Immunotherapy developer Cel-Sci Corporation has told shareholders it expects the lengthy legal dispute with its former contract research organisation (CRO) inVentiv Health Clinical LLC (now Syneos Health) to conclude by June 24, 2018.
“Closing arguments in the arbitration suit against the former CRO were concluded on April 25, 2018, and the arbitrator indicated he would render his judgement in the matter within 60 days of the conclusion of closing arguments,” CEO Geert Kersten told shareholders in a letter yesterday.
The CRO inVentiv last year merged with INC Research to form Syneos Health, a spokesperson from which told us in a statement: “We continue to maintain and intend to vigorously defend our position in this matter."
The arbitration concerns a Phase III trial of Cel-Sci’s Multikine (leukocyte Interleukin, Injection) – an immunotherapy candidate designed to treat patients with squamous cell carcinoma of the head and neck.
Cel-Sci originally hired PharmaNet to conduct the trial. When inVentiv acquired PharmaNet in 2011, it took responsibility for the Phase III study. But in 2013, Cel-Sci hired Ergomed and Icon’s Aptiv unit to take on the trial after accusing inVentiv of failing to enroll sufficient patients.
Cel-Sci filed the arbitration suit against inVentiv in October 2013, claiming an alleged breach of contract, fraud in the inducement, and common law fraud.
inVentiv rejected Cel-Sci’s claims and, according to a document filed with the US Securities Exchange Commission (SEC) in April 2015, countersued Cel-Sci for breach of contract and defamation.
Phase III update
In yesterday’s letter to shareholders, Kersten also announced enrolment had been completed for the study, which Cel-Sci said is the largest Phase III trial in the world for head and neck cancer.
“Based on overall survival data available in the scientific literature for the study’s patient population we believe that the end of the Phase III trial is approaching,” Kersten told shareholders.
“Once a sufficient number  of events (deaths) have occurred, this will put us in a position to assess our primary endpoint based on the study’s overall survival data.
“Should the study meet its primary efficacy endpoint of 10% improvement in overall survival, Cel-Sci plans to apply for regulatory approval in major markets including the US and the EU,” he added.