The trial is being conducted by Cancer and Leukemia Group B (CALGB), an oncology clinical research group sponsored by the National Cancer Institute (NCI).
LE-SN38 is NeoPharm's NeoLipid liposomal formulation of SN-38, the active metabolite of irinotecan (Camptosar), a chemotherapeutic pro-drug approved for the treatment of advanced colorectal cancer.
“Our LE-SN38 drug candidate, as well as the underlying NeoLipid drug delivery platform are an important part of our oncology portfolio,” said Guillermo Herrera, NeoPharm's president and CEO. “We are pleased to be moving LE-SN38 into phase II testing with CALGB, one of the premiere oncology clinical research groups, in the hope of eventually providing colorectal cancer patients with a new and potentially less toxic treatment option.”
The phase II trial will seek to enroll up to 54 patients. The primary endpoint of the trial is overall tumor response rate following treatment with LE-SN38 as a second-line treatment in patients with metastatic colorectal cancer. Other endpoints include determining the safety profile of LE-SN38 in this patient population, as well as the progression-free survival and overall survival for the patients treated.