November 3, 2014
By Jessica Wilson, BioSpace.com Breaking News Staff
Geron Corporation today announced the U.S. Food and Drug Administration (FDA) has removed the full clinical hold on the company’s investigational new drug (IND) application for imetelstat, which means multi-center Phase II clinical trials on the drug can begin in 2015.
In the wake of this news, share prices of Geron shot up more than 30 percent in morning trading
Menlo Park, Calif.-based Geron is a clinical stage biopharmaceutical company developing imetelstat, a first-in-class telomerase inhibitor, for the treatment of high-risk myeloid malignancies, such as myelofibrosis, a bone marrow disorder that disrupts the body’s normal production of blood cells.
According to one author on the financial web site Seeking Alpha, in March of this year, the FDA placed a hold on Geron’s clinical trials testing imetelstat for the treatment of thrombocythemia (ET), polycythemia vera (PV) and multiple myeloma trials “due to persistent low grade liver functionality test (LFT) abnormalities observed with chronic Imetelstat exposure.”
At the same time, “The FDA placed a partial clinical hold on the Mayo sponsored myelofibrosis Imetelstat study, allowing those receiving benefit to remain on the drug but preventing other patients from enrolling.” The FDA mandated that Geron and the Mayo Clinic demonstrate that the abnormalities in the LFTs were either reversible or not problematic after patients discontinued use of imetelstat.
The FDA removed the partial hold on the Mayo clinic study in June 2014, indicating that the full hold would likely be removed. In Geron’s announcement today, the company explains that the “FDA stated that Geron‘s proposed clinical development plan for imetelstat that is focused on high-risk myeloid malignancies, such as myelofibrosis (MF), is acceptable.” In addition, “the FDA acknowledged that the company does not intend to conduct further studies in, or develop imetelstat for, the treatment of essential thrombocythemia (ET) or polycythemia vera.” According to Geron, this is “consistent” with the company’s original plan, released in April 2013.
As part of Geron’s response to the FDA’s mandate, the company collected clinical follow-up information from patients who participated in Phase II trials for the treatment of ET and Multiple Myeloma (MM). In the ET study, 14 of the 18 patients saw their LFT abnormalities resolve and three of the remaining patients showed improvement in their LFTs. In the MM trial, all nine of the patients experienced resolution of their abnormal LFTs. No other liver-related adverse events were reported for patients in either study during their follow-ups.
