• Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application with the FDA for ARRY-380 and will proceed with a Phase I clinical trial in cancer patients. ARRY-380, a selective, orally active ErbB-2 inhibitor, has shown good efficacy in preclinical models of human breast cancer resulting in significant antitumor activity. The trial will begin this fall in the U.S. and Canada. The open-label, multiple-dose study is designed to evaluate safety, tolerability and pharmacokinetics of ARRY-380 following daily oral administration to patients with advanced cancer.

• Hana Biosciences, of South San Francisco, has initiated a multicenter, multinational Phase II clinical trial of Marqibo (vincristine sulfate injection, Optisome) in adult patients with relapsed acute lymphoblastic leukemia (ALL), also known as the rALLy study. Earlier this year Marqibo was granted orphan drug designation by the FDA for the treatment of adult ALL. The primary objective of study is to assess the efficacy and tolerability of weekly doses of Marqibo as a single agent without dose capping, measured by complete response rate or complete response without full platelet recovery. Secondary objectives include safety, duration of response rates and survival. The patient population is Philadelphia chromosome-negative adult patients in second relapse, or those patients who relapsed following two lines of anti-leukemia chemotherapy, including those who previously have undergone stem cell transplantation. Hana expects to enroll up to 56 patients. The company also plans to initiate a Phase III randomized, multicenter trial comparing Marqibo to vincristine in the induction, consolidation and maintenance phases of treatment in elderly patients with newly diagnosed ALL. Hana expects the Phase III clinical trial to be conducted in collaboration with U.S. and the ex-U.S. oncology cooperative groups.

• ImmunoCellular Therapeutics Ltd., of Los Angeles, said the first three patients have been enrolled in the Phase I clinical trial of its lead brain tumor vaccine product candidate, a dendritic cell-based vaccine that potentially could bolster the body's immune system to defend itself against malignant brain tumors. The vaccine technology is licensed by IMUC from Cedars-Sinai Medical Center, where the trial is being conducted.