Patient Population for the Clinical Trials of ITV-1 has been Established by the European Medicines Agency ("EMA")

Start date is expected by the end of 2023 / beginning of 2024. VIRO also offers an update on Diabetic trials and Sagaliam transaction.

ALLEN, TX / ACCESSWIRE / September 6, 2023 / Enzolytics, Inc. (OTC PINK:ENZC) (https://enzolytics.com/).

Virogentics, Inc. ("VIRO"), a wholly owned subsidiary of Enzolytics, Inc. (the "Company" or "ENZC"), a drug development biotech company, announced today that based on the Bulgarian population of HIV-infected individuals that the sample size for the ITV-1 clinical trials will be 60 individuals.

R&D Services Ltd. ("R&D"), under the leadership of Aneliya Vidinlieva, Manager Clinical Trials, assisted by Dr. Ivaylo Tsonev, Chief Medical Officer of Desing and three consultants assigned by the University of Pharmacology, will be performing the clinical trials. R&D and VIRO expect the clinical trials to begin in late 2023 or early 2024.

With locations across Bulgaria, where the Clinical Trials will be conducted, R&D services will manage all the administration of the Clinical Trials of ITV-1 conducted in public, municipal, and private healthcare institutions. R&D is certified to ISO 9001:2015, ISO 27001:2013, and ISO 14001:2015 quality assurance standards for services provided.

R&D Services Ltd.'s general responsibilities include but are not limited to the following:

• Improving the quality of the collected data during the clinical trials.
• Building up a trial site at each healthcare institution and providing all the necessary equipment for conducting clinical trials and premises for proper document and study drugs storage, in compliance with the Good Documentation Practice, Good Clinical Practice, and Good Manufacturing Practice.
• Ensuring protocol compliance, compliance with the International Conference on Harmonisation - Good Clinical Practice guideline, Bulgarian legislation and specific requirements of the Sponsor/CRO.
• Providing the necessary documents for the initial study submission.
• Prescreening of eligible patients during the initial review/approval period so that a maximum number of patients can be enrolled in the relevant time period.
• Redirecting eligible patients from trial sites that do not participate in the trial to sites that are approved; building a referral network of physicians to support the study enrollment.
• Quality checking all the needed documentation concerning the proper conduct of a clinical study (eCRF, temperature logs, subject logs, study drug accountability logs).
• Reporting any adverse events to the Sponsor/CRO.
• Ensuring document access for audits on behalf of the Sponsor/CRO, independent auditor, and regulatory authorities.

In addition, the trials being conducted by R&D will include a review by an immunologist to evaluate any correlation of patient outcomes with a different origin of immune deficiency using cell examination.