Bad start to month for Karyopharm gets worse with clinical hold
Coming just over a week after Karyopharm Therapeutics had announced that its lead drug had failed in a Phase 2 trial to extend overall survival, it was also hit with a partial clinical trial hold on the same drug. The drug, selinexor, is being tested in drug-resistant multiple myeloma but further clinical trial recruitment will be halted.
The partial trial hold is the result of failing to include certain serious adverse events within the brochures that are supplied to patients. The error means that the company will be unable to add further patients into its clinical trials and must wait on the FDA to release the partial hold.
Karyopharm released the following statement as part of a press release on the FDA’s decision: “As of Friday, March 10, 2017, Karyopharm had provided all requested materials to the FDA believed to be required to lift the partial clinical hold. By regulation, the FDA has 30 days from receipt of Karyopharm's submission to notify the company whether the partial clinical hold is lifted. Karyopharm is working diligently with the FDA to seek the release of the partial clinical hold and resume enrolment in its selinexor clinical trials as expeditiously as possible. Karyopharm believes that its previously disclosed enrolment rates and timelines for its ongoing trials will remain materially unchanged.”
The announcement of the partial hold at the same time as all the paper work having also been filed with the FDA rang alarm bells with some investors. The potential delay in the news being released explains why shares in the biotech were falling even before the news was officially announced.
The combination of this alongside its drugs failure to boost overall survival in myeloid leukaemia will go some way to damaging investor confidence, though it is still expected to file with the FDA in 2018 for selinexor.