Ironwood Pharmaceuticals Inc., of Cambridge, Mass., told licensor Bionomics Ltd., of Adelaide, Australia, that the planned Phase I trial of the investigational anti-anxiety drug candidate IW-2143 (BNC210) has begun in the U.S. The trial is designed to assess the safety and pharmacokinetics of IW-2143 in healthy volunteers, using single and multi-dose administration. (See BioWorld Today, Jan. 6, 2012.) Coronado Biosciences Inc., of Burlington, Mass., entered an agreement with the National

Merck and Co Inc., of Whitehouse Station, N.J., reported that its large study of Tredaptive (extended-release niacin/laropiprant) missed its primary endpoint. The trial enrolled 25,673 patients at high risk for cardiovascular events, and followed them for a median of 3.9 years while they received Tredaptive therapy plus statin therapy or statin therapy alone. The study found that the addition of Tredaptive did not significantly reduce the risk of coronary deaths, nonfatal heart attacks, strokes

Adventrx Pharmaceuticals Inc., of San Diego, said ANX-188 (purified poloxamer 188) passed quality control release specifications and is in the quality assurance release process for a Phase III study in sickle cell disease. Initiation of the trial is expected in about six weeks. Idera Pharmaceuticals Inc., of Cambridge, Mass., said 48 percent of patients with moderate to severe plaque psoriasis (12 of 15) treated with IMO-3100, a selective antagonist of Toll-like receptors 7 and 9, demonstrated

Acasti Pharma Inc., of Laval, Quebec, said it achieved significant progress in two ongoing clinical studies with CaPre for lipid management. The registrational Phase II double-blind, placebo-controlled clinical study has completed the first of two interim analyses. The second Phase II open-label study should be completed by the end of the first quarter of 2013. It has been delayed due to the need for further patient recruitment after the approved clinical trial amendment to add an additional 4

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data from a Phase III trial demonstrating that the Sufentanil NanoTab PCA System was noninferior (p < 0.001) to intravenous patient-controlled analgesia with morphine for the primary endpoint of Patient Global Assessment (PGA) of method of pain control over the 48-hour study period as determined by the combined percentage of patients with PGA ratings of "good" or "excellent" (78.5 percent vs. 66.1 percent, respectively

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.

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

Johnson & Johnson, of New Brunswick, N.J., reported that galantamine gave a significantly lower mortality rate compared to placebo in a study of patients with severe Alzheimer's disease. The galantamine group also had significantly less cognitive decline after two years compared to the placebo group. The study was terminated early due to an imbalance of deaths between the treatment and placebo group, favoring the treatment group. The study enrolled 2,051 subjects at 127 sites in 13 countries

BioAlliance Pharma SA, of Paris, said the European Independent Board of Experts held its first meeting on the ReLive Phase III trial of Livatag (doxorubicin transdrug) in primary liver cancer and recommended continuing the study without modification. Cell Therapeutics Inc., of Seattle, said interim results from a cooperative group-sponsored Phase II trial of brostallicin in combination with cisplatin for the treatment of women with metastatic triple-negative breast cancer were presented at the

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

UCB SA, of Brussels, Belgium, said a subgroup analysis of pooled data from three long-term open-label extension trials showed a consistent safety profile with epilepsy drug Vimpat (lacosamide), with the most commonly reported treatment-emergent adverse events being dizziness, headache and nasopharyngitis. Lacosamide exposure also was associated with a reduction in seizure frequency during the study period. A post-hoc analysis of pooled data from three Phase II/III studies suggested a greater

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

H. Lundbeck A/S, of Copenhagen, Demark, presented three-year vision data at the American Epilepsy Society meeting in San Diego. The FDA requires a risk evaluation and mitigation strategy for Sabril due to the risk of treatment-induced permanent vision loss, and the company offers an ongoing patient registry. Of the total patients enrolled in the registry, 2,676 had infantile spasms and 1,354 had refractory complex partial seizures. Because of the nature of the registry and vision testing