• Alkermes Inc., of Cambridge, Mass., said it completed enrollment in a Phase I/II trial of ALKS 29, an oral compound for the treatment of alcohol dependence. Alkermes is not disclosing the nature of the compound. The multicenter, randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of ALKS 29 in about 150 subjects with alcohol dependence. Alkermes expects to provide top-line results from the study in the first half of 2007.

• AOP Orphan Pharmaceuticals AG, of Vienna, Austria, and Lantibio Inc., of Chapel Hill, N.C., reported positive final results from their Phase II study of Moli1901 in adolescents and adults with cystic fibrosis. Data showed that subjects ages 12 and older tolerated daily administration of the inhaled drug over 28 days, and analysis of the data showed no trace of Moli1909 in the plasma of the subjects, indicating the drug has limited or no systemic absorption. Though the trial was not powered to demonstrate efficacy, patients who received 2.5 mg of Moli1901 per day showed a statistically significant improvement of lung function as measured by forced expiratory volume in one second. Moli1901, a stable 19-residue polycyclic peptide produced by fermentation of Streptomyces cinnamoneum, is being developed in Europe under a licensing and commercialization deal with Lantibio.

• Cytochroma Inc., of Markham, Ontario, said it completed enrollment in a Phase II trial of CTA018 cream for chronic plaque psoriasis. The trial is a randomized, double-blind, placebo-controlled study being conducted in 16 dermatology clinics in the U.S. A total of 147 subjects with chronic plaque psoriasis have been enrolled and are undergoing a 12-week course of treatment with one of three different concentrations of CTA018 cream or a matching placebo. The primary efficacy endpoint is a physician static global assessment. Patient perceptions of CTA018, a vitamin D analogue, also are being evaluated in addition to several other secondary endpoints

• EntreMed Inc., of Rockville, Md., began a Phase II trial to evaluate the safety and efficacy of Panzem (2-methoxyestradiol or 2ME2), alone and in combination with Sutent (sunitinib), in patients with metastatic renal cell carcinoma. The study will evaluate the potential of Panzem in patients who have failed treatment with sunitinib, as well as those currently being treated with sunitinib but showing signs of disease progression. The combination portion will determine if the addition of Panzem will restore tumor response by blocking tumor growth at both the level of the VEGF receptor and by inhibiting HIF-1alpha. Panzem currently is in Phase II trials for brain, ovarian, carcinoid and prostate cancers and a Phase I study in metastatic breast cancer.

• Medivir AB, of Huddinge, Sweden, is starting its first human trial of MIV-701, which inhibits the enzyme cathepsin K and is being developed to treat osteoporosis. Preclinical studies have shown the drug to reduce degradation of bone. Medivir will investigate how an oral dosage form of MIV-701 is taken up and tolerated by the body. It said studying biomarkers should provide a preliminary assessment of the compound's efficacy on osteoporosis, and other skeletal disorders such as arthritis and bone metastases. Data from the study are expected this year.

• Nventa Biopharmaceuticals Corp., of San Diego, presented positive results from a trial examining the safety and efficacy of pilot-process HspE7, a therapeutic vaccine for human papillomavirus-related diseases, in women with the highest grade of cervical dysplasia. The open-label Phase II trial demonstrated an overall response rate of 78 percent among the 58 evaluable patients. Nventa is advancing a new formulation of HspE7 believed to be more potent, for which a Phase I bridging trial is expected to begin by mid-2007.

• Pozen Inc., of Chapel Hill, N.C., announced positive results from a proof-of-concept, 80-subject study of PA 325, a formulation of 325 mg of aspirin surrounded by a 20-mg coating of an immediate-release formulation of a proton pump inhibitor. The study demonstrated a statically significant benefit on gastrointestinal damage vs. enteric coated aspirin 325 mg. Ten percent of the PA group had Lanza 3 or 4 gastrointestinal damage, whereas 57.5 percent of the aspirin group had that level of damage. In addition, no ulcers were seen in the PA group, while 20 percent of subjects in the aspirin group developed a gastric ulcer during the study, a statistically significant difference. Pozen's stock (NASDAQ:POZN) gained $1.46 Tuesday, or 10.3 percent, to close at $15.70.

• Replidyne Inc., of Louisville, Colo., said a Phase II trial of faropenem medoxomil in pediatric patients with acute otitis media met its primary objective of showing faropenem was effective in eradicating pathogens from the middle ear, and to permit the dose selection for Phase III trials in AOM. The study in more than 300 patients examined four different doses of faropenem, administered twice daily as an oral suspension, and demonstrated a dose response in bacteriological eradication. All doses were well tolerated. Faropenem is a member of the penem subclass within the beta-lactam class of antibiotics. Replidyne said it plans to meet with the FDA in the second quarter to share the data and discuss Phase III trial design.

• Savient Pharmaceuticals Inc., of East Brunswick, N.J., reached its Phase III enrollment target of 200 patients in two replicate six-month trials of Puricase in patients with treatment-failure gout. The trials, which are being conducted under a special protocol assessment from the FDA, are expected to conclude in the fourth quarter, with top-line results available by the end of the year. Savient said it remains on target to file a biologics license application in early 2008. Puricase is a pegylated recombinant porcine urate oxidate in development to control hyperuricemia.

• Sunesis Pharmaceuticals Inc., of South San Francisco, began dosing in a Phase I trial of SNS-032 in patients with advanced B-cell malignancies. SNS-032 is a selective, small-molecule inhibitor of cyclin-dependent kinases 2, 7 and 9. It showed in preclinical and clinical studies the ability to deplete cells of myeloid cell leukemia sequence 1, or MCL-1, a protein associated with cell survival, particularly in lymphomas and other B-lymphoid malignancies. SNS-032 targets both cell-cycle and transcriptional-regulation pathways. The trial is designed to examine safety and tolerability, as well as preliminary antitumor activity, in 30 to 40 patients. Initial safety results are expected by year-end.

• YM BioSciences Inc., of Mississauga, Ontario, said enrollment has been completed in the randomized, double-blind, placebo-controlled portion of its Phase IIb trial (DLXLEF-AP4) of AeroLEF for treating moderate to severe postsurgical pain. AeroLEF is an inhaled-delivery composition of free and liposome-encapsulated fentanyl. The 99-patient trial is evaluating safety and efficacy vs. placebo. The primary endpoint is summed pain relief plus pain intensity scores for four hours following the initial dose. Secondary endpoints included time to effective pain relief, as well as six safety measures. Results are expected around the middle of the second quarter.

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