The following items were disclosed at the International AIDS Society conference held July 22-25 in Sydney, Australia: Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented new data from two new studies of Viramune, the first drug approved from the non-nucleoside reverse transcriptase inhibitor class. Results from an extended three-year follow-up analysis of the 2NN study demonstrated that HIV-positive patients taking Viramune (nevirapine) achieved a comparable virologic and immunologic
Acambis plc, of Cambridge, UK, initiated a Phase I trial of its universal influenza vaccine candidate, ACAM-FLU-A. The vaccine is designed to target all A strains of the influenza virus. The randomized, double-blind, placebo-controlled study in the U.S. is investigating safety, tolerability and its ability to generate an immune response. The trial in up to 80 healthy subjects ages 18 to 40 also will assess two adjuvants to determine whether they improve the effect of the vaccine on the immune
Affiris, of Vienna, Austria, initiated a Phase I clinical trial of Alzheimer's vaccine Affitope AD01. In the trial, up to 24 Alzheimer's patients will receive four vaccinations over a three-month period, with results monitored for six months. The trial initiation triggers a venture capital payment from Munich, Germany-based MIG-Fonds. Cougar Biotechnology Inc., of Los Angeles, said the FDA has allowed its investigational new drug application for CB3304 in the treatment of relapsed or
BioMimetic Therapeutics Inc., of Franklin, Tenn., reported interim results from its 20-patient pilot trial comparing GEM OS1 Bone Graft to autogenous bone graft in foot and ankle indications that show 39 percent of patients receiving GEM OS1 exhibited fusion, as defined by osseous bridging of greater than 50 percent of the joint surface, compared to 33 percent of autograft patients at six weeks. At 12 weeks, 69 percent of GEM OS1-treated patients showed fusion vs. 50 percent of the autograft
Avexa Ltd., of Melbourne, Australia, completed the first 24-week, double-blind phase of its Phase IIb trial of apricitabine in HIV, and patients have progressed into the open-label section of the trial to receive 800 mg of the drug twice a day as part of their daily treatment regimen for another 24 weeks. Results from the blinded phase are expected later this quarter, though the company reported that apricitabine continues to maintain a good tolerability profile. DiaDexus Inc., of South San
Patients treated with Adlea demonstrated a 61 percent reduction in mean pain intensity from baseline to week one, and the analgesic effect was sustained at all subsequent weeks to the last scheduled in-clinic assessment at week eight, at which time a 64 percent reduction in pain from baseline was reported
Advanced Magnetics Inc., of Cambridge, Mass., said it expects to announce top-line data this summer from its fourth and final Phase III trial of ferumoxytol as an intravenous iron replacement in chronic kidney disease. Pending positive results, a new drug application filing is planned for the fourth quarter of 2007. Last month, the company raised $162.9 million through a public offering. (See BioWorld Today, May 24, 2007.) Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said the FDA
Acorda Therapeutics Inc., of Hawthorne, N.Y., began a second Phase III study of Fampridine-SR in multiple sclerosis. The study is expected to enroll about 200 patients at 35 MS clinical centers in the U.S. and Canada. The MS-F204 study, which is being conducted under a special protocol assessment from the FDA, will evaluate safety and the efficacy of Fampridine-SR in improving walking ability in MS patients. Acorda reported statistically significant results in a previous Phase III trial. (See
Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, began a study in Europe to evaluate the safety and efficacy of the Vascular Wrap paclitaxel-eluting mesh after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular access, for patients with end-stage renal disease. About 198 patients will be enrolled, paralleling a pivotal U.S. trial that's already under way. Celsion Corp., of Columbia, Md., said a Phase I dose-escalation study of
Alchemia Ltd., of Brisbane, Australia, said results from a Phase II trial of HyCAMP in metastatic colorectal cancer showed that the product demonstrated superior anticancer activity compared to Camptosar (irinotecan), with a significantly greater number of patients with observed tumor responses. Data from the 80-patient trial also showed a statistically significant increase in time to treatment failure and a significantly longer period (+116 percent) of progression-free survival for patients
ChemoCentryx Inc., of Mountain View, Calif., said data from its Phase II trial of Traficet-EN (CCX202-B), an oral, anti-inflammatory agent designed to target the CCR9 receptor, demonstrated that the product is well tolerated and showed clinical activity in patients with active Crohn's disease. Patients enrolled in the trial were randomized to receive a once-daily 250-mg capsule of Traficet-EN or placebo for 28 days. Among a defined subgroup of 39 patients identified as having more active
Avant Immunotherapeutics Inc., of Needham, Mass., reported positive preliminary results from a double-blind, placebo-controlled Phase I/II dose-escalating clinical trial of its typhoid fever vaccine candidate, Ty800, in healthy volunteers. The researchers found the single-dose, oral vaccine to be well tolerated and immunogenic, with more than 90 percent of vaccinated subjects generating immune responses. Based on those results, the firm plans to start a Phase II dose-ranging trial of Ty800 in
Alliance Pharmaceutical Corp., of San Diego, received the final approvals required to start a Phase IIb trial for Oxygen (perfluorochemical emulsion) to prevent postoperative ileus resulting from hypoxia during major surgery. The study is expected to enroll up to 128 patients undergoing primary coronary artery bypass graft surgery under cardiopulmonary bypass, and they will be randomized to receive either a dose of saline or a dose of Oxygent five to 10 minutes before bypass is begun. Dose
Avicena Group Inc., of Palo Alto, Calif., initiated a Phase I study of the neuroprotective agent AL-02 in subjects with amyotrophic lateral sclerosis. The open-label study in six patients with sporadic ALS is designed to establish the optimal dose for further studies, and to evaluate brain concentration levels of AL-02. BioDelivery Sciences International Inc., of Morrisville, N.C., announced additional statistically significant results from its Phase III trial of BEMA Fentanyl in cancer
Manhattan Pharmaceuticals Inc., of New York, finished patient dosing in two separate, ongoing Phase IIa trials of oral oleoyl-estrone. The first trial is evaluating OE for common obesity, and the second targets morbid obesity. Both trials include a post-dosing follow-up period. Study completion and data analysis will begin after the final follow-up visit, and the analysis is scheduled to be completed in July. Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., started a two-stage
Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., disclosed results from a bioequivalence study demonstrating that CPP-109 (Catalyst's Vigabatrin tablets) is bioavailable and bioequivalent to Sabril tablets, the version of Vigabatrin marketed in Europe by Sanofi Aventis,, of Paris. Vigabatrin has been marketed over the past decade in more than 30 countries under the brand name Sabril as a secondary treatment for adult epilepsy and as a primary treatment for the management of
Alba Therapeutics Corp., of Baltimore, disclosed encouraging preliminary results from its Phase IIa trial of AT-1001 in 86 patients with celiac disease. The trial was designed to evaluate the safety, tolerability and efficacy of multiple doses of AT-1001 during a two-week gluten challenge. It said dose-dependent responses were seen in intestinal permeability, and that drug patients had improved symptoms and outcomes. A Phase IIb clinical study in planned for the third quarter. CollaGenex
Aastrom Biosciences Inc., of Ann Arbor, Mich, has initiated its U.S. Phase IIb prospective, controlled, randomized, double-blind, multicenter clinical trial to treat patients suffering from peripheral arterial disease (PAD). The company will use its Tissue Repair Cell-based product to treat critical limb ischemia. Approximately 10 million people in the U.S. suffer from PAD, resulting in 100,000 amputations per year. The trial will consist of two patient groups totaling 120 people at about 20
Access Pharmaceuticals Inc., of Dallas, continued to expand the number of clinical trial sites to 11 for its ongoing Phase II trial of ProLindac, a DACH platinum prodrug in patients with recurrent platinum-sensitive ovarian cancer. The additional sites allow for the potential of more rapid patient accrual. Human Genome Sciences Inc., of Rockville, Md., reported results from its first Phase I trial of HGS-ETR1 (mapatumumab) demonstrating that the drug could be administered safety and
Alchemia Ltd., of Sydney, Australia, reported positive efficacy data from its HyCAMP Phase II trial for patients with metastatic colorectal cancer. The trial tested HyCAMP, its proprietary formulation of the anticancer drug irinotecan, against irinotecan alone. Data examined to date showed that patients on HyCAMP were able to receive more doses (a median of six cycles of therapy compared to two for irinotecan along), and median progression-free survival for HyCAMP patients was 5.2 months
The following items were disclosed at the International AIDS Society conference held July 22-25 in Sydney, Australia: Boehringer Ingelheim GmbH, of Ingelheim, Germany, presented new data from two new studies of Viramune, the first drug approved from the non-nucleoside reverse transcriptase inhibitor class. Results from an extended three-year follow-up analysis of the 2NN study demonstrated that HIV-positive patients taking Viramune (nevirapine) achieved a comparable virologic and immunologic