Geron Initiates Clinical Trial of Telomerase Inhibitor Drug in Patients with Multiple Myeloma

MENLO PARK, Calif.--(BUSINESS WIRE)--Geron Corporation (Nasdaq: GERN) today announced that it enrolled its first patient in a clinical trial of GRN163L in multiple myeloma. The trial is the fourth underway involving Geron’s novel inhibitor of telomerase, an enzyme that is expressed in all major types of cancer cells.

“We’re pleased to have participated in the design of this study”

The primary objective of the Phase I/II study is to determine the safety and maximum tolerated dose (MTD) of GRN163L when administered intravenously in patients with multiple myeloma who have failed at least two courses of standard chemotherapy. In addition, researchers will perform correlative laboratory studies on primary patient samples to characterize the effects of GRN163L on myeloma cancer cells.

“We’re pleased to have participated in the design of this study,” said Asher Chanan-Kahn, M.D., an attending physician with Roswell Park Cancer Institute’s Department of Medicine and the lead investigator of the trial. “Despite recent advances in the treatment of patients with multiple myeloma, the need for curative therapy still exists. GRN163L is intriguing because of its novel mechanism of action and demonstrated preclinical activity as a single agent in animal models. This trial should help us to understand the role that telomerase inhibition could play in multiple myeloma treatment regimens.”

Alan Colowick, M.D., Geron’s president, oncology, said, “This study is a critical step in the development of GRN163L. It will enable us to further characterize the drug’s safety profile while investigating the impact of GRN163L on multiple myeloma. Positive findings from this study could lead to a pathway for the use of GRN163L as a single agent for patients with this disease. Furthermore, we plan to initiate combination studies next year for which we will call on our early dosing experience from the current study.”

GRN163L has been investigated broadly in preclinical models of multiple myeloma. It has been shown in animal models to have single-agent activity as well as additive activity to bortezomib, a widely used drug for patients with multiple myeloma. Preclinical studies utilizing both myeloma cell lines and samples from myeloma patients have demonstrated activity of GRN163L against subpopulations of myeloma cells enriched for stem cell markers. It is believed that cancer stem cells may be responsible for relapses that are observed after patients have an initial response to cancer therapy, and that cancer stem cells are particularly resistant to standard therapies.

About Multiple Myeloma

Multiple myeloma is a malignancy of mature plasma cells. These are cells of the immune system that produce antibodies. Multiple myeloma usually arises in the bone marrow and is characterized by interference with production of blood cells, destructive lesions of bone that can cause debilitating fractures, and excessive production of specific antibody molecules. These abnormal molecules may interfere with the function of many tissues and organs in addition to bone marrow, including the kidneys. Multiple myeloma is the second most common hematological malignancy of adults, accounting for 10% of the diagnoses of hematological malignancies in the United States and 2% of cancer deaths.

The American Cancer Society has projected that 19,900 new cases and 10,790 deaths due to multiple myeloma will have occurred in the United States by the end of this year. Although the number of treatment options for multiple myeloma has increased in recent years, the vast majority of multiple myeloma patients progress or recur after initial therapy and ultimately die from the disease.

About Telomerase and GRN163L

Telomerase is a broadly applicable and critical tumor target. The enzyme is expressed in a broad array of malignant tumors, is essential for malignant cell growth and is absent or expressed transiently at low levels in most normal adult tissues.

GRN163L is a short chain oligonucleotide that is unique in its resistance to nuclease digestion in blood and tissues and in its very high affinity and specificity for telomerase. The molecule has superior cellular and tissue penetration properties due to its proprietary manufacturing chemistry and its 5’ lipid chain.

GRN163L has been demonstrated to have anti-tumor effects in a wide range of hematological and solid tumor models and appears to be unique in its observed effects on cancer stem cells: the rare, chemotherapy-resistant cancer cells that cause cancer recurrence.

Geron is developing first-in-class biopharmaceuticals for the treatment of cancer and chronic degenerative diseases, including spinal cord injury, heart failure and diabetes. The company is advancing an anti-cancer drug and a cancer vaccine that target the enzyme telomerase through multiple clinical trials. Geron is also the world leader in the development of human embryonic stem cell-based therapeutics, with its spinal cord injury treatment anticipated to be the first product to enter clinical development. For more information, visit www.geron.com.

This news release may contain forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this news release regarding potential applications of GRN163L and Geron’s telomerase technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators, and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Geron’s periodic reports, including the quarterly report on Form 10-Q for the quarter ended September 30, 2007.