Enzolytics Inc (ENZC)

[bigtalan]

This is the last two updates about why Africa hasn't started

https://finance.yahoo.com/news/enzolytics-offers-virogentics-inc-itv-145500819.html

Virogentics, Inc. Receives Permit for Export to Africa of the ITV-1 Immunotherapy Solidifying the Scheduled Administration of the Treatment
ALLEN, TX / ACCESSWIRE / August 8, 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 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.

Additionally, VIRO acknowledges the announcement by Sagaliam Acquisition Corp, ("NASDAQ:SAGA") that they had notified Continental Stock and Transfer Company that it was exercising the option to extend the time available to consummate a business combination agreement by an additional month to August 23, 2023. VIRO reports that substantial progress has been made on the combination agreement.

Barry Kostiner, the CEO of Sagaliam, stated "The VIRO team has done a great job of moving forward on their clinical and regulatory milestones. We are getting involved at the right time to provide the resources needed to build a platform for helping many people in Africa, Europe and globally."

Harry Zhabilov, Chief Scientific Officer of VIRO, stated "Every day we move closer to the ultimate goal of administering our immunotherapy to patients who we believe will benefit greatly from our technology, as well as the funding that will be unlocked by moving to NASDAQ."

Then you have this last update
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 1% of the 2022 autoimmune $104.21 billion market and the $84.56 2023 diabetes market, VIRO could realize over $2 billion in revenue in addition to what it captures in the HIV/AIDS $30.46 billion market where VIRO expects the most significant market penetration.

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.”

The above was copied from Enzolytics web site .
I would say they kept us somewhat updated then nothing on Africa after thet say they got the importing clearance. If anyone has a different update please post. GLTA