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After a four-year legal battle, immunotherapy maker CEL-SCI Corporation has won the first-ever breach-of-contract case against a contract research organization, or CRO.
In a final and binding decision, an arbitrator concluded that CRO inVentiv knowingly and fraudulently misled CEL-SCI with regard to enrollment projections for a clinical trial of CEL-SCI’s immunotherapy treatment for head and neck cancer. The arbitrator also said inVentiv used “scorched earth” litigation tactics and awarded CEL-SCI $2.9 million in damages, according to a statement from Vienna, Va.-based CEL-SCI.
The arbitrator denied inVentiv all but one of its counterclaims against CEL-SCI, which was for $429,649 for certain unpaid invoices.
inVentiv’s actions slowed the potential approval of investigational cancer drug Multikine by years, causing doubt among investors about the drug’s utility, according to the clinical development process of Multikine, CEL-SCI’s Phase 3 cancer immunotherapy, according to Geert Kersten, CEO of CEL-SCI. The company ultimately hired two other CROs, Ergomed and ICON, to complete enrollment in 2016 of 928 patients in the study. CEL-SCI is waiting for the required number of patient deaths (298) to occur to determine survival outcomes, the study’s primary goal.
CEL-SCI’s goal is to help cancer patients by boosting their immune systems before the ravages of surgery, radiation and chemotherapy, Kersten added.
“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 3 study,” he said. “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.”
Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. Multikine (leukocyte interleukin, injection), has received Orphan Drug designation from the FDA for the neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
“With this ruling against inVentiv, we have been vindicated,” Kersten said in the statement. “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.”
“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,” added John Cipriano, CEL-SCI’s senior vice president of regulatory affairs, CEL-SCI.
inVentiv, now owned by Syneos, did not immediately respond to a request for comment.
