Canada's Bradmer Pharmaceuticals has run into a serious snag that is triggering a strategic review. In a release out this morning, the developer says the CRO it hired for a late-stage brain cancer study "has indicated that it is unable to meet the targets for site initiation and enrollment of sufficient patients in a timely manner." And that means it needs more time to hit clinical milestones, which in turn will require new funds beyond this year.
"While the cash on hand is not enough to finish the clinical trial, it is substantial enough to warrant careful consideration of proper deployment," says Bradmer. "It is envisioned that this strategic evaluation process will be reviewed by the directors in March and recommendations will be forthcoming."
"We have enrolled our first cohort of patients in the trial and documented the appropriateness of dosing and protocol compliance with no reports of any serious adverse events," said CEO Alan M. Ezrin. "While the efficiency and quality review of the Phase III study to date yielded encouraging protocol adherence and proof of execution, it also revealed significant logistical issues."
The CRO, which wasn't named in the release, has been terminated but is cooperating in the transition or "wind down" phase.
- read the Bradmer press release for more