Enzolytics Inc (ENZC)

[falon]

About TRIALS

Company begins process of identifying conserved/immutable target sites on SARS-CoV-2 (the CoronaVirus) and other developments

COLLEGE STATION, TX / ACCESSWIRE / February 1, 2021

In addition, the Company offers this update on its progress toward FDA approval of ENZC's licensed ITV-1 Immunotherapy treatment previously tested in human trials in Bulgaria. On April 29, 2019, Bulgaria, as a member of the European Medicines Agency (EMA), was recognized under the Mutual Recognition Agreement (MRA) between the FDA and European Union for medicinal products for human use subject to limitations. This allows drug inspectors to rely upon information from drug inspections conducted within countries recognized under the Treaty. The limitations stated on the U.S. Food & Drug Administration Website, listed as current as of 5/08/2020, read as follows:

"The capability determinations apply to routine surveillance inspections. In the future the following product and inspection types may be included in the coverage of the agreement, pending further consideration:

Vaccines for human use
Plasma derived pharmaceuticals
Investigational products (clinical trial material)
Veterinary products
Excluded from the MRA scope are: Advanced Therapy Medicinal Products (ATMPs), human blood, human plasma, human tissues and organs and veterinary immunologicals."

To establish the effect of this new directive on the Company, Company representatives visited Sofia, Bulgaria last month and met with the Executive Director of Bulgarian Drug Administration (BDA) to determine how this treaty affects the use of the Company's ITV-1 immunotherapy treatment which was successful in clinical trials completed in 2016. This meeting was followed by a meeting with a Clinical Research Organization, Clinic Design, in Sofia. The Company believes, and is currently reviewing the applicable information, that with the BDA recognition under the MRA and its membership in the European Medicines Agency (EMA), its Immunotherapy treatment should qualify for recognition by the FDA once the Clinical Trial process and Validation order have been completed. The Company has been informed that the inclusion of the BDA in the EMA restricted the permitting of our Treatment by the BDA and the permitting will now be done by the EMA for all the European Union. As a result, some, if not all of the clinical trials may need to be completed under the EMA standards. The company is evaluating the necessary steps and cost for the FDA submission under the Mutual Recognition Agreement between the FDA and EMA.

Based on this information, the Company took the following actions. On January 28th, a notice of default and termination was registered with the courts in Sofia of the Sub License Agreement issued to IMMB BG. The company has entered into negotiations with a supportive group in Bulgaria to form a new entity and enter a funding agreement to cover any new cost of clinical trials under EMA standards and permitting by the EMA. Strategically, the Company believes that the actions will be cost effective resulting in a significant advancement of the Company's therapeutic portfolio.
https://marketwirenews.com/news-releases/enzolytics-announces-the-discovery-of-seven-newly-id-7491922242125190.html

Enzolytics Finalizes Documentation with International Medical Partners, Ltd for Clinical Trials and Initial Production of ITV-1 Company Also Provides Update on Year End Reporting
As a team, the Company with IMPL is moving forward to complete the initial production and certification of its ITV-1 patented therapeutics for treating HIV leading to the planned clinical trials under the European Medicine Agency (the "EMA"). A commitment for funding of the cost of clinical trials under EMA guidelines and cost associated with the issuance of an EMA permit are part of the negotiated agreements. Under the Mutual Recognition Agreement (the "MRA") between the EMA and the United States Federal Drug Administration (the "FDA"), the Company's belief is that issuance of the EMA permit for the ITV-1 compound should qualify ENZC's treatment for recognition by the FDA. IMBL has entered negotiations to engage Clinic Design to begin the clinical trials that is expected to be required under EMA standards. In addition, the Company is negotiating with an International known and respected European Contract Manufacturing organization ("CMO") to manufacture the required quantities of the ITV-1 Treatment to facilitate the clinical trials and permitting process under EMA guidelines.
https://marketwirenews.com/news-releases/enzolytics-finalizes-documentation-with-internationa-8973953024499637.html

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