31 May 2021

Cellivery extends global clinical trials of Covid-19 immunotherapy drug ‘iCP-NI’ in India and Europe, signing a contract with OPIS CRO

Recently, Cellivery Therapeutics Inc announced that it will expand the clinical development of Covid-19 immunotherapy drug iCP-NI to include India and Europe.
Since it has been obtained enough evidence of safety and efficacy through non-clinical tests, now it’s time to launch clinical trials, tailored to be used in local contexts, to provide treatment to those who suffer from a severe form of Covid-19 as soon as possible.

Out of four bidding big global CROs, Cellivery signed with OPIS, a company with headquarters in Italy, specialized across Europe and on a global level

OPIS is an European full-service Contract Research Organization (CRO) providing premium trial management for multi-country clinical trials. With more than 22 years of experience OPIS has successfully managed more than 1,300 clinical trials to date.

OPIS is currently conducting a number of Covid-19 vaccine and treatment trials.

Dr. Federico Mailland, a medical expert for OPIS, said, “We have confidence in Cellivery. They have reliable data on COVID-19 with full toxicity package data. Therefore, I believe that the clinical trial will be suitable for simultaneous Phase I/II conduct in a European country.”

Dr. Laura Ambrosoli, OPIS CEO says as well that the product is very promising and that OPIS is very happy to enter in a partnership with Cellivery, putting at their disposal all the expertise accrued in 22 years of clinical development.

On a global scale, there are still between 500,000 and 800,000 confirmed cases every day, with more than 10,000 deaths each day: this means seven people die every minute, about one person every 10 seconds, because of Covid-19.

India, right now, is facing an even more serious situation, considering the recent widespread of Covid-19. The number of confirmed daily cases is around 400,000 and the number of daily deaths is about 6,000. More than 600,000 have been killed by Covid-19.

As indicated by the CEO of Cellivery “The Covid-19 immunotherapy drug iCP-NI has been shown to lower the mortality rate by 80% in the Covid-19 animal model. Cellivery’s drug is not a symptom-reliever that prevents the development of mild to severe symptoms, but a disease-control treatment that saves lives from severe cases.

Therefore, after conducting Phase 1 clinical trial in Europe, it plans to proceed with Phase 2 clinical trial in Europe and India at the same time.”

Daewoong Jo, CEO of Cellivery, said: “We aim to conduct global clinical trials in India, the world’s largest Covid-pandemic country, with the fastest clinical approval in Europe, so that it can be used as a treatment as soon as possible”.

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