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Geron Announces Initiation of Clinical Trial for Its Telomerase Inhibitor Drug GRN163L in Patients With Solid Tumor Malignancies.


MENLO PARK, Calif. -- Geron Corporation (Nasdaq:GERN v. t. 1. To grin or yawn. ) announced today that it has initiated clinical testing of its lead anti-cancer compound, GRN163L, in patients with solid tumor malignancies at The University of Chicago Cancer Research Center.

This Phase I, dose-escalation trial of GRN163L is primarily designed to demonstrate the safety and tolerability of GRN163L administered intravenously (IV) on a weekly basis in patients with refractory or relapsed solid tumor malignancies. This study will also evaluate the tolerability of IV infusions of GRN163L at various rates of administration, and enable an assessment of the pharmacokinetic profile of GRN163L at escalating doses and at decreasing infusion durations. A secondary endpoint of the trial is the preliminary evaluation of anti-tumor activity of GRN163L in this patient population.

"This second trial of GRN163L is open for patient enrollment at The University of Chicago, under the leadership of principal investigator, Mark Ratain, M.D.," said Melissa Kelly Behrs, Geron's vice president of oncology. "Dr. Ratain is a recognized leader in the areas of clinical pharmacology and clinical drug development, with extensive clinical research experience in a broad array of solid tumor types."

"We are excited to be extending the clinical evaluation of this first-in-class drug, GRN163L, in the solid tumor setting," said Mark Ratain, M.D., Leon. O. Jacobson Professor, Department of Medicine and Associate Director for Clinical Sciences, Cancer Research Center at The University of Chicago. "Preclinical studies of GRN163L alone, and in combination with approved chemotherapeutic agents, indicate the importance of telomerase as a target for the treatment of cancer, and the potential utility of GRN163L in the treatment of patients with essentially any type of solid tumor malignancy. We are, therefore, very hopeful that our patients may benefit from this new drug."

Phase I/II Clinical Trial of GRN163L in CLL CLL
abbr.
chronic lymphocytic leukemia


CLL,
n.pr See leukemia, chronic lymphocytic.

CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid
 Patients

A Phase I/II clinical trial of GRN163L is also ongoing in patients with advanced chronic lymphocytic leukemia chronic lymphocytic leukemia
n. Abbr. CLL
Lymphocytic leukemia occurring mainly in older adults, characterized by slow onset and gradual progression of symptoms.
 (CLL). This trial is open for patient enrollment at Long Island Jewish Medical Center Long Island Jewish Medical Center (LIJMC) shares the title of clinical and academic hub of the North Shore-Long Island Jewish Health System. It is an 827-bed voluntary, non-profit tertiary care teaching hospital serving the greater metropolitan New York area. , North Shore University Hospital, and the Weill Medical College of Cornell University.

For more information about the GRN163L clinical trials in CLL and solid tumors, visit the U.S. National Library of Medicine Noun 1. U.S. National Library of Medicine - the world's largest medical library
National Library of Medicine, United States National Library of Medicine
 website at http://www.ClinicalTrials.gov to access a brief synopsis for each study. A link to this site is also provided on Geron's website at http://www.geron.com.

About GRN163L

GRN163L is a potent inhibitor of telomerase. Inhibition of telomerase activity by GRN163L in cancer cells results in telomere telomere /telo·mere/ (tel´o-mer) an extremity of a chromosome, which has specific properties, one of which is a polarity that prevents reunion with any fragment after a chromosome has been broken.  shortening, and leads to cell cycle arrest or apoptosis. GRN163L is a 13-mer oligonucleotide N3' -- P5' thio-phosphoramidate (NPS oligonucleotide) that is covalently attached to a C16 (palmitoyl) lipid moiety moiety: see clan. . GRN163L binds directly with high affinity to the template region of the RNA RNA: see nucleic acid.
RNA
 in full ribonucleic acid

One of the two main types of nucleic acid (the other being DNA), which functions in cellular protein synthesis in all living cells and replaces DNA as the carrier of genetic
 component of human telomerase (hTR), which lies in the active or catalytic site of hTERT, the telomerase reverse transcriptase Telomerase reverse transcriptase is an enzyme associated with Cri du chat.

Telomerase is a ribonucleoprotein polymerase that maintains telomere ends by addition of the telomere repeat TTAGGG.
. GRN163L binding to hTR results in direct, competitive inhibition of telomerase enzymatic activity. The mechanism of action of the drug is not antisense mediated.

GRN163L has been characterized preclinically and shown to inhibit telomerase in human tumor cells of many cancer types, in both cell culture systems and animal models. These studies continue to demonstrate broad anti-tumor activity of GRN163L, alone and in combination with other anti-tumor agents, and support the potential utility of GRN163L in the treatment of patients with hematologic hematological, hematologic

pertaining to or emanating from blood cells.


hematological tests
total and differential white cell counts, hematocrit estimation, erythrocyte count.
 and solid tumor malignancies.

Geron is a biopharmaceutical company focused on 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 senescence /se·nes·cence/ (se-nes´ens) the process of growing old, especially the condition resulting from the transitions and accumulations of the deleterious aging processes.

se·nes·cence
n.
, injury or degenerative disease; and iii) cell-based therapies derived from its human embryonic stem cell Embryonic stem cells (ES cells) are stem cells derived from the inner cell mass of an early stage embryo known as a blastocyst. Human embryos reach the blastocyst stage 4-5 days post fertilization, at which time they consist of 50-150 cells.

ES cells are pluripotent.
 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and  of 1995. Investors are cautioned that such forward-looking statements in this press release regarding potential applications of Geron's telomerase technology and future clinical trial results 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 annual report on Form 10-K for the year ended December 31, 2005.
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Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Date:Apr 3, 2006
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