Virogentics Inc. Receives Report from Bulgarian Academy of Sciences Administration of ITV-1 to Begin First Week in June 2023

Rhea-AI Summary

Enzolytics, Inc. subsidiary Virogentics receives analysis report from the Bulgarian Academy of Sciences for Module 3 of drug development process. Clinical trials for the European Medicine agency will begin in Germany. ITV-1 immunotherapy treatment to be administered to volunteers in Africa. ENZC and SAGA continue to negotiate terms for potential business combination.

Positive

• Virogentics receives analysis report for Module 3, allowing completion of manufacturing conditions for validation orders
• Clinical trials for the EMA to begin in Germany
• ITV-1 immunotherapy treatment to be administered to volunteers in Africa

Negative

• None.

COLLEGE STATION, TX / ACCESSWIRE / May 16, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/). Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced that the Company's wholly owned subsidiary, Virogentics (VIRO), has received the analysis report from the Bulgarian Academy of Sciences determining the protein concentration, native enzyme concentration and peptide analysis, and amino acid sequence for Module 3 for the permitting by the European Medicine agency ("EMA "). Receipt of this reportwill allow Virogentics to complete the cycle to fulfill the manufacturing conditions for production of the validation orders in mid-September of this year. Once manufacturing is complete the clinical trials for the EMA will begin in Germany by Korporativ Klinik Drug Research and Development. Once Module 3 is complete we will be formulating the requirements for Modules 4 and 5 for registration in Europe.

The administration of the ITV-1 immunotherapy treatment, scheduled to begin during the first week of June 2023 under the supervision of Neuro Pharma Ltd - Rwanda, is being dispensed to volunteers under a fast-track protocol at HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. VIRO is working with the hospitals on the protocols that will be used in the process. The impact of the treatment on the volunteers will be reported after the 17 week cycle is complete.

IPF Immune was listed on the National Institutes of Health ("NIH") website under dietary supplement during May.

Also, ENZC and SAGA are continuing to negotiate terms for the potential business combination taking into consideration the increase in ENZC's market value over the last few weeks since the initial disclosure of the transaction.

Harry Zhabilov, CSO of VIRO and ENZC stated, "The continued development of the ITV-1 family of products and advances we are making toward distribution of our patented immunotherapy treatment to HIV patients in Africa, where the largest population of Aids victims resides, is more than I could have hoped."

Enzolytics, Inc. Overview

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 has proprietary technology for producing fully human monoclonal antibodies (mAbs) against infectious diseases which is currently being employed to produce monoclonal antibody therapeutics for treating the CoronaVirus (SARS-CoV-2), HIV-1 and the Feline Leukemia virus. The Company has also identified conserved epitopes on and has plans to produce mAbs targeting many other viruses, including HIV-2, Influenza A and B, H1N1 influenza, Respiratory syncytial virus (RSV), Small-Pox, Ebola Virus, Tetanus, Diphtheria, HTLV-1/2, Rabies, Herpes zoster, Varicella zoster, Anthrax, Mason-Pfizer monkey virus (MPMV) and Visna virus (VISNA). The Company has also analyzed epitopes of animal viruses and plans to produce mAbs for treating these animal viruses.

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.

Company Contact:

Enzolytics, Inc.
1101 Raintree Circle
Allen, Texas 75013
www.enzolytics.com

SOURCE: Enzolytics, Inc.

View source version on accesswire.com:
https://www.accesswire.com/755206/Virogentics-Inc-Receives-Report-from-Bulgarian-Academy-of-Sciences-Administration-of-ITV-1-to-Begin-First-Week-in-June-2023

FAQ

What report did Virogentics receive from the Bulgarian Academy of Sciences?

Virogentics received an analysis report for Module 3 of the drug development process.

Where will the clinical trials for the European Medicine agency take place?

The clinical trials will take place in Germany.

Where will the ITV-1 immunotherapy treatment be administered?

The treatment will be administered to volunteers in Africa.

What are ENZC and SAGA negotiating?

ENZC and SAGA are negotiating terms for a potential business combination.