Geron (GERN) shares soared over 15% in pre-market trading Friday after the company announced that the U.S. Food and Drug Administration has lifted the clinical hold it had placed on the pharmaceutical company's new drug application. Geron can now proceed with a Phase I clinical trial of GRNOPC1 in patients with acute spinal cord injury.
Geron says the this will be the world's first clinical trial of a human embryonic stem cell (hESC)-based therapy in a human. The Phase I multi-center trial is designed to establish the safety of GRNOPC1 in patients with "complete" American Spinal Injury Association Impairment Scale grade A subacute thoracic spinal cord injuries.
"We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said the company's President and CEO Thomas Okarma. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged -- to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord."
The clinical hold was placed following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts within the injury site after being injected with GRNOPC1. In response, Geron developed new markers and assays as additional release specifications for GRNOPC1 and tested them. Results were submitted to the FDA to lift the clinical hold.
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