Geron Corporation (GERN) recently announced that it has moved its telomerase inhibitor drug, imetelstat (GRN163L), into a new Phase II study. The company is conducting an open label, multi-center, randomized phase II study in patients with locally recurrent or metastatic breast cancer.
The study will compare the efficacy and safety of imetelstat plus paclitaxel – with or without Roche’s (RHHBY.PK) Avastin 9bevacizumab – with that of paclitaxel (with or without bevacizumab).
While progression-free survival is the primary endpoint of the study, secondary efficacy endpoints include objective response rate and clinical benefit. The study will also evaluate the safety and tolerability profile of imetelstat.
Imetelstat is Geron’s lead telomerase inhibitor, which is being studied for the treatment of a wide array of diseases including chronic lymphoproliferative diseases, solid tumors, multiple myeloma and non-small cell lung cancer.
Imetelstat has demonstrated anti-tumor effects in a wide range of preclinical hematological and solid tumor models and is currently in two phase II studies including the recently initiated breast cancer study.
Geron initiated a Phase II study for the non-small cell lung cancer indication earlier this year – initial results from this study should be out in mid-2012. Meanwhile, two more Phase II studies with imetelstat are scheduled to commence soon – one for multiple myeloma and the other for essential thrombocythemia.
Neutral on Geron
We currently have a "Neutral" recommendation on Geron. We consider Geron to be a front-runner in the development of anti-telomerase inhibitors. Geron’s telomerase technology platform represents significant commercial opportunity. The successful development of products that target telomeres could very well change the treatment paradigm for several diseases including oncology and chronic degenerative diseases, all of which represent significant commercial potential.
While we are impressed with Geron’s technology platforms, we note that the company remains several years from achieving profitability given the absence of any marketed product in its portfolio and the early-stage nature of its pipeline.