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

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

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

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.

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

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

Advanced Cell Technology Inc., of Santa Monica, Calif., treated patients in a third cohort of each of its two Phase I trials of human embryonic stem cell-(hESC) derived retinal pigment epithelial cells for macular degeneration. The patients received 150,000 cells, compared with the 100,000-cell dose used in the second cohort. The trials will assess safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with Stargardt's macular dystrophy and dry age

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

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.

Auxilium Pharmaceuticals Inc., of Chesterbrook, Pa., reported positive top-line data from a Phase IIa trial of Xiaflex (collagenase clostridium histolyticum, or CCH) in adhesive capsulitis, commonly known as frozen shoulder syndrome (FSS). The open-label study assessed the safety and efficacy of CCH in Stage II unilateral idiopathic FSS in comparison to an exercise-only control group. Fifty patients at 11 U.S. sites were enrolled into five cohorts of 10 patients each. Four groups received up to