Enzolytics, Inc., made an announcement recently that its wholly-owned subsidiary, Virogenetics, will conduct a pilot clinical trial test for the Bulgarian National Centre for Endocrinology to assess the efficacy of ITV-1 immunotherapy on diabetes.
Enzolytics is a pharmaceutical business dedicated to commercializing its unique proteins and monoclonal antibodies to treat severe infectious disorders. The company is developing a number of therapies to treat various infectious disorders.
VIRO purchased flow equipment for the sterile filling of the ITV-1 therapy to evolve from laboratory to standardized industrial production. VIRO’s immunotherapy treatment is ready to be supplied to African hospitals in a few days at the VetProm facility. The treatments are given intramuscularly twice a week for two cycles of eight weeks, with a one-week respite in between. The results of the first delivery of ITV-1 to HIV patients are expected by the end of the year.
After the initial report on ITV-1 toxicity, the VIRO team is now moving on to the pharmacokinetics research, in close collaboration with the European Medicines Agency, to establish the most effective path to ITV-1 registration in Europe. A German business, Korporativ Klinik Drug Research and Development, will conduct this research. This study will be performed on volunteer patients at a specialized laboratory in Germany utilizing the ELAZA standards, as suggested by the EMA. VIRO used standardized industrial manufacturing procedures to generate numerous batches of ITV-1 at the Vetprom-Danson factory.
The Bulgarian Academy of Sciences is evaluating vials from this batch to determine protein concentration, native enzyme concentration, peptide analysis, and amino acid sequencing. Once this investigation is completed, VIRO will be able to fulfill the requirements of the manufacturing parameters for order production at the start of the last quarter of 2023. Following the completion of production, clinical trials for module 3 seeking EMA approval will commence in Germany. When Module 3 is completed, the company will develop the criteria for Modules 4 and 5 for European registration.
IPF Immune’s recent entry into the US market has been warmly welcomed, with the product immediately selling out. The company has received several testimonies from IPF users who claim to have seen favorable benefits on their immune systems as a result of using IPF. VIRO has received requests from numerous European nations in response to the success of IPF Immune in the US market.
VIRO is also in the process of applying to the US regulatory body for two novel nutraceutical products created by Dr. Lachezar Ivanov. The products will be for brain cleansing as well as detoxification of the liver. The liver detox is presently registered and available for purchase in Bulgaria.
The CSO of VIRO is proud of the success of the two offerings that are currently being produced in Bulgaria. The company will make progress with the extension of the nutraceutical product line.