BOSTON -- GlycoGenesys, Inc. (NASDAQ:GLGS), a biotechnology company focused on carbohydrate drug development, today announced it recently initiated a Phase I/II dose escalation clinical trial of its cancer drug candidate GCS-100LE in patients with multiple myeloma, the second most common hematologic, or blood, cancer. The first trial site is the Dana-Farber Cancer Institute in Boston. The trial will be conducted under the direction of Dr. Kenneth C. Anderson and Dr. Paul Richardson, the Principal Investigator. Dr. Richardson is the Clinical Director of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute and an Assistant Professor of Medicine, Harvard Medical School. Dr. Anderson is the Chief, Division of Hematologic Neoplasia at the Dana-Farber Cancer Institute and the Kraft Family Professor of Medicine, Harvard Medical School.
Both Drs. Anderson and Richardson are world-leading experts in the research of treatments for multiple myeloma. Among several important clinical studies in multiple myeloma, Drs. Anderson and Richardson were intimately involved in pre- clinical testing, trial design and human clinical trials that led to the regulatory approval of Velcade(R) marketed by Millennium Pharmaceuticals and Johnson and Johnson for the treatment of multiple myeloma.
About The Clinical Trial
Patients will receive GCS-100LE as a monotherapy in treatment cycles of two doses of GCS-100LE per week for 2 weeks followed by one week off therapy. If patients progress after 2 cycles or remain stable after 4 cycles, dexamethasone, a standard therapy, may be added to their treatment. Patients showing a partial or complete response on GCS-100LE as a monotherapy or GCS-100LE in combination with dexamethasone will continue on such treatment. The combination of GCS- 100LE and dexamethasone has been shown pre-clinically to have an additive effect on the killing of multiple myeloma cells.
The primary objective of the Phase I/II dose escalation study is to evaluate the safety of GCS-100LE 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-100LE as a monotherapy and in combination with dexamethasone and determine the pharmacokinetics of GCS-100LE alone and with dexamethasone.
"I'm excited to see this trial begin. Based on our preclinical work we believe there is promise for GCS-100 to have a positive effect on patients with multiple myeloma. We look forward to contributing to the development of GCS-100," stated Dr. Richardson.
Clinical Trial Strategy For Multiple Myeloma
A Phase II/III multiple myeloma trial is planned to follow this trial. The Company will work with clinical investigators and the FDA with the aim of designing this trial as a pivotal study, assuming the data supports it.
Scientific Rationale
The scientific rationale behind initiating this clinical trial is based on pre- clinical research conducted on GCS-100LE by Dr. Anderson and his colleagues at Dana-Farber's Jerome Lipper Multiple Myeloma Center. Under Dr. Anderson's direction, the Center's researchers have pioneered new pre-clinical models to evaluate the potential of new multiple myeloma drug candidates before they enter human clinical testing. Findings from their promising research on GCS-100LE were published in an abstract in Blood and presented during a poster session at the American Society of Hematology's 2004 Annual Meeting in December.
In pre-clinical studies GCS-100LE has been shown to:
--Induce cell death in multiple myeloma cells without significant toxicity against normal white blood cells.
--Directly target multiple myeloma cells while in the presence of protective bone marrow cells.
--Trigger cell death in multiple myeloma cells resistant to commonly used anti- cancer agents including dexamethasone, melphalan, doxorubicin, and Velcade(R).
--Have additive and synergistic effects when combined with caspase-activating agents dexamethasone and PK11195, respectively.
These findings provide the framework for clinical evaluation of GCS-100LE either alone or in combination with dexamethasone or other therapies to overcome drug resistance and potentially improve patient outcome in multiple myeloma.
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 Dana-Farber and The Jerome Lipper Multiple Myeloma Center
Dana-Farber Cancer Institute is a principal teaching affiliate of Harvard Medical School, a federally designated Center for AIDS Research, and a founding member of the Dana-Farber/Harvard Cancer Center (DF/HCC), a federally designated comprehensive cancer center. Providing advanced training in cancer treatment and research for an international faculty, the Institute conducts community-based programs in cancer prevention, detection, and control throughout New England, and maintains joint programs with other Boston institutions affiliated with Harvard Medical School and the Partners Health Care System, including Brigham & Women's Hospital, Children's Hospital, and Massachusetts General Hospital.
The Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute provides comprehensive, state-of-the-art care, including promising new therapies through clinical trials, to patients with multiple myeloma. In addition, the center conducts an active program of basic and clinical research aimed at improving the outcomes of patients with multiple myeloma.
GlycoGenesys, Inc.
GlycoGenesys, Inc. is a biotechnology company focused on carbohydrate-based drug development. The Company currently is conducting a Phase I dose escalation trial of GCS-100LE, a unique compound to treat cancer, in patients with solid tumors at Sharp Clinical Oncology Research in San Diego, California and the Arizona Cancer Center in Tucson and Scottsdale, Arizona. In addition, the Company is conducting a Phase I/II dose escalation trial of GCS-100LE in multiple myeloma at the Dana-Farber Cancer Institute in Boston, Massachusetts. Further clinical trials are planned for 2005. The Company's headquarters are located in Boston, Massachusetts with a laboratory in Cambridge, Massachusetts. Additional 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, 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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