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
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
Advanced Cell Technology Inc., of Santa Monica, Calif., said an independent data and safety monitoring board authorized the firm to move forward with enrollment and treatment of patients in the next cohort of each of its three ongoing trials of human embryonic stem cell-derived retinal pigment epithelial cells for eye diseases. The next cohort will receive 50 percent more cells than the previous cohort, and after six months another safety review will be conducted before continuing to treat
BioLineRx Ltd., of Jerusalem, said it received approval from French regulators to start a Phase I/II trial of BL-8020, an oral, interferon-free treatment for hepatitis C virus (HCV). The open-label trial will evaluate the efficacy, safety and tolerability of the drug in patients infected with HCV, of any genotype, who have previously failed or relapsed following standard-of-care treatment. Interim data are expected toward the end of this year. Biothera Inc., of Eagen, Minn., said it completed
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
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
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