The US drugmaker announced it had added more sites last night, explaining that only 27 patients had signed up to the study in November. This is down from the 38 patients its Ergomed recruited in October.
CEO Geert Kersten said: “This fall we have been enrolling patients at an average of rate one per day. We expect this rate will significantly increase in the first quarter of 2016 based on the number of new clinical centers that are now being activated."
Recruitment for the Phase III Multikine (Leukocyte Interleukin, Injection) trial has been a major headache for Cel-Sci. Originally, the trial was being run by PharmaNet, a contract research organisation (CRO) that was bought by inVentiv in 2011.
However, this ended in April 2013 when Cel-Sci dismissed inVentiv. The following October the drugmaker began legal proceedings accusing the CRO of breach of contract and seeking $50m (€47m) in damages.
At the time, Cel-Sci said the move “was necessary since the patient enrolment in the study dropped off substantially following a takeover of Pharmanet by inVentiv which caused many of the members of Inventiv’s study team to leave inVentiv.”
inVentiv rejects the claims and, according to a document filed with the US Securities Exchange Commission (SEC) this April, has accused Cel-Sci of breach of contract and defamation. The CRO is seeking more than $20m in damages.
The case was originally due to go to trial in May, but has been delayed until March next year according to a recent filing.
March target
Ergomed was hired – along with Icon’s Aptiv unit – to replace inVentiv in April 2013. Until last month recruitment had been accelerating according to various Cel-Sci SEC filings.
At present 635 head and neck cancer patients have been enrolled, which is some way short of the 880 Cel-Sci had hoped that Ergomed would have found by the end of the year.
According to a Cel-Sci filing, Ergomed estimates that enrolment will be completed in March 2016.