• Alkermes Inc., of Cambridge, Mass., started a Phase I trial with AIR parathyroid hormone in healthy volunteers. The drug is an inhaled formulation of Indianapolis-based Eli Lilly and Co.'s recombinant, injected parathyroid hormone, Forteo (teriparatide), based on Alkermes' AIR pulmonary technology. The Phase I study will assess the safety, tolerability and pharmacokinetics of the product in postmenopausal women.

• BioMimetic Therapeutics Inc., of Franklin, Tenn., has initiated enrollment in a study to assess the safety and efficacy of GEM OS1 Bone Graft as a substitute for autograft in foot and ankle fusion procedures. The study, which is intended to support GEM OS1 product registration in the EU, will enroll 125 patients at 10 clinical centers. The primary endpoint will be fusion rates as measured by a CT scan at nine months after surgery. The company previously reported interim data from U.S. and Canadian clinical trials that demonstrated that fusion rates for GEM OS-treated patients appeared to be at least comparable to patients treated with autograft taken from elsewhere in the patient's own body, but without the donor site pain and potential complications of harvesting autograft. BMTI also announced that it has received full approval from the FDA for its U.S. study to evaluate the GEM OS1 Bone Graft in foot and ankle fusions.

• Discovery Laboratories Inc., of Warrington, Pa., initiated a Phase II trial with Surfaxin (lucinactant) in children with acute respiratory failure (ARF). The multicenter, randomized, placebo-controlled, 180-patient trial will compare Surfaxin to standard of care with sham air control with the goal of evaluating Surfaxin's safety and ability to decrease the duration of mechanical ventilation. The trial is expected to wrap up by mid-2008. Surfaxin, a peptide-containing (KL-4) synthetic surfactant, received an approvable letter from the FDA for the prevention of respiratory distress syndrome (RDS) in premature infants. Discovery Labs recently published one-year follow-up data from two Phase III trials showing that Surfaxin demonstrated a statistically significant survival advantage in premature infants with RDS.

• Dynogen Pharmaceuticals Inc., of Waltham, Mass., reported positive results of its randomized, double-blind, placebo-controlled Phase 1b trial of DDP733 for gastroesophageal reflux disease. The study was designed to demonstrate proof of concept for DDP733 as a treatment for nocturnal GERD (NGERD). The 0.5 mg dose of DDP733 achieved statistical significance over placebo on the primary endpoint of reduction in the number of reflux events and was safe and well tolerated. Dynogen plans to start a Phase II study of DDP733 in GERD patients in 2008. The compound is an oral, partial agonist of the serotonin type 3 receptor.

• Human Genome Sciences Inc., of Rockville, Md., reported top-line 24-week follow-up data from a Phase IIb trial comparing the combination of the long-acting interferon Albuferon (albinterferon alfa-2b) and ribavirin to Pegasys (peginterferon alfa-2a, F. Hoffmann-La Roche Ltd.) in treatment-naïve, genotype 1 chronic hepatitis C virus (HCV). Albuferon 900 mcg and 1200 mcg dosed every two weeks provided a sustained virologic response (SVR) in 58.5 percent and 55.5 percent of patients, respectively, compared to 57.9 percent on Pegasys. A 1200 mcg monthly dose of Albuferon caused an SVR in 50.9 percent of patients. In a subgroup of heavier patients, 71.2 percent of those on Albuferon achieved an SVR, compared to 53.3 percent of those on Pegasys. The 900 mcg every-two-weeks dose of Albuferon also resulted in quality-of-life improvements. Albuferon is partnered with Novartis AG, of Basel, Switzerland. Human Genome Sciences' shares (NASDAQ: HGSI) fell 6 percent, or 63 cents, to close at $9.83 on Thursday.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., reported data from a randomized, open-label Phase III trial with the injectable testosterone therapy Nebido (testosterone undecanoate), administered once every three months for male hypogonadism. In the trial, 94 percent of patients receiving 1,000 mg of Nebido and 86 percent of patients receiving 750 mg of Nebido achieved a normal testosterone level, exceeding the FDA's 75 percent response criteria. Both doses also met the FDA's criteria for maximum testosterone concentrations. Indevus plans to submit a new drug application this summer.

• Isotechnika Inc., of Edmonton, Alberta, got a "no objection" letter from Health Canada for the long-term use of ISA247 in patients in the Canadian arm of the Phase IIb kidney transplant trial. The letter lets patients stay on ISA247 to commercialization of the drug, beyond completion of the 12-month trial. Patients choosing to remain on ISA247 therapy will continue to have their safety and efficacy parameters monitored. A similar protocol amendment for the long term use of ISA247, a next-generation calcineurin inhibitor, also has been submitted to the FDA.

• Labopharm Inc., of Laval, Quebec, initiated a randomized, double-blind Phase III trial comparing once-daily trazodone to placebo for major unipolar depressive disorder. The treatment period in the study is two months, and Labopharm said a positive outcome should be sufficient to support a new drug application under Section 505(b)(2). Last week, Labopharm lost half its value when the FDA delivered a second approvable letter for its once-daily formulation of the analgesic, tramadol. (See BioWorld Today, June 4, 2007.)

• Neurochem Inc., of Laval, Quebec, published Phase II/III data with Kiacta (eprodisate) in AA amyloidosis-associated renal disease in the New England Journal of Medicine. Kiacta decreased the risk of the primary endpoint, a composite of worsening of renal function or death, by 42 percent (p=0.02). At 24 months, disease had worsened in 27 percent of Kiacta patients and 40 percent of placebo patients, although this finding was not statistically significant (p=0.06). The drug did not significantly affect progression to end-stage renal disease or risk of death. Neurochem said the data were submitted to U.S. and European regulatory authorities; an FDA decision on Kiacta is expected in July. Shares of Neurochem (NASDAQ:NRMX) fell 14 percent, or $1.07, to close at $6.42 on Thursday.

• Orexigen Therapeutics Inc., of San Diego, disclosed results from a Phase I trial testing the safety and pharmacokinetics of its novel, proprietary, sustained-release formulation of zonisamide. The drug achieved a significant reduction in the incidence of spontaneous adverse events, compared to the immediate-release form. Zonisamide SR is a key component in the company's obesity product candidate, Empatic, and is being evaluated in a large, Phase IIb multicenter study.

• Vical Inc., of Chicago, said interim data on 19 subjects from an ongoing Phase I clinical trial demonstrated that intratumoral delivery of plasmid DNA encoding interleukin-2 into melanoma tumors, followed by electroporation, was administered safely following sedative premedication. The majority of adverse events were localized to the treatment site, with the most frequent being mild injection site pain. Individual tumor responses were seen in 12 of 39 (31 percent) of evaluated tumors after injection of different escalating doses (0.5 to 5 mg per tumor). Treated tumors (seven of 18, or 38 percent) showed local responses more frequently than did untreated tumors (five of 21, or 24 percent). No overall clinical responses by standard RECIST criteria were observed among the 19 subjects evaluated following one or two cycles of treatment. Two subjects showed activity in distant, untreated tumors, including one subject showing shrinkage and disappearance of lung tumors.

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