Geron Corporation’s (GERN) shares were up 21.15% with the company announcing that the FDA has lifted the partial clinical hold on an investigator-sponsored study of imetelstat.
The investigator provided follow-up information regarding the reversibility of hepatotoxicity for all patients who received imetelstat in the study in order to get the partial clinical hold lifted.
The development of imetelstat had run into trouble in Mar 2014 with the FDA placing a full clinical hold on Geron`s Investigational New Drug (IND) application for the candidate. A clinical hold is an order issued by the FDA under which the sponsor of the study is asked to delay a proposed trial or suspend an ongoing trial.
Studies affected by the clinical hold include a phase II study in essential thrombocythemia (ET) or polycythemia vera (PV) and another phase II study in multiple myeloma. Moreover, Geron’s plans of conducting a phase II study in myelofibrosis, scheduled to commence in the first half of this year, will get delayed due to the clinical hold.
Soon after the full clinical hold was announced, a partial clinical hold was placed on the investigator-sponsored study which meant that new patients could not be enrolled in the study being conducted by Mayo Clinic.
The FDA’s main concern was about the occurrence of persistent low-grade liver function test (LFT) abnormalities in the phase II study for ET/PV as well as the potential risk of chronic liver injury following long-term exposure to imetelstat. The agency expressed concern about the possibility of reversing these LFT abnormalities.
Our Take
While we are encouraged by the lifting of the partial clinical hold, the full clinical hold remains in place. Imetelstat is the only candidate in Geron’s pipeline – visibility as to when the company can commence its own studies remains low. Even if imetelstat studies continue, concerns about LFT abnormalities could limit the commercial potential of the candidate and restrict its long-term usage.
Geron is a Zacks Rank #3 (Hold) stock. Some better-ranked biotech stocks include Gilead Sciences (GILD), Osiris Therapeutics (OSIR) and Regeneron Pharmaceuticals (REGN). All three are Zacks Rank #1 (Strong Buy) stocks.
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