• Avant Immunotherapeutics Inc., of Needham, Mass., said new data from a large European trial, published in The Lancet, showed that London-based GlaxoSmithKline plc's rotavirus vaccine, Rotarix, is effective against the five most commonly circulating rotavirus types (G1, G2, G3, G4 ad G9). Those virus types are responsible for more than 98 percent of rotavirus gastroenteritis disease in Europe during the first two years of life. The protection afforded by the vaccine's two-dose schedule in infants occurs before 6 months of age. In August 2007, Avant said partner GSK's biologics license application for Rotarix had been accepted for review by the FDA.

• Biota Holdings Ltd., of Melbourne, Australia, said its long-acting neuraminidase inhibitor, CS8958, an anti-influenza treatment, has entered Phase II trials. The program is being carried out by Daiichi-Sankyo Co. Ltd., of Tokyo, in the northern hemisphere influenza season, and two trials are planned, one in Japan and one elsewhere in Asia, to test the drug's efficacy in patients with naturally acquired flu strain A or B.

• Cardiome Pharma Corp., of Vancouver, British Columbia, said interim results from its Phase IIb trial with oral vernakalant to prevent recurrence of atrial fibrillation, which originally were due in the fourth quarter of this year, will not be disclosed until March 2008, with final data in the middle of next year. By delaying the data for one quarter, Cardiome expects to add roughly 20 percent more patients into the interim analysis than originally planned, and as a result, more data will be available on patients with longer-term exposure. The company's stock (NASDAQ:CRME) closed Monday at $9.65, down 83 cents.

• Celgene Corp., of Summit, N.J., noted that The New England Journal of Medicine published updated data from a Phase III pivotal study evaluating Revlimid (lenalidomide) plus dexamethasone in previously treated multiple myeloma patients. The data in 353 previously treated multiple myeloma patients reported overall survival, as well as median time to disease progression in those receiving lenalidomide plus dexamethasone compared to patients receiving dexamethasone plus placebo. Similar results also were shown in a separate article based on data from the international study MM-010. Patients in both lenalidomide trials had been heavily treated prior to enrollment, many having failed three or more rounds of therapy with other agents. More than 50 percent of patients in the study had undergone stem cell transplants.

• Cleveland BioLabs Inc., of Buffalo, N.Y., initiated a Phase II study of Curaxin CBLC102 in advanced renal-cell carcinoma. The two-year trial will enroll up to 24 subjects, with a decrease in tumor size as the primary endpoint. Secondary endpoints will include time to tumor progression. The company plans to start additional Phase II trials of Curaxin CBLC102 in multiple cancer types in early 2008.

• CSL Behring, of King of Prussia, Pa., said it reached the primary endpoint in its Phase III trial of human pasteurized C1-inhibitor concentrate in patients with hereditary angioedema. Results from the IMPACT (International Multi-centre Prospective Angioedema C1-inhibitor Trial) study showed that patients treated with 20 U/kg b.w. C1-INH experienced a highly significant reduction in time to onset of symptom relief in HAE attacks compared to placebo. The median time to onset of relief of symptoms was 30 minutes in the treatment group compared to 1.5 hours in the placebo group.

• CytRx Corp., of Los Angeles, said results from a double-blind, placebo-controlled dosing study of its investigational amyotrophic lateral sclerosis drug, arimoclomol, showed that the compound administered at 400 mg three times daily was safe and well tolerated in healthy volunteers. The study data demonstrated no differences between arimoclomol and placebo in any of the safety measures, which included general urine and blood chemistries, renal and liver function, electrocardiogram, vital signs and physical examination. The most common reported adverse events were related to gastrointestinal irritation and only were slightly more frequent in the arimoclomol-treated subjects compared with the placebo group.

• GW Pharmaceuticals plc, of London, and Otsuka Pharmaceutical Co. Ltd., of Tokyo, said the first U.S. Phase II/III dose-ranging study has begun with adjunctive Sativex in the treatment of pain in advanced cancer patients who experience inadequate analgesia during optimized chronic opioid therapy. At about 40 centers, 336 patients will be enrolled. The primary endpoint of the study will be the response rate for patients at the end of five weeks of therapy, as defined by a 30 percent or greater reduction in the 11-point, Numeric Rating Scale. Sativex is composed primarily of two cannabinoids - CBD (cannabidiol) and THC (delta 9 tetrahydrocannabinol) - given as a metered dose oromucosal spray.

• MedImmune Inc., of Gaithersburg, Md., said it started dosing patients in its first Phase I trial of CAM-3001, a fully human monoclonal antibody (MAb) targeting the alpha subunit of the granulocyte-macrophage colony-stimulating factor receptor (GM-CSFR). The study is designed to evaluate the safety and tolerability of single doses of CAM-3001 in patients with rheumatoid arthritis. The firm said the trial represents the first in which a MAb targeting GM-CSFR is being investigated in that population. MedImmune currently holds exclusive worldwide rights to develop and market CAM-3001 under an agreement with CSL Ltd., of Melbourne, Australia.

• NovaBay Pharmaceuticals Inc., of Emeryville, Calif., reported results from a Phase I trial of lead Aganocide compound, NVC-422, a non-antibiotic anti-infective that has shown potent in vitro activity against major pathogens, including Methicillin-resistant Staphylococcus aureus. When topically applied to the anterior nares (the lower nasal passages), NVC-422, or AgaNase, appears safe and well tolerated with undetectable systemic exposure. Based on those results, NovaBay started a second Phase I trial to test the safety of NVC-422 at a higher dose and expects to have results from that study by early 2008. In parallel with the second Phase I study, NovaBay expects to begin a Phase IIa study by January 2008 in healthy volunteers who are carriers of S. aureus in their nasal passages.

• QRxPharma Pty. Ltd., of Sydney, Australia, treated patients in the first of several studies in an ongoing Phase III program for Q8003IR, an immediate-release dual-opioid pain therapy. That initial trial is designed to compare the efficacy and safety of four different dosage strengths of Q8003IR vs. placebo in a postsurgery, acute pain setting in 250 patients undergoing bunionectomy. The primary endpoints focus on pain relief and pain intensity scores over the first 48 hours postsurgery. Secondary endpoints include efficacy relating to the time to onset of analgesia and the duration of effect from a single oral dose, as well as safety as measured by the incidence and intensity of opioid-related adverse events. A safety extension trial will follow.

• VioQuest Pharmaceuticals Inc., of Basking Ridge, N.J., said the first patient has been dosed in an open-label Phase IIa study of Lenocta (sodium stibogluconate), a protein tyrosine phosphatase inhibitor, in combination with interferon-alpha, an immune stimulant approved for the treatment of hepatitis C, hepatitis B and a number of cancers. The firm expects to enroll at least 12 more participants in the study, which is evaluating the clinical efficacy and biological effectiveness of Lenocta at the highest tolerable dose in combination with interferon-alpha in patients with advanced-stage solid tumors.