Cel-Sci working to have Multikine trial partial hold lifted after receiving formal US FDA letter

By Gareth Macdonald contact

- Last updated on GMT

iStock/selvanegra
iStock/selvanegra

Related tags: Contract research organization, Food and drug administration

Cel-Sci has received written confirmation the US FDA has placed a late stage trial of its cancer cell therapy Multikine on partial clinical hold a month after agency first raised concerns.

Details of the partial clinical hold have not been made public, although Cel-Sci did say it has started work on its response to the US Food and Drug Administration (FDA). The firm also said it will seek to have the partial hold lifted.

The Virginia, Vienna-based drug manufacturer received verbal notice of the partial clinical hold on September 26​ according to a brief statement filed with the US Securities and Exchange Commission (SEC) at the time.

In the study Multikine leukocyte interleukin injection) is being assessed as a treatment for advanced primary head and neck cancer.

According to a Cel-Sci filing​ "about 860 patients were enrolled in that study at the end of July 2016​."

A testing trial

Cel-Sci has encountered a number of problems with the study.

Originally, the program was being run by PharmaNet, a US contract research organisation (CRO) that was bought by inVentiv in 2011.

Cel-Sci dismissed inVentiv in 2013​ subsequently accusing the CRO 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.”

UK contractor Ergomed was hired – along with Icon’s Aptiv unit – to replace inVentiv in April 2013.

Last year​ Ergomed said it would add additional trial sties in a bid to accelerate patient recruitment.

A Cel-Sci spokesman told us: "Ergomed continues to manage the clinical trial on behalf of CelSci and all patients are being followed up as planned​."

Related topics: Markets & Regulations, Regulations

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