Cel-Sci's Multikine Phase III trial placed on hold by US FDA
The Virginia, Vienna-based drugmaker announced this week it received a verbal notice from the US Food and Drug Administration (FDA) that its Multikine (leukocyte interleukin injection) Phase III clinical trial in advanced primary head and neck cancer has been placed on clinical hold.
The study has 926 patients enrolled, Cel-Sci said, and patients already receiving study treatments can continue to receive treatment.
Cel-Sci said it expects a formal letter from the FDA within 30 days. However, the firm did not respond to a request for further details at the time of going to press.
The company's contract research organisation (CRO) in charge of the trial, Guildford, UK-based Ergomed, would not comment on the news when contacted by in-Pharmatechnologist.
Recruitment issues
Problems with recruitment for the trial led to Ergomed adding more research sites last year, which successfully drove up numbers.
Originally, the trial was being run by PharmaNet, a contract research organisation (CRO) that was bought by inVentiv in 2011.
But 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.”
