• Astellas Pharma, of Tokyo, and Theravance Inc., of South San Francisco, presented data from two Phase III trials in which telavancin compared favorably to standard therapy in the treatment of patients with complicated skin and skin structure infections, including those caused by Gram-positive organisms. The companies are partners on the drug, which is under FDA review. Astellas also said a trial of its drug Mycamine (micafungin sodium) compared favorably to standard therapy for Candida infections and provided significant safety advantages. Mycamine is approved in the U.S. and is undergoing evaluation in Europe. The data were presented at the 17th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Munch. (See BioWorld Today, Dec. 11, 2006.)

• Helix BioPharma Corp., of Aurora, Ontario, said treatment with its topical interferon alpha-2b caused abnormal Pap smears to revert to normal for 46.7 percent of women with human papilloma virus in a Phase II trial. That compares to a regression of only 15.8 percent in the untreated group. Additionally, 60 percent of the treated women experienced resolution of their abnormal cervical findings upon colposcopic diagnosis, vs. only 9.5 percent of the untreated women. No significant local intolerance or drug-related serious adverse events were observed. Shares of Helix (TSX:HBP) rose 13.9 percent, or 23 cents, to close at $1.88.

• Nautilus Biotech, of Paris, initiated a Phase I trial of subcutaneous Belerofon, its long-lasting human interferon alpha, which may be applicable in the treatment of various diseases including chronic hepatitis C virus. The open-label, ascending-dose trial will evaluate four doses of Belerofon compared to Intron A (interferon alpha-2b, Schering-Plough Corp.) and Pegasys (pegylated interferon alfa-2a, F. Hoffmann-La Roche Ltd.). Nautilus expects initial results to be available in the third quarter. In February, the company filed an investigational new drug application for an oral version of Belerofon.

• NeoPharm Inc., of Waukegan, Ill., said an interim analysis of its Phase II colorectal cancer trial with LE-SN38 showed a failure to meet the primary endpoint of tumor response. Although the company said patients demonstrated disease stabilization, accrual in the trial has been halted. NeoPharm's shares (NASDAQ:NEOL) fell 6 cents to close at $1.64. LE-SN38 recently had been viewed as one of NeoPharm's most advanced programs, following a Phase III failure with brain cancer drug cintredekin besudotox last year and the FDA's recent decision to require an additional Phase III trial. (See BioWorld Today, Dec. 12, 2006, and March 30, 2007.)

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