GlycoGenesys, Inc. Announces Additional Cancer Indication for GCS-100LE Clinical Trial Program; Company Committed to Forming Strategic Alliance in 2005

Business Wire, Jan 25, 2005

BOSTON -- GlycoGenesys, Inc., (NASDAQ: GLGS), a biotechnology company focused on carbohydrate-based drug development, announced a new indication, chronic lymphocytic leukemia (CLL), for its cancer clinical trial program for GCS-100LE. The addition of CLL to its clinical trial program positions GlycoGenesys to pursue approval in two indications for unmet medical needs in cancer and starts the international clinical and regulatory program for GCS-100LE. In recognition of the expanded clinical program, the Company announced its commitment to establishing a strategic alliance in 2005. It also provided a brief update on its ongoing Phase I dose escalation trial, while setting forth its 2005 goals including its multiple myeloma clinical trial program planned for early 2005.

SUMMARY

Today the Company announced that it:

--anticipates initiating a Phase I/II study in CLL in both the U.S. and England in the first half of 2005;

--seeks to establish a strategic alliance in 2005 to help fund the trials planned for the latter half of the year;

--is enrolling patients at the fifth out of six planned dose levels in its Phase I Dose Escalation trial for solid tumors, and has added two additional sites to assist enrolling up to 15 more patients once the maximum tolerated dose (MTD) for this dosing regimen is established;

--expects to begin the first of a two trial program in multiple myeloma at Dana Farber Cancer Institute in 1Q05;

--plans to initiate a second multiple myeloma trial in late 2005 anticipated to be designed as a pivotal trial. The Company's goal would be to file a New Drug Application (NDA) for multiple myeloma pending the quality of such trial results in 2007; and

--plans a Phase II solid tumor trial with GCS-100LE in late 2005;

2005 GOALS FOR GCS-100LE CANCER PROGRAM

Multiple Myeloma

Based on promising data recently presented in an abstract at the American Society of Hematology's 2004 Annual Meeting, the Company plans to initiate its first clinical trial for treatment of relapsed or refractory multiple myeloma patients in the first quarter under the direction of Drs. Kenneth Anderson and Paul Richardson of the Dana Farber Cancer Institute, Boston. Both were involved in studies leading to the regulatory approval of Velcade(R) for the treatment of multiple myeloma. The first trial of the Company's two trial program originally estimated to begin in the fourth quarter of 2004 is now expected to be initiated in the first quarter of 2005. In addition to the Dana Farber Cancer Institute, additional clinical sites are planned.

The second of the two multiple myeloma trials is targeted for initiation in late 2005. The Company will work with the FDA to design such trial as a pivotal study. The Company's goal would be to file an NDA in 2007 for treatment of multiple myeloma pending the quality of such trial results.

The primary objective of the first study is to evaluate the safety of GCS-100LE when given in subjects with relapsed or refractory multiple myeloma and to identify the recommended dose for further studies. Secondary objectives are to evaluate the response to GCS-100LE as a monotherapy and in combination with dexamethasone, a standard therapy, and determine the pharmacokinetics of GCS-100LE alone and with dexamethasone.

Chronic Lymphocytic Leukemia (CLL) - New Indication

The Company is expanding its clinical trial program to include CLL based on promising data recently presented in an abstract at the American Society of Hematology's 2004 Annual Meeting by Dr. Finbarr Cotter of Barts and the Royal London Medical School. The pre- clinical findings strongly support the scientific rationale for human clinical testing of GCS-100LE for treating CLL. As a result of Dr. Cotter's findings, he and a colleague, Dr. Archibald Prentice, President of the British Society for Haematology, are working closely with GlycoGenesys to design a clinical trial program. The first CLL clinical trial, a Phase I/II study, is planned to begin in the first half of 2005 with sites in both the U.S. and England.

This new clinical program positions GlycoGenesys to pursue approval in two indications for unmet medical needs in cancer (multiple myeloma and CLL) and starts the international regulatory process for GCS-100LE. The Company may also choose to apply for Fast Track designation in the U.S. for one or both bloodborne indications in the future.

Solid Tumor

Upon completion of its ongoing Phase I solid tumor dose ranging trial, the Company plans to initiate a Phase II clinical trial. The design of this Phase II trial will be based on clinical activity and continuing preclinical studies. The Company is employing the same scientific rigor as in the bloodborne indications while completing its current clinical trial prior to choosing specific solid tumor indications for Phase II. The Phase II solid tumor program is targeted to commence in late 2005.

STRATEGIC ALLIANCE - COMMITTED TO ESTABLISHING IN 2005

The Company recognizes the breadth of its clinical trial plans warrants consummating a strategic alliance during 2005. It further believes it has now achieved an appropriate level of development to recognize value from such a relationship. The Company believes a strategic alliance would likely benefit shareholder value, further validate its technology, and provide additional resources to conduct an expanded clinical trial program. The Company anticipates the clinical trials planned to begin later in 2005 will be undertaken in conjunction with a strategic alliance. The timing and/or success of these efforts can not be predicted or assured but the Company is committed to achieving this goal.