The trial date has been scheduled for May 4, and Vienna, Virginia-based biotech CEL-SCI is seeking $50m in damages from inVentiv Health Clinical which it alleges breached its contract, committed fraud in the inducement, and committed common law fraud in its management of the trial.
Arbitration proceedings against inVentiv were initiated back in October 2013, following the dismissal of the contract research organisation (CRO) six months prior in a Phase III trial of its head and neck cancer candidate Multikine.
“The Company filed this arbitration because, among other reasons, the number of patients that have been enrolled and treated in the study fell below the level agreed to with inVentiv Health Clinical,” CEL-SCI declared in a recent SEC filing.
The firm alleges that it was necessary to terminate the contract with inVentiv “since the patient enrollment in the study dropped off substantially following a takeover of Pharmanet by inVentiv [completed in July 2011] which caused many of the members of the CRO’s study team to leave the CRO.”
In a response sent to Outsourcing-Pharma.com, inVentiv described the accusation by its former client as unfounded.
“inVentiv Health is currently engaged in arbitration regarding this matter. We are vigorously defending ourselves against this meritless claim. We continue to be committed to operational excellence and our partnerships with our clients.”
The CRO filed a counterclaim in December 2013 alleging breach of contract on the part of CEL-SCI for the dismissal and is seeking at least $2m in damages.
Trial enrolment
Despite the arbitration, the global Phase III Multikine trial is continuing under the management of Icon subsidiary Aptiv Solutions and Ergomed which were hired by CEL-SCI following inVentiv’s dismissal.
CEL-SCI has announced this week trial enrolment increased more than eight-fold in 2014 under the management of the two new CROs, compared with the total enrolment of 24 in 2013, the year it dismissed inVentiv.
“During 2014 we enrolled more patients than we did in several years when we worked with our prior CRO,” CEL-SCI CEO Geert Kersten said. “As we continue to work with our new CROs, we expect strong continued growth in monthly and quarterly patient enrolment for the balance of 2015.”
We contacted Ergomed for more information as to how it is managing enrolement for this trial: "Ergomed is managing to increase the recruitment through its unique Site Management Model and Study Physician Team which are both specifically structured for complex trials like the Cel-Sci study," a spokesperson said.
"The patients are coming from several countries: currently Europe, Israel, Taiwan and Sri Lanka and we expect additional patients in the future from Asia, Turkey, as well as some other Europen countries and the USA. Ergomed is responsible for recruitment in most of these countries."