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

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

Advanced Cell Technology Inc., of Marlborough, Mass., treated the first patient in patient cohort 2a of its Phase I trials, consisting of patients with better vision, in its U.S. trial for Stargardt's Macular Dystrophy (SMD), a form of juvenile macular degeneration. The patient was injected with 100,000 human embryonic stem cell-derived retinal pigment epithelial cells. As the company announced on Jan. 22, patients with a visual acuity of 20/100 are eligible for enrollment in cohort 2a in the

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

InDex Pharmaceuticals AB, of Stockholm, Sweden, completed enrollment for its Phase III COLLECT study of Kappaproct. The multinational, randomized, double-blind, placebo-controlled study reached the recruitment goal of 120 patients with treatment-refractory ulcerative colitis. InDex is expecting final study results in mid-2014. The primary endpoint of the study is the induction of clinical remission at week 12. The patients will be followed for a total of 52 weeks. Kythera Biopharmaceuticals

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

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

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