Profile: Array Biopharma Inc (ARRY.O)
12 Dec 2013
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of small molecule drugs to treat patients afflicted with cancer and inflammatory diseases. The drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target pathways. The Company’s drug candidates include AMG 151, MEK162, ARRY-380, ARRY-520, ARRY-543 and ARRY-614.
AMG 151 - Glucokinase Activator for Type 2 Diabetes Program Partnered with Amgen
In December 2009, the Company granted Amgen, the global rights to the small molecule glucokinase activator program, including, AMG 151. Glucokinase activators (GKAs), such as AMG 151, represents a new class of drugs for the treatment of Type 2 diabetes. Glucokinase (GK) is the enzyme that senses glucose in the pancreas. GK also increases glucose utilization and decreases glucose production in the liver. In 2009, the Company completed a phase I trial to evaluate AMG 151 in a single ascending dose study in Type 2 diabetic patients. During the fiscal year ended June 30, 2010 (fiscal 2010), the Company initiated two Phase 1 studies, a multiple ascending dose (MAD), trail in patients with Type 2 diabetes to evaluate safety, exposure and glucose control over a 10-day period and a relative bioavailability study assessing the effect of food and formulation on exposure.
MEK162 - MEK Inhibitor for Cancer Program Allied with Novartis
In April 2010, the Company granted Novartis under a License Agreement with the global right to develop and commercialize MEK162, which is in a Phase I cancer trial, as well as ARRY-300 and other specified MEK inhibitors. Under the agreement, the Company is responsible for completing the on-going Phase I clinical trial of MEK162 and might conduct further development of MEK162 in colorectal cancer. In fiscal 2010, the Company initiated a Phase I dose escalation trial of MEK162 in cancer patients and established the maximum tolerated dose.
ARRY-380 - HER2 Program Wholly owned by Array
HER2, also known as ErbB2, is a receptor tyrosine kinase, which is over-expressed in breast cancer and other cancers, such as gastric and ovarian cancer. Herceptin (trastuzumab), the intravenously-dosed protein inhibitor that modulates HER2, has been approved for HER2 positive metastatic breast cancer patients, as well as an adjuvant to surgery in early stage breast cancer patients. The second indication has expanded the number of breast cancer patients eligible for an HER2 inhibitor. ARRY-380 is an orally active, reversible and selective HER2 inhibitor. In fiscal 2010, the Company continued dose escalation in a Phase 1 trial to evaluate the safety, maximum tolerated dose and pharmacokinetics of ARRY-380 in patients with advanced cancer and plan to expand the trial at the maximum tolerated dose in HER2 positive cancer patients.
ARRY-520 - KSP Program Wholly-owned by Array
ARRY-520 inhibits kinesin spindle protein (KSP), which plays a role in mitotic spindle formation. ARRY-520 has demonstrated efficacy in preclinical hematological tumor models with response rates observed in models of acute myeloid leukemia (AML), and multiple myeloma (MM). In addition, ARRY-520 was active in a range of tumor models resistant to other molecules with different mechanisms of action, such as the taxanes. In fiscal 2010, the clinical development activities for ARRY-520 consisted of completed enrollment in a Phase I trial in patients with solid tumors, completed enrollment in a Phase I trial in patients with AML, and continued a phase 1/2 trial in patients with MM.
ARRY-543 - HER2 / EGFR Program wholly owned by Array
HER2 and EGFR are receptor kinase targets that are over-expressed in a number of malignancies, including breast, lung, pancreas, colon, head and neck cancers. In a Phase I trial, ARRY-543 produced prolonged stable disease in patients with solid tumors who had previously failed prior treatments. ARRY-543 was well-tolerated up to 400 milligrams twice daily, or BID, dosing. In a Phase Ib trial in patients with HER2-positive metastatic breast cancer (MBC), and ErbB-family cancer patients, ARRY-543 was tolerated and demonstrated evidence of tumor regression and prolonged stable disease in EGFR- and HER2-expressing cancers.
ARRY 614 - p38 / Tie2 for Cancer Program wholly owned by Array
P38 regulates the production of numerous cytokines, such as TNF, IL-1 and IL-6, the increased production of which can cause inflammation and aberrant tissue proliferation. ARRY-614, an orally active compound that inhibits both p38 and Tie2, has been found in preclinical models to block angiogenesis, to inhibit inflammation and to antagonize tumor growth, with a low side effect profile after prolonged dosing. In fiscal 2010, the Company continued a Phase I trial in patients with myelodysplastic syndrome (MDS), patients to determine the safety, maximum tolerated dose, pharmacokinetics and to obtain preliminary efficacy data of ARRY-614 in this patient population.
Array Biopharma Inc
3200 Walnut Street
BOULDER CO 80301