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Geron Halts Human Stem Cell Research Trial

MENLO PARK, Calif., Nov. 15 (UPI) — A U.S. medical research company says it is halting medical research of a human embryonic stem cell therapy in patients with spinal cord injury.

The U.S. Food and Drug Administration granted approval to Geron Corp. last year to conduct the world’s first clinical trial of a human embryonic stem cell therapy in humans. The study, which is currently in Phase 1, is being ended for financial reasons, Geron said Monday.

The Menlo Park, Calif., company said it is eliminating 66 full-time positions and turning its focus back to cancer research. Geron said it 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,” Geron CEO Dr. John A. Scarlet said Monday. “Stem cells continue to hold great medical promise.

Geron said 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 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,” Scarlett said in a release. “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.

Imetelstat, Geron’s lead telomerase inhibitor, is currently being evaluated in four Phase 2 clinical oncology studies for lung cancer, breast cancer, essential thrombocythemia and multiple myeloma. 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 said it expects data from these trials to be available in 2013.



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