• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, began a study in Europe to evaluate the safety and efficacy of the Vascular Wrap paclitaxel-eluting mesh after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular access, for patients with end-stage renal disease. About 198 patients will be enrolled, paralleling a pivotal U.S. trial that's already under way.

• Celsion Corp., of Columbia, Md., said a Phase I dose-escalation study of ThermoDox for nonresectable liver cancer has completed enrollment. In the trial, conducted under a Cooperative Research and Development Agreement at the National Cancer Institute, 24 primary and metastatic liver cancer patients, with up to four lesions ranging from 3 cm to 7 cm, were treated with ThermoDox in combination with radiofrequency ablation at doses ranging from 20 mg/m2 to 60 mg/m2. Designed to determine the product's maximum safe dose and safety profile, additional analyses will evaluate any clinical effects. Data are being collected.

• Exelixis Inc., of South San Francisco, began a Phase II trial of XL647 in non-small-cell lung cancer patients who previously benefited from erlotinib or gefitinib or have a documented T790M mutation in the epidermal growth factor receptor (EGFR). XL647 is designed to simultaneously inhibit the activity of multiple receptor tyrosine kinases, including EGFR, HER2 and vascular endothelial growth factor receptor type 2 (VEGFR2). Although the T790M mutation confers resistance to the inhibitory effects of erlotinib and gefitinib, preclinical data indicated that XL647 can potently inhibit that mutation and other mutant forms of EGFR. Separately, GlaxoSmithKline plc, of London, is deciding over the next three months to review other data on XL647 and decide whether to exercise its option to select the compound for further development, per terms an existing collaboration between the companies.

• Human Genome Sciences Inc., of Rockville, Md., began the second of two pivotal Phase III trials of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus. Being conducted primarily in Asia, South America and Eastern Europe, it is designed to enroll about 810 patients who will be treated for 52 weeks. The primary efficacy endpoint is the patient response rate after that year. Enrollment is expected to wrap up next year. LymphoStat-B is being developed in agreement with GlaxoSmithKline plc, of London. Dosing in the first began earlier this year. (See BioWorld Today, Feb. 14, 2007.)

• Introgen Therapeutics Inc., of Austin, Texas, said data published in the current issue of Molecular Cancer Therapeutics described the clinical benefit of its lead product Advexin in a patient with a rare inherited form of cancer known as Li-Fraumeni Syndrome, a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. Specifically, treating the tumor with Advexin led to improvement of tumor-related symptoms and resulted in a complete response as determined by positron emission tomography scans. That is the first reported treatment of Li-Fraumeni tumors with a therapy targeted to the underlying molecular cause of the disorder, the company said.

• Mersana Therapeutics Inc., of Cambridge, Mass., began a Phase I trial of its lead product candidate, XMT-1001, in patients with solid tumors. The open-label, dose-escalation study's primary objectives are to determine the safety, tolerability and pharmacokinetic profile of the compound, a polymer-based prodrug of camptothecin.

• Rexahn Pharmaceuticals Inc., of Rockville, Md., received FDA clearance to begin a Phase II trial of its lead oncology compound, Archexin, in patients with renal cell carcinoma. The non-blinded study is designed to assess the product's efficacy in advanced patients who have failed previous treatment or are unwilling or unable to be treated with standard systematic line therapy. Enrollment is expected to begin next quarter.