US FDA eases clinical hold on Geron's imetelstat

There was a touch of good news yesterday for Geron Corp (Nasdaq: GERN), after the US Food and Drug Administrated partially lifted the clinical hold on the investigator-sponsored clinical trial of imetelstat in myelofibrosis (Myelofibrosis IST). The FDA had imposed a full hold on a company-sponsored study earlier this month which sent the firm’s stock into a 60% nosedive (The Pharma Letter March 12).

In its latest announcement, the FDA said that patients currently enrolled in this trial at the Mayo Clinic Rochester, Minnesota, are deriving clinical benefit may continue imetelstat treatment under a partial clinical hold placed by the FDA. This is now Geron’s only investigational compound and which previously failed as a treatment for breast cancer and non-small cell lung cancer (NSCLC; TPL September 11, 2012). Geron’s shares dipped 1.75% to $2.24 by close of trading on Thursday.

The partial clinical hold means that no new patients may be enrolled into the Myelofibrosis IST, and patients currently enrolled must demonstrate that they are deriving clinical benefit in order to continue taking imetelstat. Mayo Clinic informed Geron in January 2014 that the Myelofibrosis IST had ceased enrolling new patients, and did not cite any safety concerns as the basis for that decision. The investigator has agreed to provide to the FDA specific criteria he will use to determine which patients will continue imetelstat treatment in the Myelofibrosis IST.