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

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

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

Iroko Pharmaceuticals LLC, of Philadelphia, will present positive Phase III data for its nonsteroidal anti-inflammatory drug pipeline at two medical meetings summarizing studies of submicron indomethacin and submicron diclofenac for osteoarthritis pain. Both studies met the primary endpoint of significant pain relief compared to placebo. Data for indomethacin will be presented at the 29th Annual Meeting of the American Academy of Pain Medicine in Fort Lauderdale, Fla. Data for diclofenac will

Pacira Pharmaceuticals Inc., of Parsippany, N.J., reported Phase IV (EXCLAIM) results for Exparel (bupivacaine liposome injectable suspension) in postsurgical analgesia. Patients who received Exparel after abdominoplasty, breast augmentation, breast reduction or a combination procedure had low pain scores, high satisfaction with their pain control and minimal opioid use. Pacira presented the findings at The Aesthetic Meeting 2013.

BioLineRx Ltd., of Jerusalem, said it received regulatory approval in the U.S. to begin a Phase IIa trial of BL-8040, a selective antagonist of chemokine receptor CXCR4, in acute myeloid leukemia (AML). The open-label study under an investigational new drug application is designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adults with relapsed/refractory AML. The primary endpoints are safety and tolerability, with secondary endpoints including the

Reviva Pharmaceuticals Inc., of San Jose, Calif., reported top-line results from its Phase II REFRESH study of RP5063 in schizophrenia and schizoaffective disorder, with the dopamine serotonin stabilizer showing overall broad efficacy across the Positive and Negative Syndrome Scale total scores, as well as subscales: Positive, Negative and General Psychopathology. RP5063 also showed efficacy in the Clinical Global Impression Severity Scale and was well tolerated. The study enrolled 234 patients

Arena Pharmaceuticals Inc., of San Diego, initiated dosing in a Phase I trial of APD334, an oral drug candidate targeting the sphingosine 1-phosphate subtype 1 receptor, for the potential treatment of autoimmune diseases. The randomized, double-blind, placebo-controlled study will evaluate the safety, tolerability and pharmacokinetics of single-ascending doses of APD334 in up to 64 healthy adult volunteers. Emergent BioSolutions Inc., of Rockville, Md., expanded the protocol for its ongoing

Aastrom Biosciences Inc., of Ann Arbor, Mich., enrolled its first patients in a Phase IIb trial of ixCELL-DCM to assess safety and efficacy of ixmyelocel-T in advanced heart failure that is caused by ischemic dilated cardiomyopathy. The randomized, double-blind, placebo-controlled trial will enroll 108 patients at about 30 sites in the U.S. to receive ixymyelocel-T through a catheter. The primary endpoint will be the average number of events per patient, over a 12-month period. Aragon

Aspireo Pharmaceuticals Ltd., of Tel Aviv, Israel, reported results of a Phase II study in acromegaly patients showing that Somatoprim, its somatostatin analogue, demonstrated a dose-dependent effect on lowering excess growth hormone in treatment-naïve patients. No serious adverse events were reported, and the reported adverse events were mild to moderate and transient in nature. The trial was designed to test single-ascending doses of Somatoprim in up to 20 patients. Cellular Biomedicine

Ampio Pharmaceuticals Inc., of Greenwood Village, Colo., said the FDA accepted its investigational new drug application and announced treatment of the first 15 patients in a trial using Ampion to treat osteoarthritis of the knee. The trial will proceed in two parts, with the first run-in portion to evaluate two doses of Ampion in 320 adults to determine the optimal dosage for the second portion of the pivotal study. The number of patients required in the second part will be determined based on

Anaeropharma Science Inc., of Tokyo, initiated a Phase I trial of APS001F in U.S. patients with advanced or metastatic solid tumors whose disease is no longer responsive to available treatments. The dose-escalation trial is designed to evaluate the safety, tolerability and efficacy of APS001F, a living recombinant bifidobacterium designed to express the cytosine deaminase gene in tumors. The therapy is expected to limit the systemic toxicity of the antitumor agent 5-FU. Anthera Pharmaceuticals

Boston Therapeutics Inc., of Manchester, N.H., said it will focus its pipeline to accelerate the commercialization of PAZ320, a chewable complex carbohydrate to manage postprandial glucose (PPG) or postmeal blood sugar in people with diabetes, and Ipoxyn, an anti-necrosis drug designed to target both human and animal tissue and organ systems deprived of oxygen and in need of metabolic support. PAZ320 recently completed a Phase II trial in Type II diabetics, showing a 40 percent reduction of PPG

BioCryst Pharmaceuticals Inc., of Research Triangle Park, N.C., said it started a Phase I trial in healthy volunteers to evaluate orally administered BCX4161 , a selective inhibitor of plasma kallikrein in development for the prevention of attacks in patients with hereditary angioedema. The study is expected to assess safety, characterize plasma drug levels and estimate the extent of kallikrein inhibition achieved. Data are expected later this year. Catabasis Pharmaceuticals Inc., of

Phosphagenics Ltd., of Melbourne, Australia, said it achieved all the endpoints of its Phase I trial of its oxymorphone patch by successfully delivering the opioid into the bloodstream via its TPM transdermal patch. The company will proceed with Phase II trials in the second half of 2013.