Friday, September 16, 2005

GlycoGenesys' drug candidate GCS-100 update

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), 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. 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."

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.

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