Patient Population for the Clinical Trials of ITV-1 has been Established by the European Medicines Agency ("EMA")
- Start date for ITV-1 clinical trials announced
- Growth in nutraceutical division in North American market
- Potential revenue of over $2 billion from autoimmune and diabetes markets
- Filing of utility patent applications
- Advancement of multiple therapeutics targeting infectious diseases
- None.
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.
The Company's therapeutic developments will include participation by many established pharm entities, including the following. VETPROM AD, a division of the French company Danhson, currently headed by Stanislav Stoev, Executive Director,represents over 65 years of continuous operations in the Bulgarian economy and is one of the largest pharmaceutical manufacturers of medicinal products (for human and veterinary use), food supplements and cosmetics in Bulgaria. VETPROM manufactures products under its brand name, as well as for third parties under contract manufacture agreements operating under accepted ISO 9001:2008 System for quality of management and the integrated system for Good Manufacturing Practice, under requirements of Volume 4, Good manufacturing practice (GMP) Guidelines.
The German Cooperative Clinical Grug Research and Development (CCDRD) is a contract research organization for clinical phase I-IV trials and will be performing the pharmacokinetics study on ITV-1 under the guidance and leadership of the CEO Rossen Koytchev, MD, PhD and Petra Kowalski PhD, Director of Business Development. CCDRD was founded in 1990 and has been performing clinical trials for over 30 years. The company is headquartered in Hoppegarten near Berlin, Germany.
The Center of Phytochemistry was set up as a joint project of the Bulgarian Government, UNDP, and UNESCO for scientific and applied research and training of specialists in organic chemistry and chemistry of natural products. The organization was renamed The Institute of Organic Chemistry with Centre of Phytochemistry (IOCCP) and is the leading scientific institution in t organic and bio-organic chemistry field in Bulgaria. VIRO has engaged IOCCP, represented by Prof. DSc Pavlina Dolashka, a member of its organizing committee and scientific committee to perform the biochem analysis of ITV-1 at the Bulgarian Academy of Science.
Documentation and correspondence that is required with the EMA as part of the permitting and application process will be performed for VIRO by Vili Topalova, MD EU QPPV Medical Director of AV Consult Pharm ("AVCP"). AVCP is a consulting company in the fields of Regulatory Affairs, Pharmacovigilance, Medical Devices vigilance, Cosmetovigilance, price and reimbursement and other consultancies for medical treatments. AVCP's expertise is based on years of experience with the Bulgarian Drug Agency (BDA) and the technical expertise of its employees - former experts and employees of the Bulgarian Drug Agency (BDA).
As a result of a delay in delivery of the Toxicity report to the African hospitals, GOMA, PRC, and Panzi Hospital, Bukavu, DRC, the administration of the ITV-1 immunotherapy initial injections into the HIV/AIDS-infected volunteers was delayed. We expect that to commence soon.
Since entering the U.S. Market six months ago, VIRO's growing nutraceutical division has resulted in the exclusive distribution licensing of + Liver Rescue™ in the North American market. This product accelerates the functions of the liver (accelerated emission of alcohol dehydrogenase), thereby reducing the harmful effects of alcohol on the body and the central nervous system. This is a new revolutionary nutritional supplement in the form of a drink, which is currently being marketed in Europe with great success. Coupled with the monthly increasing production and sales of IPF Immune™, the market potential for these products is favorable.
Currently, the Company is pursuing testing IPF Immune as an immunomodulator under EMA guidelines on patients with cirrhosis, as an after-radiation and chemotherapy treatment of cancer patients in an attempt to reduce recovery time from the effects, impact on HIV patients immune system (in addition to the ITV-1 Clinical trials), application for type 2 diabetes patients effect on blood sugar levels and glycosylated Hb (in addition to the clinical trials of ITV-1 as a treatment for type 2 diabetes scheduled for later this year), herpes, COVID, influenza and all diseases where there is an immune system decline - including autoimmune disease. With the potential of both ITV-1 and IPF Immune to participate in the aforementioned markets, capturing
VIRO has also filed two utility patent applications covering its new developments, one covering the European Union and one for the United States.
"With the quality of our partners and our past success with ITV-1 Clinical trials, we at VIRO are expecting great success in not only the ITV-1 application to HIV but also its application to Diabetes and other areas being pursued," stated Harry Zhabilov, CSO of VIRO.
ENZC has provided SAGA with its draft of the Business Combination Agreement and related documents and is awaiting any edits or comments in anticipation of a final version being circulated for signature by October 31, 2023.
Barry Kostiner, CEO of Sagaliam, commented, "We are continuing to make progress on the consummation of our transaction with Enzolytics. The deep bench of expertise and therapeutic solutions is impressive. In addition to our dedicated scientists, we have an outstanding team of collaborators who support all aspects of the business including regulatory, clinical and manufacturing operations. The goal is to build a pharmaceutical platform company, going beyond one-off therapies, to providing solutions for broad categories of chronic disease."
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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