Virogentics Inc. Announces Pilot Clinical Trial of ITV-1 at National Center for Endocrinology in Bulgaria and Expansion of Nutraceutical Line
COLLEGE STATION, TX / ACCESSWIRE / May 8, 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, Virogenetics (VIRO), will be conducting a pilot clinical trial test for the state owned Bulgarian National Center for Endocrinology to gauge the effectiveness of the ITV-1 immunotherapy on Diabetes.
To facilitate the transition from laboratory production to standardized industrial production at the VetProm-Danson facility in Bulgaria, VIRO purchased a flow machine for the sterile filling of the ITV-1 treatment into individual vials. At the VetProm facility, VIRO recently fulfilled the initial order for the immunotherapy treatment for distribution to the participating hospitals in Africa that are scheduled for delivery on May 10, 2023. The treatments are administered by intramuscular injection twice a week over two eight-week cycles with a one week break between cycles. Results from this initial administration of ITV-1 to HIV patients is expected by late fall of this year.
Further, after the initial report on the Toxicity of ITV-1, the VIRO team, working in close cooperation with the European Medicine Agency (“EMA”) to determine the fastest and most effective path to registration of ITV-1 in Europe, is now progressing to the study on pharmacokinetics. This study will be conducted by the German company, Korporativ Klinik Drug Research and Development. The methodology for this research will be done on volunteer patients using pl ELAZA standards, as recommended by the EMA, in a specialized laboratory in Germany. VIRO produced several batches of ITV-1 at the Vetprom-Danson plant using standardized industrial production methods. Vials from this batch are being analyzed at the Bulgarian Academy of Sciences to determine protein concentration, native enzyme concentration and peptide analysis, and amino acid sequence.
Once this study is complete, VIRO will be able 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 module 3 for the EMA permitting will begin in Germany. When Module 3 is complete, the Company will formulate the requirements for modules 4 and 5 for registration in Europe.
Over the last two years, Virogentics’ Virognetic’s research and development team, headed by Harry and Diana Zhabilov and supported by the medical consultants Dr. Lachezar Ivanov, Prof. Dolashka, Dr. V. Topalova, and S. Stoev the executive director of the Vetprom manufacturing facility, part of the French concern Danson, have made great strides with the GMP production of ITV-1 as well as the FDA registered nutraceutical food supplement IPF Immune.
IPF Immune’s recent introduction into the U.S. market has been met with great enthusiasm, quickly selling out. Our product is sold over multiple on-line sites including Amazon and Wal-Mart. The Company has received many testimonials from users of IPF stating that they, individually, have experienced positive effects from IPF’s use on their bodies immune system. In response to the success of IPF Immune in the US market, VIRO has received inquiries from several European countries including Spain, Germany, Romania, Greece, and Bulgaria and is now in the process of registering IPF Immune in Europe.
VIRO is also in the process of completing the application with the United Stated Federal Drug Administration (the “FDA”) for two new additional nutraceutical products developed by Dr. Lachezar Ivanov. The products will be for detoxification of the brain and detoxification of the liver. The liver detox is currently registered and being sold in Bulgaria. The brain detox initial registration application will be filed with the FDA and subject to its approval.
Harry Zhabilov, CSO of VIRO and ENZC stated, “I am proud of the success and progress that the VIRO Team has brought to ENZC through the two products currently being manufactured and developed in Bulgaria. With the expansion of the nutraceutical product line and our first administration of the ITV-1 immunotherapy in Africa, we believe that in the last half of 2023, great strides will be made toward fulfilling my vision for the ITV-1 family of products. The potential of additional funding through the previously discussed SPAC transaction will increase the opportunities for further product development especially with the Multiple Sclerosis application patent being developed.”
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.
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SOURCE: Enzolytics, Inc.