CVB, Parexel Biotech partner on adaptive platform trial of PTSD

12th November 2019 (Last Updated December 24th, 2019 06:51)

Nonprofit research organisation Cohen Veterans Bioscience (CVB) has formed a strategic partnership with Parexel’s new division Parexel Biotech.

CVB, Parexel Biotech partner on adaptive platform trial of PTSD
Military warfighters, veterans and all people with PTSD deserve precision therapy. Credit: PRNewsFoto/Cohen Veterans Bioscience.

Nonprofit research organisation Cohen Veterans Bioscience (CVB) has formed a strategic partnership with Parexel’s new division Parexel Biotech.

The collaboration is aimed at analysing pharmaco-therapeutics to treat post-traumatic stress disorder (PTSD) using CVB’s adaptive platform.

PTSD is a mental disorder developed after experiencing or witnessing a violent act, such as a terrorist attack, natural disaster, combat or sexual assault.

Parexel Biotech started providing clinical trial implementation services from last month, which will be extended through a multi-year period.

Commenting on the collaboration, Parexel CEO Jamie Macdonald said: “We are delighted to be part of this important adaptive platform trial exploring a precision medicine approach for the treatment of PTSD.

“We look forward to partnering with CVB on this innovative trial design in the brain disorders arena and to contributing to this important new therapy, which has significant potential to benefit patients.”

In September 2018, CVB was granted a research award from Advanced Technology International.

Granted on behalf of the US Army Medical Research Development Command (MRDC), the award is for a three-and-a-half-year trial designed to test the safety and efficacy of pharmaco-therapeutics for PTSD.

The trial will be assessed through an adaptive platform trial (APT) led by CVB, which will also serve as the Clinical Coordinating Center (CCC) of the trial.

This Phase II adaptive clinical trial is expected to commence in the second half of next year.

During the trial period, at least two yet-to-be-selected active drugs will be assessed.

The trial aims to identify a drug and advance to Phase III testing anticipated in 2022.

According to CVB, the whole trial will eventually lead to an additional FDA-approved drug for treating PTSD.

Cohen Veterans Bioscience president and CEO Magali Haas said: “In our selection of Parexel Biotech to conduct this programme, which has far-reaching implications for the field, we focused on their world-class reputation, proven track record of delivery and highly-flexible partnership approach.”