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August 12, 2014
08:34 EDTGERNGeron says imetelstat remains on full clinical hold
Geron's stated in conjunction with its quarterly report last night that the company's IND for imetelstat remains on full clinical hold, affecting the company's clinical trials in essential thrombocythemia or polycythemia vera and in multiple myeloma. "The company is working diligently to seek release of the full clinical hold and is currently in the process of compiling preclinical and clinical information from Geron-sponsored studies, as well as information available from other imetelstat studies, such as the Myelofibrosis IST, regarding LFT abnormalities and the incidence and reversibility of hepatotoxicity. Until the FDA lifts the full clinical hold on Geron's IND, the company will be unable to initiate any new clinical trials for imetelstat in the United States under that IND. In light of the full clinical hold on the company's IND, Geron has committed to the FDA that it will not initiate any new clinical studies under the transferred IND from Mayo Clinic until Geron has had further communication with the FDA regarding the company's IND and its development plans for imetelstat in hematologic myeloid malignancies with high unmet medical need. Such communication will include updated analyses of efficacy and safety data from the Myelofibrosis IST. Pending the outcome of anticipated interactions with the FDA, Geron plans to initiate a Geron-sponsored clinical trial of imetelstat in MF which could potentially occur as early as the first quarter of 2015," the company stated.
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