• Ardea Biosciences Inc., of Carlsbad, Calif., said the UK's Medicines and Healthcare Products Regulatory Agency cleared the company to start a Phase IIa trial of RDEA806, a non-nucleoside reverse transcriptase inhibitor, in HIV patients. The study is designed to evaluate once-daily and twice-daily dosing regimens in HIV-1 patients who are naïve to antiretroviral treatment, and the primary endpoint will be the change from baseline in plasma viral load.

• Cytokinetics Inc., of South San Francisco, initiated a Phase I/II trial to test ispinesib monotherapy in first-line, chemotherapy-naïve patients with locally advanced (Stage IIIb) or metastatic (Stage IV) breast cancer. The Phase I portion is designed to determine the dose-limiting toxicity and maximum tolerated dose (MTD) of ispinesib, as administered as a one-hour intravenous infusion on days 1 and 15 of a 28-day cycle. Once MTD is established, the study will move into the Phase II portion, which will assess the overall response rate to ispinesib of patients with measurable locally advanced or metastatic breast cancer who have not received prior chemotherapy, using RECIST criteria. Ispinesib, a kinesin spindle protein inhibitor, is partnered with London-based GlaxoSmithKline plc.

• OxiGene Inc., of Waltham, Mass., said its lead candidate, Zybrestat (combretastatin-A4 phosphate) achieved the pre-specified primary efficacy endpoint for the first stage of an ongoing Phase II ovarian cancer trial testing the drug in combination with carboplatin and paclitaxel. In addition to the three of 18 patients who, so far, have achieved a partial response - a minimum of three partial responses was needed to move into the second phase of the trial - preliminary results also indicated stable disease in seven of the first 11 evaluable subjects. The trial now is proceeding with the second stage, which will involve the enrollment of an additional 25 patients. Zybrestat also is in an ongoing pivotal trial in anaplastic thyroid cancer.

• Third Wave Technologies Inc., of Madison, Wis., said it achieved its subject enrollment goals for its human papillomavirus trials. Total enrollment was comprised of 2,000 normal subjects and 1,400 women with atypical Pap test results. The next steps in the trial include obtaining the final colonoscopy and biopsy data, validating and locking down the database, opening the database and completing and submitting premarket applications to the FDA. Third Wave's HPV products include a test to screen for 14 high-risk types of HPV and a test to enable clinicians to determine if a patient is infected with HPV Types 16 or 18, which represent the most carcinogenic types.