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).
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
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
Critical Pharmaceuticals Ltd., of Nottingham, UK, completed a second clinical study of CP024, a growth hormone nasal spray in development for growth disorders in children and adults. The results showed that CP024 was safe and well tolerated with highly reproducible pharmacokinetics. The drug strongly induced production of insulin-like growth factor, a principal mediator of growth hormone activity. Critical Pharmaceuticals said that the trial provided proof of concept for the product
Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum, of Stockholm, Sweden, reported data confirming that investigational recombinant factor VIII Fc (rFVIIIFc) fusion protein and factor IX Fc (rFVIXc) fusion protein gave long-lasting protection from bleeding with fewer injections than the standard of care for hemophilia. In A-LONG, patients with hemophilia A maintained low bleeding rates with once-to-twice weekly prophylactic injections of rFVIIIFc. In B-LONG, prophylactic
Pozen Inc., of Chapel Hill, N.C., reported results from two Phase III studies of PA32540 in ischemic stroke showing that compared to EC-ASA (aspirin), treatment with PA32540 significantly reduced the rate of endoscopic gastroduodenal ulcers (2.0 percent vs. 12.4 percent; p = 0.005). The rate of adjudicated major adverse cardiac events was similar in both groups. Adverse GI events commonly lead to discontinuation of aspirin therapy, which can increase the risk of adverse cardiovascular and
Vaximm AG, of Basel, Switzerland, said top-line data from its Phase I/II dose-escalation study of oral cancer vaccine VXM01 met key safety and tolerability endpoints. The study, VXM01-01-DE, enrolled 45 patients with inoperable pancreatic cancer at the Heidelberg (Germany) University Hospital. In addition to standard-of-care treatment, the patients received several doses of the therapeutic vaccine, which targets the tumor vasculature, or placebo. Results indicated the vaccine was safe and well
Eli Lilly and Co., of Indianapolis, halted its Phase III rheumatoid arthritis (RA) program for tabalumab, an anti-B cell activating factor monoclonal antibody, for lack of efficacy. The company said the tabalumab Phase III ILLUMINATE program in systemic lupus erythematosus is continuing. In December 2012, Lilly discontinued the Phase III RA registration study FLEX-M for lack of efficacy. FLEX-M was investigating tabalumab in patients with moderate to severe RA who had an inadequate response to
Teva Pharmaceutical Industries Ltd., of Jerusalem, said it enrolled the first patient in the Phase IV MODERATO study to test Azilect (rasagiline tablets) on cognitive function in adults with mild cognitive impairment in Parkinson's disease. The study will measure cognitive function using the Scales for Outcomes of Parkinson's Disease-Cognition after 24 weeks of treatment and will enroll about 170 patients.
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