FDA slams brakes on Immunomedics' cancer trial

Here's one way to threaten the timeline for a clinical study. The FDA has halted Immunomedics' ($IMMU) clinical trial of a therapy called clivatuzumab tetraxetan for pancreatic cancer because one patient in the study was given a larger dose than prescribed, according to the Morris Plains, N.J.-based developer of antibody drugs.

The error occurred in a radiopharmacy where a patient was give a greater amount of a radioactive isotope called Y-90 than planned. That prompted U.S. regulators to put what the company calls a "partial clinical hold" on the Phase Ib/II trial of clivatuzumab tetraxetan. The company noted in a statement that the hold on the trial isn't due to issues with the safety of the product, and the drug labeled with the radioisotope has been safety given to 100 patients to date.

"We are preparing the requested remediation documents for the agency to ensure that this single error by the radiopharmacy will not reoccur in our trial, so that the partial clinical hold can be lifted as soon as possible," Immunomedics CEO Cynthia Sullivan said in a statement. "We are also working closely with the FDA to ensure patients who are eligible for retreatment can go on to receive additional cycles of therapy, once the partial hold is lifted. The Phase Ib/II study is now fully enrolled, so we are hopeful to continue retreatment cycles for those patients who may benefit from this experimental therapy."

The company aims to move ahead with development of the drug, which is one of five in its clinical pipeline, according to its planned timeline, Sullivan added. The firm's stock slid 6% yesterday to $3.50 per share, according to Reuters.

- here's the release
- see the Reuters' report

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