After a four and a half year battle, a decision has been delivered by the arbitrator in Cel-Sci Corporation's arbitration suit against clinical development giant inVentiv, now part of Syneos Health. The arbitrator ruled that inVentiv materially breached its contract with Cel-Sci. inVentiv was the CRO that Cel-Sci had hired to manage the company's global phase 3 head and neck cancer study from 2011 to 2013.

This is a final and binding decision and to Cel-Sci’s knowledge, marks the first ever decision in favour of a pharmaceutical or biomedical company against a CRO for breach of contract. Cel-Sci wins breach of contract ruling against clinical research organization inVentiv, now known as Syneos Health

“With this ruling against inVentiv, we have been vindicated. inVentiv’s actions slowed down the clinical development process of our phase 3 cancer immunotherapy Multikine. 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 3 cancer study, knowing Cel-Sci has prevailed," stated Geert Kersten, CEO of Cel-Sci.

The arbitration ruling in favor of Cel-Sci was for breach of contract by inVentiv on Cel-Sci’s Phase 3 cancer trial for its investigational product Multikine (Leukocyte Interleukin Injection). inVentiv, which had enrolled fewer than 100 patients during its time as CRO, was replaced on the Phase 3 study in March 2013 with two new CROs, Ergomed and ICON. Working with Ergomed and ICON, Cel-Sci successfully completed enrollment of 928 patients in the world’s largest Phase 3 study in head and neck cancer. The last patient was enrolled in the trial in September 2016 and the Company is currently waiting for the required number of events to occur to determine survival outcomes, the phase 3 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 3 clinical trial that resulted in crippling delays in recruiting patients. The CROs that Cel-Sci hired to replace inVentiv and who have completed enrollment in our study demonstrated that there is a great amount of interest in our investigational product and that when properly managed our Phase 3 trial could be enrolled and completed in a reasonable period of time,” stated John Cipriano, Senior VP of Regulatory Affairs, Cel-Sci.

“As of September 2016 our pivotal global Phase 3 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 3 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 3 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. This is a logical concept and one that made sense to 24 regulatory agencies, including the US FDA, when we applied for conducting this global Phase 3 study. If the Phase 3 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,” said Geert Kersten, CEO of Cel-Sci.