GlycoGenesys Initiates Phase I/II Trial of GCS-100LE in Multiple Myeloma

GlycoGenesys 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. Patients will receive GCS-100LE as a monotherapy in treatment cycles of two doses of GCS-100LE per week for two weeks followed by one week off therapy. If patients progress after two cycles or remain stable after four 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 preclinically 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.