We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor.  We ask that you disable ad blocking while on Silicon Investor in the best interests of our community.  If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.
Biotech / Medical : Geron Corp. -- Ignore unavailable to you. Want to Upgrade?

To: FJB who wrote (3319)10/20/2011 11:54:32 AM
From: Savant1 Recommendation  Respond to of 3553
4 enrolled & probs>>
Geron Presents Clinical Data Update From GRNOPC1 Spinal Cord Injury Trial    MENLO PARK, Calif., Oct 20, 2011 (BUSINESS WIRE) -- Geron Corporation (GERN)  today announced two presentations on the company's ongoing Phase 1 clinical trial  of its human embryonic stem cell-based therapy, GRNOPC1, in patients with spinal  cord injury. Safety data were presented at the Pre-Conference Symposia of the  joint 2011 American Congress of Rehabilitation Medicine and American Society of  Neuro-Radiology Annual Meeting in Atlanta, GA. A second presentation was given at  the Working 2 Walk 2011 conference in Rockville, MD. The presentations were given  by Joseph Gold, Ph.D., Geron's Senior Director of Neurobiology and Stem Cell  Therapies and Linda Jones, P.T., M.S., Geron's Senior Clinical Trials Manager for  GRNOPC1.    "We are pleased to report that the lowest intended dose of GRNOPC1 has been  administered to four patients with complete thoracic spinal cord injuries," said  Stephen M. Kelsey, M.D., Geron's Head of Research & Development and Chief Medical  Officer. "To date, GRNOPC1 has been well tolerated with no serious adverse  events."    Phase 1 Clinical Trial Data    Data were presented on four patients with neurologically complete American Spinal  Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries,  who received GRNOPC1 at a dose of two million cells delivered by injection into  the lesion site using a syringe positioning device designed by Geron. GRNOPC1 was  administered between 7 and 14 days after injury. Low-dose tacrolimus was given  for temporary immune-suppression from the time of injection for 46 days, at which  point the dose was tapered and withdrawn completely at 60 days.    Endpoints of the trial are safety and evaluation of neurological function, using  standardized testing at specified timepoints to monitor sensory and lower  extremity motor function. The trial protocol also includes multiple MRI scans.  Initial follow-up of patients is one year. One patient in the trial has completed  the Day 365 follow-up visit. The most recent patient to be enrolled in the  clinical trial has completed the Day 30 follow-up. After one year the patients  enter a period of long-term follow-up that includes annual in-person visits for  the first five years and subsequent yearly check-ups via telephone for an  additional nine years.    Safety data to date from the trial has shown:    -- No surgical complications during or after the procedures.    -- No adverse events related to the injection procedures or to GRNOPC1.    -- A few mild adverse events related to tacrolimus.    -- No evidence of cavitation in the spinal cord at the injury sites on MRI.    -- No unexpected neurological changes.    -- No evidence of immune responses to GRNOPC1.    GRNOPC1 was delivered to four spinal cord injured patients at a dose of two  million cells without complications from either the cells or the surgical  procedure itself, and without any negative effects on the spinal cord or  neurological function of the patients to date. The only side-effects observed  were due to the immunosuppressive drug tacrolimus, which is administered for the  first two months after injection of GRNOPC1. Furthermore, there is no evidence to  date of immune rejection of GRNOPC1, an allogeneic cell therapy, including after  withdrawal of immunosuppressive drug.    About GRNOPC1    GRNOPC1 contains hESC-derived oligodendrocyte progenitor cells that have  demonstrated remyelinating, nerve growth stimulating and angiogenic properties  leading to restoration of function in rodent models of acute spinal cord injury.  Preclinical studies have shown that administration of GRNOPC1 significantly  improved locomotor activity and kinematic scores of rodents with spinal cord  injuries when injected seven days after the injury. Histological examination of  the injured spinal cords treated with GRNOPC1 showed improved axon survival and  extensive remyelination surrounding the rodent axons. For more information about  GRNOPC1, visit For further information about  the Phase 1 clinical trial, including location of clinical sites, visit    About Spinal Cord Injury    Spinal cord injury is caused by trauma to the spinal cord that results in a loss  of motor control, sensatory perception, bowel and bladder control, and numerous  other voluntary or involuntary body functions. A traumatic blow to the spine can  fracture or dislocate vertebrae that may cause bone fragments or disc material to  injure the nerve fibers and damage the oligodendrocyte cells that insulate the  nerve fibers in the spinal cord. Most human spinal cord injuries are contusions  (bruises) rather than lacerations to the cord. Every year approximately 12,000  people in the U.S. sustain spinal cord injuries. There are currently no approved  therapies for the treatment of spinal cord injury.    About Geron    Geron is developing first-in-class biopharmaceuticals for the treatment of cancer  and chronic degenerative diseases. The company is advancing anti-cancer therapies  through multiple Phase 2 clinical trials in different cancers by targeting the  enzyme telomerase and with a compound designed to penetrate the blood-brain  barrier. The company is developing cell therapies from differentiated human  embryonic stem cells for a range of indications, with the first product in a  Phase 1 clinical trial for spinal cord injury. For more information, visit    This news release may contain forward-looking statements made pursuant to the  "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995.  Investors are cautioned that statements in this press release regarding potential  applications of Geron's human embryonic stem cell technologies and GRNOPC1  constitute forward-looking statements that involve risks and uncertainties,  including, without limitation, risks inherent in the development and  commercialization of potential products, uncertainty of clinical trial results or  regulatory approvals or clearances, need for future capital, dependence upon  collaborators and protection of our intellectual property rights. Actual results  may differ materially from the results anticipated in these forward-looking  statements. Additional information on potential factors that could affect our  results and other risks and uncertainties are detailed from time to time in  Geron's periodic reports, filed with the Securities and Exchange Commission,  including the quarterly report on Form 10-Q for the quarter ended June 30, 2011.