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
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
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
Adynxx Inc., of San Francisco, said the first patient was dosed in a Phase II study of AYX1 , its lead candidate to prevent post-surgical pain. The 90-patient, placebo-controlled study will evaluate the safety and efficacy of a single administration of AYX1 given prior to unilateral total knee arthroplasty to reduce acute pain and prevent the transition to persistent pain. The study will follow patients for 42 days, with a primary endpoint of pain with walking. Secondary and exploratory
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
Boehringer Ingelheim GmbH, of Ingelheim, Germany, said The New England Journal of Medicine published findings from the RE-MEDY and RE-SONATE trials investigating Pradaxa (dabigatran etexilate) in the long-term prevention of deep vein thrombosis or pulmonary embolism. The results demonstrate that Pradaxa 150 mg twice daily is an effective option with a favorable safety profile for the extended prevention of recurrence of venous blood clots (known as venous thromboembolism) after a first event
Amicus Therapeutics Inc., of Cranbury, N.J., reported additional six-month (Stage 1) results from the first ongoing Phase III global registration study (Study 011) of investigational oral migalastat HCl monotherapy (150 mg, every-other-day) in males and females with Fabry disease who had genetic mutations identified as amenable to migalastat HCl. Stage 1 results were highlighted in an oral platform presentation at the Lysosomal Disease Network WORLD Symposium in Orlando, Fla. Study 011 consists
Amicus Therapeutics Inc., of Cranbury, N.J., reported positive preliminary results from all four dose cohorts in its Phase II study (Study 010) evaluating the safety and pharmacokinetics of chaperone AT2220 (duvoglustat HCl) co-administered with enzyme replacement therapy (ERT) in Pompe disease (Myozyme and Lumizyme [alglucosidase alfa, or recombinant human GAA enzyme (rhGAA), Sanofi SA/Genzyme Corp.]). Myozyme and Lumizyme are the only approved treatments for Pompe disease, in which deficient
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
Advanced Cell Technology Inc. (ACT), of Marlborough, Mass., said its clinical partner, the University of California, Los Angeles (UCLA), received FDA approval for its investigational new drug application. Steven Schwartz, professor of ophthalmology at the David Geffen School of Medicine at UCLA and retina division chief at UCLA's Jules Stein Eye Institute, plans to lead a Phase I/II study using ACT's retinal pigment epithelial (RPE) cells, derived from human embryonic stem cells (hESC), to
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.
Amarantus BioScience Inc., of Sunnyvale, Calif., said additional analysis of preclinical data reported last month on its mesencephalic astrocyte-derived neurotrophic factor (MANF) in Parkinson's disease showed statistical significance in increasing dopaminergic nerve terminal reinnervation and increasing dopamine concentrations in the striatum. The company retained a Swiss neuroscience-focused consulting firm to conduct a full audit of data from the preclinical experiments and to assist
Tekmira Pharmaceuticals Corp., of Vancouver, British Columbia, said that complete results from a Phase I trial of its RNAi therapeutic, ALN-VSP have been published. The company said that the results validate longer-term safety and tolerability of its LNP delivery platform. Alnylam Inc., of Cambridge, Mass., licensed the LNP technology from Tekmira, and is developing several products under that license. Tekmira is due a $5 million payment related to initiation of clinical trials for ALN-VSP 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