FDA clinical trials Geron
Geron Corporation’s (GERN - Analyst Report) shares plunged 61.6% on news that the FDA has placed a full clinical hold on the company’s only pipeline candidate, imetelstat.
What is a Clinical Hold?
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. Geron had submitted an Investigational New Drug (IND) application for imetelstat to the FDA. However, the FDA issued a verbal notice placing the company’s IND application for imetelstat on hold. So, not only will the company not be able to initiate a study on imetelstat, the notice will also affect currently ongoing studies on imetelstat which have been sponsored by Geron.
Currently ongoing studies 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 most likely get delayed due to the clinical hold. Chances remain that investigator-sponsored studies will also be placed on clinical hold.
Cause for Concern
Although Geron is yet to receive a written notice regarding the clinical hold, the company said that the FDA is concerned 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 is concerned about the possibility of reversing these LFT abnormalities.
The full clinical hold on imetelstat is a major setback for Geron. Geron has suffered imetelstat-related setbacks earlier too – the company had to drop its plans to develop the candidate for breast cancer and non-small cell lung cancer. With the FDA voicing concerns about safety, we currently have low visibility on when imetelstat-based studies can resume/commence.
Even if imetelstat studies continue, concerns about LFT abnormalities could limit the commercial potential of the candidate and restrict its long-term usage.
BMC Medical Research Methodology at the 35th Annual Conference of the .. — BMC Pediatrics
The conference will focus on issues such as design and analysis of clinical trials, methods in biostatistics and development of clinical prediction models.
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