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Virogentics Inc. Announces Pilot Clinical Trial of ITV-1 at National Center for Endocrinology in Bulgaria and Expansion of Nutraceutical Line
Virogentics Inc. Announces Pilot Clinical Trial of ITV-1 at National Center for Endocrinology in Bulgaria and Expansion of Nutraceutical Line.
About this update from Enzolytics Inc.
[{"type":"text","content":"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 fo...