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Array BioPharma Reports Financial Results for the Third Quarter of Fiscal 2009
Array reported revenue of
Array reported revenue of
SUMMARY OF RECENT PROGRESS
“We had a total of 18 presentations and publications on Array-invented
drugs at the 2009 AACR conference last month demonstrating the progress
we’ve made advancing our oncology pipeline,” said
Clinical trial initiated in Type II diabetic patients:
ARRY-403 – GK activator for Type II diabetes: Array initiated dosing Type II diabetic patients in a Phase 1 clinical trial with its novel small molecule glucokinase activator (GKA), ARRY-403. In the Phase 1 trial, the compound is being evaluated in a single-dose escalation study to evaluate safety, tolerability, pharmacokinetics and blood glucose control. In preclinical studies, ARRY-403 demonstrated effective control of both fasting and non-fasting blood glucose concentrations, and was shown to be highly dependent on blood glucose concentrations.
Three clinical programs advanced for the treatment of chronic inflammatory disease and pain:
ARRY-797 - p38 inhibitor for AS: Array continued a worldwide, 126-patient, 12-week Phase 2 proof-of-concept clinical trial with ARRY-797, a p38 inhibitor, in patients with ankylosing spondylitis (AS). Array also completed a dose escalation trial with ARRY-797 to test tolerability of up to 1200 mg daily in a sub-chronic setting for seven days and completed enrollment of a 28-day Phase 1b trial of ARRY-797 in patients with stable rheumatoid arthritis (RA) taking methotrexate.
ARRY-162 - MEK inhibitor for RA: Array completed patient enrollment in a worldwide, 200-patient, 12-week Phase 2 proof-of-concept clinical trial with ARRY-162, a MEK inhibitor, added to methotrexate in patients with rheumatoid arthritis.
ARRY-300 – MEK inhibitor: Array completed a Phase 1 trial with ARRY-300, a targeted small molecule MEK inhibitor. The Phase 1 trial was a randomized, single-blind, placebo-controlled, single-ascending dose study to evaluate the safety, pharmacokinetics and pharmacodynamics of ARRY-300 in healthy volunteers.
Four clinical programs advanced for the treatment of cancer & were
presented at the
ARRY-520 – KSP inhibitor for AML & MM: Array continued a Phase 1 trial of ARRY-520, a novel KSP inhibitor, in patients with solid tumors and Phase 1/2 trials of ARRY-520 in patients with acute myelogenous leukemia (AML) and in patients with multiple myeloma (MM).
AACR Highlights: Preclinical hematological tumor models were particularly responsive to treatment with ARRY-520, with a 100 percent complete response rate observed in AML, acute promyelocytic leukemia, and MM xenografts. Treatment of MM xenografts with ARRY-520 resulted in significant regression of tumors that had previously progressed after treatment with Velcade® (bortezomib) or Revlimid® (lenalidomide). In addition, ARRY-520 retained activity in a wide range of tumors resistant to other molecules with different mechanisms of action, such as the taxanes. Examination of pharmacodynamic activity in preclinical models reinforced that hematological cancers were among the most sensitive to ARRY-520.
ARRY-614 - p38 / Tie-2 inhibitor for MDS: Array is planning a Phase 1b trial of ARRY-614, a p38/Tie-2 inhibitor, in patients with myelodysplastic syndromes (MDS) to determine the safety, maximum tolerated dose, pharmacokinetics and preliminary estimates of efficacy of the compound in this patient population. This study is expected to begin during the second quarter of 2009. Array recently completed a Phase 1 clinical trial with ARRY-614 in a single and multiple dose escalation study in healthy volunteers for safety, tolerability, exposure and inhibition of mechanism related biomarkers.
AACR Highlights: In preclinical hematological tumor models, ARRY-614 demonstrated activity both as a single agent and in combination with Revlimid® (lenalidomide). Results show that ARRY-614 was well-tolerated and effective in inhibiting cytokines, including IL-6 and TNF, which play a role in the regulation of growth and survival in a number of cancers, particularly hematological cancers. As a single agent, ARRY-614 effectively inhibited angiogenesis in vivo and inhibited tumor growth in preclinical models of MM. Additionally, data show that administering p38 inhibitors in combination with lenalidomide yielded superior inhibition of proinflammatory cytokines and that combining ARRY-614 with standard-of-care agents, lenalidomide and Decadron® (dexamethasone), in MM provided additional anti-tumor effects.
ARRY-543 - ErbB-2 / EGFR inhibitor for solid tumors: Array continued its Phase 1b trial of ARRY-543 in combination with Xeloda® (capecitabine) in patients with solid tumors. Array initiated two additional Phase 1b trials, in combination with Taxotere® (docetaxel) and Gemzar® (gemcitabine).
AACR Highlights: Preliminary results presented on Array’s Phase 1 trial showed that ARRY-543 was generally well-tolerated and demonstrated evidence of tumor regression and prolonged stable disease in EGFR- and ErbB2-expressing cancers. Of the confirmed patients with ErbB2-positive metastatic breast cancer treated with ARRY-543, 63 percent achieved stable disease for 16 weeks or longer. Twenty one patients were evaluated: 12 had available biopsies and eight were confirmed ErbB2-positive. Clinical benefit was demonstrated in five of these eight patients and patients with confirmed co-expression of ErbB2 and EGFR tended to have the best clinical benefit. In patients with other cancers shown to express ErbB family members, three patients, with ovarian cancer, cervical cancer and cholangiocarcinoma, respectively, treated with ARRY-543 also achieved stable disease for 16 weeks or more; the patient with cholangiocarcinoma experienced a tumor marker response that was accompanied by a 25 percent regression of target lesions.
ARRY-380 – ErbB-2 inhibitor for cancer: Patient recruitment in a Phase 1 trial of ARRY-380, an oral, selective ErbB-2 inhibitor, remains on track to complete in 2009. The trial is designed to evaluate the safety, maximum tolerated dose, and pharmacokinetics of ARRY-380 in cancer patients.
CONFERENCE CALL DETAILS
Array will hold a conference call on
Conference Call Information
|Tuesday, May 5, 2009|
|9:00 a.m. eastern time|
A replay of the call will be available as a webcast on www.arraybiopharma.com and by phone for one week by dialing toll-free (888) 203-1112 or (719) 457-0820. The access code is 2844590.
This press release contains forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995,
including statements about our future plans for advancing certain of our
proprietary drug programs, the potential to earn future milestone
payments, license fees or royalty revenue, and the plans of our
collaborators to further develop drugs we have out-licensed or on which
we are collaborating. These statements involve significant risks and
uncertainties, including those discussed in our annual report filed on
form 10-K for the year ended
|Array BioPharma Inc.|
|Condensed Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended||Nine Months Ended|
|March 31,||March 31,|
|License and milestone revenue||1,639||2,098||
|Cost of revenue||5,515||5,725||15,698||16,278|
Research and development for proprietary drug discovery
|General and administrative||4,461||3,737||13,435||12,944|
|Total operating expenses||30,005||33,292||97,381||91,219|
|Loss from operations||(23,967||)||(25,581||)||(77,907||)||(68,497||)|
|Impairment of marketable securities||(3,381||)||-||(17,742||)||-|
|Basic and diluted net loss per share||$||(0.62||)||$||(0.51||)||$||(2.12||)||$||(1.35||)|
|Number of shares used to compute per share data||48,068||47,428||47,747||47,236|
|Summary Balance Sheet Data|
|March 31,||June 30,|
|Cash, cash equivalents and marketable securities||$||72,932||$||125,531|
|Property, plant and equipment, gross||$||83,455||$||81,966|
|Stockholders' equity (deficit)||$||(54,958||)||$||38,027|
Tricia Haugeto, 303-386-1193