John Scarlett's plan to reinvent Geron as a developer of new and exciting cancer drugs has slammed into a fresh debacle. The CEO of the Menlo Park, CA-based biotech ($GERN) said that its mid-stage program for GRN1005--in-licensed from Angiochem--was being jettisoned after investigators failed to see the kind of patient response they were looking for in a Phase II study for brain cancer. And without a pause Scarlett announced that he was terminating 43 of the company's 107 staffers in a move to conserve cash.
Coming fast on the heels of a mid-stage failure for its other lead therapy, Geron shares crumbled yet again, sliding 21% even though the company touted new signs of hope for its troubled program for imetelstat.
Geron also washed its hands of its deal with Angiochem, a 2012 Fierce 15 company, citing an inability to enroll patients for the study. Whatever happened to the enrollment, though, the study's independent review process found no "intra-cranial responses" in the interim analysis, which was completed among the first 30 evaluable patients. Investigators had been studying the drug's impact on brain metastases which had developed in patients with non-small cell lung cancer.
The fresh Phase II fiasco came a little more than two months after Geron wrote off a pair of lead drug studies after tracking discouraging progression-free survival data in a Phase II study of imetelstat. At the time Geron's shares plunged on the news that it was halting a key breast cancer trial, shedding about half of their value as investors pondered the company's grim prospects. Big trouble developed for imetelstat, involved in a 166-patient study for metastatic HER2-negative breast cancer, as researchers found that the paclitaxel comparator arm was doing better than the lead drug.
But Geron never gave up on the drug, and now--in another twist--used the same release that announced the GRN105 failure and company restructuring, with the news that it had achieved positive data from a Phase II study of single agent imetelstat in patients with essential thrombocythemia and planned to present them at the American Society of Hematology annual meeting on Dec. 9.
"We are very disappointed that the results of the GRN1005 program fell short of our criteria for further development," said Scarlett. "Our immediate focus now is on the use of imetelstat in hematologic malignancies and solid tumors with short telomeres, which represent an opportunity for significant therapeutic advances and value creation."
The drama at Geron followed years of pioneering efforts on the embryonic stem cell front, which Scarlett shelved and recently out-licensed in exchange for a minority stake in a company helmed by ex-Geron CEO Thomas Okarma.
- here's the press release