Posted by Jef Akst "The Scientist"
20th August 2009
The Geron Corporation announced on Tuesday (August 18) that its stem cell study of spinal cord injury -- the first-ever clinical trial using human embryonic stem cell (hESC)-based therapy -- has been put on hold by the US Food and Drug Administration (FDA) pending the review of some newly submitted animal data.
The study, which received clearance on January 23 of this year after a 7 month hold by the FDA, aims to treat patients with severe spinal cord injury by injecting hESC-derived progenitors of neural support tissue into the spinal cord. So far, no patients have received the experimental therapy.
Since Geron submitted its Investigational New Drug application to the FDA in March, 2008, the company has continued to pursue animal studies on the therapy (referred to as GRNOPC1), particularly with regard to increasing dosages and applying the therapy to other neurodegenerative diseases. This week's hold from the FDA came shortly after submitting the data from some of this work.
Holds on clinical trials are not all that uncommon, especially in cases of novel treatments such as this one, points out The Niche, Nature's stem cell blog: A similar hold was issued by the FDA in February, for example, for a NeuralStem trial on Lou Gehrig's disease. However, given the timing of this hold, it is likely that safety concerns arising from the higher-dosage experiments prompted the move by the FDA, analyst Joseph Pantginis told the New York Times.
Geron didn't reply to a call requesting comment yesterday. The company stated in a press release that it "will work closely with the FDA to facilitate their review of the new data and to release the clinical hold."
20th August 2009
The Geron Corporation announced on Tuesday (August 18) that its stem cell study of spinal cord injury -- the first-ever clinical trial using human embryonic stem cell (hESC)-based therapy -- has been put on hold by the US Food and Drug Administration (FDA) pending the review of some newly submitted animal data.
The study, which received clearance on January 23 of this year after a 7 month hold by the FDA, aims to treat patients with severe spinal cord injury by injecting hESC-derived progenitors of neural support tissue into the spinal cord. So far, no patients have received the experimental therapy.
Since Geron submitted its Investigational New Drug application to the FDA in March, 2008, the company has continued to pursue animal studies on the therapy (referred to as GRNOPC1), particularly with regard to increasing dosages and applying the therapy to other neurodegenerative diseases. This week's hold from the FDA came shortly after submitting the data from some of this work.
Holds on clinical trials are not all that uncommon, especially in cases of novel treatments such as this one, points out The Niche, Nature's stem cell blog: A similar hold was issued by the FDA in February, for example, for a NeuralStem trial on Lou Gehrig's disease. However, given the timing of this hold, it is likely that safety concerns arising from the higher-dosage experiments prompted the move by the FDA, analyst Joseph Pantginis told the New York Times.
Geron didn't reply to a call requesting comment yesterday. The company stated in a press release that it "will work closely with the FDA to facilitate their review of the new data and to release the clinical hold."