• Human Genome Sciences Inc., of Rockville, Md., initiated dosing in ACHIEVE 2/3, a Phase III trial of Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment-na ve patients with chronic hepatitis C virus genotypes 2 and 3. ACHIEVE is the second of two pivotal trials of Albuferon, and HGS aims to file global marketing applications for the product in 2009. The product is being developed in partnership with Basel, Switzerland-based Novartis AG. In separate news, HGS reported interim results from a Phase IIb trial of Albuferon in combination with ribavirin in patients with genotype 1 chronic HCV who are na ve to interferon alpha-based treatment regimens. Data show that the group receiving Albuferon 900-mcg doses every two weeks achieved a higher rate of sustained virologic response at 12 weeks following completion of therapy, as well as more favorable health-related quality-of-life scores, compared to the Pegasys treatment group. (See BioWorld Today, Oct. 5, 2006.)

• IDM Pharma Inc., of Irvine, Calif., completed patient enrollment in two Phase II studies of melanoma therapeutic Uvidem, which is partnered with Paris-based Sanofi-Aventis. The U.S. trial involved 38 patients with malignant melanoma and the European study enrolled 53 patients with resected Stage II/III melanoma. IDM expects to provide initial results later this year.

• Marinus Pharmaceuticals Inc., of Branford, Conn., dosed the first patient in an international, randomized Phase IIb study of its lead compound, ganaxolone, in infants suffering from infantile spasms (also called West syndrome). The FDA has granted orphan designation to the product in that indication. Infantile spasms is a rare form of epilepsy.

• Nymox Pharmaceutical Corp., of Hasbrouck Heights, N.J., completed a long-term follow-up study of NX-1207 for benign prostatic hyperplasia. The study assessed 114 patients eight months to 19 months after treatment. Data are expected in a week or two, Nymox said. The most recently reported trial on the drug, a Phase II study, showed positive efficacy and safety results after three months, and an overall reduction in mean prostate volume.

• Pharmasset Inc., of Princeton, N.J., initiated the multiple-ascending dose portion of an ongoing Phase I trial of R7128 in up to 40 patients chronically infected with hepatitis C virus genotype 1. The primary objective of this part of the study, which is being conducted in collaboration with Basel, Switzerland-based F. Hoffmann-La Roche Ltd., is to assess the safety, tolerability and pharmacokinetics of R7128 after once-daily or twice-daily dosing for 14 days. Initiation of that study triggered a $5 million milestone payment to Pharmasset from Roche.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., reported efficacy and safety data from the Phase III study of its interleukin-1 (IL-1) Trap (rilonacept) in patients with cryopyrin-associated periodic syndromes (CAPS), showing that the product met its primary endpoint in the change in disease activity, as measured using a composite symptom score composed of daily evaluations of fever/chills, rash, fatigue, joint pain and eye redness/pain. The company, which initially reported those data in October, presented results at the American Academy of Allergy, Asthma and Immunology meeting in San Diego.

• TargeGen Inc., of San Diego, completed a Phase I trial of TG100801, a topical, small-molecule multi-target kinase inhibitor, in 42 healthy volunteers. Preliminary results show that the drug is well tolerated in humans at the low and high doses tested when applied topically twice daily for 14 days. Final results are expected by the end of April. TG1008801 is in development for treating macular degeneration and other eye diseases.

• Targeted Genetics Corp., of Seattle, said Phase I data of tgAAC09 in 80 healthy volunteers not infected with HIV show that a single intramuscular injection of the vaccine candidate appears to be safe and well tolerated and stimulated a modest immune response against gag, the principal HIV protein encoded by tgAAC09. Results demonstrated HIV-specific T-cell responses in 20 percent of participants receiving the highest dose tested, though antibody responses were not observed. Those data were presented at the Conference on Retroviruses and Opportunistic Infections in Los Angeles.