Enzolytics, Inc. Finalizing Regulatory Labeling Requirements for Delivery of ITV-1 Treatments for Use in Hospitals in Central and Eastern Africa – Company also Provides Additional Details on the Sale of Biogenysis and Virogentics
COLLEGE STATION, TX / ACCESSWIRE / April 21, 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 representative traveled to Africa to arrange for the delivery of its ITV-1 immunotherapy treatments to African hospitals and to finalize the information to be included on product labels as required by the African regulatory agencies. The anti-HIV treatment consists of two 8-week cycles of 16 injections with a one-week break, totaling a 17-week treatment period. After the delivery of the vials, the hospitals will administer the treatments over the 17-week treatment period and periodically provide ENZC with clinical data of its effectiveness. Once the initial patients are treated and when ITV-1 demonstrates effectiveness, the Company expects to provide additional treatments to treat up to 30,000 additional patients living in the Central and Eastern region of Africa.
ENZC has received a response from the European Medicines Agency informing the Company that the required method for pharmacokinetics study will be in accordance with ELAZA standards.
The Bulgarian Academy of Science will be providing the following studies on ITV-1: 1) determination of the protein concentration in the initial sample using the Bradford method, 2) electrophoretic analysis, 3) determination of the concentration of the native enzyme in samples, 4) HPLC analysis, 5) analysis of the peptides obtained after hydrolysis in samples using a UHPLC-Q-TOF mass spectrometer system including the Bruker Impact HD Q-TOF system equipped with a Captive Spray nano Booster ionization source and compass 1.7 software. LC-M-analysis of the system UHPLC-Q-TOF -LCMS samples 2 filtered through a filter 0.45 and through a filter 0.2, 6) determination of the amino acid sequence of the peptides and the concentration, 7) interpretation of the obtained results. This quantitative analysis process will be used for validation for Module 3 of the clinical trials.
In addition, the ITV-1 project is finalizing negotiations with a selected German entity along with its associate laboratory to prepare a development plan for the validation of the methodology for the analysis of porcine pepsin as part of the EMA permitting requirements.
ENZC would like to provide additional information and clarification regarding the recent announcement of the sale of Biogenysis (“BGEN”) and Virogentics (“VIRO”) to Sagaliam Acquisition Corp. (NASDAQ: SAGA) (“Sagaliam”), a special purpose acquisition company (“SPAC”). After any required approval of the transaction by the various regulatory authorities, the Company intends to issue a dividend of the sales proceeds to ENZC shareholders on the date of record of the declared and approved dividend. ENZC shares will continue to trade on the OTC PINK Market. The sale transaction will not interfere with the trading of ENZC stock. Regarding the definitive purchase agreement, it is being finalized with an expected execution date of May 19, 2023. The previous release stated the transaction was expected to close on May 19, 2023, which was an error. Once the transaction document is finalized it will be subject to regulatory approval.
BGEN will continue to operate under the direction of Dr. Gaurav Chandra as Chairman and CEO and Charles Cotropia as BGEN Director. BGEN will continue to pursue production of species-specific monoclonal antibodies (mAbs) and continued advancement in its disruptive proprietary technology involving the application of Artificial Intelligence (AI) in therapeutic discoveries and production.
VIRO will continue to be managed by Diana Zhabilov as Chairman and CEO and Harry Zhabilov as its CSO and Director, furthering the progress on clinical trials and permitting through the EMA of ITV-1, marketing of IPF Immune™ in the United States as well as registration in Europe, development of the multiple sclerosis treatment and a new initiative involving the use of ITV-1 to treat diabetes. Dr. Lachezar Ivanov will continue to provide invaluable consulting services to VIRO.
The Company continues to explore the spin-out opportunities with RobustoMed, Inc. Under the terms of the definitive sales agreement contemplated in the non-binding letter of intent, BGEN and VIRO will become wholly owned subsidiaries of Sagaliam, currently trading on NASDAQ, and will adopt SAGA Scientific Holdings Corp. as the corporate name. The definitive agreement with Sagaliam Acquisition Corp. will be subject to the approval of the Sagaliam Board of Directors and Sagaliam shareholders, which has not yet been obtained.
The transaction, once completed, will provide BGEN and VIRO with significant additional capital to continue their development and expansion of existing and future technology platforms. “The progress we have made on the African project coupled with the sale transaction of VIRO and BGEN allows the ENZC shareholders to witness the unlocking of the value of the underlying technologies of ENZC”, said Harry Zhabilov, CSO of VIRO.
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.
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SOURCE: Enzolytics, Inc.