• Alba Therapeutics Corp., of Baltimore, completed Phase Ib proof-of-concept studies for its lead compound, AT1001, an antagonist to the zonulin system aimed at treating celiac disease. In a cohort of 21 patients, oral administration of AT1001 vs. placebo induced a significantly positive result in the target endpoint.

• Alexion Pharmaceuticals Inc., of Cheshire, Conn., said updated results from its failed Phase III PRIMO-CABG2 trial with pexelizumab showed that the drug reduced the primary endpoint of the combined incidence of death or nonfatal myocardial infarction through postoperative day 30 following coronary artery bypass graft (CABG) surgery (pexelizumab = 15.2 percent vs. placebo = 16.3 percent). Mortality was reduced from 3.8 percent in the pexelizumab group, compared to 4.6 percent in the placebo group. The data, presented at the 2006 American College of Cardiology meeting in Atlanta, first were reported in November. (See BioWorld Today, Nov. 28, 2005.)

• Amgen Inc., of Thousand Oaks, Calif., said results from a Phase II study showed that treating anemia with Aranesp (darbepoetin alfa) in patients with symptomatic heart failure was well tolerated, while effectively raising hemoglobin and improving patients’ symptoms as measured by the Kansas City Cardiomyopathy Questionnaire. The data were presented that the 2006 American College of Cardiology in Atlanta. Based on the Phase II results, Amgen initiated a Phase III RED-HF (Reduction of Events with Darbepoetin alfa in Heart Failure) trial to evaluate the effect of Aranesp on morbidity and mortality in symptomatic heart failure patients.

• BioMS Medical Corp., of Edmonton, Alberta, is expanding the clinical development program for its lead candidate, MBP8298. The drug is undergoing an international pivotal Phase II/III trial with secondary progressive multiple sclerosis. BioMS now plans to initiate a clinical trial for MBP8298 in relapsing-remitting MS patients in the second half of 2006.

• Biopure Corp., of Cambridge, Mass., said the FDA notified the Navy of its intention to consult an FDA advisory committee within six months to discuss the Navy’s proposed RESUS trial of Biopure’s oxygen therapeutic Hemopure (hemoglobin glutamer - 250 [bovine]) for out-of-hospital treatment of hemorrhagic shock resulting from traumatic injury. The investigational new drug application submitted by the Navy in June remains on clinical hold due to issues related to the predicted risk-benefit profile of the product under the proposed protocol.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said ISIS 301012 did not interact with simvastatin or ezetimibe, currently available lipid-lowering drugs, in a drug-drug interaction study. In the study, after only four doses, ISIS 301012 achieved a median reduction of 33 percent in apoB-100 and a median reduction of 28 percent in LDL-C, and there were no adverse events. Isis initiated the Phase II development program of the product in September.

• Myriad Genetics Inc., of Salt Lake City, said Phase II data from a follow-on study of Flurizan in patients with mild Alzheimer’s disease suggested that participants on 800 mg twice a day of Flurizan continued to demonstrate increasing benefit through month 21 in cognition and memory loss, and that they maintained more of their global function and activities of daily living than those on 400 mg twice daily of Flurizan or than the projected placebo. The data were presented at the 19th annual meeting of the American Association of Geriatric Psychiatry in San Juan, Puerto Rico.

• NitroMed Inc., of Lexington, Mass., said data from a continuing analysis of patients treated with BiDil (isosorbide dinitrate/hydralazine hydrochloride) in the African American Heart Failure Trial suggest that the drug decreases systolic blood pressure (SBP) in black heart failure patients with higher baseline SBP (>126 mmHg), but not in those with lower baseline SBP (<126 mmHg). The beneficial effects of BiDil on clinical outcomes were shown to be independent of baseline SBP. The results were presented at the 2006 American College of Cardiology meeting in Atlanta.

• Pharmacopeia Drug Discovery Inc., of Princeton, N.J., said one of the compounds that came out of its collaboration with Schering-Plough Corp., of Kenilworth, N.J., has demonstrated activity in Phase I studies. The compound, a CXCR2 antagonist, is being evaluated as a treatment for chronic obstructive pulmonary disease. In a Phase I randomized, double-blind trial of 18 healthy volunteers, results showed that in the treated subjects, ozone-induced sputum neutrophilia was inhibited.

• The Medicines Co., of Parsippany, N.J., said the ACUITY trial of Angiomax (bivalirudin) met its objectives in favor of the drug. The results, presented at the American College of Cardiology Scientific Session, confirmed data that demonstrated replacing heparin with Angiomax improves outcomes, even in high-risk patients with acute coronary syndromes. The trial enrolled more than 13,800 patients and was conducted at 448 sites in 17 countries.

• Vical Inc., of San Diego, said its licensee, Sanofi-Aventis Group, of Paris, presented encouraging data from a Phase IIb trial of its angiogenesis product candidate NV1FGF, using Vical’s DNA delivery technology. Sanofi-Aventis plans to advance the candidate into Phase III testing in patients with critical limb ischemia in the fourth quarter. The data were presented at the 55th annual Scientific Session of the American College of Cardiology in Atlanta.

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