Geron: 'First in class' in stem cells

"Geron (NASDAQ: GERN) is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes," says Tom Bishop.

In his BI Research advisory he explains, "The company is also a, if not the, world leader in the development of human embryonic stem cell-based therapeutics." Here's his in-depth analysis of the company.

"The company is advancing an anti-cancer drug and a cancer vaccine that targets the enzyme telomerase through multiple clinical trials in different cancers. Geron has agreed with the FDA on a path that should enable it to begin clinical trials on patients with severed spinal cords in Q3 2010.

"Recently Geron announced the publication of preclinical data demonstrating that its telomerase inhibitor drug, imetelstat (GRN163L), inhibited telomerase activity and reduced tumor size in xenograft models of glioblastoma (a brain cancer), and inhibited the activity of glioblastoma stem cells in culture.

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" Thomas Okarma, Ph.D., M.D., Geron's president and chief executive officer says, 'The blood-brain tumor barrier limits the delivery of most therapeutic drugs to brain tumors, but these data show that imetelstat penetrates that barrier. We will further investigate imetelstat's anti-cancer stem cell potential clinically in our Phase II trials in breast and lung cancers, multiple myeloma and chronic leukemia that will begin later this year.'

" It is worth reminding you what is going on here. Telomerase is an enzyme that is found in cancer cells that are replicating out of control, but is not found in normal cells. So Geron’s imetelstat a 'telomerase inhibitor'), combined with a proprietary, patented '5 lipid chain' helps it slip through the cell barriers (that block other therapies) and basically lock up the telomerase, which breaks he cancer’s replication capability.

"The company has found that this technology works on a multitude of cancers in the lab and has progressed beyond Phase I for testing it on the four cancers noted above, which should enter Phase II trials later this year.

"The shares, which couldn’t seem to get any traction earlier, suddenly rose nearly 20% in short order in the days surrounding this press release.

"This is a little surprising since it was pre-clinical data, but the most important take away here is that no other cancer therapies have done a very good job of crossing the brain barrier and treating brain cancers so that capability is perhaps the key.

"Also Geron reported in early December on interim data from a Phase II trial of GRNVAC1, a dendritic cell vaccine targeting telomerase in patients with acute myelogenous leukemia (AML). The company announced that it had already met its end points of safety and tolerability.

"Most exciting to me was that one of the 20 patient’s WT-1 levels(a marker for cancer’s presence) went from positive to negative, indicating that the cancer was coming back and then after vaccinations with GRNVAC1 the patient went back into remission. The study will continue for another year.

"Geron is also working on the requested animal study for the FDA so that it can proceed into Phase I clinical trials (Phases I, II, III always mean the trials are in humans) with its GRNOPC1 human embryonic stem cell treatment for severed spinal cords in Q3.

"Recall that in animal studies it increased motor function in rats with severed spinal cords. After treatment the rats (the best animal model for simulating human response in this case, amazingly enough) were able to get around and bear weight on their limbs better than the control group and that the gap in the spinal cord filled in.

"So, overall, this is exciting stuff here. 2010 should be a very interesting yea. We continue to rate the stock a buy on price pullbacks below $6."