• Aoxing Pharmaceutical Co. Inc., of New York, initiated a registration trial of buprenorphine/naloxone sublingual tablets for opioid addiction. The multicenter, randomized, single-blind, active-control trial will enroll 240 patients in China and will consist of three phases: a brief induction phase, a multiweek maintenance phase and a detoxification phase. Aoxing plans to complete clinical trials by 2012.

• ArqQule Inc., of Woburn, Mass., started dosing in a Phase I trial of ARQ 736, a RAF kinase inhibitor being developed for cancer. The trial will assess safety and tolerability of ARQ 736 in patients with advanced solid tumors that contain BRAF mutations.

• Auxilium Pharmaceuticals Inc., of Malvern, Pa., published results of its pivotal Phase III trial of Xiaflex (collagenase clostridium histolyticum) for adult Dupuytren's contracture, a condition affecting connective tissue in the palm of the hand that causes progressive contracture of the hand. In the trial, Xiaflex reduced the angle of contracture in the metacarpophalangeal and proximal interphalangeal joints. Sixty-seven percent of patients experienced a clinically significant result. Results are in the December 2010 online edition of The Journal of Hand Surgery.

• Biogen Idec Inc., of Weston, Mass., and Swedish Orphan Biovitrum AB, of Stockholm, Sweden, dosed their first patient in a Phase II/III trial of recombinant factor VIII Fc fusion protein (rFVIIIFc). The open-label, multicenter, registration trial will enroll 150 males with hemophilia A, ages 12 and older in 60 centers around the world. Participants must have a history of 150 prior exposure days to any current factor VIII product and a platelet count of more than 100,000 cells per uL. Three arms of the study will evaluate high-dose prophylaxis, low-dose prophylaxis and on-demand dosing.

• Columbia Laboratories Inc., of Livingston, N.J., and Watson Pharmaceuticals Inc., of Morristown, N.J., reported top-line results from the Phase III PREGNANT study showing that Prochieve 8 percent vaginal progesterone gel was associated with a statistically significant reduction in the rate of preterm birth at less than or equal to 32 6/7 weeks gestation vs. placebo gel, meeting the primary endpoint of the study. There also was evidence of improvement in infant outcome, and the adverse event profile for the Prochieve arm was comparable to placebo. Based on those data, Columbia Labs intends to file a new drug application in the second quarter of 2011.

• GeoVax Labs Inc., of Atlanta, expanded its Phase IIa trial to test three doses of recombinant poxvirus vaccine MVA62B without the use of the recombinant DNA-vectored vaccine, which was used to prime immune responses in the first part of the trial. The study is sponsored by the National Institute of Allergy and Infectious Diseases.

• Genentech Inc., of South San Francisco, a unit of Roche AG, reported that its investigational schizophrenia drug, RG1678, produced clinically meaningful reduction in the negative symptoms of schizophrenia in a Phase II study, as well as beneficial changes in patients' functioning. The drug was given in combination with commercially available antipsychotics. RG1678 is glycine reuptake inhibitor.

• Generex Biotechnology Corp., of Worcester, Mass., said data from an ongoing Phase II trial of its breast cancer vaccine, AE37, showed that patients receiving AE37 and Herceptin (trastuzumab, Genentech Inc./Roche AG) simultaneously showed an increase in specific immune stimulation of T cells compared to AE37 given after trastuzumab therapy.

• Lytix Biopharma A/S, of Oslo, Norway, and KAEL-GemVax Co. Ltd., of Seoul, South Korea, enrolled the first patient in the companies' joint study to test LTX-315 as an adjuvant for the GV1001 peptide cancer vaccine. The study will include about 20 patients and is designed to document the safety, tolerability and anti-telomerase immune responses of GV1001 in combination with LTX-315.

• QRxPharma Ltd., of Sydney, Australia, completed patient enrollment in a pivotal Phase III trial of MoxDuo IR designed to evaluate analgesic efficacy and safety of the drug, a fixed-dose combination of morphine plus oxycodone, for managing moderate to severe pain in patients who have undergone total knee replacement surgery. Top-line results are expected in February 2011.

• Sequella Inc., of Rockville, Md., filed an investigational new drug application with the FDA for its candidate, SQ109, for H. pylori-related duodenal ulcers. The company will begin a Phase IIa trial to evaluate safety, tolerability and antimicrobial activity of SQ109 for duodenal ulcers. The compound also is in Phase II trials for pulmonary tuberculosis.

• Sunovion Pharmaceuticals Inc., of Marlborough, Mass., presented clinical data for Stedesa (slicarbazepine acetate), its epilepsy candidate, in a poster session at the 2010 annual meeting of the American Epilepsy Society in San Antonio. The presentations covered a Phase I study of plasma pharmacokinetics in cerebrospinal fluid and pooled data from two Phase III studies in patients with a history of partial-onset seizures.

UCB SA, of Atlanta, reported findings highlighting the long-term benefits of Vimpat (lacosamide) as an adjunctive therapy for adults with uncontrolled partial-onset seizures. An open-label extension study found that, after a year of Vimpat treatment, patients reported significant improvements in all aspects of seizure severity and across almost all health-related quality-of-life assessments. A separate study demonstrated sustained efficacy in adults taking Vimpat as an adjunctive therapy up to five years. Data were presented at the American Epilepsy Society meeting in San Antonio.

• Vivus Inc., of Mountain View, Calif., reported that its investigational drug for erectile dysfunction, avanafil, met all primary endpoints in a Phase III study. Those patients treated with avanafil who attempted sexual intercourse within 15 minutes of dosing had an 80 percent success rate. The open-label study enrolled 712 men with a general history of erectile dysfunction and 226 diabetic men with erectile dysfunction at 40 centers in the U.S. Data from an earlier Phase III trial in ED met its primary endpoint last year. (See BioWorld Today, Nov. 19, 2009.)