• Amarillo Biosciences Inc., of Amarillo, Texas, said data of low-dose, orally administered interferon alpha in treating idiopathic pulmonary fibrosis showed the treatment was well tolerated with no reported side effects. The study has enrolled 10 planned subjects who are being administered 150 units of IFNa three times daily via orally dissolving lozenges. Results also showed a significant reduction in the cough associated with IPF. The data were presented at the Southern Regional Meeting of the Society for Clinical Investigations in Atlanta.

• Celgene Corp., of San Francisco, said Phase II data of CC-10004, an oral therapy for patients with severe plaque-type psoriasis, showed that 73.7 percent of enrolled patients demonstrated improvement in their psoriasis symptoms with 15.8 percent of those patients showing a greater than 50 percent reduction in their PASI score. Eight of the evaluable 15 patients demonstrated greater than a 20 percent reduction in epidermal skin thickness. The data were reported at the 64th Annual American Academy of Dermatology meeting in San Francisco.

• Corgentech Inc., of South San Francisco, said data from one of two Phase I/II trials of Avrina, its NF-kappaB Decoy drug candidate in atopic dermatitis, showed that the lowest dose evaluated was the most efficacious. The dose of 0.25 percent almost achieved statistical significance in the analysis of the combined eczema score at day 22, despite the small patient population. The drug also was found to be safe and well tolerated. Data were presented at the 64th American Academy of Dermatology meeting in San Francisco.

• Cortex Pharmaceuticals Inc., of Irvine, Calif., said its lead Ampakine drug, CX717, showed positive results for the treatment of adults with attention deficit hyperactivity disorder. Forty-nine patients with ADHD completed the randomized, double-blind, placebo-controlled, two-way crossover design performed at seven U.S. sites. Cortex undertook the Phase IIa trial to assess dosing and efficacy in adults, and the primary outcome measure was the ADHD Rating Scale (ADHD-RS), which evaluates both the inattentiveness and hyperactivity symptoms. The overall score showed a positive trend in the 800 mg twice-daily dose group (n=22) with a statistically significant effect on the hyperactivity subscale (p=0.050) compared to placebo. The 200-mg bid dose (n=27) did not show a significant effect. CX717 was well tolerated, and there were no serious adverse events or other significant safety concerns, including rises in blood pressure or heart rate, with either dose.

• Dyax Corp., of Cambridge, Mass., said top-line data from its completed open-label Phase II trial of DX-88 to treat hereditary angioedema showed the therapy was well tolerated and successful in treating all types of attacks, including peripheral, abdominal and life-threatening laryngeal attacks. These results were found regardless of whether DX-88 was administered through the intravenous or subcutaneous route. The product is being developed in a joint venture with Genzyme Corp., also of Cambridge. The data were presented at the American Academy of Asthma, Allergy & Immunology Conference in Miami.

• Dynavax Technologies Corp., of Berkeley, Calif., said data showed safety and statistically significant efficacy in its two-year, multicenter Phase II/III trial of Tolamba, a ragweed allergy immunotherapeutic. Tolamba achieved its efficacy endpoint, which was the change from baseline in total nasal symptom scores during the peak period of the 2005 ragweed season. The Tolamba-treated group received a single short, six-injection per six-week course of therapy prior to the 2004 ragweed season. Prior to the 2005 season, one-half of the subjects received a two-injection booster over two weeks. The results were presented at the 2006 annual meeting of the American Academy of Allergy, Asthma & Immunology in Miami.

• Halozyme Therapeutics Inc., of San Diego, completed enrollment of five patients for its Chemophase Phase I trial. Chemophase is a recombinant therapeutic being developed to enhance the deliver of chemotherapy. The initial clinical protocol was designed to evaluate a single intravesical administration of Chemophase along with the anticancer drug mitomycin in patients with superficial bladder cancer.

• Icagen Inc., of Research Triangle Park, N.C., has met the midway point of enrollment in its pivotal Phase III trial of ICA-17043 for the chronic oral treatment of sickle cell disease, with 150 of the total expected 300 patients now enrolled. The company reaffirmed its prior guidance for enrollment completion in the second half of the year and said interim efficacy analysis is expected during the third quarter.

• Jerini AG, of Berlin, said it is on track to report top-line Phase III results from its hereditary angiodema trial in mid-2006. So far, a total of 153 subcutaneous open-label treatments with the company’s drug, Icatibant, have been administered, with 91 percent of patients being treated with only a single injection within 24 hours. Jerini anticipates filing for marketing approval in both the U.S. and Europe by the end of the year.

• Medarex Inc., of Princeton, N.J., and PharmAthene Inc., of Annapolis, Md., said the FDA granted orphan drug designation to Valortim (MDX-1303) for anthrax infection. Valortim is a fully human antibody created using Medarex’s UltiMAb human antibody development system that targets the Bacillus anthracis protective antigen. The product is in a Phase I open-label, dose-escalation trial to evaluate the safety, tolerability, immunogenicity and pharmacokinetics of a single dose of Valortim administered intravenously or intramuscularly in healthy volunteers.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, said its low-dose Phase IIb trial of obesity drug AOD9604 is proceeding on schedule for full enrollment by April or May. To date, more than 230 subjects have been enrolled in the study, designed to test the drug’s efficacy at lower doses than previously tested - 1 mg, 0.5 mg and 0.25 mg. The trial is expected to be completed by January. In other news, Metabolic has moved the start of its Phase IIa trial of ACV1, its pain drug, from the second quarter to the third quarter due to a delay relating to the formulation of the drug material for the study.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., and its co-development partner Johnson & Johnson Pharmaceuticals Research & Development LLC, a unit of New Brunswick, N.J.-based Johnson & Johnson, started a three-arm, randomized Phase II study of Velcade and pemetrexed in patients with locally advanced or metastatic non-small-cell lung cancer who have failed prior chemotherapy treatment. Also under way is a two-arm, randomized Phase II study of Velcade in combination with erlotinib for patients with locally advanced or metastatic NSCLC and a study of single-agent Velcade in relapsed bronchioalveolar carcinoma and adenocarcinoma of the lung. The new study will enroll about 135 patients and has a primary endpoint of objective response rate as assessed by Response Evaluation Criteria in Solid Tumors (RECIST). Velcade is indicated for multiple myeloma patients who have received at least one prior therapy.

• Neuren Pharmaceuticals Ltd., of North Sydney, Australia, said it has received all necessary regulatory approvals and will start a Phase I trial of its second drug, NNZ-2566, for traumatic brain injury. The trial will be carried out in 35 healthy volunteers at the Royal Alfred Hospital in Melbourne, and is expected to conclude by the third quarter.

• Tibotec Pharmaceuticals Ltd., of Cork, Ireland, said its new drug application for the HIV protease inhibitor TMC114 has been accepted for priority review by the FDA, and the compound has a PDUFA date of June 23, 2006. The NDA is based on data from two studies. Phase III trials with TMC114, boosted with low-dose ritonavir, are ongoing in treatment-experienced and treatment-na ve HIV-1 patients.

• ZLB Behring, of King of Prussia, Pa., a division of Melbourne, Australia-based CSL Ltd., offered positive Phase III data for its Vivaglobin (immune globulin subcutaneous), a replacement therapy for treating patients with primary immunodeficiency. Vivaglobin is the first and only FDA-approved subcutaneous immunoglobulin treatment and can be self-administered by PI patients under a physician’s care. The data were presented at the Annual Meeting of the American Academy of Allergy, Asthma & Immunology in Miami, where ZLB also presented data showing that its C1-inhibitor concentrate is effective in relieving abdominal pain and abdominal-wall tension in patients with hereditary angioedema who experience abdominal attacks. No approved treatment for acute HAE attacks is available in North America, and ZLB is currently conducting Phase II/III trials at 45 sites.

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