Geron Corporation (GERN) recently announced that it has enrolled the first patient in its phase I clinical study that is being conducted with GRNOPC1. GRNOPC1, a human embryonic stem cell (hESC)-based product, is being developed for the treatment of spinal cord injury.

Stem cells generally are self-renewing primitive cells that can develop into functional, differentiated cells. Geron is looking to use its human embryonic stem cell technology for the development of transplantation therapies. The company intends to provide standard starting material for the manufacture of therapeutic cells and facilitate pharmaceutical research and development practices by providing cells for disease models and screening, and for assigning function to newly discovered genes.

GRNOPC1 is Geron’s lead candidate in the hESC program. The safety and tolerability of GRNOPC1 in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A thoracic spinal cord injuries will be evaluated in the recently initiated phase I study.

The commencement of the phase I study with GRNOPC1 is a major milestone for Geron. GRNPOC1 had previously been placed under clinical hold for several months by the US Food and Drug Administration (FDA) based on preclinical data which showed a higher frequency of cysts in animals treated with GRNOPC1.

However, the clinical hold was lifted by the FDA earlier this year, thereby paving the way for the company to move ahead with human testing.

While Geron intends to develop GRNOPC1 initially for spinal cord injury, the company has plans to study the candidate for other neurological diseases, including multiple sclerosis, Canavan disease and Alzheimer’s disease.

Geron has another candidate, GRNCM1, in its hESC program. GRNCM1 is being studied for the treatment of patients with myocardial disease.

Neutral on Geron

We consider Geron to be a front-runner in the development of anti-telomerase inhibitors. Geron’s telomerase technology platform represents significant commercial opportunity. The successful development of products that target telomeres could very well change the treatment paradigm for several diseases including oncology and chronic degenerative diseases.

While we are impressed with Geron’s technology platforms, we note that the company remains several years from achieving profitability given the lack of any marketed product in its portfolio and the early stage nature of its pipeline.

 
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