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UPDATE 2-Geron, FDA agree on spinal injury drug trial

Sat Oct 31, 2009 12:11am IST
 
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* Says reached agreement with FDA

* Expects to re-initiate early-stage study in Q3 2010

* Shares up as much as 12 pct (Adds analyst comments, details, updates share movement)

Oct 30 (Reuters) - Stem cell research company Geron Corp (GERN.O: Quote, Profile, Research) 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.  Continued...

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