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.

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

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

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.

AMAG Pharmaceuticals Inc., of Lexington, Mass., reported preliminary data from the IDA-303 study showing that the 151 patients who received their first course of therapy with ferumoxytol achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6 g/dL, a change consistent with the 2.7 g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both pivotal IDA-301 and IDA-302 studies. The single-arm, open-label extension trial was designed to

Merck & Co. Inc., of Whitehouse Station, N.J., said the data safety monitoring board of the IMPROVE-IT trial testing cholesterol-lowering drug Vytorin (ezetimibe/simvastatin) completed its planned review and recommended that the study continue. The study design calls for the collection of 5,250 clinical endpoints, and Merck remains blinded to the actual results of the analysis and to other safety and efficacy data. No additional interim analyses are planned for the 18, 141-patient, event-driven

Janssen Research & Development LLC, of Raritan, N.J., a unit of Johnson & Johnson, said it launched EXPLORER, a global research program for oral anticoagulant Xarelto (rivaroxaban) to evaluate its use in patients with chronic heart failure and in those with coronary artery disease or peripheral artery disease. Janssen and partner Bayer AG, of Leverkusen, Germany, will enroll patients into five global clinical trials, which will involve a total of 28,850 patients.

Bio-Path Holdings Inc., of Houston, said it started enrolling patients in the fifth dosage cohort in its Phase I trial testing BP-100-1.01 (liposomal Grb-2) as a systemic treatment for blood cancers, including acute myeloid leukemia, chronic myelogenous leukemia, acute lymphoblastic leukemia and myelodysplastic syndrome. Patients in the fifth cohort will receive a dose of 60 mg/m2 twice a week for four weeks. The firm remains on track to complete Phase I dosing by midyear. Zealand Pharma A/S

Kowa Co. Ltd., of Tokyo, and Eli Lilly and Co., of Indianapolis, reported results showing that Livalo (pitavastatin), after 12 weeks of therapy, had a significantly greater decrease in low-density lipoprotein cholesterol in HIV-infected adults with dyslipidemia, with and without viral hepatitis B or C, compared to pravastatin (-49.4 mg/dL and -33.6 mg/dL, respectively; p < 0.001). Data were presented at the Conference on Retroviruses and Opportunistic Infections in Atlanta.

InnaVirVax, of Evry, France, presented interim results of a Phase I/IIa trial of VAC-3S at the Conference on Retroviruses and Opportunistic Infections in Atlanta, showing safety at three doses tested and immune response among patients in the two highest doses. The trial enrolled 25 patients with HIV on antiretroviral therapy, with a CD4 T-lymphocyte count higher than 200/mm3. After all patients had received three injections, no serious adverse effects or viral rebounds were observed. The

Boehringer Ingelheim Pharmaceuticals Inc., of Ridgefield, Conn., part of Boehringer Ingelheim GmbH, reported the first interim results in HCV/HIV co-infected patients from the company's ongoing hepatitis C (HCV) clinical trial program, HCVerso. The results, from the Phase III trial STARTVersoTM 4, were presented at the 20th annual Conference on Retroviruses and Opportunistic Infections (CROI) in Atlanta. The results showed that 80 percent of HCV/HIV co-infected patients achieved early treatment

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., reported positive preliminary results from the second of two Phase III trials of tavaborole (known as Study 302). Tavaborole is a topical anti-fungal for the treatment of onychomycosis, a fungal infection of the nail and nail bed that affects approximately 35 million people in the U.S. Results from the first Phase III trial (known as Study 301) were announced in January. In both studies, tavaborole achieved statistically significant and

Antisense Pharma GmbH, of Regensburg, Germany, revised its business objectives related to the advancement of its next-generation TGF-beta inhibitor oligonucleotide program. The company is analyzing data from SAPPHIRE (G005), the Phase III study of lead compound trabedersen (AP12009) in glioma that was terminated early, with final results expected in the third quarter. However, preliminary safety data analyses suggested the benefit/risk ratio might not favor the trabedersen treatment arm due to

Synthetic Biologics Inc., of Rockville, Md., said its flupirtine sublicensee, Meda AB, of Goteborg, Sweden, received a green light from the FDA to conduct a Phase II proof-of-concept study for the treatment of fibromyalgia, as reported in Meda's 2012 year-end report. Meda has announced that the randomized, double-blind, placebo and active-controlled study of patients with fibromyalgia will be conducted at 25 clinics in the U.S. Flupirtine is described as a first-in-class type of central nervous

Sihuan Pharmaceutical Holdings Group Ltd., of Hong Kong, said pinoxacin hydrochloride received approval for clinical studies from the State Food and Drug Administration. Phase I studies are set to begin in the first half of this year. The compound is in the DPP-4 inhibitor class of oral hypoglycemic agents, a drug with a new structure for treating Type II diabetes.

GenSpera Inc., of San Antonio, said the first patient has been treated in a Phase II trial of lead compound, G-202, in patients who have hepatocellular carcinoma (HCC). Data from the G-202 Phase Ib program in solid tumor patients showed the compound was well tolerated, with prolonged disease stabilization observed in several hepatocellular carcinoma patients who had previously progressed on sorafenib therapy. The company's technology platform combines plant-derived cytotoxin thapsigargin with a

Mundipharma International Corp., of Cambridge, UK, said results from the StiL NHL-1 study published in The Lancet showed that a first-line treatment regimen of bendamustine plus Rituxan (rituximab, Biogen Idec Inc. and Roche AG) doubled progression-free survival compared with CHOP plus rituximab in newly diagnosed patients with indolent non-Hodgkin's lymphoma and mantle cell lymphoma (69.5 months vs. 31.2 months; p < 0.0001).