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Clinic Roundup
(BioWorld Today Via Thomson Dialog NewsEdge) , of Quebec City, said it has completed patient recruitment for its first Phase III efficacy trial of cetrorelix in benign prostatic hyperplasia. The study involves about 600 patients primarily in the U.S. and Canada, with additional sites in Europe. The trial will assess an intermittent dosage regimen of cetrorelix as a safe and tolerable treatment providing prolonged improvement in BPH-related signs and symptoms.
? Basilea Pharmaceutica Ltd., of Basel, Switzerland, said it has opened an additional Phase III study to evaluate the efficacy and safety of isavuconazole, a triazole water-soluable prodrug, in treating serious and life-threatening invasive fungal infections. The firm said it currently is conducting pivotal randomized Phase III studies focusing on first-line treatment against invasive aspergillus or candida bloodstream infections. The additional study is expected to provide confirmation of the potential advantages of intravenous and oral isavuconazole over existing antifungals in terms of consistently effective drug levels, convenience and clinical safety.
? Biogen Idec Inc., of Cambridge, Mass., said results of a Phase IV, open-label, head-to-head study of intramuscular Avonex (interferon beta-1a) and high-dose, high-frequency subcutaneous Rebif (interferon beta-1a), marketed by EMD Serono Inc., of Rockland, Mass., provided clinical evidence that the two drugs show similar efficacy over 18 to 30 months of continued therapy in patients with relapsing-remitting multiple sclerosis. The trial, known as PROOF, involved 217 patients with 136 completing a median of 25.9 months of Avonex 30 mcg once weekly and a median of 22.2 months Rebif 44 mcg three times weekly.
? BioMS Medical Corp., of Edmonton, Alberta, said on review of data from the firm's on-going MAESTRO-03 U.S. pivotal Phase III clinical trial of MBP8298 for the treatment of secondary progressive multiple sclerosis, its independent data safety monitoring board has recommended that the trial continue. The company said that more than 65 percent of the required 510 patients have been enrolled in the study, with full enrollment anticipated for the end of the first half of this year.
? Celsion Corp., of Columbia, Md., said early data from a 13-patient Phase I study of ThermoDox for breast cancer on the chest wall showed satisfactory toxicity and promising clinical activity. Two patients treated at the 30 mg/m2 dose level have shown a complete local response in the treated area. The study has now enrolled four patients at the 40 mg/m2 dose level of which three patients have been treated. Data on the local effect are awaited. Those preliminary data are subject to further confirmation at time of study completion.
? Cephalon Inc., of Frazer, Pa., said that the European Commission has granted marketing authorization for Efentora, a buccal tablet formulation of fentanyl. The drug is intended to treat breakthrough cancer pain in adult patients who already are receiving maintenance opioid therapy for chronic pain.
? Inhibitex Inc., of Atlanta, said it is presenting data from a Phase I clinical study of FV-100, a highly potent antiviral compound in development for the treatment of shingles, at this week's International Conference on Antiviral Research in Montreal. Pharmacokinetic and safety data from the study, which was conducted in the U.S. under an exploratory investigational new drug application, will be presented at a poster session and in an oral session.
? Iomai Corp., of Gaithersburg, Md., said it has received approval from the Department of Health and Human Services to expand its program to develop an immunostimulant adjuvant patch for use with an injected H5N1 influenza vaccine. The firm said the decision was based on positive clinical data generated in a 500-subject, Phase I/II study recently completed by Iomai. A Phase II dose-ranging study will identify the optimum dose of antigen and adjuvant that can be used in a one-dose or two-dose regimen to enhance the immune response to a H5N1 influenza vaccine. The research is being funded under a $128 million contract awarded by HHS in January 2007.
? Kythera Biopharmaceuticals Inc., of Los Angeles, said it has started a second Phase II clinical trial of ATX-101 for the reduction of unwanted submental, or under chin, fat. The 60-patient, multicenter, randomized, double-blind, placebo-controlled, Phase II trial is aimed at assessing the safety and effectiveness of ATX-101 as a liposculpting agent. The firm plans to seek approval of the drug in the U.S., Europe and Asia.
? MedImmune, of Gaithersburg, Md., said it advanced its efforts to develop CAT-354 in asthma with the start of two new trials with a monoclonal antibody targeting interleukin-13. One of the studies is a Phase II trial in Europe and Australia designed to test the potential of the anti-IL-13 antibody in patients with uncontrolled asthma despite optimal treatment. The other is a Phase I study to assess pharmacokinetics in healthy adult patients.
? Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., said a U.S. Phase II study of its proprietary drug NX-1207 for benign prostatic hyperplasia is nearing completion. The company anticipates the reporting of final results and statistical analysis for the study within the next few weeks.
? Oculus Innovative Sciences Inc., of Petaluma, Calif., said the Journal of College of Physicians and Surgeons Pakistan has published results from a randomized, controlled study of the firm's Microcyn technology in 100 patients in Pakistan with infected diabetic wounds. Results of the study showed a statistically significant benefit with Microcyn vs. saline in duration of hospital stay, downgrading of the wound category and wound healing time, the primary endpoints.
? Pacgen Biopharmaceuticals Corp., of Vancouver, British Columbia, said it has completed the recruitment of more than 200 patients in its Phase IIb dose-ranging clinical trial for PAC-113, a peptide-based antifungal targeting oral candida infections in immunocompromised patients, such as those with HIV infection. The firm said it is on track to report final results from the study in June. The trial will establish the efficacy for PAC-113 in eliminating clinical signs and symptoms of oral candidiasis, provide an optimal dosing level for Phase III pivotal trials and evaluate the safety and tolerance of the compound.
? SkyePharma plc, of London, and its development and marketing partner Mundipharma International Ltd., of Cambridge, UK, said results of an randomized, open-label, parallel group study showed that Flutiform (100 mcg fluticasone and 10 mcg formoterol) was just as effective as Seretide (100 mcg fluticasone and 50 mcg salmeterol) in treating pediatric patients with asthma. A statistical analysis showed that, in both treatment groups, there was an improvement in lung function from the baseline measurement while the performance of Flutiform was not statistically inferior to that of Seretide.
? Summit Corp. plc, of Oxford, UK, said Phase I results showed that its acne treatment SMT D002 suppressed sebum production at statistically significant levels of 90 percent compared with placebo, therefore meeting its primary endpoint. The study was conducted in 18 healthy volunteers and examined the effect of repeat oral doses of SMT D002 over a four-day period. Results also showed that SMT D002 was safe with no serious or unexpected adverse effects reported.
Copyright ? 2008 Thomson BioWorld, All Rights Reserved.
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