Geron to Halt Spinal Cord Injury Trial and Focus on Oncology Programs
Geron Corporation (Nasdaq: GERN) today announced that, effective immediately, the Company will halt its spinal cord injury clinical trial and focus on its first-in-class oncology programs. As a consequence, the Company will discontinue further development of its stem cell programs and is seeking partners for these novel assets.
Shepherd Center was the first site to enroll a patient in Geron's stem cell trial for people with spinal cord injury, which was the first government-approved attempt to test a therapy from human embryonic stem cells. Two patients were enrolled at Shepherd Center for treatment, the first in October 2010.
“This trial was a difficult but important one and will help future cell transplantation clinical trials move forward in important ways,” said Shepherd Center's Dr. Keith Tansey in a feature by the Washington Post. Dr. Tansey is director of spinal cord injury research and a member of Shepherd's investigative team for the Geron clinical trial.
"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 Geron's Chief Executive Officer, John A. Scarlett, M.D. "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, Geron's lead telomerase inhibitor, is currently being evaluated in four Phase 2 clinical oncology studies for the following indications: non-small cell lung cancer, breast cancer, essential thrombocythemia and multiple myeloma. Geron expects top-line data from these trials to be available before the end of the fourth quarter of 2012. GRN1005, an LRP-directed peptide-drug conjugate, is entering two Phase 2 clinical trials this year, one for brain metastases arising from non-small cell lung cancer and the other for brain metastases from breast cancer. Geron expects top-line data from these trials to be available before the end of the second quarter of 2013.
The decision to narrow Geron's technology and therapeutic focus was made after a strategic review of the costs, value inflection timelines and clinical, manufacturing and regulatory complexities associated with the Company's research and clinical-stage assets. With this decision, Geron is eliminating 66 full-time positions, representing 38% of its workforce. As a result, the Company expects one-time cash expenditures of approximately $5 million in the fourth quarter of 2011 and approximately $3 million in the first half of 2012. Geron expects to end 2011 with cash and investments in excess of $150 million.
Geron is seeking partners with the technical and financial resources to enable further development of its stem cell programs. "Our employees, collaborators and shareholders can be proud of the pioneering role they have played to advance our stem cell technology into the clinic," said Dr. Scarlett. "Stem cells continue to hold great medical promise. We believe that our leadership role in the field and the quality of our stem cell assets-which are widely recognized as being 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." In order to facilitate transfer of these programs to partners, Geron will retain a core group of employees from its stem cell operations through the end of the second quarter of 2012.
Geron plans to close the GRNOPC1 trial for spinal cord injury to further enrollment, although it will continue to follow all enrolled patients, accruing data and updating FDA and the medical community on their progress. In this trial, GRNOPC1 has been well tolerated with no serious adverse events.
Shepherd Center, located in Atlanta, Georgia, is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis, spine and chronic pain, and other neurological conditions. Founded in 1975, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. In its more than four decades, Shepherd Center has grown from a six-bed rehabilitation unit to a world-renowned, 152-bed hospital that treats more than 740 inpatients, nearly 280 day program patients and more than 7,100 outpatients each year in more than 46,000 visits.