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Biotech / Medical : Geron Corp.
GERN 3.020+3.8%Feb 5 9:30 AM EST

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From: Savant6/17/2013 5:46:13 PM
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Geron reports updated results from its Imetelstat Phase 2 proof-of-concept trial in Essential Thrombocythemia
Co announces that updated clinical results from the co's Phase 2 trial of imetelstat in essential thrombocytopenia were presented in an oral session at the Congress of the European Hematology Association. Efficacy Results All 18 ET patients were refractory to, intolerant of or had refused conventional therapies (hydroxyurea, anagrelide and/or interferon-alpha). Platelet counts were reduced in all patients (a 100% hematologic response rate) and normalized in 16 out of 18 patients (an 89% complete response (CR) rate). The JAK2 V617F gene mutation was detected in eight patients. Seven out of the eight (88%) patients achieved 72% to 96% reductions in JAK2 V617F allele burden that qualified as partial molecular responses within three to 12 months of treatment with imetelstat. Molecular PRs were maintained in six of the seven (86%) patients, with a median follow-up of 9.5 months (range 0 to 19 months) after first achieving a response. The median durations of hematologic and molecular response have not yet been reached. Safety Results In the trial, long-term administration of imetelstat was generally well tolerated. There were no new safety signals observed in the six-month update, and no patients discontinued the trial due to drug-related adverse events. The majority of the non-hematologic adverse events were mild-to-moderate in severity, the most frequent assessed as imetelstat-related by investigators being gastrointestinal events and fatigue. No drug-related Grade 4 non- hematologic adverse events were reported.
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