Colorectal Cancer Research

The biotech company Lorus has announced the enrollment of the first cancer patient in a Phase I clinical study evaluating its small molecule anticancer drug candidate LOR-253. The open-label, dose escalation study will enroll patients with advanced or metastatic solid tumors for which no effective therapy is currently available, or whose cancer has not responded to conventional or standard therapies. The primary objectives of the study are to determine the maximum tolerated dose and recommended Phase II dose of LOR-253. Additional study objectives include the safety profile, antitumor activity, and pharmacokinetics of LOR-253. The study will be conducted under the direction of Dr. Andrea Cercek and Dr. Leonard Saltz in New York City at the Memorial Sloan Kettering Cancer Center, which is a recognized world leader in the investigation of novel cancer therapies. The study plans to enroll approximately 22-37 patients during the dose escalation stage. In addition, up to 10 patients will be added at the recommended Phase II dose level for assessment of tumor biomarkers related to the anticancer mechanism of LOR-253. Preference will be given to enrolment of patients with colorectal cancer and non-small cell lung cancer in this expanded treatment group, based on the strong anticancer efficacy of LOR-253 against these cancer types in preclinical studies. LOR-253 is a first in class drug, being the first clinical-stage compound to stimulate KLF-4 (Kruppel-like factor 4), a tumor suppressor factor which is characteristically deficient in a variety of cancers, including colorectal cancer and lung cancer, and so represents a new approach to cancer therapy. The study is listed in clinicaltrials.gov and can be accessed by clicking the following: http://clinicaltrials.gov/ct2/show/NCT01281592 .