ArQule Inc., of Woburn, Mass., began patient dosing in a Phase I trial with ARQ 087, an oral multikinase inhibitor with pan-FGFR (fibroblast growth factor receptor) activity. The primary objective of the trial is to determine safety, tolerability and the recommended Phase II dose. Patients with metastatic solid tumors who are refractory to available therapies or for whom no standard systemic therapy exists will be enrolled. The number of patients expected to be enrolled will depend on the

ARCA biopharma Inc., of Broomfield, Colo., said a paper published in the European Journal of Heart Failure discusses the post-hoc analyses of data from the Phase III study, designated BEST (Beta-Blocker Evaluation of Survival Trial), testing Gencaro (bucindolo hydrochloride) in heart failure. Data demonstrated that patients with established atrial fibrillation (AF) receiving Gencaro in the trial had improvements in heart failure clinical endpoints, and those receiving Gencaro were more likely

Eli Lilly and Co., of Indianapolis, provided an update on the next steps planned for solanezumab, its Phase III monoclonal antibody being studied as a potential therapy for patients with mild Alzheimer's disease. Following discussions with regulators in the U.S., Europe and Canada, Lilly plans to conduct an additional Phase III study of solanezumab in patients with the condition, but other details of the study, which will begin no later than the third quarter of next year, are yet to come.

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., disclosed positive results from a Phase II safety, pharmacokinetics and efficacy trial of its boron-based phosphodiesterase-4 inhibitor, AN2728, in adolescents, ages 12 to 17, with mild to moderate atopic dermatitis. The 23-patient study showed that 74 percent of patients achieved an Investigator Static Global Assessment (ISGA) score of zero or 1 after four weeks of treatment, and 35 percent achieved an ISGA score of zero or 1 with a minimum

Bristol-Myers Squibb Co., of New York, and Pfizer Inc., also of New York, disclosed data from a Phase III study testing Eliquis (apixaban) for the prevention of recurrent venous thromboembolism (VTE). Data from the year-long trial, published in the New England Journal of Medicine, showed that treatment with Eliquis significantly reduced the recurrence of VTE and death from any cause compared to those treated with placebo.

Active Biotech AB, of Lund, Sweden, and Ipsen SA, of Paris, said the Phase III study of tasquinimod in prostate cancer is fully enrolled, with more than 1,200 randomized patients. That achievement triggers a €10 million (US$12.9 million) milestone payment from Ipsen to Active Biotech. The study is testing tasquinimod in patients with metastatic castrate-resistant prostate cancer, with radiological progression-free survival as the primary endpoint and overall survival as a secondary endpoint

Iroko Pharmaceuticals LLC, of Philadelphia, reported that a Phase III study of submicron indomethacin for postsurgical pain met its primary endpoint of significant pain relief compared to placebo. The trial enrolled 462 patients, who were randomized to submicron indomethacin, celecoxib or placebo. Submicron indomethacin met that goal at all doses tested. The drug was developed using technology licensed to Iroko from iCeutical Pty Ltd., which alters the pharmacokinetic absorption properties of

Isis Pharmaceuticals Inc., of Carlsbad, Calif., reported that three drugs were found to be safe and well tolerated in separate Phase I studies. The drugs, ISIS-PTP1B(Rx), ISIS-GCGR(Rx), and ISIS-GCCR(Rx), are in development for indications related to metabolic disorders including Type II diabetes. ISIS-PTP1B(Rx) is designed to target protein tyrosine phosphatase-1B, ISIS-GCGR(Rx) is designed to target the glucagon receptor and ISIS-GCCR(Rx) is designed to target the glucocorticoid receptor

BrainCells Inc., of San Diego, said it completed a Phase I multiple-ascending-dose study of BCI-838, an oral prodrug of the company's Group II mGluR2/3 antagonist, BCI-632. BCI-838 showed a favorable safety profile, with no treatment-related trends in clinical laboratory results, vital sign measurements, 12 lead ECG results or physical examination findings, and the drug was well tolerated up to the dose levels predicted for efficacy. The company will advance the compound into a proof-of-concept

Pfizer Inc., of New York, said randomized Phase II data showed that PD-0332991 in combination with letrozole significantly extended progression-free survival (PFS) compared to letrozole alone in postmenopausal women with estrogen receptor-positive human epidermal growth factor receptor-1-negative locally advanced or metastatic breast cancer. Patients in the combination arm showed a median PFS of 26.1 months vs. 7.5 months in the letrozole-only arm, a statistically significant improvement (p < 0

Jazz Pharmaceuticals plc, of Dublin, Ireland, said the first patient was enrolled and dosed in a 25-patient study testing Erwinaze (asparaginase Erwinia chrysanthemi) administered intravenously as an alternative method of administration to treat patients with acute lymphoblastic leukemia with hypersensitivity to E. coli-derived asparaginase therapy. Preliminary pharmacokinetic data are expected in the second half of 2013. NeuroVive Pharmaceutical AB, of Lund, Sweden, said Phase I data

Emmaus Medical Inc., of Torrance, Calif., completed patient enrollment in a Phase III trial of L-glutamine for sickle cell disease. The randomized, double-blind, placebo-controlled trial will assess safety and efficacy of L-glutamine for sickle cell anemia and beta0-thalassemia. The trial has enrolled 225 patients at 31 sites in the U.S. (See BioWorld Today, Oct. 12, 2012.) InnaVirVax, of Evry, France, said interim results of a Phase I/IIa trial showed good safety and tolerability for the VAC

Theravectys SAS, of Paris, was granted authorization by the National Security Agency for Medicines and Health Products in France and the Federal Agency for Medicines and Health Products in Belgium to launch a Phase I/II trial with its anti-HIV therapeutic vaccine candidate based on lentiviral vector technology.

Bayer AG, of Leverkusen, Germany, said its BAY 86-6150 is being investigated in a Phase II/III study, dubbed TRUST (TReatment with Unique recombinant rFVIIa STudy), and the recruitment of the first cohort is now complete. TRUST is designed to test the recombinant Factor VIIa protein in patients with hemophilia A or hemophilia B who have developed neutralizing antibodies. The study is composed of two parts: The first will involve sequential dose escalation for assessing dose response and

Advanced Cell Technology Inc., of Marlborough, Mass., said it treated three additional patients in its U.S. trials testing retinal pigment epithelial cells derived from human embryonic stem cells. A Phase I/II study is in patients with dry age-related macular degeneration, while a separate study is testing the cells in Stargardt's macular dystrophy. Anthera Pharmaceuticals Inc., of Hayward, Calif., reported additional data from its Phase IIb PEARL-SC study at the Asian Lupus Summit meeting in

Bayer AG, of Leverkusen, Germany, said results of two pivotal Phase III studies, published in The Lancet, demonstrated the efficacy of regorafenib in patients with metastatic colorectal cancer or gastrointestinal stromal tumor who have exhausted all other treatment options. Data from the CORRECT study showed regorafenib plus best supportive care significantly improved overall survival and progression-free survival compared to placebo plus BSC (6.4 months vs. 5 months and 1.9 months vs. 1.7

AesRx LLC, of Newton, Mass., said it plans to present data from its Phase I study of antisickling agent Aes-103 at the American Society of Hematology meeting in Atlanta. The data showed the drug is safe and well tolerated and suggested Aes-103 is biologically active in humans in a manner consistent with its proposed mechanism of action in sickle cell disease. The first-in-human, double-blind, placebo-controlled trial examined the effects of single doses of Aes-103 at 300 mg, 1,000 mg, 2,000 mg

Accera Inc., of Broomfield, Colo., started a clinical efficacy trial examining the effects of AC-1204 in patients with mild-to-moderate Alzheimer's disease (AD). AC-1204 is a formulation of caprylic triglyceride designed to improve cognitive function in mild to moderate AD. The randomized, double-blind, placebo-controlled, parallel-group, multicenter trial will be conducted at 60 sites in the U.S. and is expected to enroll more than 400 patients. The study will evaluate the effects of once

The Journal of the American Academy of Dermatology published results from two pivotal trials by Valeant Pharmaceuticals International Inc., of Montreal, of efinaconazole 10 percent topical solution for onychomycosis, a nail infection caused by fungi. The primary endpoint of the randomized, double-blind, vehicle-controlled study enrolling 1,655 subjects was complete cure rate at week 52. In Study 1, 17.8 percent of subjects given efinaconazole achieved complete cure, compared to 3.3 percent of