Dallas, Texas 12/12/2013 (FINANCIALSTRENDS) – Geron Corporation (NASDAQ:GERN) is a clinical-stage bio- pharma company that is developing its first-in-class telomerase-inhibitor named imetelstat. This is used in the treatment of hematologic-myeloid malignancies. Geron Corporation (NASDAQ:GERN) is focused on developing imetelstat in the treatment of 1 or more hematologic-myeloid malignancies, like M, MDS or AML. In 2013 October Geron Corporation announced closing of its transaction to divest its stem cell assets.
A new outlook
Some time ago, Geron Corporation (NASDAQ:GERN) underwent a management change and since then a lot of things about the company have changed. The company has become more business savvy and there is a noticeable change of direction as well and all of this has been attributed to the new management team. In addition to this very evident change the company has also been going full-steam ahead with its Imetelstat research. Data on this product candidate was presented at the American Society of Hematology (ASH) that was held on Monday post the bell. The data shows that this drug has the capacity to send some myelofibrosis patients into total remission. This is one thing that Jakafi, Incyte’s myelofibrosis drug cannot do. This drug is the only one which has FDA approval in the treatment of this disease.
The data that was presented at the ASH meeting suggests that the drug is noticeably improving clinical-symptoms apart from the ones that are seen under the microscope. Despite all the good data, investors went whole-hog with selling the company’s shares. This is partly because the clinical- trial had not been designed specifically as a pivotal trial. This is something that is required to support an imetelstat approval from the Food Drug Administration. The only recourse for the company to confirm the findings of the study will be to run a much larger trial.
The larger issue on hand, is the safety of the drugs. There is some indication that the WBC and platelet count is reducing especially when imetelstat is dosed more frequently. This might be something manageable. However, the current study had only 33 patients and it is not possible to pinpoint the exact level of the risk with that small a patient count.
The fact is that Myelofibrosis has the potential to transition into leukemia, and patients can die from it. This makes it important for the Food Drug Administration to be tolerant of the manageable side effects. It still remains to be seen how this drug competes with the drugs that Incyte and Gilead have in the market.
A long way to go
In line with this thought, the company’s Chief Executive Officer said at the ASH that the plan is to eventually conduct a PhaseII, multi-center study in 2014H1. This could well take 6 months to reach completion. If it is successful, Phase III will follow which will turn out to be a 12 month deal. The FDA procedures take another 6-12 months and if imetelstat does see the light of day, it will not be before a 3 year time frame. Simply put, Geron Corporation (NASDAQ:GERN) will have to maintain that kind of holding power and work out all the details in such a manner that the medication actually works.