The first trial site is the Dana-Farber Cancer Institute in Boston. 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 Paul Richardson, the trial’s principal investigator and the clinical director of the Jerome Lipper Multiple Myeloma Center at the Dana-Farber Cancer Institute.
A phase II/III multiple myeloma trial is planned to follow this trial. GlycoGenesys will work with clinical investigators and the FDA with the aim of designing this trial as a pivotal study, assuming the data supports it.