COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.
The Company's ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA) but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company total confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.
The steps now in place to accomplish the Company's goal of bringing its anti-HIV ITV-1 therapeutic to patients are:
- The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.
- IMPL is owned equally by the Company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania.
- The Company has engaged the Contract Manufacturing Company (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.
- The Company has engaged the Contract Research Organization (CRO) Clinical Design Ltd. in cooperation with PharmaLex to prepare and establish a drug development programme concerning creation of protocols for human clinical trials that will lead to the licensing of the Company's ITV-1 therapeutic under the European Medicine Agency (EMA).
- The production at Danhson Ltd. will produce initial quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinical Designs, Ltd.
- IMBL is contracting with PharmaLex, a leading EU regulatory consulting company to manage document review of the product compliance with EMA requirements.
- The clinical trials will be funded fully by the Company's European partners in IMPL. None of the clinical trials costs will be borne by the Company.
- The Company's CSO Harry Zhabilov will direct and monitor the production the ITV-1 therapeutic by Danhson Ltd. in beginning the steps outlined above.
The Company's two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as possible. No unanswered issues have arisen.
Harry Zhabilov, CSO of ENZC, stated, "We are excited about the progress we have made with the assistance of our partners at IMBL. Engaging Danhson Ltd., Clinical Design and PharmaLex is an integral step toward our success in the EMA permitting process. As this is the second time ITV-1 has gone through clinical trials and the first trials were successful, our confidence is at an all-time high regarding permitting, and with the reciprocal treaty between the EMA and FDA, we believe that the "redo" on clinical trials will be a blessing in disguise in the long run."
CEO Charles Cotropia said, "The Company's objective is to provide new, better and safer therapeutics to treat HIV. Currently, treatment is solely through the lifelong use of antiretrovirals (ARVs) which are expensive and have long lasting, serious negative effects on the body. The costs for such ARVs are excessive - from $27,540 per year for Dovato by ViiV/Glaxo SmithKline to $42,635 per year for Biktarvy by Gilead and a lifetime costs of up to $350,000 - and even then, only 54% of those ineffective by HIV have access to such treatments - leaving 46% with no treatment. New and improved therapies, that are less expensive and more effective, are desperately needed. Providing these better therapies are our Company's objective."
About Enzolytics, Inc.
Enzolytics, Inc. is a drug development Company committed to the commercialization of its proprietary proteins and monoclonal antibodies for the treatment of 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), which studies have shown is effective in treating HIV/AIDS. IPF is the active component of ITV-1 and is a purified extract of porcine pepsin. ITV-1 has also been shown to modulate the immune system.
The Company is also implementing its proprietary technology to produce fully human monoclonal antibodies (mAbs) against infectious diseases, including HIV, rabies, influenza A, influenza B, tetanus, and diphtheria. Its proprietary methodology for producing fully human monoclonal antibodies is currently employed to produce monoclonal antibody therapeutics for numerous infectious diseases, including the Coronavirus (SARS-CoV-2) and HTLV-1.
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 ITV-1 or its therapeutic monoclonal antibodies 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 and 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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Tom Nelson, CEO
Investor Relations Contact
2000 North Central Expressway
Plano, TX 75074
Texas A&M University
Institute for Preclinical Studies
College Station, TX 77843-44
SOURCE: Enzolytics, Inc.