Geron has
been given verbal notification from the U.S. Food and Drug Administration (FDA)
that its application for imetelstat has been placed on full clinical hold,
affecting all ongoing company-sponsored clinical trials. A full clinical hold
is an order that the FDA issues to a trial sponsor to suspend an ongoing
clinical trial or delay a proposed trial.
The clinical
hold affects the remaining eight patients in the company's Phase 2 study in
essential thrombocythemia (ET) or polycythemia vera (PV) and the remaining two
patients in the company's Phase 2 study in multiple myeloma. Geron released astatement as well as a recording of a conference call to go over details.
This comes only a few months after Sanofi's clinical trial was discontinued due toneurotoxicity issues.
