GLGS Glycogenesys Inc. (MM)

GCS-100 Targets Galectin-3 in Multiple Myeloma Cells In Vitro, Leading to Increased Anti-Tumor Activity When Combined With Dexamethasone GlycoGenesys, Inc. (NASDAQ:GLGS), a biotechnology company, today announced the publication of an in-depth article introducing new and exciting in vitro findings about the Company's cancer drug candidate GCS-100. The paper was authored by Dr. Kenneth C. Anderson and researchers at the Dana-Farber Cancer Institute in collaboration with GlycoGenesys employees. It appeared in the American Association of Cancer Researcher's publication Cancer Research, September 15, 2005; Vol. 65, No.18 edition. To provide the context to understand the potential commercial implications of these new findings, it is important to know that GlycoGenesys' cancer drug candidate GCS-100 has been shown to bind to Galectin-3. Galectin-3 is over-expressed in a variety of cancers including multiple myeloma, as well as solid tumors. Galectin-3 is a protein that protects cancer cells from dying. Notably, GCS-100 is currently in clinical testing for the treatment of multiple myeloma and solid tumors. With this as a background, this new in vitro data generated at the Dana-Farber Cancer Institute illustrates for the first time that GCS- 100 decreases Galectin-3 expression in multiple myeloma cells when tested in combination with dexamethasone (a drug frequently used to treat multiple myeloma). These findings further showed that decreased Galectin-3 expression correlates with increased anti-tumor activity. This data adds to the understanding of how GCS-100 works in killing multiple myeloma cells. The following additional findings show that GCS-100 has the potential to selectively kill and inhibit the growth of multiple myeloma cells, including drug-resistant cells, as well as prevent metastasis in patients with multiple myeloma: -- GCS-100 selectively causes programmed cell death (apoptosis) in multiple myeloma cell lines without killing normal white blood cells; -- GCS-100 blocks the growth of multiple myeloma cells from patients resistant to Velcade(R), thalidomide, and dexamethasone; -- GCS-100 inhibited the growth of multiple myeloma cells even when grown in the presence of bone marrow cells. The bone marrow environment protects multiple myeloma cells and provides a survival advantage for growing cells; -- GCS-100 overcomes the protective effect of several proteins important for drug resistance and growth of multiple myeloma and other cancers, for example Bcl-2, Hsp-27, and NF-kB; -- GCS-100 was shown to prevent the movement of multiple myeloma cells caused by VEGF, a protein important in angiogenesis and growth of multiple myeloma cells. The paper concludes that "Collectively, these findings provide the frame work for clinical trials of GCS-100, either alone or in combination with dexamethasone, to enhance clinical efficacy, reduce toxicity, and overcome drug resistance to conventional and Velcade therapy in patients with relapsed/refractory multiple myeloma." CEO's Comments Bradley J. Carver GlycoGenesys' CEO and President and an author of the paper, stated, "Our ongoing myeloma trial is designed to get two looks at GCS-100, both alone and in combination with dexamethasone. This new preclinical data is quite relevant to our clinical trial strategy in multiple myeloma." He continued, "Thus, our top priority is to continue generating human clinical data." GlycoGenesys has an ongoing Phase I/II dose escalation trial for treatment of multiple myeloma being conducted at Dana-Farber Cancer Institute and the Lucy Curci Cancer Center in Rancho Mirage, California. Additional sites are planned. About The Trial The Company is currently enrolling patients in it's Phase I/II dose escalation trial for treatment of multiple myeloma. The primary objective of the study is to evaluate the safety of GCS-100 when given to patients with relapsed or refractory multiple myeloma and to identify the recommended dose for future studies. Secondary objectives are to evaluate the response to GCS-100 as a monotherapy and in combination with dexamethasone and determine the pharmacokinetics of GCS-100 alone and with dexamethasone. About Multiple Myeloma (MM) Multiple myeloma is a bone marrow cancer in which white blood cells known as plasma cells, normally responsible for the production of infection-fighting antibodies, become abnormal and are overproduced. The proliferation of these abnormal plasma cells, called myeloma cells, results in decreased production of normal blood cells and disease-fighting antibodies. This proliferation causes growth of tumors that spread to multiple sites - hence the term multiple myeloma. The decreased white blood cell production weakens the immune system and decreased red blood cell production leads to fatigue and weakness, while the myeloma tumors cause bone destruction, pain and fractures. MM is the second most common hematologic malignancy and although the disease is predominantly a cancer among older individuals (the average age of onset is 65 to 70 years of age), recent statistics indicate both increasing incidence and onset at a younger age. In the United States, more than 50,000 individuals have MM and over 14,600 new cases of the disease are diagnosed each year. Worldwide, there are approximately 74,000 new cases and over 45,000 deaths due to multiple myeloma each year. About GlycoGenesys, Inc. GlycoGenesys, Inc. is a biotechnology focused on carbohydrate drug development. 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 Memorial Hospital, Clinical Oncology Research in San Diego, California and the Arizona Cancer Center in both Tucson and Scottsdale, Arizona. In addition, GCS-100LE is being evaluated in a Phase I/II trial for multiple myeloma at the Dana-Farber Cancer Institute in Boston, Massachusetts and the Lucy Curci Cancer Center in Rancho Mirage, California. Further clinical trials are planned for 2005, 2006 and 2007. 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 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, risks relating to raising sufficient capital to fund the Company's operations, 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.