• Archemix Corp., of Cambridge, Mass., said it successfully completed a Phase I trial of its aptamer therapeutic ARC1779, which is being developed as an anti-thrombotic agent for use in angioplasty and the blood disorder thrombotic thrombocytopenic purpura. ARC1779 is designed to selectively block the activation, adhesion and aggregation of platelets by inhibiting the binding of von Willebrand factor to the GPIb receptor on platelets. Data from the trial are expected to be presented this year in a peer-reviewed forum, Archemix said. It said based on the proof of mechanism from the Phase I study, it plans to start a Phase II study of ARC1779 in the fourth quarter to evaluate safety and efficacy in acute coronary syndrome patients. It also plans to initiate a Phase Ib study in patients suffering from TTP.

• Avanir Pharmaceuticals Inc., of Aliso Viejo, Calif., presented data from its successful Phase III trial of Zenvia in patients with diabetic peripheral neuropathic pain. Zenvia (dextromethorphan/quinidine) is an NMDA receptor antagonist and sigma-1 agonist. Positive data initially were reported in April. Highlights of data presented at the Second International Congress on Neuropathic Pain in Berlin showed a 45-mg dose of the drug achieved 53 percent, 59 percent and 59 percent improvements on a pain scale vs. baseline at days 30, 60 and 90, a statistically significant result for the primary endpoint. The 30-mg dose achieved 43 percent, 48 percent and 48 percent improvement, respectively, while placebo achieved 27 percent, 34 percent and 39 percent improvement. Twenty-eight percent of patients in the DM/Q 45 arm and 27 percent in the DM/Q 30 arm obtained "a lot" or "complete" pain relief at three months vs. 17 percent in the placebo group (p=0.0008 and p=0.0017, respectively). The trial met statistical significance for four of the five secondary endpoints. (See BioWorld Today, April 19, 2007.)

• Merck Serono SA, of Geneva, and Newron Pharmaceuticals SpA, of Milan, Italy, presented data suggesting safinamide has a positive effect on cognitive performance in patients with early Parkinson's disease. Data on safinamide, an oral alpha-aminoamide derivative in Phase III trials in PD, were presented at the Movement Disorder Society's congress in Istanbul, Turkey. Certain previously released data from the Phase III trial showed safinamide as an add-on to dopamine agonist therapy significantly improved motor symptoms and activities of daily living. Follow-on data demonstrated safinamide in patients with early stage PD resulted in an improvement in cognitive domains, in particular executive function and working memory.

• NuPathe Inc., of Conshohocken, Pa., reported positive results from a Phase I study of NP101 SmartRelief, a treatment for acute migraine that combines NuPathe's iontophoretic transdermal technology with sumatriptan. Results of the study showed that the product maintained continual therapeutic dosing levels of sumatriptan an average of four times longer than treatment with a 6 mg injection of Imitrex, and up to twice as long as treatment with the 50 mg tablet of Imitrex. NP101 also was generally well tolerated.

• Pozen Inc., of Chapel Hill, N.C., and GlaxoSmithKline plc, of London, said new data from two large trials show that Trexima, when taken early, was nearly twice as effective as placebo in eliminating all traditional migraine symptoms at two and four hours across multiple attacks with just one tablet. In each study, about 40 percent of patients in the treatment arm were migraine-free at two hours, compared to about 20 percent on placebo. Trexima is the proposed brand name for a tablet containing sumatriptan 85 mg formulated with RT technology and naproxen sodium 500 mg, and the product is under review by the FDA for treating acute migraines in adults. Findings from the studies were presented at the American Headache Society's meeting in Chicago.

• ProEthic Pharmaceuticals Inc., of Montgomery, Ala., said Phase III data of PRO-513 showed that the drug relieved migraine pain for patients within 30 minutes, reduced the associated symptoms of the migraine attack and had benefits that lasted up to 24 hours. The two-hour pain-free patient response, which was the primary endpoint of the study, was 25 percent in the PRO-513 arm vs. 10 percent in the placebo arm. Data were presented at the American Headache Society's meeting in Chicago.

• Scios Inc., a Mountain View, Calif., subsidiary of Johnson & Johnson, began enrollment of the first patients in its ASCEND-HF study, a trial evaluating the effectiveness of Natrecor (nesiritide) in acutely decompensated heart failure. The 7,000-patient trial of the approved drug is designed to further assess the long-term clinical outcomes and benefit/risk profile of Natrecor in those patients. The primary objective of the trial is to assess whether Natrecor in addition to standard care, compared with placebo plus standard care, improves patient outcomes as measured by heart-failure rehospitalization and all-cause mortality through 30 days, and if it improves heart failure symptoms.

• YM BioSciences Inc., of Mississauga, Ontario, received a no-objection letter from Health Canada to initiate its planned Phase II trial nimotuzumab in patients with recurrent diffuse intrinsic pontine glioma, a form of inoperable, treatment-resistant brain cancer that affects children. Nimotuzumab is a humanized monoclonal antibody that targets the epidermal growth factor receptor. The single-arm trial in about 40 patients is expected to begin soon. The trial also is expected to be extended to the U.S., subject to a positive review by the FDA. The primary endpoint relates to response rates.

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