Enzolytics Inc. (OTCMKTS: ENZC) Completes Steps Necessary For ITV-1 Medication Production And Clinical Studies Ahead of EMA Approval

Enzolytics Inc. (OTCMKTS: ENZC) has finalized an agreement and arrangements with Danhason and Clinic Design to advance its Anti-HIV treatment ITV—1 into clinical trials and production. These processes are necessary before the European Medicines Agency (EMA) approves a product for patient use.

Danhson to manufacturer Enzolytics’ ITV-1 treatment

The medication will be manufactured at Danhson Pharmaceutical Company facilities, and Clinic Design will undertake clinical studies. The medicines’ production is due to be completed within the next six months, with clinical trials following soon after. Pharmalex, an EU regulatory consultancy firm, will oversee the trial’s protocol.

The company announced earlier this year the formation of International Medical Partners (“IMPL”), a Limited Liability Company in Bulgaria in which it owns a 50% stake. Enzolytics will fund the initial ITV-1 therapeutic production with its partners in IMPL, funding the clinical trials and EMA licensing costs.

IMPL to supply ITV-1 therapeutics to 27 EU states

IMPL will be the sole distributor of the ITV-1 treatment in all 27 EU member nations, including Liechtenstein, Iceland, and Norway, as well as Georgia, Russia, Ukraine, Belarus, Moldova, Armenia, Azerbaijan, Uzbekistan, Kazakhstan, Kyrgyzstan, Tajikistan, Turkmenistan, Latvia, Estonia, and Lithuania. In addition, IMBL could distribute the ITV-1 treatment outside of its exclusive jurisdiction where an exclusive license is not available. The Registry Office in Sofia has received all of the papers required for IMPL registration.

CSO of Enzolytics Harry Zhabilov said, “We are excited about the progress we have made with the assistance of our IMBL partners. Contracting with Danhson, Clinic Design and PharmaLex is integral to the success of the EMA permitting process. As this is the second time our ITV-1 therapeutic has progressed through clinical trials and the first trials were successful, we are fully confident that we will succeed in the permitting process. With the reciprocal treaty between the EMA and FDA, we believe that the EMA approval with lead to further advancement of our ITV-1 as a successful therapy.”

Friedrich Claassens

Leave a Comment
Published by
Friedrich Claassens

Recent Posts

Tshepong Victim Empowerment Centre celebrates ORANGE DAY

Tshepong Victim Empowerment Centre commemorates ORANGE DAY every month on the 25th of each month..… Read More

2 hours ago

Four in court for alleged Public Works tender collusion

The Special Investigating Unit (SIU) says the arrest of four people linked to alleged tender… Read More

3 hours ago

Two suspected cable thieves arrested while on their way to Zimbabwe

Jo'burg Metro Police Department JMPD and SAPS officers in the JHB and CBD have arrested two… Read More

5 hours ago

Several dignitaries wish people Happy Africa Day 2022

The African Union Commission celebrates "Africa Day" on May 25 each year to acknowledge its… Read More

6 hours ago

Pastor Luthando Matodlana found guilty of raping 22-Year-Old man

One South African pastor, Luthando Matodlana of God, is Love Ministry in Motherwell, Gqeberha, South… Read More

7 hours ago

Mec Lekwene inspects Robert Mangaliso Sobunke hospital – Food Service Unit

Today, the Northern Cape Health MEC, Mr Maruping Lekwene, conducted an oversight visit to Robert… Read More

8 hours ago