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

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

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.

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

Benitec Biopharma Ltd., of Sydney, Australia, selected the Duke Clinical Research Unit in Durham, N.C., as a site for its upcoming Phase I/II first-in-human trial of TT-034 in hepatitis C virus (HCV). The open-label, dose escalation study will evaluate the safety and activity of single doses of TT-034 in patients with chronic HCV genotype 1 infection who failed previous treatments. The trial is expected to involve 14 patients in 5 sequential dose cohorts, although additional consolidation

Affinium Pharmaceuticals Inc., of Toronto, said its Phase IIa trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections (ABSSSI) demonstrated efficacy and safety, marking a proof-of-concept milestone for Affinium's first-in-class antibiotic targeted against bacterial fatty acid biosynthesis inhibition. The study in 103 patients confirmed the efficacy, safety and tolerability of 200 mg of oral AFN-1252 dosed twice daily for five to 14 days in patients with ABSSSIs due

LEO Pharma UK, of Princes Risborough, UK, reported that data published in the Journal of the American Medical Association Dermatology demonstrated the long-term effectiveness of Picato (ingenol mebutate) in treating actinic keratosis (AK), a leading cause of nonmelanoma skin cancer. The data showed that about 45 percent of patients who achieved clearance after the initial two- or three-day treatment experienced sustained clearance of AK lesions a year later. Patients in the overall study

Teva Pharmaceutical Industries Ltd., of Jerusalem, and H. Lundbeck A/S, of Copenhagen, Denmark, said the ANDANTE (Add oN to Dopamine AgoNists in the TrEatment of Parkinson's disease), testing Azilect (rasagiline tablets) as an add-on treatment to dopamine agonists compared to placebo met its primary endpoint. Results showed that the addition of Azilect 1 mg/day provided a statistically significant improvement in total Unified Parkinson's Disease Rating Scale score from baseline to week 18 in

Acorda Therapeutics Inc., of Ardsley, N.Y., said data from a Phase I study showed that a single dose of 20-mg Diazepam Nasal Spray had comparable plasma bioavailability to 20 mg of diazepam rectal gel. Diazepam Nasal Spray is being developed for treating people with epilepsy who experience cluster seizures, also known as acute repetitive seizures. Data were presented at the American Academy of Neurology meeting in San Diego. Acorda plans to submit a new drug application under the 505(b)(2

Acasti Pharma Inc., of Laval, Quebec, a subsidiary of Neptune Technologies & Bioressources Inc., reported preliminary data from a randomized, open-label, dose-ranging, multicenter trial assessing the safety and efficacy of NKPL66, or CaPre, in mild-to-high hypertriglyceridemia. Data from 157 patients who completed four weeks of treatment with 0.5, 1, 2 or 4 grams of CaPre per day were assessed, with CaPre achieving a statistically significant triglyceride reduction of up to 23 percent, compared

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, and Eli Lilly and Co., of Indianapolis, started a Phase IIIb trial to evaluate the glycemic efficacy and safety of linagliptin in patients with Type II diabetes with prevalent albuminuria (defined as urinary albumin-to-creatinine ratio [UACR] 30-3000 mg/g creatinine), while remaining on current standard therapy for diabetic nephropathy.

Eli Lilly and Co., of Indianapolis, presented findings at the European Association of Urology Congress in Milan, Italy, showing that Cialis 5 mg once daily co-administered with finasteride (Proscar, Merck & Co. Inc.) significantly improved scores on the International Prostate Symptom Score (IPSS), compared to placebo/finasteride, in men with lower urinary tract symptoms of benign prostatic hyperplasia (LUTS/BPH) and enlarged prostates. On a pre-specified secondary measure, Cialis/finasteride

Alnylam Pharmaceuticals Inc., of Cambridge, Mass., began dosing patients in a Phase I trial of ALN-TTRsc for TTR-mediated amyloidosis. The randomized, double-blind, placebo-controlled trial will be carried out in the UK with a primary objective of safety and tolerability of single and multiple doses of subcutaneous ALN-TTRsc. Secondary objectives of the trial include clinical activity by serum TTR levels. The company expects to present data from the trial in mid-2013. Upon completion, it will