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Geron announces end of stem cell programs
MENLO PARK, Calif.--In a surprising move for the industry, Geron Coproration, which develops first-in-class biopharmaceuticals for cancer and chronic degenerative diseases, has announced that effective immediately, it will be halting its stem cell programs. Further development of the programs will be discontinued, and the company will instead turn its focus towards its first-in-class oncology programs.
"I deeply believe in the promise of stem cells," John A. Scarlett, M.D., CEO of Geron, said in an interview with Investor Stemcell. "I don't think that promise is in any way, shape or form changed by what we're doing."
Geron has featured as one of the main players in the field of stem cell research, having helped to fund the initial derivation of human embryonic stem cells at the University of Wisconsin in the 1990s and being responsible for beginning the first clinical trial, in 2010, of an embryonic stem cell-derived therapy.
The divestiture of the stem cell program will cut 66 full- time positions from Geron's work force, a 38 percent reduction. The decision was not made due to trial results but as a way for the company to conserve resources after a review of its research and clinical-stage assets. Geron expects one-time cash expenditures as a result of this decision of approximately $5 million in Q4 2011 and approximately $3 million in the first half of 2012, and expects to end 2011 with cash and investments in excess of $150 million.
"In the current environment of capital scarcity and uncertain economic conditions, we intend to focus our resources on advancing our Phase 2 clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and have important clinical development milestones occurring over the next 20 months," said Scarlett. "By narrowing our focus to the oncology therapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points for shareholders without the necessity of raising additional capital. This would not be possible if we continue to fund the stem cell programs at the current levels."
Imetelstat is a telomerase inhibitor currently undergoing four Phase II clinical oncology studies for different indications, including breast cancer, non-small cell lung cancer, multiple myeloma and essential thromocythemia. GRN1005 is an LRP-directed peptide-drug conjugate and is entering a pair of Phase II clinical trials this year, one for brain metastases arising from breast cancer and one for brain metastases from non-small cell lung cancer. Geron expects data from the trials to be available before the end of Q4 2012 and Q2 2013 respectively.
Geron is in the process of looking for partners with the necessary resources and experience to pick up and further develop its stem cell programs. The company currently has nine stem cell lines, as well as five hESC-derived product candidates in its stem cell program, with indications such as spinal cord injury, heart disease, type 1 diabetes, osteoarthritis, osteoporosis, ADME drug screening, cancer immunotherapy and immune rejection. GRNOPC1, its spinal cord injury product, is currently in a Phase I trial, which will be closed to further enrollment. Geron intends to follow all enrolled patients to collect data and keep the U.S. Food and Drug Administration and the medical community updated on their progress. So far, GRNOPC1 has been well tolerated with no serious adverse events.
SOURCE: Geron press release