$ENZC Enzolytics Announces Its Progress Toward Completion of Clinical Trials for Its Anti-HIV ITV-1 Therapeutic and Plans for Its Distribution Throughout Europe
https://www.accesswire.com/651564/enzolytics-...out-europe
COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.
The Company's ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA) but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company total confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.
The steps now in place to accomplish the Company's goal of bringing its anti-HIV ITV-1 therapeutic to patients are:
The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.
IMPL is owned equally by the Company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania.
The Company has engaged the Contract Manufacturing Company (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.
The Company has engaged the Contract Research Organization (CRO) Clinical Design Ltd. in cooperation with PharmaLex to prepare and establish a drug development programme concerning creation of protocols for human clinical trials that will lead to the licensing of the Company's ITV-1 therapeutic under the European Medicine Agency (EMA).
The production at Danhson Ltd. will produce initial quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinical Designs, Ltd.
IMBL is contracting with PharmaLex, a leading EU regulatory consulting company to manage document review of the product compliance with EMA requirements.
The clinical trials will be funded fully by the Company's European partners in IMPL. None of the clinical trials costs will be borne by the Company.
The Company's CSO Harry Zhabilov will direct and monitor the production the ITV-1 therapeutic by Danhson Ltd. in beginning the steps outlined above.
The Company's two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as possible. No unanswered issues have arisen.
Harry Zhabilov, CSO of ENZC, stated, "We are excited about the progress we have made with the assistance of our partners at IMBL. Engaging Danhson Ltd., Clinical Design and PharmaLex is an integral step toward our success in the EMA permitting process. As this is the second time ITV-1 has gone through clinical trials and the first trials were successful, our confidence is at an all-time high regarding permitting, and with the reciprocal treaty between the EMA and FDA, we believe that the "redo" on clinical trials will be a blessing in disguise in the long run."
CEO Charles Cotropia said, "The Company's objective is to provide new, better and safer therapeutics to treat HIV. Currently, treatment is solely through the lifelong use of antiretrovirals (ARVs) which are expensive and have long lasting, serious negative effects on the body. The costs for such ARVs are excessive - from $27,540 per year for Dovato by ViiV/Glaxo SmithKline to $42,635 per year for Biktarvy by Gilead and a lifetime costs of up to $350,000 - and even then, only 54% of those ineffective by HIV have access to such treatments - leaving 46% with no treatment. New and improved therapies, that are less expensive and more effective, are desperately needed. Providing these better therapies are our Company's objective."
https://www.accesswire.com/651564/enzolytics-...out-europe
COLLEGE STATION, TX / ACCESSWIRE / June 14, 2021 / Enzolytics, Inc. (OTC PINK:ENZC) (http://enzolytics.com/) has concluded definitive plans to advance its previously tested ITV-1 anti-HIV therapeutic to clinical trials and distribution throughout Europe. Completion of these steps will establish its anti-HIV therapy as a significant revenue source for the Company, a meaningful milestone for both human health and Company profitability.
The Company's ITV-1 anti-HIV therapeutic earlier progressed toward certification under the Bulgarian Drug Agency (BDA) but that process was interrupted before completion. However, in that process, significant positive clinical trial results in patients were documented. These positive results give the Company total confidence that the now planned clinical trials under the European Medicines Agency (EMA) will likewise be successful.
The steps now in place to accomplish the Company's goal of bringing its anti-HIV ITV-1 therapeutic to patients are:
The Company has formed International Medical Partners Ltd. (IMPL) in partnership with European partners.
IMPL is owned equally by the Company and its partners and has the licenses to distribute the ITV-1 therapeutic in the 27 European countries covered by the European Medical Agency plus Russia, Georgia, Ukraine, Moldova, Belarus, Armenia, Azerbaijan, Kazakhstan, Uzbekistan, Turkmenistan, Kyrgyzstan, Tajikistan, Estonia, Latvia and Lithuania.
The Company has engaged the Contract Manufacturing Company (CMO) Danhson Ltd. to produce the initial quantity of ITV-1 used in preparing the required Best Methods Report for future production and clinical trials documentation.
The Company has engaged the Contract Research Organization (CRO) Clinical Design Ltd. in cooperation with PharmaLex to prepare and establish a drug development programme concerning creation of protocols for human clinical trials that will lead to the licensing of the Company's ITV-1 therapeutic under the European Medicine Agency (EMA).
The production at Danhson Ltd. will produce initial quantities of the therapeutic to be used for completion of preclinical testing and then initiating clinical trials with Clinical Designs, Ltd.
IMBL is contracting with PharmaLex, a leading EU regulatory consulting company to manage document review of the product compliance with EMA requirements.
The clinical trials will be funded fully by the Company's European partners in IMPL. None of the clinical trials costs will be borne by the Company.
The Company's CSO Harry Zhabilov will direct and monitor the production the ITV-1 therapeutic by Danhson Ltd. in beginning the steps outlined above.
The Company's two-year audit is proceeding in accordance with GAAP requirements and will be completed and filed as soon as possible. No unanswered issues have arisen.
Harry Zhabilov, CSO of ENZC, stated, "We are excited about the progress we have made with the assistance of our partners at IMBL. Engaging Danhson Ltd., Clinical Design and PharmaLex is an integral step toward our success in the EMA permitting process. As this is the second time ITV-1 has gone through clinical trials and the first trials were successful, our confidence is at an all-time high regarding permitting, and with the reciprocal treaty between the EMA and FDA, we believe that the "redo" on clinical trials will be a blessing in disguise in the long run."
CEO Charles Cotropia said, "The Company's objective is to provide new, better and safer therapeutics to treat HIV. Currently, treatment is solely through the lifelong use of antiretrovirals (ARVs) which are expensive and have long lasting, serious negative effects on the body. The costs for such ARVs are excessive - from $27,540 per year for Dovato by ViiV/Glaxo SmithKline to $42,635 per year for Biktarvy by Gilead and a lifetime costs of up to $350,000 - and even then, only 54% of those ineffective by HIV have access to such treatments - leaving 46% with no treatment. New and improved therapies, that are less expensive and more effective, are desperately needed. Providing these better therapies are our Company's objective."
