BioAlliance Pharma SA, of Paris, said Japanese partner Sosei Group Corp., of Tokyo, started a Phase III study of SO-1105, an antifungal agent administered as a mucoadhesive buccal tablet, for the treatment of oropharyngeal candidiasis. The study will involve open active comparator miconazole gel and will evaluate efficacy and safety. Sosei licensed Japanese rights to the compound from BioAlliance, which markets the product as Loramyc/Oravig. Lithera Inc., of San Diego, said the first patient

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

Merck & Co. Inc., of Whitehouse Station, N.J., said researchers from the Clinical Trial Service Unit at Oxford University presented results from the HPS2-THRIVE (Heart Protection Study 2-Treatment of HDL to Reduce the Incidence of Vascular Events) study of Tredaptive (extended-release niacin/laropiprant) during the late-breaking clinical trial session at the American College of Cardiology 62nd Annual Scientific Session in San Francisco. The composite primary endpoint of major vascular events

Gilead Sciences Inc., of Foster City, Calif., said data from the double-blind, placebo-controlled, parallel Phase IV TERISA (Type II Diabetes Evaluation of Ranolazine In Subjects With Chronic Stable Angina) study showed that adding ranolazine (Ranexa) to background anti-anginal therapy in chronic angina patients with Type II diabetes significantly reduced the frequency of weekly angina episodes compared to placebo and background anti-anginal therapy. Following a single-blind, four-week placebo

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.

AcelRx Pharmaceuticals Inc., of Redwood City, Calif., reported top-line data demonstrating that the first of two pivotal Phase III studies testing its sublingual Sufentanil NanoTab PCA (patient-controlled analgesia) System met its primary endpoint, which evaluated pain intensity over the 48-hour study period compared to baseline, or Summed Pain Intensity Difference (SPID-48), in patients following major open abdominal surgery. Results showed that patients receiving Sufentanil NanoTabs realized

Pfizer Inc., of New York, said results from a Phase III study demonstrated immunogenicity, tolerability and safety of Prevnar 13 (pneumococcal 13-valent conjugate vaccine [diphtheria CRM197 protein]) in adults infected with HIV. Results were presented at the Conference on Retroviruses and Opportunistic Infections in Atlanta. UCB SA, of Brussels, Belgium, reported results from a Phase III study showing that lacosamide monotherapy met the primary endpoint, with a significantly lower exit rate

Argos Therapeutics Inc., of Durham, N.C., said it validated the durability of the immune response for metastatic renal cell carcinoma patients treated with AGS-003. The company also said it confirmed the correlation between specific immune markers and overall survival in those patients is statistically significant. Data from the studies will be presented during two poster sessions at Keystone Symposia's Understanding Dendritic Cell Biology to Advanced Diseases Therapies Conference this week in

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

Alchemia Ltd., of Brisbane, Australia, said it completed enrollment in a pivotal Phase III trial evaluating HA-Irinotecan for the treatment of metastatic colorectal cancer, with 415 patients recruited, including 71 subjects enrolled in a substudy designed to provide additional pharmacokinetic and cardiotoxicity data. The primary endpoint of the study is progression-free survival, and results are expected in early 2014. CytRx Corp., of Los Angeles, said it completed enrollment of 140 patients

Boehringer Ingelheim GmbH, of Ingelheim, Germany, enrolled the first patient in its Phase III study (POLO-AML-2) investigating volasertib, a selective polo-like kinase inhibitor, in combination with chemotherapy in patients with acute myeloid leukemia (AML) who are ineligible for intensive therapy. The primary endpoint is objective response to the combination treatment compared to the chemotherapy alone, with overall survival as the main secondary endpoint. At the American Society of Hematology

Agenus Inc., of Lexington, Mass., said it completed patient screening for its Phase II study for HerpV, a recombinant, off-the-shelf therapeutic vaccine candidate for the treatment of genital herpes in herpes simplex virus-2-positive patients. HerpV contains Agenus' QS-21 Stimulon adjuvant. The study is testing the biological efficacy of the vaccine as measured by the effect on genital viral shedding after three injections. A booster of HerpV will be given at six months after treatment to

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

Adynxx Inc., of San Francisco, said the first patient was dosed in a Phase II study of AYX1 , its lead candidate to prevent post-surgical pain. The 90-patient, placebo-controlled study will evaluate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty to reduce acute pain and prevent the transition to persistent pain. The study will follow patients for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory

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.