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Geron Corporation (GERN) up 36% on news of FDA go-ahead

Today's Financial News - Posted January 24, 2009

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One of our top biotech picks, Geron Corporation, is basking in the glory of FDA clearance to begin trials of its human embryonic stem cell-based therapy for patients with acute spinal cord injury.

By Laura Cadden, TodaysFinancialNews.com

Baltimore (TFN): This summer, new sufferers of acute spinal cord injuries may have a greater chance for recovery than their predecessors.

The U.S. Food and Drug Administration (FDA) has given approval for a safety trial of the first ever human embryonic stem cell (hESC)-based therapy, GRNOPC1, to treat recently injured paraplegics.

The maker of GRNOPC1, Geron Corporation (NASDAQ:GERN), saw its share price bolt up by 36.08% Friday on the electrifying news.

“A new chapter in medical therapeutics…”

For the Phase I trial, Geron hopes to inject up to 10 patients at seven potential medical facilities around the U.S. (two are located here in Baltimore, Maryland Shock Trauma Center and Kernan Hospital).

Eligible patients must have documented “complete” subacute thoracic spinal cord injuries (lower body paralysis) with specific neurological levels of T3 to T10 spinal segments. And the living cells in GRNOPC1 must be injected into the patient’s lesion site within seven to 14 days after the injury occurs.

“This is the dawn of basic research being translated into human clinical trials for people living with spinal cord injury. We are hopeful that what is learned from the results will enable us to move forward with therapies for people living with spinal cord injuries.” - Peter T. Wilderotter, president and CEO of the Christopher & Dana Reeve Foundation

Though the main focus of this trial is safety, the researchers will be monitoring for any and all signs of improved sensation and neuromuscular control.

The company hopes to move forward as soon as possible with testing increased doses and expanding the patient base to include subjects with spinal cord injuries of varying severity.

“This marks the beginning of what is potentially a new chapter in medical therapeutics – one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells. The ultimate goal for the use of GRNOPC1 is to achieve restoration of spinal cord function…” — Geron president president and CEO, Thomas Okarma, Ph.D., M.D.

Read the company’s full press release here: http://www.geron.com/investors/factsheet/pressview.aspx?id=863

And that isn’t all that’s going on at Geron…

Geron’s scientists are using stem cell-oriented technology to create telemerase-based treatments to fight cancer.

I began following this company back in November because of its work on a cancer vaccine. Read the full article, “The 3 Hottest Stem Cell Stocks Under $5″,  here: http://www.todaysfinancialnews.com/us-stocks-and-markets/the-3-hottest-stem-cell-stocks-under-5-5756.html

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In December, the company announced that an interim analysis of its GRN163L Phase I clinical trials for the treatment of patients with relapsed and refractory multiple myeloma.

It revealed that two patients in the study showed a tumor fraction decrease by 78% and 48% respectively. In addition, telomerase activity in the myeloma stem cell-containing fraction of the patients’ bone marrow dropped by 33% and 63%, respectively. Read more details in my article, “Four Biotechs Set To Soar”, here: http://www.todaysfinancialnews.com/investment-strategies/four-biotechs-set-to-soar-7090.html

TFN readers who acted on my recommendation in that article and bought shares of Geron on January 12 at the entry price of $4.83 are up 46.79% today!

Patently ambitious

It was funding from Geron that enabled researchers at the University of Wisconsin to be the first to isolate embryonic stem cells in 1998.

The company possesses a number of important patents related to hESC manufacturing and the production of oligodendrocytes, neural cells, pancreatic islets and cariomyocytes.

Geron Corporation is, quite simply, a cornerstone in the next generation of medical treatment.

We are long on this stock.

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