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

Acceleron Pharma Inc., of Cambridge, Mass., said it started a Phase II study testing protein therapeutic ACE-536, in patients with beta-thalassemia. The trial will evaluate safety, tolerability and efficacy of the drug in nontransfusion-dependent patients, and efficacy measures will include increases in hemoglobin and red blood cell levels and biomarkers of erythropoiesis, hemolysis, iron metabolism and bone metabolism. ACE-536 is being developed in partnership with Celgene Corp., of Summit, N

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

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

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

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).

Amicus Therapeutics Inc., of Cranbury, N.J., reported positive results from clinical and preclinical studies of the pharmacological chaperone AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease at the Lysosomal Disease Network World Symposium. The results from a Phase II study established human proof-of-concept that co-administration of AT2220 just prior to infusing ERT (Myozyme/Lumizyme, or rhGAA enzymes) increases GAA enzyme activity in muscle tissue compared to ERT alone

Ablynx NV, of Ghent, Belgium, reported efficacy and safety data for its anti-IL-6R nanobody, ALX-0061, at the 24-week final analysis of the Phase II part of a Phase I/II study in patients with moderately to severely active rheumatoid arthritis on a stable background of methotrexate. The Phase II data showed ACR20, ACR50 and ACR70 scores of up to 100 percent, 75 percent and 63 percent, respectively, for patients who were consistently dosed at 3mg/kg Q4W over 24 weeks. At all doses tested, ALX

Janssen Research & Development LLC, of Titusville, N.J., a unit of Johnson & Johnson, said updated Phase III results showed Zytiga (abiraterone acetate) plus prednisone continued to provide statistically significant improvements in disease progression compared to placebo plus prednisone, and longer overall survival in men with metastatic castration-resistant prostate cancer. The randomized, multicenter, placebo-controlled study also demonstrated statistically significant improvement compared to