• Astion Pharma AS, of Copenhagen, Denmark, said it has started enrolling patients for three pivotal Phase III studies of ASF-1057 for the treatment of seborrheic dermatitis, an inflammatory dermatological disease affecting the upper skin layers that is characterized by a red, greasy and scaly eczema that typically occurs on the face, chest or scalp. Two of the pivotal placebo-controlled studies are designed to document the effect of ASF-1057, glycerol monocaprylate formulated in a base cream containing the excipient nicotinamide, in the treatment of seborrheic dermatitis and establish the safety profile in short-term treatment. The other Phase III study will focus on safety in the use of ASF-1057 in long-term treatment. The Phase III program, the firm said, potentially will form the basis for a registration of ASF-1057 in Europe for seborrheic dermatitis if the results meet expectations for efficacy on the primary endpoints.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, said it is continuing to treat patients with stable disease participating in the CTCE-9908 Phase I/II clinical trial. The firm said that although enrollment was completed at the end of September, three patients with stable disease continue to receive CTCE-9908, a peptide analogue of the chemokine SDF-1, and an antagonist of its receptor, CXCR4. SDF-1. The company said that one patient with small bowel carcinoma is completing the seventh month of therapy, the maximum allowed by the protocol. The primary adverse effect reported at the maximum dose tested was moderate phlebitis, or blood vessel inflammation. Patients enrolled in the study all had terminal cancers with metastatic disease that no longer responded to standard therapy, or for which no curative therapy exists. Final results are expected in April 2008. Chemokine said it plans to start an international Phase II study in 2008 and is seeking to secure funding.

• Epiphany Biosciences, of San Francisco, has begun a Phase II clinical trial with valomaciclovir (EPB-348) for the treatment and management of acute infectious mononucleosis. The acute mononucleosis study at the University of Minnesota will be the first of several planned studies of valomaciclovir against EBV related diseases.

• F. Hoffmann-La Roche, of Basel, Switzerland, said results of a Phase II clinical trial suggested that Avastin may have the potential to be used as a curative treatment following breast cancer surgery. Data from the trial will be presented next week at the 30th San Antonio Breast Cancer Symposium. Roche markets Avastin in nations outside the U.S., while South San Francisco-based Genentech Inc., of which Roche owns a majority, sells the drug in the U.S. as a treatment for colorectal and non-small-cell lung cancer. An FDA advisory panel Dec. 5 voted against approval of the drug for metastatic breast cancer. (See BioWorld Today, Dec. 6, 2007.)

• Resverlogix Corp., of Calgary, Alberta, has received FDA approval to initiate a Phase Ia clinical trial of oral RVX-208 in the U.S. RVX-208 is a novel first-in-class small molecule that increases the production of ApoA-I and HDL. ApoA-I is regarded as the critical cardioprotective protein for the treatment of cardiovascular diseases. The trial is taking place in the U.S. It consists of three arms: an ascending single dose, a fed and fasted dose effect study and a seven-day ascending multiple dose that will enroll a total of 70-80 healthy volunteers. The primary objective is to evaluate oral RVX-208 in healthy adult subjects for safety, tolerability and pharmacokinetics.

• Speedel Holding AG, of Basel, Switzerland, has begun the proof-of-concept Phase IIa trial with its next-generation renin inhibitor SPP635 for the treatment of hypertension in diabetic patients. The current study will be carried out in Europe with a more-difficult-to-treat group suffering from both diabetes and mild-to-moderate hypertension. For four weeks, the clinical trial will examine the safety, tolerability and efficacy of two different doses of SPP635 in about 50 patients with type II diabetes, mild-to-moderate hypertension, and proteinuria.

• Targacept Inc., of Winston-Salem, N.C., has initiated a Phase I clinical trial of its product candidate TC-6499. The trial triggers a $6 million milestone payment to Targacept under the terms of its alliance agreement with GlaxoSmithKline, of London. TC-6499 is a novel small molecule that Targacept plans to develop initially as a treatment for neuropathic pain. In preclinical studies, TC-6499 demonstrated analgesic activity in multiple models of neuropathic pain. TC-6499 was discovered using Targacept's proprietary drug design technology known as Pentad. The study is designed to evaluate the safety, tolerability and pharmacokinetics of TC-6499. The trial is a double-blind, placebo-controlled study with escalating single doses of TC-6499 administered orally to healthy volunteers.

• TorreyPines Therapeutics Inc., of La Jolla, Calif., said that pharmacokinetic data obtained in a Phase I maximum tolerated dose clinical trial of NGX426, the oral prodrug of tezampanel, showed that the area under the curve (AUC), which represents the total amount of drug absorbed by the body, of a single, 80-mg, oral dose of NGX426 is comparable to the AUC of a single, 40-mg, subcutaneous dose of tezampanel. In addition, the firm said that recently demonstrated efficacy of 40 mg of tezampanel in a Phase IIb clinical trial suggested that NGX426 also may be effective in treating acute migraine headache. TorreyPines said it plans to initiate a Phase IIa study of NGX426 in acute migraine in the first half of 2008.

• XTL Biopharmaceuticals Ltd., of Valley Cottage, N.Y., presented data describing a family of small-molecule inhibitors of HCV that target the NS5A viral protein. Potency of those compounds was evaluated in a replicon assay, and the compounds had single-digit nM (nanomolar) and low double-digit nM potencies against genotypes Ib and Ia, respectively. Those genotypes constitute the majority of HCV infections in the U.S. The data were presented at a scientific conference in Lahaina, Hawaii.

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