• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started a Phase II trial of Iclusig (ponatinib) in adults with metastatic and/or unresectable gastrointestinal stromal tumors (GIST). The open-label study is designed to enroll about 45 patients and will provide initial data on the drug's efficacy and safety in patients with GIST following failure of prior tyrosine kinase inhibitor therapy. Patients whose tumors have an activating mutation in exon 11 of the cellular KIT, the primary driver for patients with GIST and KIT mutations, will be enrolled in Cohort A, while patients whose tumors have other activating mutations will be enrolled in Cohort B.

• Bionomics Ltd., of Thebarton, Australia, said it completed enrollment in its Phase II trial testing the combination of vascular disrupting agent BNC105 plus mTOR inhibitor Afinitor (everolimus, Novartis AG) in patients with advanced renal cell carcinoma. The study, dubbed DisrupTOR-1, enrolled 135 patients with advanced metastatic disease and has randomized them to receive either Afinitor alone or Afinitor plus BNC105. Once enrolled, patients are treated until disease progression or until adverse effects prohibit further therapy.

• Foamix Ltd., of Rehovot, Israel, reported Phase II data showing that its minocycline foam was highly effective in patients with moderate to severe acne, with once-daily treatment of the 4 percent foam exhibiting an average 71 percent reduction in inflammatory lesions after six weeks, with respective reductions of 55 percent in non-inflammatory lesions. Additional data from the 150-patient trial showed that Investigator's Global Assessment (IGA) scores significantly improved during the trial, with 53 percent of patients in the minocycline arm showing an IGA score of either "clear" or "almost clear," compared to 20 percent of placebo-treated patients.

• Immunomedics Inc., of Morris Plains, N.J., reported that adding two doses of epratuzumab labeled with the radioisotope yttrium-90 to a combination with Rituxan (rituximab, Roche AG and Biogen Idec Inc.) and CHOP chemotherapy (R-CHOP) appeared to improve elderly diffuse large B-cell lymphoma patients' responses to treatment. Data, which were updated at the Society of Nuclear Medicine and Molecular Imaging meeting in Vancouver, British Columbia, showed that, for the 61 patients who received the two consolidation 90Y-epratuzumab treatments, overall response rate was 91.8 percent (56 of 61 patients), with 50 patients (81.9 percent) achieving a complete or unconfirmed complete response. Epratuzumab is a humanized antibody designed to bind to the CD22 receptor on B cells.

• Medicago Inc., of Quebec City, said Health Canada cleared the firm to start a Phase II dose-sparing trial for its H5N1 avian influenza VLP vaccine candidate. The placebo-controlled study will use the intramuscular route of administration, with alum or GLA-based adjuvant, in healthy adults ages 18 to 60. A total of 390 subjects are expected to be enrolled and randomized to receive two doses of the H5 VLP vaccine formulated with alum adjuvant or GLA-SE adjuvant or placebo. The primary endpoints are immunogenicity evaluated 21 days after each administration, as well as safety and tolerability after each administration and 12 months after the last injection. As a secondary endpoint, the immunogenicity and cross-reactive antibodies induced by the H5 VLP vaccine will be evaluated. The trial is anticipated to take 15 months to complete, with initial safety and immunology data expected this summer.

• Navidea Biopharmaceuticals Inc., of Dublin, Ohio, reported results from a meta-analysis study of Lymphoseek (technetium Tc 99m tilmanocept) injection that compared the recently approved receptor-targeted radiopharmaceutical against commonly used vital blue dye (VBD) in identifying lymph nodes likely to harbor cancer cells over a period of time after injection. Results indicated that Lymphoseek demonstrated reliable histopathological detection of lymph nodes in lymphatic mapping across the likely time range of the procedure from injection to surgery – 15 minutes to 30 hours. Data were presented at the Society of Nuclear Medicine and Molecular Imaging meeting in Vancouver, British Columbia. The study involved 332 patients evaluated in the company's two Phase III trials designed to compare Lymposeek and VBD in patients with breast cancer and melanoma.