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

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

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.

Aduro BioTech Inc., of Berkeley, Calif., said it completed enrollment in a Phase II trial of CRS-207 and GVAX Pancreas Cancer Vaccine eight months ahead of schedule. The vaccine regimen was given to patients with metastatic pancreatic cancer, and it was well tolerated with no unexpected adverse events. An interim analysis of safety and efficacy will be reported in the first quarter of 2013. Ariad Pharmaceuticals Inc., of Cambridge, Mass., published results of a Phase I trial of ponatinib in

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

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

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

Astex Pharmaceuticals Inc., of Dublin, Calif., said results from the dose-escalation portion of a Phase I/II study showed that SGI-110, a DNMT inhibitor, is well tolerated at doses higher than the biologically effective dose. Subcutaneous administration achieved efficient conversion to decitabine, resulting in an improved pharmacokinetic profile over the intravenous Dacogen (decitabine) formulation, and clinical responses were observed in the heavily pretreated population of patients with

Aeterna Zentaris Inc., of Quebec City, said perifosine, its oral AKT inhibitor, combined with temsirolimus was well tolerated in an investigator-driven Phase I trial in recurrent or progression malignant glioma. The study, which involves 32 patients with recurrent or progression glioma, anaplastic astrocytoma, anaplastic oligodendroglioma and transformed low-grade gliomas, currently is accruing to dose level five after two dose-limiting toxicities in the dose level seven group and dose level

Pfizer Inc., of New York, said top-line data from a Phase III study testing pregabalin controlled-release (CR) formulation in patients with fibromyalgia indicated that the product had a statistically significant positive effect compared to placebo in the primary endpoint, defined as time to loss of therapeutic response. The trial is the second of three Phase III studies testing the CR formulation for once-daily therapy. The first study in partial onset seizures did not meet its primary endpoint

Pfizer Inc., of New York, said top-line results from a Phase III study testing the 165-mg dose and the 330-mg dose of pregabalin controlled-release (CR) formulation in adults with partial onset seizures showed that the trial did not meet its primary endpoint comparing the change in seizure frequency to placebo, although both doses were well tolerated. The study is one of three Phase III trials designed to test pregabalin CR for use as a once-daily therapy. The other two studies are testing the