Agenus Inc., of Lexington, Mass., said it started a Phase II study of HerpV, a recombinant off-the-shelf therapeutic vaccine candidate, containing the company's QS-21 Stimulon adjuvant, for treating genital herpes in herpes simplex virus 2-positive subjects. The study will enroll 75 patients who have a history of frequent disease recurrences and will test the efficacy of the vaccine as measured by effect on genital viral shedding. Celgene Corp., of Summit, N.J., said its Celgene International
Abbott, of Abbott Park, Ill., said results from three-year long-term data from an ongoing extension study of the Humira (adalimumab) ULTRA 1 and ULTRA 2 studies in ulcerative colitis showed a reduction in observed mean Partial Mayo score from 5.9 at the time of first Humira dose to 1.4 at week 172. A 55.3 percent remission rate, per Partial May score, at week 60 of the extension study also was seen. Data were presented at the American College of Gastroenterology meeting in Las Vegas. Eli
Histogen Inc., of San Diego, said preliminary data from an ongoing Phase I/II study showed that its Hair Stimulating Complex (HSC) produced statistically significant improvement across all targeted hair growth parameters, with an 86 percent responder rate. The study tested HSC in 56 men with androgenetic alopecia and also was well tolerated, with no study-related adverse events reported. Data were presented at the International Society of Hair Restoration Surgery meeting in the Bahamas. Ipsen
Janssen Research & Development LLC, of Spring House, Pa., a unit of Johnson & Johnson, said a Phase IIb study testing Stelara (ustekinumab) in moderate to severe Crohn's disease showed that, among patients who had previously failed or were intolerant to at least one tumor necrosis factor antagonist, a significantly greater proportion receiving intravenous Stelara achieved the primary endpoint of clinical response at week six, defined as a 100-point reduction in Crohn's Disease Activity Index
Nabi Biopharmaceuticals Inc., of Rockville, Md., reported Phase II data showing that smoking cessation candidate NicVAX (nicotine conjugate immunotherapeutic) in combination with Chantix (varenicline, Pfizer Inc.) did not meet the study's primary endpoint. A preliminary assessment of the data showed that subjects treated with the combination quit smoking at a similar rate to those treated with placebo plus Chantix. The study enrolled 558 subjects in the Netherlands. NicVAX previously failed two
Pfizer Inc., of New York, said a Phase III study of Inlyta (axitinib) did not meet its primary endpoint of demonstrating statistically significantly longer progression-free survival (PFS) vs. Nexavar (sorafenib, Onyx Pharmaceuticals Inc. and Bayer AG) in treatment-naïve patients with advanced renal cell carcinoma. A preliminary review of the data showed that the median PFS for Inlyta exceeded median PFS for sorafenib but fell short of statistical significance.
Chiesi Group, of Parma, Italy, said it completed a Phase I trial of inhaled PDE4 inhibitor CHF 6001 that showed the drug was well tolerated up to the highest doses administered, in single and multiple dose parts of the study. Based on those data, two Phase IIa studies are ongoing in patients with asthma and chronic obstructive pulmonary disease. Pfizer Inc., of New York, said it completed a study to assess the efficacy and safety of Chantix/Champix (varenicline) 1 mg twice daily compared to
ArQule Inc., of Woburn, Mass., said it reached a special protocol assessment agreement with the FDA for a pivotal Phase III trial of tivantinib in patients with hepatocellular carcinoma (HCC). The study will test the drug, a selective MET inhibitor, as a single agent in previously treated patients with MET diagnostic-high inoperable HCC, with a primary endpoint of overall survival in the intent-to-treat population. The secondary endpoint is progression-free survival. About 300 patients will be
Abbott, of Abbott Park, Ill., said initial results from its Phase IIb study of its interferon-free regimen for hepatitis C virus (HCV) showed sustained virological response at 12 weeks post-treatment in 99 percent of treatment-naïve and 93 percent of null responder patients with genotype I HCV. Patients received a combination of ABT-450/r, ABT-267, ABT-333 and ribavirin for 12 weeks. Almirall SA, of Barcelona, Spain, reported data from the MOVE 2 study supporting the use of Sativex, an
Ferring Pharmaceuticals SA, of Saint Prex, Switzerland, reported preliminary results from a study showing treatment with melt-in-the-mouth desmopressin, an orally disintegrating tablet, reduced period limb movements (PLMS) in children with nocturnal enuresis (bedwetting). The anti-diuretic effect of desmopressin melt correlated strongly with reduced PLMS, with 90 percent of children in the study experiencing reduced PLMS. Data were presented at the Joint Congress of the International Children's
Arena Pharmaceuticals Inc., of San Diego, said it started dosing in a Phase I trial of APD811, an oral drug candidate designed to target the prostacyclin receptor for the treatment of pulmonary arterial hypertension. The dose-titration study is planned to enroll up to 30 healthy adult volunteers and will evaluate safety, tolerability and pharmacokinetics of multiple ascending doses. Biogen Idec Inc., of Weston, Mass., reported data from studies testing oral BG-12 (dimethyl fumarate) at the
Pfizer Inc., of New York, disclosed top-line Phase III data from an open-label long-term safety study of ALO-02 (oxycodone hydrochloride and naltrexone hydrochloride extended-release capsules) in patients with moderate-to-severe chronic, noncancer pain. The primary objective of the study was to evaluate the safety of ALO-02 administered for up to 12 months. The study showed that the adverse event profile was as expected based on similar long-term safety studies with other extended-release
Cytori Therapeutics Inc., of San Diego, began a Phase I/II trial (ATHENA) of its cell therapy for refractory heart failure resulting from myocardial ischemia. The randomized, double-blind trial of safety and feasibility will enroll 45 patients at six centers in the U.S. who will be randomized to cell therapy or inactive placebo injection. All patients will have adipose tissue removed. The tissue is used for processing into adipose-derived stem and regenerative cells. Euthymics Bioscience Inc
Actinium Pharmaceuticals Inc., of New York, presented Phase I data showing that Actimab-A, its antibody-directed alpha-emitter drug candidate for front-line acute myeloid leukemia (AML) in older patients, demonstrated significant antileukemic activity across all dose levels. Data were presented at the Hematologic Malignancies 2012 Conference in Houston. Actimab-A is being testing in a Phase I/II trial in combination with low-dose cytarabine in older AML patients. Canyon Pharmaceuticals Inc
Pierre Fabre Dermatolgie Laboratories, of Castres, France, a subsidiary of Pierre Fabre Laboratories, reported Phase III data showing that propranolol oral solution in infantile hemangioma resulted in complete or nearly complete resolution of the hemangioma for a sizeable majority of the infants who were treated, compared to an almost complete lack of effect from placebo. The company said it expects to submit for the drug's use in children in both the U.S. and Europe. Teva Pharmaceutical
Acorda Therapeutics Inc., of Ardsley, N.Y., reported safety data from more than 62,400 people with multiple sclerosis (MS) taking Ampyra (dalfampridine) extended-release tablets during the first two years of availability in the U.S., with results showing a similar safety profile as observed in clinical trials. During the first two years following FDA approval, 160 seizures were reported, or about 4.6 per 1,000 patient-years of use, which is comparable to the rate of seizure seen in the overall
Argos Therapeutics Inc., of Durham, N.C., said its ongoing Phase III ADAPT study testing personalized immunotherapy candidate AGS-003 in Stage IV kidney cancer was reviewed during the International Kidney Cancer Symposium in Chicago. The ADAPT study, which is being conducted under a special protocol assessment, is testing AGS-003 in combination with well-established targeted drug therapies and is expected to enroll about 450 newly diagnosed patients with metastatic disease. Enrollment is
Eli Lilly and Co., of Indianapolis, reported detailed data from two Phase III trials of solanezumab in Alzheimer's disease, showing that a prespecified analysis of pooled data in patients with mild disease, a statistically significant slowing of cognitive decline was shown, representing a 34 percent reduction in decline. The company previously reported that the drug missed its endpoints in two Phase III trials in Alzheimer's. The company said next steps for the drug, a monoclonal antibody that
Grupo Ferrer Internacional SA, of Barcelona, Spain, said it successfully completed an absorption, tolerability and safety trial in adult and juvenile patients from 2 months of age with impetigo involving Ozenoxacin formulated as a topical treatment for infectious dermatological conditions. The study will form the basis for the first regulatory filing for nonfluorinated quinolone antibacterial agent in 2013.
Eisai Co. Ltd., of Tokyo, and Bial SA, of S. Mamede do Coronado, Portugal, reported at the European Congress on Epileptology in London that it expects data from recently launched studies designed to increase the understanding of Zebinix (eslicarbazepine acetate), a once-daily adjunctive therapy for adults with partial-onset seizures with or without secondary generalization. Started in March, the Eslicarbazepine acetate in Partial-Onset Seizures study is intended to enroll about 800 patients
Agenus Inc., of Lexington, Mass., said it started a Phase II study of HerpV, a recombinant off-the-shelf therapeutic vaccine candidate, containing the company's QS-21 Stimulon adjuvant, for treating genital herpes in herpes simplex virus 2-positive subjects. The study will enroll 75 patients who have a history of frequent disease recurrences and will test the efficacy of the vaccine as measured by effect on genital viral shedding. Celgene Corp., of Summit, N.J., said its Celgene International