• Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-520, a kinesin spindle protein inhibitor that demonstrated tumor regression in preclinical models of human solid tumors and leukemias. Array plans to begin the Phase I study to evaluate the intravenously administered compound in patients with advanced cancer. The study will test safety, tolerability and pharmacokinetics, as well as examine indicators of therapeutic activity.

• BioSante Pharmaceuticals Inc., of Lincolnshire, Ill., started a Phase III trial of LibiGel (transdermal testosterone gel) in female sexual dysfunction (FSD). The six-month study will enroll about 360 surgically menopausal women and will be conducted under a Phase III protocol and investigational new drug application reviewed by the FDA. A previous Phase II study showed that LibiGel significantly increased satisfying sexual events in women suffering FSD. The company expects that two Phase III safety and efficacy trials, plus one year of safety data, will meet the requirements for a new drug application.

• GlaxoSmithKline plc, of London, said Phase III data published in the New England Journal of Medicine indicate that Tykerb (lapatinib) plus Xeloda (capecitabine, from F. Hoffmann-La Roche Ltd.) is superior to capecitabine alone in women with HER2- (ErbB2) positive advanced breast cancer who had progressed following prior therapy, including Herceptin (trastuzumab, from Genentech Inc.). Based on the findings, the study authors concluded that given its distinct mechanism of action and activity as a small-molecule dual receptor tyrosine kinase inhibitor, Tykerb should be investigated as an earlier treatment for HER2- (ErbB2) positive breast cancer. The drug is under regulatory review in the U.S. and Europe for advanced or metastatic HER2- (ErbB2) positive breast cancer in women who have progressed despite prior therapy, including Herceptin.

• Keryx Biopharmaceuticals Inc., of New York, and the Multiple Myeloma Research Consortium in Norwalk, Conn., began a Phase I study to explore the all-oral combination of KRX-0401 (perifosine), Revlimid (lenalidomide, from Celgene Corp.) and dexamethasone for relapsed or refractory multiple myeloma. The open-label trial is being conducted to determine the drug combination's safety and efficacy in these patients, as well as the highest dose at which KRX-0401 can be safely administered to multiple myeloma patients when combined with Revlimid and dexamethasone. KRX-0401 already is in multiple clinical trials for multiple myeloma.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., and its European partner Sigma-Tau SpA, of Pomezia, Italy, completed enrollment in the Phase III trial of Zadaxin (thymalfasin or thymosin alpha 1) in combination with pegylated interferon alpha and ribavirin to treat patients infected with the hepatitis C virus. The trial is being conducted by Sigma-Tau in Europe and has enrolled 553 patients. Separately, SciClone said it submitted a regulatory application to authorities in China for approval of DC Bead to treat liver cancer. The product is comprised of microscopic beads that block the supply of nutrients and blood to a tumor when administered by catheter into a blood vessel.

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said top-line results from its Phase II trial of glufosfamide in combination with gemcitabine as a first-line treatment of pancreatic cancer showed that 21 percent (6 patients) of the 28 patients evaluated had a partial response (including one unconfirmed partial response) and 36 percent (10 patients) had stable disease. Objective response was assessed radiologically after every two cycles of therapy. Glufosfamide in combination with gemcitabine was found to be generally well tolerated, though preliminary analysis of the safety data suggests a slightly higher incidence of treatment-related nephrotoxicity than previously observed with either agent used individually. News of the early data boosted the company's stock (NASDAQ:THLD) 61 cents, nearly 20 percent, Thursday to close at $3.81. Analyst Joel Sendek, of Lazard Capital Markets, maintains a "hold" rating on the stock pending glufosfamide survival data expected in the second half of 2007. Threshold anticipates reported data in the first part of the year from a Phase III study of glufosfamide as a second-line therapy in pancreatic cancer.