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Geron Corporation Announces Multiple Presentations on Its Telomerase Inhibitor Drug GRN163L at the AACR 2005 Annual Meeting

Posted on: Wednesday, 20 April 2005, 09:00 CDT

Geron Corporation (Nasdaq:GERN) announced the presentation of new data from preclinical studies of its telomerase inhibitor drug GRN163L at the American Association for Cancer Research (AACR) 2005 Annual Meeting in Anaheim, California. Reported were updates on various IND-enabling efficacy and safety studies, as well as new data on the combined use of GRN163L with VELCADE(R) in an animal model of human multiple myeloma. The data were described in six poster and oral presentations, three authored by Geron scientists alone and three in association with academic collaborators from Indiana University and Memorial Sloan Kettering Cancer Center. GRN163L is the company's lead anti-cancer compound.

Use of GRN163L in Combination Chemotherapy with VELCADE(R)

The new data on the effects of combination chemotherapy with GRN163L in multiple myeloma were derived from collaborative studies between Geron scientists and Dr. Malcolm Moore at the Memorial Sloan Kettering Cancer Center in New York. The results were presented by Robert Tressler, Ph.D., Geron's executive director of preclinical drug development, in an invited talk at the symposium "Telomeres and Telomerase in Cancer," and separately in greater detail at a poster session on "Senescence" by Server Ertam, a graduate student in Dr. Moore's laboratory. The studies were conducted in immune compromised mice that were injected subcutaneously with an aggressive tumor line of human multiple myeloma. Animals were treated with i) a control solution (PBS), ii) GRN163L alone, iii) VELCADE (R) alone or iv) both GRN163L and VELCADE (R). The results showed that relative to the control group, tumor growth was reduced 30% by GRN163L alone (p less than .001) and 68% by the GRN163L and VELCADE (R) combination (p less than .001). VELCADE(R) alone had no efficacy in this model at the dose used. All treatments were well tolerated.

"We are very excited by these findings because VELCADE(R) is an approved therapy for multiple myeloma," said Melissa Kelly, Geron's vice president of oncology. "The results suggest that in human cancer patients GRN163L might have stand-alone efficacy in multiple myeloma which can be further enhanced by combination with approved standard of care therapies."

Use of GRN163L in Combination Chemotherapy with TAXOL(R) and Melphalan

Other presentations described findings from Geron and Dr. Moore's laboratory on the efficacy of GRN163L used in combination with TAXOL(R) in animal models of human ovarian cancer, and with melphalan in animal models of human multiple myeloma and melanoma. Mr. Ertam presented data on the combination of GRN163L and TAXOL(R) in a rodent model of human ovarian cancer. His results showed a 90% reduction in tumor mass by GRN163L alone, 80% reduction with TAXOL(R) alone, and 96% reduction resulting from the combination of the two agents. The combination treatment was well tolerated, without any evidence of hematologic toxicity.

Dr. Ning Go of Geron Corporation presented data on the combined use of GRN163L with melphalan in an animal model of malignant melanoma. Immune compromised mice inoculated with SK-MEL-2 human melanoma cells were treated with GRN163L, melphalan or the combination one day after tumor cell inoculation. The results showed that the GRN163L/melphalan combination was superior (p less than 0.001) to either agent alone, resulting in a 68% reduction in tumor volume without any additional toxicity.

GRN163L Toxicokinetic Studies in Monkeys

Dr. Tressler reviewed a series of studies in rodents and monkeys designed to define the plasma half-life, tissue distribution, safety and toxicokinetic profile of GRN163L. He reported that the rodent studies demonstrated significant organ biodistribution and durable (3 to 7 days) inhibition of telomerase in tissues, while the initial plasma half-life in monkeys was 3-5 hours with a longer terminal half-life. These data support a weekly IV dosing schedule in man.

"The toxicokinetic data generated in cynomolgus monkeys is also important in demonstrating the dose and time dependent patterns of GRN163L concentrations in plasma following intravenous injection over a six hour period," stated Dr. Tressler. "The study mimicked our intended route and schedule of administration for initial human clinical studies which, together with a series of additional pilot and pivotal safety studies, has allowed us to define what we anticipate to be a safe starting dose for GRN163L in our initial phase 1-2 trial."

"We are pleased to describe our positive IND-enabling efficacy and safety studies on GRN163L as we move the drug closer to our phase 1-2 trial," said Thomas Okarma, Ph.D., M.D., Geron's president and CEO. "Moreover, the continued demonstration of enhanced efficacy without increased toxicity observed when GRN163L is combined with approved chemotherapeutic agents such as melphalan, TAXOL(R), and VELCADE(R), allows us to begin planning additional studies for GRN163L in other tumor types in combination with standard of care therapies."

"The AACR Annual Meeting is considered the world's leading multidisciplinary event in the cancer research field, and we are pleased to be presenting our latest drug development work on GRN163L at this conference," stated Calvin B. Harley, Ph.D., Geron's chief scientific officer. "This year's meeting had over 80 presentations on telomerase. The importance of this universal cancer target was further highlighted by the presentation of the prestigious Kirk A. Landon-AACR Prize for Basic and Translational Cancer Research to Dr. Elizabeth Blackburn, the Morris Herzstein Professor of Biology and Physiology at the University of California, San Francisco, for her ground-breaking research on telomeres and telomerase."

Geron is a biopharmaceutical company developing and commercializing three groups of products: i) therapeutic products for oncology that target telomerase; ii) pharmaceuticals that activate telomerase in tissues impacted by senescence, injury or degenerative disease; and iii) cell-based therapies derived from its human embryonic stem cell platform for applications in multiple chronic diseases.

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 such forward-looking statements in this press release regarding potential applications of Geron's technology constitute forward-looking statements that involve risks and uncertainties, including, without limitation, risks inherent in the development and commercialization of potential products, need for future capital 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 annual report on Form 10-K for the year ended December 31, 2004.

Source: Business Wire

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