Monday, June 07, 2004 9:29:44 AM
-- GlycoGenesys, Inc. (GLGS, Trade), a biotechnology company focused on carbohydrate drug development, announced today that it has initiated a Phase I dose escalation clinical trial in multiple solid tumor cancer indications evaluating GCS-100LE at Sharp Clinical Oncology Research in San Diego, CA. Dr. Charles Redfern is the Principal Investigator of the study.
GCS-100LE is a substantially ethanol-free formulation of the Company's cancer drug candidate GCS-100(R). Preclinical and toxicology data support dose escalations above the 80 mg/m2 reached in a previous clinical trial, as well as the use of a daily dosing regimen to potentially achieve the maximal biological effect of GCS-100LE in humans. GlycoGenesys developed this formulation of GCS- 100 to avoid potential ethanol-related adverse events at higher dose levels in future trials. Further, GlycoGenesys believes this ethanol removal has increased GCS-100's potential for development as an anticancer therapeutic administered alone or in combination with a variety of cancer therapies.
"We're very pleased with both the financial and operational accomplishments made during the first quarter of 2004. We raised approximately $4.3 million, opened our glycobiology lab, and produced our low-ethanol formulation of GCS-100 for clinical trials," stated John W. Burns, Senior Vice President and Chief Financial Officer of GlycoGenesys, Inc. "The first quarter's net loss applicable to common stock was approximately $845,000 more this year compared to last year primarily due to increased drug production costs, professional fees, preclinical research expenses and the build out and equipment costs of our new lab facility. These expense increases were partially offset by decreases in clinical trial costs for the period. The recent initiation of our Phase I dose escalation trial for GCS-100LE represents one of several corporate milestones planned for this year," added Mr. Burns.
GlycoGenesys, Inc. is a biotechnology company that develops and licenses products based on glycobiology. The Company's human therapeutic product GCS-100, a unique compound to treat cancer, has been evaluated in Phase II(a) human clinical trials for both colorectal and pancreatic cancers. The Company most recently initiated a Phase I dose escalation trial of GCS-100LE at Sharp Clinical Oncology Research in San Diego, California. Further information is available on GlycoGenesys' web site: www.glycogenesys.com.
GlycoGenesys, Inc. is a biotechnology company developing novel drug candidates primarily based on glycobiology. Our product development strategy focuses on therapeutic applications where there is an unmet medical need for life-threatening or debilitating diseases. The Company's lead drug candidate, GCS-100, is a potential treatment for multiple forms of cancer. We plan to advance GCS-100 through the clinical trial process, while selectively building an integrated pipeline of potential new drug candidates.
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