• Amylin Pharmaceuticals Inc., of San Diego, said positive Phase II obesity results showed an average weight loss across the pramlintide-treatment groups to range from 8.4 to 13.4 pounds from baseline, compared to 6.2 pounds for the placebo group. Twice-daily and three-times-daily regimens demonstrated efficacy, and weight loss experienced with pramlintide was progressive through 16 weeks. Pramlintide was well tolerated and no new safety signals were observed in the dose-ranging study, which included higher doses than previously tested.

• Penwest Pharmaceuticals Co., of Danbury, Conn., reported positive Phase IIa results on nalbuphine ER (PW4142), an extended-release tablet being developed for pain. Data showed, among other things, that the drug reduced pain intensity in a dose-dependent manner over the 12-hour study period. Separation from placebo began at 90 minutes post-dose for the higher strength and at six hours for the lower strength and was maintained at all time points over the remaining dosing interval. No unusual side effects were reported.

• The Immune Response Corp., of Carlsbad, Calif., said final Phase II data reported at last week’s Conference on Retroviruses and Opportunistic Infections in Denver indicated that the company’s whole-inactivated HIV-1 immunogen induces HIV-specific immune responses in HIV-infected, antiretroviral drug-na ve patients. Specifically, the product showed potential to stimulate key immunologic parameters and to stabilize the loss of CD4+ cells, which could help prolong the time before patients need to initiate antiretroviral therapy. The HIV-1 immunogen’s effect on immune reconstitution was evidenced by an augmented production of factors known to reduce HIV replication, such as beta chemokines and alpha defensin.

• Therion Biologics Corp., of Cambridge, Mass., completed enrollment in a Phase III pancreatic cancer study of PANVAC-VF, which also received orphan drug designation from the FDA. The trial, being conducted under a special protocol assessment with the FDA, has enrolled 250 pancreatic cancer patients who had received prior treatment with gemcitabine. Therion plans to submit a biological license application later this year.

• TopoTarget A/S, of Copenhagen, Denmark, began a pivotal Phase II study of its histone deacetylase inhibitor, Savicol, to test its ability to treat colon polyps in 60 patients with familial adenomatous polyposis. The oral cancer product has orphan drug status for that indication in both the U.S. and Europe. Results from the study are expected in the first half of next year. Its endpoints include measures of polyp burden, pathology of biopsies and an analysis of colorectal biomarkers.

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