Advanced Cell Technology Inc., of Santa Monica, Calif., treated patients in a third cohort of each of its two Phase I trials of human embryonic stem cell-(hESC) derived retinal pigment epithelial cells for macular degeneration. The patients received 150,000 cells, compared with the 100,000-cell dose used in the second cohort. The trials will assess safety and tolerability of hESC-derived RPE cells following sub-retinal transplantation in patients with Stargardt's macular dystrophy and dry age

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

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

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

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

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

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