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Biotech / Medical : Geron Corp. -- Ignore unavailable to you. Want to Upgrade?

To: JMarcus who wrote (2857)	9/26/2005 2:32:07 PM
From: JMarcus	Read Replies (1) \| Respond to of 3576

I just sent the following email message to Carl Harl, Science Writer for the SF Chronicle: ----------------------------- In your article today you stated about stem cell therapy for spinal cord injuries: <<When can they be tried in humans? The answer: No time soon.>> Your article's focus on the research by one company, StemCells, Inc. About its pipeline, I agree with you. They are a long ways away from human trials. But there is another celebrated stem cell company, Geron Corp, whose research is much further along. I attended their stockholders meeting on 5/6/05. At that event, the company's CEO, Thomas B. Okarma, stated that Geron anticipates starting Phase I trials, in humans, to treat spinal cord injury, sometime in mid-2006. If he keeps to that schedule, I'm sure you'll agree that human trials are much nearer that your article suggested. I took notes at the stockholders meeting on 5/6/05. Set forth below is what I recorded from what Dr. Okarma said on that occasion about the contemplated Phase I human trial. Also, you might want to listen to the investor presentation that his is giving today to see if he gives investors an update on the preparations for the trial. Here are my notes: <<Geron’s preclinical research using glial progenitor cells derived from hESCs has shown that the cells turn into oligodendrocytes when injected into a damaged spinal cord. The cells generate new nerve growth that can be measured. These glial progenitor cells cause exuberant mylenation (something lost in people with complete spinal cord lesions). This can be quantified both upstream and dowstream from point of injection. People with spinal cord injuries suffer extensive demylenation of spinal cord cells and this demylenation has a major impact upon their disability. Even partial remylenation is sufficient to restore transmission of electrical conduction up the spinal cord. That is the goal of the proposed Phase I trial, which Geron hopes to initiate in mid-2006. As of the date of the stockholders meeting, Geron was working on the protocol for the Phase I human trial. They contemplate taking people with complete thoracic lesions (paraplegics) and then injecting them with the glial progenitor cells within 6-10 days post injury (yes – for this proof-of-principal trial, they are not proposing to use patients whose injuries are older). There will be an escalating dose design. 3 months evaluation and 3 months follow-up. Immmune suppression with cyclosporine will be used on a temporary basis. After using cyclosporine on a temporary basis, they expect to be able to withdraw it without causing rejection of the injected glial progenitor cells.>> If you review GERN's 10Q report from last August, you will see no official guidance regarding the timing of the upcoming trial. I surmise that this is just a case of the company being more conservative about what they will put in writing (especially in a document filed with the SEC) than what they will say orally at investor presentations. Here is all that the 10Q says on the spinal cord injury trial: <<Our hESC therapy programs focus on treating injuries and degenerative diseases with cell therapies based on cells derived from hESCs. A core of knowledge of hESC biology, as well as a significant continuing effort in deriving, growing, maintaining, and differentiating hESCs, underlies all aspects of this group of programs. Many of our researchers are allocated to more than one hESC project, and the percentage allocations of time change as the resource needs of individual programs vary. In our hESC therapy programs, we have concentrated our resources on several specific cell types. We have developed proprietary methods to culture and scale up undifferentiated hESCs and differentiate them into therapeutically relevant cells. We are now testing six different therapeutic cell types in animal models of human disease. In four of these cell types, we have preliminary results suggesting efficacy as evidenced by functional improvements or engraftment of the cells in the treated animals. After completion of these studies, and assuming continued success, we expect to begin one or more Phase 1 clinical trials, most likely including one for the treatment of spinal cord injury. >> I have been a stockholder of the company off and on for half a dozen years or so. I have no other relationship with the company.