New In Vitro Study of GlycoGenesys' GCS-100LE Yields Promising Data in Chronic Lymphocytic Leukemia and other B-cell Cancers.BOSTON & SAN DIEGO -- Data Presented at American Society of Hematology Annual Meeting GlycoGenesys, Inc., (Nasdaq: GLGS), a biotechnology company focused on carbohydrate-based drug development, announced today that an in vitro in vitro /in vi·tro/ (in ve´tro) [L.] within a glass; observable in a test tube; in an artificial environment. in vi·tro adj. In an artificial environment outside a living organism. study showed for the first time that its lead drug candidate, GCS-100LE, triggered cell death in both B-cell malignant cell lines and primary cancer cells taken from patients with 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 CLL abbr. chronic lymphocytic leukemia CLL, n.pr See leukemia, chronic lymphocytic. CLL 1. Chronic lymphocytic leukemia 2. Cholesterol-lowering lipid ). GCS-100LE, currently in a Phase I dose escalation trial for solid tumors, is a novel carbohydrate-based compound being developed for the treatment of solid tumors and multiple myeloma multiple myeloma A malignant proliferation of abnormal plasma cells that populate the marrow-containing bones of the body. The affected plasma cells produce myeloma protein, a monoclonal antibody that replaces normal antibodies in the blood, thereby increasing susceptibility . Data from the new study was presented last evening by world-renowned cancer researcher and GlycoGenesys collaborator, Dr. Finbarr E. Cotter cot·ter n. 1. A bolt, wedge, key, or pin inserted through a slot in order to hold parts together. 2. A cotter pin. [Origin unknown. of Barts School of Medicine, London, at the American Society of Hematology (ASH) 46th Annual Meeting and Exposition in a poster session on Lymphoma Therapy - New Biologic Agents. The poster was titled "GCS-100, a Galectin 3 Antagonist, Is a Novel Caspase-9 Apoptosis Activating Agent for the Treatment of Indolent indolent /in·do·lent/ (in´dah-lint) 1. causing little pain. 2. slow growing. in·do·lent adj. 1. Disinclined to exert oneself; habitually lazy. 2. B-Cell Malignancies." Dr. Cotter's Poster Presentation Highlights GCS-100LE was found to: --Induce significant apoptosis (cell death) in both malignant B-cell lines and in primary patient chronic lymphocytic leukemia cells in vitro with minimal effect against normal B-cells and stem cell stem cell In living organisms, an undifferentiated cell that can produce other cells that eventually make up specialized tissues and organs. There are two major types of stem cells, embryonic and adult. cultures. --Greatly enhance the apoptotic effect of chemotherapy at low doses, even in the presence of high levels of anti-apoptotic proteins such as Bcl-2. --Induce cell death in B-cell malignancies including chronic lymphocytic leukemia via caspase-9, a known apoptotic pathway utilized by approved chemotherapy agents. Activation of caspase-9 has been shown to predict a good anti-cancer response in B-cell malignancies. These findings lay the framework for clinical evaluation clinical evaluation Medtalk An evaluation of whether a Pt has symptoms of a disease, is responding to treatment, or is having adverse reactions to therapy of GCS-100LE in B-cell malignancies, especially for potential treatment of chronic lymphocytic leukemia. The Study The study investigated the mechanism by which GCS-100LE induces apoptosis (programmed cell death pro·grammed cell death n. See apoptosis. programmed cell death proposed system of cell death, often including poly(ADP)-ribosylation, ensures that a cell will not survive if it is so badly damaged that its recovery would harm the ) in indolent B-cell lymphomas. It found that GCS-100LE induced apoptosis in malignant cell lines as well as in primary cells from patients with chronic lymphocytic leukemia with minimal effect on normal B cells. Notably, low doses of GCS-100LE significantly enhanced the effect of chemotherapy in these cancer cells. GCS-100LE was found to induce a specific apoptotic pathway, the mitochondrial mitochondrial pertaining to mitochondria. mitochondrial RNAs a unique set of tRNAs, mRNAs, rRNAs, transcribed from mitochondrial DNA by a mitochondrial-specific RNA polymerase, that account for about 4% of the total cell RNA that caspase-9 pathway. The apoptotic effect of GCS-100LE occurred even in the presence of the protein Bcl-2, a natural inhibitor of cell death, which confers resistance to widely used chemotherapy drugs in several cancers. GCS-100LE has been previously shown to bind to to contract; as, to bind one's self to a wife s>. See also: Bind Galectin-3, a protein that generally has a higher expression in B-cell cancers. This may be the cause of GCS-100LE's targeting of malignant B-cells. Dr. Finbarr Cotter, GlycoGenesys' collaborator and primary author of the study abstract said, "Our recent study shows for the first time that GCS-100LE has strong activity against primary cancer cells taken from patients with chronic lymphocytic leukemia. In these primary cells and in other B-cell cancer cell lines, GCS-100LE works through a specific caspase-dependent apoptotic pathway. Moreover, other studies have shown that GCS-100LE can activate additional beneficial anti-cancer mechanisms. These attributes of GCS-100LE suggest its application in several different types of cancer and its combination with chemotherapeutic agents that work through complementary pathways for a potential synergistic or additive therapeutic effect. I am keen to commence clinical studies based on this preclinical work." Bradley J Carver, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of GlycoGenesys, a secondary author of the study abstract, further commented, "Our poster presentations at this year's annual meeting of the American Society of Hematology underscore the clinical rationale and versatility of GCS-100LE to be developed for potential treatment of several bloodborne cancers. We are encouraged by Dr. Cotter's recent findings. They provide solid scientific rationale for expanding the clinical development of GCS-100LE beyond our current programs in solid tumor and multiple myeloma. About Indolent B-cell Malignancies In the U.S., over 320,000 people are estimated to have some form of B-cell malignancy and each year approximately 55,000 new cases and 20,000 deaths occur from these cancers. Between 80% and 85% of non-Hodgkin's lymphomas are of B-cell origin. Indolent B-cell malignancies include chronic lymphocytic leukemia, follicular lymphoma follicular lymphoma n. See nodular lymphoma. follicular lymphoma Follicle center lymphoma A heterogeneous group of NHLs arising in follicular center cells, which comprises 50% of all NHLs in adults–US, and B-cell non-Hodgkin's lymphoma as well as other lymphomas. They are low-grade or slow-growing lymphomas that permit long survival periods but are continuously recurring and virtually incurable in advanced stages. Current treatment options are characterized by low-cure rates due to the slow-growing nature of these lymphomas. Patients without symptoms are monitored closely for development of symptoms including tumor masses and major organ involvement. At such times, treatment is started. About GCS-100LE GCS-100LE is a novel carbohydrate compound with potential application in solid tumors and bloodborne cancers. Independent research has shown that Galectin-3, a key target of GCS-100LE is implicated im·pli·cate tr.v. im·pli·cat·ed, im·pli·cat·ing, im·pli·cates 1. To involve or connect intimately or incriminatingly: evidence that implicates others in the plot. 2. in several cellular activities. GCS-100LE has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. , the process by which cancer cells recruit a blood supply from the body in order to proliferate; and appears to interfere with a process called cellular adhesion, which plays a key role in metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to , or the spread of cancer beyond the primary tumor. Galectin-3 has high expression in many cancers, but not in normal cells, conferring broad potential applications for GCS-100LE in solid and bloodborne cancers. GCS-100 has been evaluated at low dose levels in previous clinical trials for patients with colorectal, pancreatic and other types of solid tumors. GCS-100LE, a low ethanol formulation, is currently in a dose escalation Phase I trial for solid tumors with Phase I and II clinical trials for multiple myeloma planned in 2005. About GlycoGenesys, Inc. GlycoGenesys, Inc. is a biotechnology company that develops and licenses compounds based on glycobiology. The Company's drug candidate GCS-100, a unique compound to treat cancer, has been evaluated in previous clinical trials at low dose levels in patients with colorectal, pancreatic and other solid tumors with stable disease and partial response documented. The Company currently is conducting a Phase I dose escalation trial to evaluate higher dose levels of GCS-100LE, a low ethanol formulation of GCS-100, at Sharp Clinical Oncology Research in San Diego, California “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. . Further studies are planned for the first and second quarter of 2005. Further information is available on GlycoGenesys' web site: www.glycogenesys.com. Safe Harbor Statement Any statements contained in this release that relate to future plans, events or performance are forward-looking statements that involve risks and uncertainties, including, but not limited to, risks of product development (such as failure to demonstrate efficacy or safety), risk related to FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. and other regulatory procedures, market acceptance risks, the impact of competitive products and pricing, the results of current and future licensing, joint ventures and other collaborative relationships, the results of financing efforts, developments regarding intellectual property rights and litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. , and other risks identified in the Company's Securities and Exchange Commission filings. Actual results, events or performance may differ materially. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as the date hereof. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. |
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