• Ariad Pharmaceuticals Inc., of Cambridge, Mass., said it started patient dosing in a Phase I/II trial of AP26113, a dual inhibitor of anaplastic lymphoma kinase and epidermal growth factor receptor, in non-small-cell lung cancer (NSCLC). The initial Phase I dose-escalation trial will include patients with advanced solid tumors, particularly those with NSCLC, who are either refractory to standard treatment or have no standard treatment available to them. The primary objective will be to determine the safety, tolerability and pharmacokinetic profile, find the recommended dose and measure preliminary antitumor activity. About 30 to 50 patients will be enrolled. The Phase II portion of the trial is expected to begin in the second half of 2012 and will enroll about 80 patients.

• Nektar Therapeutics Inc., of San Francisco, said proof-of-concept data from a Phase I trial of NKTR-181 showed that the opioid analgesic produced a clear dose-dependent response in a cold pressor test in healthy subjects. Pupillometry data from the study demonstrated that NKTR-181's centrally mediated opioid effects are dose-linear and that the molecule enters the brain slowly. It also achieved a predictable, dose-linear pharmacokinetic profile, with an average half-life of about 12 hours. Those data were presented at the American Academy of Pain Management meeting in Las Vegas.

• Orexo AB, of Uppsala, Sweden, said it obtained positive results from a clinical study aimed at determining the commercial formulation for OX219, a single tablet combining buprenorphine and naloxone, for opioid dependence. Orexo has consulted with the FDA and plans to pursue approval on the 505(b)(2) pathway.

• ProtoKinetix Inc., of Vancouver, British Columbia, reported results showing that AAGP, its anti-inflammatory molecule, can penetrate protective barriers of the eye without side effects. The company's primary focus is on AAGP, anti-aging glycopeptides, in diabetes, inflammatory diseases, skin protection and anti-aging.

• Repros Therapeutics Inc., of The Woodlands, Texas, said it started dosing of the final cohort in its Phase II low-dose trial of Proellex, which will involve a dose of 12 mg per day. Following study completion, Repros plans to request an end-of-Phase II meeting with the FDA during the first half of 2012 to discuss Phase III studies testing Proellex in endometriosis. The company initiated the dosing study last year after the agency lifted a long-standing clinical hold. (See BioWorld Today, June 14, 2010.)

• Theraclone Sciences Inc., of Seattle, said it dosed the first subjects in a Phase I trial of TCN-032, a fully human monoclonal antibody for influenza A virus. The study, supported in part by the company's deal with Tokyo-based Zenyaku Koygyo Co. Ltd., will test a single I.V. administration of TCN-032 compared to placebo in 40 healthy adults. Study results are expected in the first half of 2012.

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