Cel-Sci says arbitration with inVentiv nearing an end

Cel-Sci Corp. says its long-running legal battle with former CRO, inVentiv Health Clinical LLC is nearing a conclusion.

The Virginia biotech made the announcement this week also revealing that, in agreement with litigation backer Lake Whillans, it has modified its deal with Wilk Auslander, which is the law firm handling the $50m (€42m) damages case against inVentiv.

CEO Geert Kersten said: "We are finally near the end of this arbitration. Both Lake Whillans, very experienced in commercial litigation, and CEL-SCI believe that this special incentive to the law firm representing our interests may be very beneficial to our shareholders."

Under the revised deal, Lake Whillans will pay Wilk Auslander up to $250,000 for any expenses it incurs.

In addition, Lake Whillans and CEL-SCI have agreed to give the law firm 3.75% of the proceeds in excess of $10m.

Patient recruitment

The arbitration relates to a Phase III trial of Cel-Sci’s candidate immunotherapy Multikine (Leukocyte Interleukin, Injection) in the treatment of patients suffering squamous cell carcinoma of the head and neck.

Originally, the study was being run by a contract research organisation (CRO) called PharmaNet. inVentiv bought PharmaNet in 2011, taking over responsibility for the programme.

Two years later Cel-Sci dismissed inVentiv, accusing it of failing to enrol sufficient patients.

Cel-Sci hired UK contractor Ergomed and Icon’s Aptiv unit to take on the study in April 2013.

inVentiv rejected Cel-Sci’s claims and, according to a document filed with the US Securities Exchange Commission (SEC) in April 2015, countersued accusing Cel-Sci of breach of contract and defamation.

Arbitration proceedings between the two parties began on September 26, 2016. The same day, Cel-Sci announced the US Food and Drug Administration (FDA) imposed a partial clinical hold on the Phase III study.

In August this year, Cel-Sci announced the hold had been lifted.