• Aegerion Pharmaceuticals Inc., of Bridgewater, N.J., said results from a second Phase II trial of AEGR-733, its lead cholesterol-lowering candidate, demonstrated a reduction in low-density lipoprotein levels by 51 percent from baseline in subjects with homozygous familial hypercholesterolemia. The product also showed efficacy in reducing total cholesterol levels by 58 percent, triglyceride levels by 65 percent and apolipoprotein B levels by 56 percent from baseline. Those data were published in the New England Journal of Medicine.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., said preliminary results of a European Phase IIb trial of Droxidopa showed statistical significance in reducing the fall in orthostatic systolic blood pressure in patients receiving 300 mg of the drug three times daily. The trial involved 121 patients in the intent-to-treat population to receive either placebo or Droxidopa three times daily for 28 days in doses ranging from 100 mg to 300 mg. Droxidopa is an orally available synthetic amino acid for neurogenic orthostatic hypertension.

• Ecopia BioSciences Inc., of Montreal, completed the dose-escalation portion of its Phase I trial of ECO-4601, the company's lead cancer drug candidate, with no dose-limiting toxicities observed. The company will initiate the extension phase of the study, which is expected to involve up to 15 patients and should be completed by the end of the second quarter.

• GenVec Inc., of Gaithersburg, Md., reached agreement with the FDA to proceed with endoscopic ultrasound administration of TNFerade as an additional option to percutaneous injection for patients participating in its PACT pivotal trial in locally advanced pancreatic cancer. PACT is designed to enroll 330 patients to evaluate the efficacy of TNFerade plus standard of care vs. standard of care alone. TNFerade is an adenovector containing the gene for tumor necrosis factor-alpha.

• Humanetics Corp., of Minneapolis, said the FDA cleared the company's investigational new drug application to start Phase I trials of BIO 3000, an oral drug in development for the prevention and prophylactic treatment of acute radiation syndrome. Humanetics gained a worldwide, exclusive license to the compound from the Henry M. Jackson Foundation for the Advancement of Military Medicine Inc., acting on behalf of the Uniformed Services University of the Health Sciences and the National Institutes of Health.

• Onyx Pharmaceuticals Inc., of Emeryville, Calif., and Bayer Pharmaceuticals Corp., of West Haven, Conn., said results of a pivotal Phase III trial demonstrate that Nexavar (sorafenib) tablets doubled median progression-free survival in patients with advanced renal-cell carcinoma. Those data were published in the New England Journal of Medicine. Nexavar gained FDA approval in December 2005.

• ProMetic Life Sciences Inc., of Montreal, received regulatory approval from Health Canada to expand the clinical program for its lead compound, PBI-1402, to include anemic patients with chronic kidney disease. The 12-week trial, which will be followed by a four-week observational period, is designed to monitor the safety and tolerability of PB-1402 and determine whether it has additive effects when combined with erythropoietin in that patient population. PB-1402 also is in a Phase Ib/II trial in chemotherapy- and/or cancer-induced anemia.

• Protherics plc, of London, said the FDA granted fast-track designation for Voraxaze, an adjunctive therapy for cancer patients experiencing, or at risk of, toxicity from methotrexate. Protherics, which said in November it planned to resubmit a biologics license application for Voraxaze following the agency's request for additional manufacturing data, anticipates possible approval of the product in the second half of 2008. The company was asked for additional information regarding its marketing authorization application in Europe, and also expects possible approval in the second half of 2008. Clinic Roundup