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1/23/09 World's first HESC-based therapy in man by Geron

Big News Release from Geron's Website:1/23/09 Geron Corporation (1) announced that:

the FDA has granted clearance of the company's Investigational New Drug (IND) application for the clinical trial of GRNOPC1 in patients with acute spinal cord injury. The clearance enables Geron to move forward with the world's first study of a human embryonic stem cell (hESC)-based therapy in man. Geron plans to initiate a Phase I multi-center trial that is designed to establish the safety of GRNOPC1 in patients with 'complete' American Spinal Injury Association (ASIA) grade A subacute thoracic spinal cord injuries.
Thomas Okarma, Ph.D., M.D., Geron's president and CEO stated that:
FDA's clearance of our GRNOPC1 IND is one of Geron's most significant accomplishments to date...This marks the beginning of what is potentially a new chapter in medical therapeutics - one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is 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.

A bit from Geron's extensive website info. (2):Geron has selected up to 7 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....Geron's H1 hESC master cell bank is fully qualified for human use and was shown to be karyotypically normal and free of measurable contaminants of human or animal origin.
Dr. Okarma will host a conference call and video Webcast presentation for investors and the media at 6:00 a.m. PST/9:00 a.m. EST today. Participants can access the conference call,the video Webcast presentation is also available-visit Geron's website for the link.
Peek at some recent FDA history (4/10/08) about Spinal Cord Injury GRNOPC1 Transplantation from Geron's powerpoint presentation about h-ESC's and therapeutic development.(3)
NYSTEM Ethics Committee meeting to be held January 26, 2006, the Meeting Agenda below , see their website.(4)
(1)http://www.geron.com/media/pressview.aspx?id=863 View Geron's Product Pipeline re: regenerative medicine and these glial cells at http://www.geron.com/patients/
(2)http://www.geron.com/GRNOPC1Clearance/grnopc1-backgrounder.pdf Excerpted points of interest:
Several additional steps need to be completed prior to initiation of each of the clinical trial sites. These steps include clinical protocol review and approval by the IRB (institutional review board) of each participating medical center.

(3)http://www.fda.gov/ohrms/dockets/ac/08/slides/2008-0471S1-4.ppt#1757,4,Spinal Cord Injury: GRNOPC1 Transplantation
(4) http://stemcell.ny.gov/ethics/ecm_1_26_2009.html
Dear Readers: please continue on your digital track and read more below.

More bits excerpted from Geron's info:

The sites are leading referral centers for neurotrauma with experienced, board-certified spine surgeons who will perform the GRNOPC1 injections. Each of the participating medical centers is affiliated with a qualified long-term rehabilitation center where the long-term assessment for safety and efficacy for each treated patient will take place using standard tests administered by trained rehabilitation specialists....

The production and commercialization of GRNOPC1 is protected by a portfolio of patent rights owned by or exclusively licensed to Geron... In Phase I, clinical trials are conducted with a small number of people to assess safety and to evaluate the pattern of drug distribution and metabolism within the body.

The ESSCB Ethics Committee 1/26/09 meeting agenda includes:Report on Funding Committee Activities,Program Update,Federal Developments,Committee Discussion: Respect for the Embryo, Science Museum Programs by Dr. Alan J. Friedman, Payment of Gamete Donors, Informed Consent: Review and Discussion of ISSCR and NAS Requirements and Consent Documents.

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