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news.Geron has completed patient enrollment in the randomized Phase 2 clinical trial of Imetelstat, in combination with paclitaxel, in patients with locally recurrent or metastatic breast cancer (MBC).
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Imetelstat is a potent and specific inhibitor of telomerase, which is required for tumor cell immortality and growth.
The open label, multi-center, randomized Phase 2 trial (B014) study enrolled a total of 166 MBC patients to evaluate the efficacy and safety of Imetelstat plus paclitaxel versus paclitaxel alone.
The primary efficacy endpoint of the trial is an estimation of progression-free survival (PFS), and secondary efficacy endpoints included objective response rate and clinical benefit rate of Imetelstat plus paclitaxel.
Geron executive vice president and chief medical officer Stephen M. Kelsey said they are planning to report top-line results from this trial by the end of Q4 2012, provided that a sufficient number of progression events have occurred.
In preclinical models, Imetelstat has been found to inhibit breast cancer progenitor cells as well as tumor growth and metastasis.