The Burrill Report


Geron cut short a mid-stage trial of its experimental breast cancer drug imetelstat and said it would likely scratch plans to pursue late-stage testing of the drug in lung cancer as after worries arose about the drug’s safety and efficacy in a breast cancer trial.

Stem cell therapy, once at the heart of the company’s portfolio, was sidelined in November 2012 when the biotech elected to focus on cancer therapeutics instead citing capital constraints and the belief that it could get to market faster with its cancer therapies.

Now, safety concerns that have surfaced in its trial of imetelstat for metastatic HER2-negative breast cancer patients have caused it to halt that trial, while what it calls “a modest trend of efficacy” in advanced non-small cell lung cancer make it “doubtful” the company will move ahead with late-stage testing in that indication too.

In the breast cancer trial, Geron was comparing imetelstat in combination with the chemotherapy paclitaxel to paclitaxel alone. But when a review conducted by its Internal Safety Monitoring Committee showed a greater number of deaths and cases of patients quitting paclitaxel in the imetelstat arm compared to the control arm, Geron decided to shut the study down. The analysis showed a median progression-free survival period of 6.2 months for patients receiving treatment with imetelstat in combination with paclitaxel, compared to 8 months for patients receiving paclitaxel alone.

Data from a separate lung cancer trial suggested “a modest but not statistically significant trend in (progression-free survival) in favor of the imetelstat arm,” says the company.

Geron ended the second quarter of 2012 with $122 million in cash and investments, with which it will continue imetelstat development. Because both the breast and lung cancer trials have been winding down, the effect on the company’s research and development spending and burn rate is likely to be small, Geron CEO and president John Scarlett told analysts on a September 10 call about the trials.

Investors pummeled Geron’s shares in unusually large trading volume September 10, sending it down 126 percent to close at $1.28 per share from a September 7 close of $2.90 per share.

Geron says it is already looking ahead to trials of the drug for essential thrombocythemia and multiple myeloma. It expects to releases data from those trials in the fourth quarter of this year. It also plans to continue developing GRN1005, its peptide-drug conjugate designed to transport the chemotherapeutic paclitaxel across the blood-brain barrier.


September 14, 2012
http://www.burrillreport.com/article-geron%e2%80%99s_course_correction_hits_rocky_road.html