Pharma fallout: Biotrial details emerge

By Melissa Fassbender contact

- Last updated on GMT

Image: iStock
Image: iStock

Related tags: Clinical trial

New information, including Bial’s clinical protocol document have emerged over the past week, providing new insight into the Biotrial tragedy.

Last week, the European Federation for Exploratory Medicines Development, a federation which represents associations and their members who are involved in the early stages of the development of new medicines across Europe, released a statement​ expressing concern.

Once the facts are shared we will be in a position to evaluate what can be learned. Our federation will continue working with other clinical trials stakeholders - regulators, innovators, patients and researchers - to minimise risks in early development of much needed new medicines​.”

While little is known about the potential causes of the adverse reactions, French Authorities are conducting an on-going investigation.

The first reports on the Rennes tragedy were understandably confused. Adding to the shock of the tragedy, the secretive stance taken by the drug manufacturer made things even murkier​,” Dr. Daniele Piomelli, Louise Turner Arnold Chair in Neurosciences and Professor of Anatomy & Neurobiology and the University of California, Irvine School of Medicine told Outsourcing-Pharma.com.

One person died and several were hurt. This is a tragedy and we cannot turn away from it,” added Piomelli. “As a scientist active in the field, I feel an obligation to understand what went wrong.  And to demand transparency from the drug manufacturer.​”

More clarity, but also perhaps more confusion, has emerged after an investigative journalist at the French newspaper Le Figaro obtained a copy​ of the trial’s protocol. The newspaper submitted it to three experts for review.

According Le Fiagor’s reports, the document actually describes a series of trials with complicated protocols, specifically four parts: the single ascending dose (SAD) part, the food interaction (FI) part, the multiple ascending dose (MAD) part, and a specific PD part.

It also described the animal drug trials which consisted of repeated daily dosing of the molecule (BIA 10-2474) for up to 13 weeks in mice, dogs, and monkeys, and up to 26 weeks in rats. Apparently these treatments produced no toxicity signs.

The protocol also addressed drug safety concerns, explaining that if any arised, dosing would be staggered. The starting dose was 0.25 mg BIA 10-2474 with levels to be increased by approximately two-fold until it reached 100 mg.

Getting to the bottom

In its most recent statement Bial explained that they are “continually and closely following the health state conditions of the other 5 volunteers​.”

The volunteer who had no symptoms has returned home, and two other volunteers have been transferred to local hospitals within their residence areas. Two volunteers still remain at the University Hospital of Rennes.

We have been informed that the most recent medical examinations present a positive scenario. We will continue to accompany the volunteers’ condition, and expect a full recovery​,” BIAL said in its statement.

The statement also addresses the initial reports that the molecule was a cannabinoid.

The experimental molecule tested in the referred clinical trial, under the code name BIA 10-2474, is a long-acting inhibitor of FAAH (Fatty Acid Amide Hydrolase) – and not a derivative of cannabis sativa - resulting in increased anandamide levels, an endogenous cannabinoid, and consequent amplification of its actions on the central nervous system and in peripheral tissues."

Piomelli is also the Editor-in-Chief of the publication Cannabis and Cannabinoid Research. In talking about the potential effects the first reporting could have on future cannabioid research, she told us “With Cannabis, everything is tinged with political hues, which does not make the task any easier. The scientific community should take advantage for this opportunity to diffuse messages based on data and thoughtful reflection​.”

A lot of people are looking at the cannabinoid field with hope for new medicines,” she added. “The tragic events of Rennes should motivate us to do better. To start off, as scientists we must do our part to get at the bottom of this incredible story​.”

Related topics: Clinical Development

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