Virogentics, Inc. Provides Update on African Project, European Medicine Agency Application and Clinical Trials for Application for Type 2 Diabetes
Progress on Sagaliam Acquisition Corp Transaction
ALLEN, TX / ACCESSWIRE / August 4, 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, updated the progress being made on the permit application with the European Medicine Agency (EMA) for the patented immunotherapy ITV-1 treatment of HIV/AIDS virus, for use by patients after receiving chemo and radiation treatment to facilitate recovery from the treatments and those with immunodeficiency.
A report has been prepared by the Bulgarian Academy of Science Institute of Organic Chemistry, describing the module 3 clinical trials to be conducted using the Company’s ITV-1 therapeutic. The report consists of a description of the research to be performed, the methods for pharmaceutical development of ITV-1 immunotherapy, a technical report of the production process, production control procedures used, analytical procedures, process validation, batch analysis guidelines, characterization of impurities, opening and closing system description and stability expectations. The documentation for the clinical trial will be prepared by Kiwi Farma. A meeting is scheduled in Sofia, Bulgaria on September 19 with the Director of Business Development of CCDR and Development Company, the German company Cooperative Clinical Research and Development (Korporativ Klinik Drug Research and Development) engaged by VIRO to perform the Pharmacokinetic study on the porcine pepsin. Professor, Doctor and Doctor of Medical Sciences, Lachezar Ivanov, will represent the Company in these discussions to identify the specific dates and details regarding the start of clinical trials for the European Medicine Agency.
Professor, Doctor and Doctor of Medical Sciences, Lachezar Ivanov, is a valuable member of the VIRO ITV-1 team. Born on August 13,1962 in Sofia Bulgaria, he graduated from Sofia Medical Academy with a medical degree in 1989, obtaining the first specialty of AG. After graduation Dr. Ivanov worked at the Military Medical Academy, where he completed an internship (in all clinical specialties), followed by a specialty in internal medicine. He has also completed courses in ultrasound of abdominal areas and specialty pulmonology. Dr. Ivanov presented his first dissertation in 2005, graduating with degrees in management and administration in healthcare. He is working on additional presentations in the healthcare field. He currently holds a position as a faculty member at the Medical University of Sofia. Since 2005, Dr. Ivanov has represented the people of Bulgaria in the Parliament of Bulgaria. For 18 years he has been a member of the Health Commission, having held the position of Chairman of the Commission, and currently holds the Deputy Chairman office of the Commission. Dr. Ivanov is a consultant to the largest hospitals in Bulgaria, VMA and Lozenetz Hospital. Throughout his career, Dr. Ivanov has had numerous papers published in medical journals on a variety of topics.
In the second and third quarters of 2023, VIRO will continue meetings with Director Iseness in connection with the launch of pharmacokinetics studies to submit documents and begin the preparation of the investigators’ brochure. The studies are being performed on volunteers in anticipation of the start of module 3 clinical trials administering ITV-1 later this year. Once the trials are completed, the findings will be included in the EMA permitting application which has been prepared by Kiwi Farma in close association with EMA assigned representative member of its Regulatory Science & Innovation Task Force, who has given the Company invaluable methodical help and guidance.
Included in the analytical procedures of the clinical trials for module 3 are the following: 1) analysis of 8 samples of the hydrolyzed pepsin preparation, 2) spectrophotometric analysis with UV-Vis spectrophotometer SHIMADZU of 8 samples, 3) determination of the protein concentration by the Bradford method, 4) electrophoretic analysis of 8 samples by one-dimensional polyacrylamide gel electrophoresis and reading the degree of hydrolysis, 4) analysis using the ImageQuant TL8 software program determining the distribution of proteins based on their molecular weight and concentrations, and 5) analysis of the peptides obtained after hydrolysis in 2 samples using UHPLC-Q-TOF mass spectrometer which includes the Bruker Impact HD Q-TOF system. The interpretation of the results from these studies will be used to prove the effectiveness and preservation of the action of hydrolyzed pepsin.
VIRO and Dr. Ivanov have completed conversations with R & D Services, LTD, (“RDS”) a specialized provider of onsite operational and administrative support of clinical trials at state funded, municipal and private health facilities. RDS is certified under the international standards ISO 14001:2015, ISO 27001:2013 and ISO 14001:2015. RDS has a well-developed patient referral network enabling the inclusion of a maximal number of patients in a minimal amount of time, once the centers are established and the clinical trial is launched. RDS will provide a designated software platform for tracking patients participating in clinical trials.
VIRO has also moved forward preparing preliminary studies from data received and processed from volunteers, who have been taking insulin for years to control their type 2 diabetes, to determine the impact ITV-1 has on the volunteer’s blood sugar levels. The initial results have been extremely encouraging and show great promise. Clinical studies for diabetes are expected to begin in October 2023, including documentation, reports, and the selection of a principal investigator.
In addition to the EMA, VIRO’s African project is progressing in August with the initial administration of ITV-1 to HIV/AIDS infected volunteers at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC under the supervision of Neuro Pharma Ltd – Rwanda
The Company has also received notice from the U.S. Trademark Office that its application for the federal registration of the IPF trademark has been approved. The application for registration will now be published for a 30- day period and absent any opposition, the mark will be federally registered.
Finally, ENZC has negotiated additional compensation in the form of a monthly management fee to be paid by Sagaliam Acquisition Corp (SAGA) to ENZC over a 30-month period following the close of the purchase of BGEN and VIRO. The funds will be used to facilitate the continued compliance of ENZC’s OTC Market filing requirements, administration of the dividend payment of the 45 million SAGA share issuance received as part of the SAGA purchase transaction to the ENZC shareholders and the Company’s development of a new business strategy to be implemented after the close of the sale of BGEN and VIRO. ENZC and SAGA have continued the process of documenting the Business Combination agreement and expect to provide further guidance later this month.
Harry Zhabilov, Chief Scientific Officer of VIRO stated, “It is gratifying to reach this stage. This is the culmination of decades of work from my family. We have a fantastic team of researchers, clinicians, regulatory and government officials who have facilitated our progress to reach this milestone, not only with HIV, but also the application to diabetes and other therapies. We are continuing to move forward and are excited about beginning to bring our therapies from the lab to patients.”
Barry Kostiner, CEO of Sagaliam, commented, “Enzolytics has assembled an impressive team in Bulgaria, and is benefitting from the European regulators who have supported the accelerated development of therapeutics for the benefit of patients desperately in need of improved efficacy at lower costs. EMA’s dedication to fostering a healthy and well-regulated pharmaceutical landscape is truly commendable and deserving of praise. I am looking forward to my meetings with our team in Sofia next month, and contributing to the advancement of the financial, implementation and marketing plan.”
Professor, Doctor and Doctor of Medical Sciences, Lachezar Ivanov, advisor to Enzolytics, commented, “I greatly enjoy my partnership with the Enzolytics team. We have put together a winning combination of researchers and medical professionals dedicated to producing world-class therapies. I look forward to meeting Barry in person and introducing him to our team. The expertise we have assembled in Bulgaria is impressive, and we are eager to accelerate our therapeutics development and implementation with the expansion of resources to be made available as part of the Sagaliam transaction.”
Charles Cotropia, CEO of Enzolytics, stated, “Virogentics’ progress in the further development and human trials of its ITV-1 anti-HIV immunotherapy is highly significant. Its development and application in this much needed health area will represent a tremendous success.”
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.