• ConjuChem Biotechnologies Inc., of Montreal, said it will be presenting Phase I/II data on its PC-DAC:Exendin-4 albumin conjugate in Type II diabetes at the American Diabetes Association meeting in Chicago. The study in 70 patients taking the drug as an adjunct therapy to metformin showed all three treatment groups had reductions in fasting plasma glucose that were statistically significant vs. baseline over the five-week treatment period. Statistical significance for the combined groups also was seen vs. placebo.

• Eurand NV, of Milan, Italy, presented previously released data from two Phase III trials of Zentase (formerly EUR-1008) demonstrating that the drug significantly improved absorption of fat, protein and other nutrients. Eurand is in the process of submitting a rolling new drug application for Zentase, a porcine-derived pancreatic enzyme product, in the treatment of exocrine pancreatic insufficiency. The data were presented at the European Cystic Fibrosis Society meeting in Antalya, Turkey.

• Inovio Biomedical Corp., of San Diego, said interim data from an open-label, Phase I/II breast cancer trial demonstrated that a single treatment with the company's Selective Electrochemical Tumor Ablation (SECTA) therapy resulted in complete responses in six of eight evaluable patients and caused no serious adverse events. SECTA involves administration of bleomycin sulfate delivered intratumorally with Inovio's MedPulser electroporation system. Earlier this month, two Phase III trials of SECTA in squamous cell head and neck cancer were halted due to data monitoring committee concerns about efficacy and serious adverse events, including higher mortality rates in the treatment arm. Inovio expects to complete an analysis of available data from the trials this year, and continues to negotiate with potential partners for SECTA while conducting European trials. (See BioWorld Today, June 6, 2007.)

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., said results from the first of two pivotal Phase III studies demonstrated that Rylomine (intranasal morphine) met its primary endpoint of improving the Sum of the Pain Intensity Difference (SPID) scores in patients with moderate-to-severe pain after elective orthopedic surgery. Patients in the two Rylomine treatment arms and the intravenous morphine arm all demonstrated statistically significant (p<0.01) improvement compared to placebo. There were no serious adverse events attributable to Rylomine. Data analyses are ongoing.

• Lorus Therapeutics Inc., of Toronto, said enrollment is under way in a new trial in patients with acute leukemia and myelodysplastic syndrome (MDS), testing GTI-2040, an antisense drug that specifically targets the R2 component of ribonucleotide reductase. The study is designed to evaluate the safety and activity of GTI-2040 as a single agent for acute leukemia and MDS using a novel treatment schedule.

• Myriad Genetics Inc., of Salt Lake City, said it is providing molecular diagnostic testing for two Phase II trials being run by London-based AstraZeneca plc's KuDOS Pharmaceuticals unit. The ICEBERG studies will evaluate the ability of AZD2281 (KU-0059436), a poly-ADP-ribose polymerase inhibitor, to treat patients with breast cancer or ovarian cancer associated with an inherited mutation in one of the BRCA1 or BRCA2 cancer genes. Myriad will be reimbursed for testing expenses, and has exclusive worldwide rights to diagnostic applications of findings from the study.

• Nuvelo Inc., of San Carlos, Calif., said Phase II data demonstrated that 7.5 mcg/kg and 10 mcg/kg doses of recombinant nematode anticoagulant protein c2 (rNAPc2) reduced the incidence and duration of ischemia by more than 50 percent and did not significantly increase bleeding in patients with non-ST-elevation acute coronary syndromes. The 203 patients in the double-blind, placebo-controlled, dose escalation portion of the trial also were treated with other antithrombotics. Half of the 52 patients in the open-label portion of the trial also received a half-dose of unfractionated heparin. The data were published in Journal of the American College of Cardiology.

• OSI Pharmaceuticals Inc., of Melville, N.Y., initiated two Phase I solid tumor trials with OSI-906, an oral insulin-like growth factor-1 receptor (IGF-1R) inhibitor. The trials are designed to determine the maximum tolerated dose of OSI-906 in continuous and intermittent dosing schedules while evaluating the drug's safety and pharmacokinetic profile.

• Surface Logix Inc., of Boston, started a Phase II trial with SLx-4090 in patients with dyslipidemia. The study will investigate the drug's effect on reducing plasma lipid levels by preventing the intestinal absorption of cholesterol and triglycerides. SLx-4090 is an enterocyte-specific microsomal triglyceride transfer protein inhibitor.

• Symbollon Pharmaceuticals Inc., of Framingham, Mass., said it closed patient enrollment in its IoGen Phase III pivotal trial. The study is designed to evaluate the effectiveness of IoGen, a nonhormonal therapy for moderate to severe cyclic pain and tenderness associated with fibrocystic breast disease. Symbollon said 115 patients have been randomized with 30 more in the screening process. Results are expected in the first quarter of 2008.

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