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GlycoGenesys, Inc. Announces Scientific Rational for Developing GCS-100LE for Potential Treatment of Multiple Myeloma at American Society of Hematology Annual Meeting.

BOSTON & SAN DIEGO -- GCS-100LE overcomes drug resistance of approved therapies and is shown to have synergistic and additive effects in combination with other drugs for treatment of Multiple Myeloma in vitro

GlycoGenesys, Inc., (NASDAQ: GLGS), a biotechnology company focused on carbohydrate drug development, announced today its lead drug candidate, GCS-100LE, was shown in vitro to trigger cell death in multiple myeloma, including cell lines resistant to standard treatments. The data was presented at The American Society of Hematology 46th Annual Meeting and Exposition in a poster session called New Targets and Immune Based Therapy in a presentation entitled "Mitochondria and Caspase-Independent Cell-Death Triggered By GCS-100, a Novel Carbohydrate-Based Therapeutic in Multiple Myeloma (MM) Cells." The poster was presented by Company collaborator, Dr. Dharminder Chauhan, of Dr. Kenneth Anderson's laboratory at the Medical Oncology Department, Dana Farber Cancer Institute, Boston, Massachusetts.

Highlights of Poster Presentation

GCS-100LE was found to:

--Directly target multiple myeloma cells including in their bone marrow microenvironment.

--Trigger cell death in multiple myeloma cells resistant to traditional anti-cancer agents including dexamethasone, melphalan, doxorubicin, and Velcade(R), which are commonly used in treatment of multiple myeloma.

--Decrease the viability of Velcade-resistant multiple myeloma patient cells.

--Inhibit growth and survival of multiple myeloma cells conferred by the bone marrow microenvironment.

--Overcome drug-resistance conferred by anti-apoptotic protein Bcl-2 and heat shock protein- 27.

--Induces cell death in multiple myeloma without activating known cell death activating pathways, caspases 8, 9,and 3, without significant toxicity against normal peripheral mononuclear cells, suggesting a potentially novel mechanism of action and providing strong rational for combining GCS-100LE with approved agents that activate caspase-dependent cell death.

--To have additive and synergistic effects when combined with caspase-activating agents dexamthasone and PK1195, respectively.

These findings lay the framework for clinical evaluation of GCS-100LE either alone or in combination with other therapies to overcome drug resistance and improve patient outcome in multiple myeloma.

Bradley J Carver, President and CEO of GlycoGenesys, noted that "We are very pleased to have this promising data presented at the ASH Annual Meeting by such distinguished clinicians and researchers. As a co-author with my colleagues on this abstract and working closely with Dr.'s Anderson and Chauhan over the last year, we are excited about our plans to enter the clinic in multiple myeloma with GCS-100LE in early 2005 at the Dana Farber Cancer Institute."

The Study

Multiple myeloma cancer cells use normal bone marrow stromal cells and the bone marrow microenvironment to prevent apoptosis (programmed cell death), which allows them to divide and grow abnormally. GCS-100LE works by directly targeting multiple myeloma cells in their bone marrow microenvironment, interfering with their ability to adhere to the bone marrow stromal cells and inhibiting their growth and proliferation, eventually leading to cell-death. GCS-100LE was shown to trigger growth arrest and apoptosis in a number of multiple myeloma cell lines including cell lines resistant to standard treatments such as dexamethasone, melphalan and doxorubicin. In tests with multiple myeloma cells from patients who have had unsuccessful treatment due to drug resistance, GCS-100LE demonstrated similar results, including in cells from patients resistant to bortezomib (Velcade(R)). GCS-100LE was effective against these patient's cells without significant toxicity to normal peripheral mononuclear cells, which naturally help defend against infections and disease.

In this study, it was shown that GCS-100LE induced apoptosis in multiple myeloma cells through a mitochondria and caspase-independent apoptotic pathway. This provides a rationale for combining it with treatments that work through potentially complimentary apoptotic pathways, including caspase-dependent pathways. For example, in combinatonGCS-100LE, acts synergistically with PK-11195 and additively with dexamethasone.

About Multiple Myeloma

Multiple myeloma (also known as myeloma or plasma cell myeloma) is a progressive hematologic (blood) disease. It is a cancer of the plasma cell, an important part of the immune system that produces immunoglobulins (antibodies) to help fight infection and disease. Hypercalcemia, anemia, renal damage, increased susceptibility to bacterial infection, and impaired production of normal immunoglobulin are common clinical manifestations of multiple myeloma. It is often also characterized by diffuse osteoporosis, usually in the pelvis, spine, ribs, and skull.

The estimated frequency of multiple myeloma is 4-5 new cases per 100,000 persons per year. Accordingly, in the United States 15,270 new cases are expected to be diagnosed in 2004. At present there are approximately 50,000 people in the United States living with multiple myeloma.

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-100, is implicated in several cellular activities. GCS-100 has at least three mechanisms of action: it may induce apoptosis, or programmed cell death; appears to interfere with angiogenesis, 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, 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-100 in solid and blood-borne cancers. GCS-100 has been evaluated at lower dose levels in Phase II(a) clinical trials for colorectal and pancreatic cancer. 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 to begin in 2005.

About GlycoGenesys, Inc.

GlycoGenesys, Inc. is a biotechnology company that develops and licenses products based on glycobiology. The Company's cancer drug candidate GCS-100LE, a unique compound to treat cancer, has been evaluated in previous human clinical trials at low dose levels in patients with colorectal, pancreatic and other types of solid tumor cancers 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-100LE, at Sharp Clinical Oncology Research in San Diego, California. Further studies are planned for the first and second quarter of 2005. Further information is available on GlycoGenesys' web site:

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 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, 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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Publication:Business Wire
Geographic Code:1USA
Date:Dec 6, 2004
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