Geron Will Re-initiate Clinical Trials (NASDAQ:GERN)
Geron Corporation (NASDAQ:GERN) today announced that they have reached an agreements with the Food and Drug Administration to re-initiate clinical trials for spinal cord injury. The company said that they plan to advance clinical development of their human embryonic stem cell (hESC)-based product, GRNOPC1 which will be used for the treatment of spinal cord injuries. The plan is to let Geron Corporation restart the Phase 1 clinical trial of GRNOPC1 in patients who are suffering from complete thoracic spinal cord injury and to support the future expansion of the clinical trial with patients who are suffering from cervical injuries.
Geron Corporation is one of the developers for the first-in-class biopharmaceuticals that is used for the treatment of cancer and chronic degenerative diseases like spinal cord injury, diabetes and heart failure. GRNOPC1 that is being developed by Geron Corporation is made for the treatment of spinal cord injury but Geron is also trying to explore the same drug candidate for other neurological diseases like multiple sclerosis, Alzheimer and heart stroke. The company has received recommendations from the Food and Drug Administration panel that the positive data from the clinical trials of GRNOPC1 can be used to support both release of clinical hold as well as the expansion of this drug candidate for the treatment of patients suffering from cervical injuries.
Geron Corporation expects that the data from this study will be able to re-initiate the clinical trial in the third quarter of 2010. Initially, Geron has been performing many preclinical studies to expand the GRNOPC1 program beyond spinal cord injuries and patients with thoracic injuries. In order to optimize the manufacturing and product release of GRNOPC1 the company has developed new candidate markers and assays. Data from the trials using new markers were submitted to the FDA for review.
