as it seeks to introduce novel therapies.