• ArQule Inc., of Woburn, Mass., said data from a Phase I combination trial of ARQ 501 and docetaxel demonstrated clinical tolerability, favorable pharmacokinetics and promising signs of antitumor activity in cancer patients with a range of advanced solid tumors who had failed prior treatments with chemotherapy. Those results were published in an abstract at the 2006 American Society of Clinical Oncology meeting in Atlanta.

• Genentech Inc., of South San Francisco, said a Phase IIIb study of a quarterly dosing regimen of Lucentis (ranibizumab) to treat wet age-related macular degeneration met its primary efficacy endpoint by preventing vision loss as measured by mean change in visual acuity from baseline to month 12. In the study, called PIER, patients received Lucentis (0.3 mg or 0.5 mg) or sham injections once a month for the first three months followed by doses once every three months for a total of 24 months. Data suggested that treating patients on a quarterly basis may be less effective than monthly or individualized dosing. The one-year data were presented at the Retinal Physician Symposium in the Bahamas. Genentech submitted a biologics license application to the FDA in December for Lucentis. (See BioWorld Today, Jan. 3, 2006.)

• Immunomedics Inc., of Morris Plains, N.J., said repeated use of its radiolabeled antibody against the carcinoembryonic antigen, 131l-labetuzumab, has been found to be safe and well tolerated by patients with colorectal cancer that has metastasized to the liver. The Phase II study enrolled 12 patients to date who have received two infusions of the antibody three months apart. Complete bone marrow recovery was reported in all cases, and no cancer recurrence was detected at a median follow-up of four months. Results were accepted for publication at the 42nd annual meeting of the American Society of Clinical Oncology in Atlanta.

• Introgen Therapeutics Inc., of Austin, Texas, reported data at the American Society of Gene Therapy meeting in Baltimore describing the beneficial effects and key markers of clinical activity in a cancer patient with Li-Fraumeni Syndrome, a genetic disorder characterized by inherited mutations in the p53 tumor suppressor gene. Treatment of a tumor in the patient with the company's Advexin product led to improved tumor-related symptoms and resulted in a complete response. In addition, molecular studies of biopsies of the tumor before and after treatment identified key markers of p53 pathway abnormalities that are used to predict and evaluate Advexin's effects.

• NicOx SA, of Sophia Antipolis, France, recorded an equity investment of €15 million (US$19.4 million) from New York-based Pfizer Inc., stemming from a March agreement granting Pfizer exclusive right to apply NicOx's nitric oxide-donating technology across the entire field of ophthalmology. Prior to the investment, NicOx has received about €8 million from the deal, and stands to receive total potential milestones in excess of €300 million, plus royalties. (See BioWorld Today, March 3, 2006.)

• Stressgen Biotechnologies Corp., of San Diego, changed its name to Nventa Biopharmaceuticals Corp. to reflect the company's corporate vision and clinical strategy. Nventa focuses on drugs for diseases caused by the human papillomavirus. The company's ticker on the Toronto Stock Exchange was changed to "NVN."

• Threshold Pharmaceuticals Inc., of Redwood City, Calif., said an independent data monitoring committee concluded that the company should complete its Phase III study of glufosfamide for the second-line treatment of metastatic pancreatic cancer after evaluating data collected to date and finding no major safety concerns. Top-line results are expected at the end of this year from the randomized, open-label trial, which is evaluating overall survival as its primary endpoint.

• Ziopharm Oncology Inc., of New York, reported interim results from an ongoing Phase I study of ZIO-101 in solid tumors, showing that six of 24 patients treated had clinical benefit, including five patients (two each with renal-cell cancer and colorectal cancer and one with head and neck cancer) who showed stable disease. Data were published in an abstract at the 2006 American Society of Clinical Oncology meeting in Atlanta. In a separate abstract, Ziopharm reported that ZIO-101 showed evidence of anti-leukemia activity in four of eight patients treated in a Phase I study. That trial is ongoing.

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