NeoPharm's Colorectal Cancer Trial Misses Endpoint

NeoPharm has reported findings from a Phase II clinical trial in second-line metastatic colorectal cancer patients using its drug candidate LE-SN38.

LE-SN38 is NeoPharm's liposomal formulation of SN-38, the active metabolite in Camptosar (irinotecan), a chemotherapeutic drug approved for the treatment of advanced colorectal cancer.

The objectives of the open-label trial were to determine the objective response rate following treatment with SN-38 liposome, as well as to assess the drug's toxicity profile and effect on progression-free survival and overall survival.

While the interim analysis of data following the completion of treatment of the first 21 patients demonstrated disease stabilization, the study did not meet the primary tumor response endpoint. No new patients will be accrued into this trial, which was conducted by the National Cancer Institute's Cancer and Leukemia Group.

Patients currently receiving therapy will continue treatment per protocol until a study endpoint is reached. NeoPharm will consider next steps, including additional data analyses and the possibility of other studies.

NeoPharm also recently announced that the FDA has recommended an additional Phase III clinical trial of its experimental treatment for glioblastoma multiforme before the agency could accept a new drug application.