Geron, FDA agree on spinal injury drug trial

Stem cell research company Geron Corp said it reached an agreement with U.S. health regulators which may enable it to restart the early stage trials of its cell therapy to treat complete thoracic spinal cord injury.

In August, the U.S. Food and Drug Administration (FDA) placed a clinical hold on Geron's investigational new drug application after some of the animals developed cysts in the injury site.

While the early stage trial still remains on clinical hold, a recent agreement with the FDA outlines what is necessary to move the spinal cord injury program forward, Merriman Curhan Ford analyst Joe Pantginis said in a note to clients.

Geron, which expects to re-initiate the early stage trial in the third quarter of 2010, said the FDA has advised that positive data from an ongoing preclinical study using its product can be used to support both release of the clinical hold and the drug's expansion to cervical patients.

However, analyst Pantginis said, "A great amount of work still needs to be done before any patient is ultimately enrolled into the study."

Currently Geron is developing three different drugs in the field of oncology, including cancer vaccine Grnvac1, which is in a mid-stage trial, and cancer drug Grn163l, which is in an early-stage trial.

"While volatility is still expected from the stem cell platform at Geron, we believe the increased visibility and data flow from the telomerase program (Grn163l) should drive the stock going forward," Pantginis said.

Investors are expecting Geron to report Grn163l's safety and dosing data at a Nov. 15 conference.

Shares of the company, which reported narrower-than-expected quarterly loss on Thursday, touched a high of $6.49, before paring some gains to trade up 5 percent at $6.07 Friday afternoon on Nasdaq.

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