MENLO PARK, Calif.--In a surprising move for the industry, Geron Coproration, which developsfirst-in-class biopharmaceuticals for cancer and chronic degenerativediseases, has announced that effective immediately, it will be haltingits stem cell programs. Further development of the programs will bediscontinued, and the company will instead turn its focus towards itsfirst-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'tthink that promise is in any way, shape or form changed by what we'redoing."
Geron has featured as one of the main players in the field of stem cellresearch, having helped to fund the initial derivation of humanembryonic stem cells at the University of Wisconsin in the 1990s andbeing 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 positionsfrom Geron's work force, a 38 percent reduction. The decision was notmade due to trial results but as a way for the company to conserveresources 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 investmentsin excess of $150 million.
"In the current environment of capital scarcity and uncertain economicconditions, we intend to focus our resources on advancing our Phase 2clinical trials of imetelstat and GRN1005. These two novel and promising oncology drug candidates target major unmet medical needs and haveimportant clinical development milestones occurring over the next 20months," said Scarlett. "By narrowing our focus to the oncologytherapeutic area, we anticipate having sufficient financial resources to reach these important near-term value inflection points forshareholders without the necessity of raising additional capital. Thiswould not be possible if we continue to fund the stem cell programs atthe current levels."
Imetelstat is a telomerase inhibitor currently undergoing four Phase II clinicaloncology studies for different indications, including breast cancer,non-small cell lung cancer, multiple myeloma and essentialthromocythemia. GRN1005 is an LRP-directed peptide-drug conjugate and is entering a pair of Phase II clinical trials this year, one for brainmetastases arising from breast cancer and one for brain metastases fromnon-small cell lung cancer. Geron expects data from the trials to beavailable 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 ninestem cell lines, as well as five hESC-derived product candidates in itsstem cell program, with indications such as spinal cord injury, heartdisease, type 1 diabetes, osteoarthritis, osteoporosis, ADME drugscreening, cancer immunotherapy and immune rejection. GRNOPC1, itsspinal cord injury product, is currently in a Phase I trial, which willbe closed to further enrollment. Geron intends to follow all enrolledpatients 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.
"Our employees, collaborators and shareholders can be proud of thepioneering role they have played to advance our stem cell technologyinto the clinic," said Scarlett. "Stem cells continue to hold greatmedical promise. We believe that our leadership role in the field andthe quality of our stem cell assets--which are widely recognized asbeing among the most innovative, comprehensive and advanced cell therapy programs in the world--will be an important point of differentiation in our discussions to partner these assets."
SOURCE: Geron press release
