Geron’s Clinical Trials of Imetelstat put on Hold

FDA asks Geron to Halt Development of Imetelstat

The FDA has placed it’s only pipeline candidate, imetelstat, on full clinical hold. The news sent shares of GERN plunging 61% on March 12, 2014. Geron had submitted an Investigation New Drug (IND) application for imetelstat, but the FDA issued a verbal notice halting the trials.

Geron Clinical Trials on Hold_optThis will affect all of their ongoing studies, including phase 2 studies in essential thrombocythemia (ET), polycythemia vera (PV) and multiple myeloma. Geron had planned to conduct a phase 2 study in myelofibrosis scheduled to start in the first half of 2014, this study will most likely get delayed as well.

The FDA is concerned about the occurrence of low-grade liver function test, as well as the potential risk of chronic liver injury following long-term exposure to imetelstat. The full clinical hold is a major setback for the company. More details can be found here.

About David Wallace

Founder of PV Reporter, a resource for Myeloproliferative Neoplasm (MPN) patients and caregivers. After being diagnosed with Polycythemia Vera (PV) in 2009, I utilized social media to connect with "informed patients" and develop a better understanding of emerging treatment options. My philosophy on patient care is straight forward - "educating the patient is essential, so the patient can guide their physician to meet his or her needs." PV Reporter is a comprehensive resource hub giving visitors vital tools to become "empowered patients."

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