By: Adam Feuerstein | 01/27/14 - 08:48 AM EST
(GERN) shares are down about 15% to $4.84 in Monday's pre-market trading session in reaction to what appears to be a rather innocuous update on the Mayo Clinic's ongoing study of imetelstat in myelofibrosis patients.
Enrollment in the Mayo Clinic study has been stopped at 79 patients, 20 of which have discontinued treatment since the study's inception, Geron said in an 8-K filed Monday morning.
Investors might be reacting negatively to the 20 patients discontinuing from the study. Geron provided no other details. There were five patient discontinuations in the Mayo imetelstat study disclosed at the last update. Here's the slide from Geron's most recent investor presentation:
Geron shares may also be reacting to the absence of a meaningful update on imelelstat's efficacy results. The stock was up significantly last week, in part because of expectations that Mayo's Dr. Ayalew Tefferi would be presenting new data from the study at a medical conference over the weekend. That update did not take place.
Here's the full text of Geron's 8-K filed this morning:
In November 2012, Dr. Ayalew Tefferi (the "investigator"), of Mayo Clinic, initiated an investigator-sponsored clinical trial to evaluate imetelstat in patients with myelofibrosis and other myeloid malignancies (the "Myelofibrosis IST"). Mayo Clinic has informed Geron Corporation (the "Company" or "Geron") that effective January 22, 2014, the Myelofibrosis IST has been closed to new patient enrollment, and that the remaining patients in the study will continue to receive imetelstat treatment and be followed under the Myelofibrosis IST protocol. The Company believes that approximately 79 patients have been enrolled in the Myelofibrosis IST, including nine patients with blast-phase myelofibrosis and nine patients with refractory anemia with ringed sideroblasts ("RARS"), a subpopulation of myelodysplastic syndromes, and that approximately 20 patients have discontinued from the study since its inception.
In December 2013 at the American Society of Hematology Annual Meeting, the investigator presented preliminary data from the first two cohorts of patients in the Myelofibrosis IST, including preliminary efficacy data for 22 patients and preliminary safety data for 33 patients. Based on this preliminary efficacy and safety data, the Company plans to initiate a Geron-sponsored, multi-center, Phase 2 clinical trial of imetelstat in patients with myelofibrosis in the first half of 2014. The Company also believes that the total accrued patients in the Myelofibrosis IST will be adequate for gathering additional and updated safety and efficacy data to support the imetelstat development program.
The Company expects that the investigator will present at a future medical conference additional and updated safety and efficacy data, including longer-term durability, for those patients previously reported and for additional remaining patients in the Myelofibrosis IST.
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