Virogentics, Inc. ("VIRO") a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today it has received approval of the final protocol from the Department for HIV and AIDS, Ministry of Health of the DRC (Democratic Republic of the Congo). This paves the way for the projected August administration of the patented immunotherapy ITV-1 treatment to volunteers under a fast-track protocol supervised by Neuro Pharma Ltd - Rwanda, at HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. Approval of the protocol criteria was the final step necessary to meet the requirements to inject the African HIV/Aids volunteer patients, subject to the review and approval of the ethics committee of the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-AFRICA).
Dr. Amogne Wondwossen, Associate Professor in Internal Medicine and Infectious diseases (MD, PhD) Addis Ababa University College of Health Sciences, School of Medicine, Internal Medicine Department, Honorary full Professor in Molecular and Clinical Medicine, University of Dundee, Scotland will supervise the clinical trials using best method standards.
Additionally, VIRO anticipates providing an update on the European Medicine Agency (EMA) progress in the coming days.
Harry Zhabiov, Chief Scientific Officer of VIRO stated, "With the approval by the Department for HIV and AIDS, Ministry of Health VIRO has cleared the major hurdles to allow ITV-1 to again be administered into a control group of volunteers suffering from the debilitating disease, HIV/AIDS. We expect the results from this clinical trial test in Africa to show the same results as the Bulgarian clinical trials from 2017."
Barry Kostiner, CEO of Sagaliam, commented, "I continue to be impressed by the progress of Mr. Zhabiov and his team. The need in Africa for low-cost solutions to the AIDS epidemic is great. Virogentics promises to deliver a high efficacy, economic solution. The heavy lifting has already been completed, with the science well understood, and strong expectations for success in the African patient trials. Our African partners, both government leadership and healthcare institutions, understand the importance of ITV-1 and have facilitated accelerated regulatory approval and the launch of clinical trials. The hurdle to bringing the Virogentics solutions to wide adoption is funding. I am grateful that we have the opportunity to use the Sagaliam Nasdaq platform to facilitate the raising of capital to accelerate the administration of Virogentics technology in Africa and globally."
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.
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