AMAG Pharmaceuticals Inc., of Lexington, Mass., said a new subgroup analysis from IDA-301, a Phase III, randomized, placebo-controlled trial, was presented at the first poster session of the American College of Obstetrics and Gynecology annual meeting in New Orleans. In the full IDA-301 study, 608 adult patients with iron deficiency anemia (IDA) who had failed or could not tolerate oral iron were treated with ferumoxytol and 200 received placebo, with the demographics and all baseline

Esperion Therapeutics Inc., of Ann Arbor, Mich., disclosed full results of a Phase II trial of ETC-1002 in patients with Type II diabetes and hypercholesterolemia. The trial met its primary endpoint, demonstrating that ETC-1002 lowered LDL-C by up to 43 percent, and was associated with improvements in control of other cardiometabolic risk factors. ETC-1002 was well tolerated. The data were presented in an oral session at the Arteriosclerosis, Thrombosis, and Vascular Biology 2013 Scientific

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported additional findings for sufentanil NanoTab PCA system, its lead product in moderate to severe acute pain in the hospital setting. New analyses from the Phase III comparison trial demonstrated that sufentanil delivered through the AcelRx system produced greater reduction in pain intensity in the first four hours after initiating treatment than intravenous patient-controlled analgesia (IV PCA) with morphine (p < 0.01). In addition

Agenus Inc., of Lexington, Mass., said preliminary data from a Phase II trial showed that newly diagnosed glioblastoma multiforme (GBM) patients treated with Prophage G-100 (heat shock protein-peptide complex-96, HSPPC-96) vaccine plus the standard of care showed a 146 percent increase in progression-free survival (PFS) and a 60 percent increase in overall survival (OS) as compared to the standard of care alone. Results were presented at the 81st American Association of Neurological Surgeons

Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported positive topline results from AUGMENT COPD, the second six-month pivotal Phase III trial evaluating the efficacy and safety of investigational fixed-dose combinations of aclidinium bromide (LAMA) and formoterol fumarate (LABA), delivered in the Pressair (Genuairn outside the U.S.) inhaler. The 400/12 mcg combination of aclidinium/formoterol demonstrated statistically significant improvements in change from

Cyclacel Pharmaceuticals Inc., of Berkeley Heights, N.J., reported updated median overall survival data from an ongoing Phase II trial of oral sapacitabine in older patients with intermediate-2 or high-risk myelodysplastic syndromes after treatment failure of front-line hypomethylating agents. Median overall survival to date for all 63 patients treated is about nine months, while median overall survival for each of the three randomization schedules is about 10 months for arm G, 10 months for

BioLineRx Ltd., of Jerusalem, said the first patient was enrolled in a Phase I/II trial of BL-8020, an orally available, interferon-free treatment for hepatitis C virus (HCV). The open-label trial will evaluate efficacy, safety and tolerability at two sites in France, enrolling up to 32 HCV-infected patients of any genotype who previously failed or relapsed following standard-of-care treatment. The primary endpoint is to evaluate the effect of the 16-week combination therapy, comprised of

Derma Sciences Inc., of Princeton, N.J., said patient screening started in the second of two Phase III trials testing topical drug candidate DSC127 for the treatment of diabetic foot ulcers. The study will have three arms of 211 patients each and will test a 0.03 percent formulation of the drug against a topical vehicle and against a standard-of-care hydrogel. The first Phase III trial, which started in February, is testing two arms of 211 patients each, evaluating DSC127 vs. topical vehicle

Active Biotech, of Lund, Sweden, and Ipsen, of Paris, said they now plan to conduct the primary progression-free survival analysis for the 10TASQ10 global Phase III trial of tasquinimod in 2014, at the same time as the first interim overall survival analysis, when more mature data are available. The product, a small molecule that binds to S100A9, is the subject of a study across 37 countries in 1,245 metastatic castrate-resistant prostate cancer patients who have not yet received chemotherapy

Pfizer Inc., of New York, said that top-line data for a Phase IV trial of Celebrex (celecoxib) capsules or naproxen in juvenile idiopathic arthritis patients demonstrated no difference in changes to systolic blood pressure, the primary endpoint, and diastolic blood pressure, the secondary endpoint. The safety profile was similar in both groups. Celebrex has been approved by the FDA for juvenile rheumatoid arthritis since 2006, but little is known of the impact of nonsteroidal anti-inflammatory

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported that its Phase II study of sublingual sufentanil NanoTab for acute pain, ARX-04, met its primary endpoint of significantly greater pain reduction than placebo (p = 0.003). Patients who had received bunionectomy surgery were dosed with 30 mcg sufentanil no more than once per hour. Adverse events were mild to moderate, with two severe events (infections) reported, which were determined to be unrelated to the study drug. AcelRx will

Acorda Therapeutics Inc., of Ardsley, N.Y., and Mayo Clinic reported that enrollment has begun in the first trial of rHIgM22, a remyelinating antibody being studied for the treatment of multiple sclerosis (MS...Acorda licensed the worldwide rights to the antibodies from the Mayo Clinic in 2000. (See BioWorld Today, Feb. 17, 2012

Advaxis Inc., of Princeton, N.J., said the first patient was dosed in a Phase I/II study of ADXS-HPV in 25 patients with HPV-associated anal cancer. The trial is being coordinated by the Brown University Oncology Research Group, and is expanding into the third tumor type, following cervical cancer and head and neck cancer. The primary objectives include the evaluation of adverse events and a six-month clinical response. BioInvent International AB, of Lund, Sweden, said the first patient has

ADial Pharmaceuticals LLC, of Charlottesville, Va., said the FDA approved its plan to initiate Phase III trials of AD04 in alcohol use disorder in certain targeted genotypes. Patients will initially be screened for the targeted genotypes, and those with one or more of the targeted genotypes will be enrolled in the trial. Enrolled patients will then be randomized between the active drug and placebo. The endpoints for demonstrating the efficacy of AD04 in the trial are percent of heavy drinking

Ceregene Inc., of San Diego, reported top-line data from its double-blind, randomized, controlled Phase IIb study of CERE-120 (AAV-neurturin), a gene therapy designed to deliver the neurotrophic factor neurturin, for Parkinson's disease. The trial did not demonstrate statistically significant efficacy on the primary endpoint, which was UPDRS-motor off. However, one of the secondary endpoints (Diary-off score), as defined and prespecified in the statistical analysis plan, did produce

Inovio Pharmaceuticals Inc., of Blue Bell, Pa., said its SynCon universal H1N1 influenza vaccine generated protective antibody levels comparable to an FDA-approved seasonal influenza vaccine against a currently circulating flu strain. Data from the Phase I study in healthy volunteers were presented at the World Vaccine Congress in Washington. Northwest Biotherapeutics Inc., of Bethesda, Md., said that a patient treated with DCVax-L for glioblastoma multiforme in 2002 has celebrated his 10th

Alkermes Inc., of Dublin, Ireland, said top-line data from a Phase II study showed that ALKS 5461, a drug in development to treat patients who have an inadequate response to standard therapies for clinical depression, significantly reduced depressive symptoms across a range of standard measures, including the study's primary outcome measure, the Hamilton Depression Rating Scale (p = 0.026), the Montgomery-Asberg Depression Scale (p = 0.004) and the Clinical Global Impression-Severity Scale (p

Achillion Pharmaceuticals Inc., of New Haven, Conn., said it started a Phase II trial of sovaprevir and ACH-3102, in combination with ribavirin, for the treatment of genotype 1 chronic hepatitis C virus patients who have not received prior therapy. The study will evaluate the all-oral, 12-week, interferon-free regimen for safety, tolerability and efficacy in up to 50 patients. Initially, 30 patients will be enrolled and randomized to receive either a combination of sovaprevir, ACH-3012 and

Almirall SA, of Barcelona, Spain, and Forest Laboratories Inc., of New York, reported top-line results from a six-month pivotal Phase III study testing fixed-dose combinations of aclidinium bromide, a long-acting muscarinic beta2 agonist, and formoterol fumarate, a long-acting beta2 agonist, delivered using Almirall's inhaler Genuair. Both combinations of aclidinium/formoterol showed statistically significant improvements in the co-primary endpoints of change from baseline in morning predose