Find out what it's like to work at Geron and learn more about our job opportunities.

Visit Working with Us

 
 

Geron Company Overview

Geron is a clinical stage biopharmaceutical company developing a telomerase inhibitor, imetelstat, in hematologic myeloid malignancies.

The discovery and early development of imetelstat, our sole product candidate, was based on our core expertise in telomerase and telomere biology. Telomerase is an enzyme that enables cancer cells, including malignant progenitor cells, to maintain telomere length, which provides them with the capacity for limitless, uncontrolled proliferation.

Imetelstat is a potent and specific inhibitor of telomerase. Using our proprietary nucleic acid chemistry, we designed imetelstat to be an oligonucleotide that targets and binds with high affinity to the active site of telomerase, thereby directly inhibiting telomerase activity and impeding malignant cell proliferation. We developed imetelstat from inception and own exclusive worldwide commercial rights with U.S. patent coverage extending through 2025.

Based on the data from our Phase 2 clinical trial evaluating imetelstat in essential thrombocythemia (ET) which showed durable hematologic and molecular responses in patients, and preliminary data from the first two cohorts of an investigator sponsored trial (IST) at Mayo Clinic evaluating imetelstat in myelofibrosis (MF), which we refer to as the Myelofibrosis IST, we intend to, subject to the full clinical hold discussed below, develop imetelstat to treat one or more hematologic myeloid malignancies such as MF, myelodysplastic syndromes, (MDS) or acute myelogenous leukemia (AML).

In March 2014, we received written notice from the U.S. Food and Drug Administration (FDA), that our Investigational New Drug application (IND) for imetelstat has been placed on full clinical hold following their review of data related to hepatotoxicity in our then-ongoing clinical studies. A full clinical hold is an order that the FDA issues to a trial sponsor to suspend all ongoing clinical trials and delay all proposed trials. With this clinical hold, any patients in an ongoing Geron-sponsored clinical trial cannot receive any further treatment with imetelstat. Therefore, we have stopped imetelstat treatment in our Phase 2 clinical trial in ET. We have previously announced that our Phase 2 ET trial was a mechanistic proof-of-concept study, and that we did not plan to develop imetelstat for commercial use in ET.

In January 2014, we announced that we were planning to initiate a Geron-sponsored multi-center, Phase 2 clinical trial of imetelstat in MF in mid-2014. However, until the FDA lifts the full clinical hold, or partially lifts the clinical hold, for example by permitting us to study imetelstat in indications other than ET, we are unable to submit any new clinical trial protocols to the FDA under our IND for imetelstat and are unable to initiate any new clinical trials for imetelstat in the United States. Therefore, the initiation of this potential Geron-sponsored Phase 2 clinical trial will be delayed. We plan to work diligently with the FDA to seek the release of the full clinical hold.

Find out what it's like to work at Geron and learn more about our job opportunities.

Visit Working with Us

Close
Form content here please :)