• Acceleron Pharma Inc., of Cambridge, Mass., reported positive results from a Phase I trial of ACE-011, a bone-forming agent, which showed that the drug was well tolerated, with no serious adverse events, and that the pharmacokinetic properties showed a linear profile with dose and a mean half-life of about 24 to 32 days. A single dose of ACE-011 caused a rapid, sustained, dose-dependent increase of up to 35 percent in serum levels of the marker of bone formation, bone-specific alkaline phosphatase, with a slight decrease in serum levels of markers of bone resorption. Those data were presented at the American Society for Bone and Mineral Research meeting in Honolulu. Based on those results, the company anticipates initiating Phase II studies later this year.

• Alba Therapeutics Corp., of Baltimore, dosed the first patient in its Phase IIb trial of AT-1001, an oral inhibitor of gastrointestinal barrier dysfunction, for the maintenance of remission in patients with celiac disease. The study is designed to evaluate the efficacy, safety and tolerability of the drug in CD subjects during a six-week gluten challenge, while also testing components of a celiac disease activity rating index. AT-1001 has been granted fast-track designation by the FDA. Alba also is investigating the drug in Type I diabetes and Crohn's disease.

• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., said it expects to begin the first of two Phase III trials of AZ-004 (Staccato loxapine) late in the first quarter of 2008. The drug initially is being developed for acute agitation in patients with schizophrenia or bipolar disorder, and the two trials are expected to enroll about 300 patients each. AZ-004 is the combination of Alexza's Staccato system with the antipsychotic loxapine, and the drug previously met its endpoint in a Phase IIa trial, showing a statistically significant reduction in agitation in schizophrenic patients compared to placebo. The drug is being developed through a product development collaboration with Symphony Capital LLC.

• Depomed Inc., of Menlo Park, Calif., completed patient enrollment in a Phase II trial of Gabapentin GR, an extended-release formulation of gabapentin, in menopausal hot flashes. The 13-week study involves 124 menopausal women with recurrent, moderate to severe hot flashes, who will be randomized into one of four treatment arms, including a placebo arm, with the primary endpoint being the frequency and severity of hot flashes relative to baseline. Depomed anticipates reporting top-line results in the first quarter of 2008.

• GenVec Inc., of Gaithersburg, Md., said data from a Phase I/II trial testing a malaria vaccine candidate using the company's adenovector technologies in healthy volunteers showed the vaccine induced strong T-cell responses against the target antigens in all subjects. That vaccine, which is produced using GenVec's 293-ORF6 cell line and associated manufacturing process, is designed to provide protection against both the liver and blood stage of the parasite. The second part of the trial is designed to evaluate the protective effects of the vaccine after a malaria challenge. The vaccine candidate is being tested in trials sponsored by the Naval Medical Research Center (NMRC) and the U.S. Military Vaccine Program. GenVec has a separate vaccine collaboration with the PATH Malaria Vaccine Initiative and the NMRC, and preclinical data from that program demonstrated T-cell and antibody responses to all antigens in animals following delivery of the multivalent adenovectors. As a result, two multivalent vectors were selected for clinical development of new malaria vaccines. All those data were presented at a malaria vaccines conference in London.

• OncoMethylome Sciences SA, of Liege, Belgium, reported data from its colorectal cancer program showing that it successfully identified methylation markers that, when combined in a test panel, are accurate in detecting early stage disease via stool samples. The markers detected early stage colorectal cancer with 86 percent sensitivity and 96 percent specificity. Data were published at a molecular diagnostics in cancer conference in Atlanta.

• Osteologix Inc., of San Francisco, said data from its Phase I study demonstrated that NB S101, its dual-acting bone agent, had greater strontium bioavailability than a similar osteoporosis drug, strontium ranelate, which is sold as Protelos in Europe by French company Servier. Results, presented at a bone and mineral research meeting in Honolulu, showed that a single 1-gram dose of NB S101 was as effective as 2 grams of Protelos in increasing strontium to levels proven to prevent fracture. The company is testing NB S101 in a Phase II study evaluating its effect in modulating bone turnover and improving bone mineral density in women with low bone mass. Data from that study are expected in the fourth quarter.

• Zelos Therapeutics Inc., of West Conshohocken, Pa., reported data from a 12-month Phase II study of Ostabolin-C in postmenopausal women with osteoporosis, showing that the drug met its primary endpoint of a significant change in lumbar spine bone mineral density at one year. An increase in LS-BMD was observed in all treatment groups with a maximum mean increase of 11 percent. The proportion of patients who developed a clinically relevant LS-BMD increase of 3 percent or more was 79 percent after four months and 97 percent after 12 months in the 45 mcg dose group. Zelos also reported data from a Phase I study of an inhaled version of Ostabolin-C being developed in collaboration with Nektar Therapeutics Inc., of San Carlos, Calif. Results from that study in healthy, postmenopausal women showed that the inhaled formulation was able to increase serum markers of bone formation to levels comparable with the effect of subcutaneous delivery at a similar time point. Ostabolin-C is a cyclic parathyroid hormone analogue in late-stage clinical development for osteoporosis. Data from both studies were presented at a bone and mineral research meeting in Honolulu.

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