• Aradigm Corp., of Hayward, Calif., said results of a Phase IIa trial of inhaled hydroxychloroquine (HCQ) in patients with moderate-persistent asthma did not meet the pre-specified clinical efficacy endpoints. The trial was funded by Tucson, Ariz.-based APT Pharmaceuticals Inc., and APT and Aradigm plan to continue data analysis to decide whether to pursue additional work on inhaled HCQ. No serious adverse events were reported, either related to the drug or Aradigm's AERx delivery system.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., said the first patients were dosed in its second U.S. Phase III pivotal trial and the first Phase III study outside the U.S. for its lead compound, AA4500, in Dupuytren's contracture, a condition in which the joints in the hand contract, impairing the ability for patients to move their fingers. The U.S. study is expected to involve more than 200 patients randomized on a 2:1 basis to receive either AA4500 or placebo, with the primary endpoint of reducing the contracture angle to within 0 to 5 degrees of normal as measured by digital goniometry. Data from the trial, plus results from an open-label extension study, are anticipated to be included in a biologics license application. Auxilium reported positive results from the first U.S. Phase III study in June. The ex-U.S. study will involve up to 60 patients in Australia and Switzerland and will follow a similar protocol to the U.S. trial. (See BioWorld Today, June 22, 2006.)

• MGI Pharma Inc., of Minneapolis, said interim results from 35 patients in its Phase II combination study of Gliadel Wafer (polifeprosan 20 with carmustine implant) in newly diagnosed, resectable, high-grade malignant glioma showed a median survival of 18.6 months when Gliadel Wafer and temozolomide are used in combination with surgery and radiotherapy. The trial is expected to enroll a total of 40 patients. Data were presented at the Society for Neuro-Oncology meeting in Orlando, Fla.

• Neopharm Inc., of Waukegan, Ill., said results from a 22-patient Phase I trial showed that 0.5 g/mL of cintredekin besudotox delivered via convection-enhanced delivery followed by external beam radiation therapy with or without concurrent temozolomide following tumor resection appears to be safe and well tolerated in patients with newly diagnosed malignant glioma. Data were presented at the Society for Neuro-Oncology meeting in Orlando, Fla.

• Pharmacyclics Inc., of Sunnyvale, Calif., said pooled results from two Phase III trials of Xcytrin (motexafin gadolinium) injection combined with whole-brain radiation therapy (WBRT) significantly prolonged time to neurologic progression (TNP) in non-small-cell lung cancer patients with brain metastases. Analysis showed that the median TNP was 15.4 months for patients receiving WBRT plus Xcytrin compared to nine months for patients treated with WBRT alone. Data were presented at the Society for Neuro-Oncology meeting in Orlando, Fla. Pharmacyclics previously reported results from both Phase III studies, in which the drug failed to meet the primary endpoints, but the company reported findings that suggested Xcytrin in combination with WBRT might be statistically significant. The company anticipates using the pooled data from both trials to file a new drug application for Xcytrin by the end of the year. (See BioWorld Today, Dec. 17, 2001, and Dec. 20, 2005.)

• Shire plc, of Basingstoke, UK, said two-year data demonstrated that patients treated with its phosphate binder, Fosrenol, showed similar phosphate control and lower serum calcium levels than standard therapy. Fosrenol treatment showed no adverse effects on bone histology, and more patients in the Fosrenol group demonstrated increases in bone formation rate than patients in the standard therapy group. Those data were presented at the Society of Nephrology meeting in San Diego.

• Somaxon Pharmaceuticals Inc., of San Diego, reported positive results from its third Phase III trial of Silenor (dexepin HCl) in insomnia. Data from the study, which enrolled 255 elderly subjects with at least a three-month history of insomnia, showed that the drug met its primary endpoint, demonstrating a statistically significant improvement compared to placebo in subjective total sleep time, as measured at one week. Silenor also achieved statistical significance with respect to secondary endpoints, including wake after sleep onset and sleep quality, with those effects maintained throughout the four-week trial. Somaxon expects results from its final Phase III trial in December, with a new drug application anticipated in the third quarter of 2007.

• Vernalis plc, of Winnersh, UK, said partner Novartis AG, of Basel, Switzerland, selected a second compound for preclinical development under the companies' collaboration on heat-shock protein 90 in oncology. That candidate will be an oral follow-on to an intravenous compound and was discovered using Vernalis' fragment-based drug discovery platform. Under the terms of the 2004 deal, Novartis will pay Vernalis a $1.5 million milestone payment. (See BioWorld Today, Aug. 10, 2004.)