Cel-Sci has announced that it has won a breach of contract ruling against the clinical research organisation, inVentiv (now known as Syneos Health) in its arbitration suit.
Legal outcome
The legal dispute, which has been ongoing for four and a half years, has reached its conclusion with the arbitrator ruling that inVentiv materially breached its contract with Cel-Sci.
“With this ruling against inVentiv, we have been vindicated. inVentiv’s actions slowed down the clinical development process of our Phase III cancer immunotherapy Multikine,” stated Geert Kersten, CEO of Cel-Sci. “The delays in the study caused by inVentiv not only delayed the potential approval of this investigational cancer drug by years, but it caused investors to wonder about the utility of the drug. This affected the reputation and share price of the company. Usually small companies do not win long legal battles against multi-billion dollar opponents, but we persevered and won our claim for breach of contract. We now move forward with a clean slate and an almost completed Phase III cancer study, knowing Cel-Sci has prevailed.”
The clinical research organisation was originally hired to manage Cel-Sci’s Phase III head and neck cancer study from 2011 to 2013. After enrolling fewer than 100 patients during its time as CRO, inVentiv was replaced on the Phase III study by two new CROs — Ergomed and ICON. Under these new CROs, 928 patients were successfully enrolled and the company is now waiting for the required number of events to occur to determine survival outcomes, the study’s primary goal.
“The arbitrator’s decision against inVentiv provides further vindication of our long-standing contention that we were not dealt with in good faith and fairly, and that inVentiv improperly managed our Phase III clinical trial that resulted in crippling delays in recruiting patients. The CROs that Cel-Sci hired to replace inVentiv and who have completed enrolment in our study demonstrated that there is a great amount of interest in our investigational product and that when properly managed our Phase III trial could be enrolled and completed in a reasonable period of time,” commented John Cipriano, senior VP of Regulatory Affairs, Cel-Sci.
“As of September 2016, our pivotal global Phase III cancer study was fully enrolled. The patient volunteers in the study have all been treated and we are now in the follow-up phase of this study. Based on overall survival data available in the scientific literature for the study's patient population, Cel-Sci believes that the end of the Phase III trial is approaching at which time the company will be able to assess efficacy data on the Study’s primary endpoint. The primary endpoint of the Phase III Study is a 10% improvement in overall survival in patients treated with the Multikine treatment regimen plus SOC vs patients treated with SOC alone,” said Dr Eyal Talor, Chief Scientific Officer of Cel-Sci.
“The bottom line is as follows. Our idea, and aim, is to help cancer patients by boosting their immune system BEFORE the ravages of surgery, radiation and chemotherapy,” stated Geert Kersten, CEO of Cel-Sci. “This is a logical concept and one that made sense to 24 regulatory agencies, including the FDA, when we applied for conducting this global Phase III study. If the Phase III study achieves its primary endpoint we have the chance to become the first newly approved treatment in 60 years for advanced primary (not yet treated) squamous cell carcinoma of the head and neck. Head and neck cancer represents about 6% of all cancers.”