Geron Gets Green Light To Test Embryonic Stem Cell Therapy On Humans
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
FDA lifted its clinical hold on Geron’s human embryonic stem cell therapy for spinal-cord injury, granting the company’s IND application and creating a hallelujah moment for frustrated believers in embryonic stem cell medicine.
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Geron stem cell therapy gets new clinical hold
FDA put a second clinical hold on Geron's IND for OPC1, a human embryonic cell therapy for spinal cord injury, the company reports Aug. 18. The agency cited review of new nonclinical animal study data the company generated and submitted during its ongoing research as the reason for the hold. Geron got the go-ahead from FDA in January to conduct a Phase I study in eight to 10 patients with functionally complete thoracic spinal cord injuries, lifting a clinical hold imposed in May 2008 (1Pharmaceutical Approvals Monthly Feb. 28, 2009). FDA had asked for additional evidence that the injected glial cells do not migrate abnormally far from the injected region and for assurances that MRI imaging of patients in follow-up would not be obstructed by metal rods inserted to stabilize the spine. That unobstructed imaging requirement could be what has held up enrollment in the study, which had aimed to treat the first patient in the first half of 2009, and Geron may use the hiatus imposed by the hold to negotiate with the agency for an amendment, Lazard Capital Markets analyst Joel Sendek said in a same-day note. Sendek now predicts the first patient will be treated early in 2010, with data reported in mid-2011 based on an enrollment period of one year
FDA Puts Geron’s Stem-Cell Drug On Hold
Agency provides verbal notice; “on point” IND philosophies apparently not aligned.
Merck Enters Cancer Vaccine Collaboration With Geron
Merck acquires expertise in telomerase-targeting cancer vaccines in a deal with Menlo Park, Calif.-based Geron. Under the agreement, Geron will receive an upfront payment, milestone payments and royalties. Merck also gains the option to partner on Geron’s investigational prostate cancer vaccine.