September 6th, 2023

Virogentics, Inc., 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.

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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.

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August 8th, 2023

Virogentics, Inc., a drug development biotech company, announced today the receipt of an export permit for the delivery of the treatments to be administered to the volunteer HIV/AIDS patients at the HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. The results of this African pilot clinical trial will be used in the development of the European Medicine Authority (EMA) clinical trials expected to begin in late 2023/early 2024.

 

August 4th, 2023

Virogentics, Inc., a drug development biotech company, announced today 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.

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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.

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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.

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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.

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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.

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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.

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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.

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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

 

July 24th, 2023

Virogentics, Inc., a drug development biotech company, announced today it has received approval of the final protocol from the Department for HIV and AIDS, Ministry of Health of the DRC (Democratic Republic of the Congo). This paves the way for the projected August administration of the patented immunotherapy ITV-1 treatment to volunteers under a fast-track protocol supervised by Neuro Pharma Ltd - Rwanda, at HEAL Africa Hospitals, GOMA, PRC and Panzi Hospital, Bukavu, DRC. Approval of the protocol criteria was the final step necessary to meet the requirements to inject the African HIV/Aids volunteer patients, subject to the review and approval of the ethics committee of the Center for Innovative Drug Development and Therapeutic Trials for Africa (CDT-AFRICA).

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April 21st, 2023

Virogentics, Inc., a drug development biotech company, announced today 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 VIRO 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.

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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.

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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.

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February 8th, 2023

Virogentics, Inc., a drug development biotech company, announced today the preliminary results of Toxicology studies of the Company's ITV-1 anti-HIV therapeutic confirming that the therapy is non-toxic and demonstrating the safety of administration of this patented proprietary immunotherapy. Establishing this result is essential to permitting under the European Medicines Agency (EMA) and the acceptance for administration of ITV-1 to HIV-infected patients in Africa. The tests and protocol being conducted are a GLP-Compliant Intramuscular Dose (approximately 28-Day) Study, followed by a 4-Week Recovery Period of ITV-1 in Sprague-Dawley Rats.

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