Geron plans to initiate a Phase I multi-center trial that is designed to assess the safety and tolerability of GRNOPC1 in patients with "complete" American Spinal Injury Association (ASIA) Impairment Scale grade A subacute thoracic spinal cord injuries.
Patients who will be eligible for the Phase I trial must have documented evidence of functionally complete spinal cord injury with a neurological level of T3 to T10 spinal segments and agree to have GRNOPC1 injected into the lesion sites between seven and 14 days after injury.
The Phase I trial of GRNOPC1 has not yet been initiated and therefore enrollment of potential patients has not begun. Please also be advised that GRNOPC1 must be injected within 7 to 14 days following injury, so the only patients who will potentially be eligible to participate are patients injured after the trial begins.
Geron has selected seven U.S. medical centers as candidates to participate in this study and in planned protocol extensions. The sites will be identified as they come online and are ready to enroll subjects into the study.
Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy, such as improved neuromuscular control or sensation in the trunk or lower extremities. Once safety in this patient population has been established and the FDA reviews clinical data in conjunction with additional data from ongoing animal studies, Geron plans to seek FDA approval to extend the study to increase the dose of GRNOPC1, enroll subjects with complete cervical injuries and expand the trial to include patients with severe incomplete (ASIA Impairment Scale grade B or C) injuries to enable access to the therapy for as broad a population of severe spinal cord-injured patients as is medically appropriate.
If you would like more information about GRNOPC1, including the full press release and background information, click here.
We do not maintain a mailing list for distribution of information. If you would like to join our email distribution list for press releases, which will inform you about significant company developments, please send your name and email address to Geron at info@geron.com.
