• Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions. AVR118 is a cytoprotective agent in development for cachexia-related disorders and has shown topical wound healing properties in animal models.

• Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2 study of DX-88 (ecallantide) in hereditary angioedema demonstrated clinical response at or before four hours for all dose levels of the drug, with 92 percent response at 5 mg/m2 (I.V.), 85 percent response at 10 mg/m2 (I.V.), 87 percent response at 20 mg/m2 (I.V.) and 92 percent response at 30-mg flat dose subcutaneous. Median time to response was 29 minutes. Data were presented at the American College of Allergy, Asthma and Immunology meeting in Philadelphia.

• Human Genome Sciences Inc., of Rockville, Md., said 76-week results of a Phase II trial showed LymphoStat-B (belimumab) reduced disease activity in patients with serologically active systemic lupus erythematosus, exhibited durable biological activity, and appeared safe and well tolerated. In the LymphoStat-B treatment groups, the percentage of serologically active SLE patients who achieved the combined response rate selected as the primary efficacy endpoint for Phase III trials increased from 46 percent at week 52 to 56 percent at week 76, with no increase in infections or infectious events observed over time.

• Immunomedics Inc., of Morris Plains, N.J., said its partner, UCB SA, of Brussels, Belgium, received an FDA notice lifting the clinical hold on trials of epratuzumab in lupus patients. The hold was placed in September after UCB voluntarily suspended Phase III dosing following a routine quality-assurance audit. The companies will submit protocol amendments to seek approval to treat patients who remain in the suspended studies and who are in need of re-treatment.

• NovaCardia Inc., of San Diego, said results from Phase II trials of KW-3902, an adenosine A1 receptor antagonist for congestive heart failure, showed that the drug provided an increase in glomerular filtration rate, a measure of renal function, of 32.1 percent over baseline compared to an 8.3 percent increase with placebo over an eight-hour period. Those data were presented at the American Heart Association's meeting in Chicago.

• Pharmos Corp., of Iselin, N.J., said initial analysis of data from a Phase I study of its NanoEmulsion topical drug delivery technology formulated with diclofenac, an approved nonsteroidal anti-inflammatory drug, showed that the drug was well tolerated with no severe or serious adverse events. Pharmacokinetic analysis demonstrated low systemic exposure of diclofenac with no drug accumulation following repeated daily administrations. The trial tested the product in 16 healthy volunteers, who received 14 days of three daily administrations.

• Surface Logix Inc., of Boston, presented positive data from its first Phase I trial assessing the safety and tolerability and establishing the pharmacokinetic and pharmacodynamic profile of SLx-4090, an enterocyte-specific microsomal triglyceride transfer protein inhibitor for dyslipidemia. Results were presented at the American Heart Association's Scientific Sessions 2006 conference in Chicago.

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