• Biomira Inc., of Edmonton, Alberta, filed an investigational new drug application for the small molecule PX-478, an inhibitor of hypoxia-inducible factor (HIF)-1 alpha, a protein involved in tumor growth and survival. In various preclinical cancer models, oral PX-478 demonstrated antitumor activity as well as tumor regression and growth inhibition. Biomira plans to begin a Phase I trial with the drug in the third quarter, followed before the end of the year by the initiation of another Phase II cancer trial with PX-12, the filing of an IND for cancer drug PX-866 and the continuation of Phase III lung cancer trials with Stimuvax.

• Cytos Biotechnology AG, of Zurich, Switzerland, said CYT003-QbG10 was well tolerated in a Phase IIa atopic dermatitis trial but had no treatment effect at the doses tested. The 36-patient study involved six weekly injections with 300 mcg of drug or placebo and evaluation according to Eczema Area and Severity Index. Cytos said it will consider the next steps for CYT003-QbG10 in atopic dermatitis after evaluating higher doses in a trial for allergic rhinitis due to house dust mite allergy, an indication that already has generated positive Phase II results.

• GTx Inc., of Memphis, Tenn., initiated a Phase IIb trial of the selective androgen receptor modulator Ostarine in cancer cachexia. The randomized, double-blind, placebo-controlled study will enroll 150 patients for four months of treatment with placebo, 1 mg of Ostarine or 3 mg of Ostarine. Top-line data are expected in the summer of 2008 for the primary endpoint of change in total lean body mass and secondary endpoints including functional performance and safety. GTx also plans to initiate a Phase IIb trial with Ostarine in chronic kidney disease muscle wasting by the end of the year and is conducting two pivotal Phase III trials with the selective estrogen receptor modulator Acapodene (toremifene citrate).

• MedImmune Inc., of Gaithersburg, Md., began dosing in a Phase I trial of RSV/PIV-3 in at-risk children ages 6 months to 24 months. The vaccine candidate is designed to help prevent respiratory syncytial virus and parainfluenza virus Type 3 infections. A previously completed study in healthy adults and nonsusceptible older children demonstrated the product was safe and well tolerated. The new study will evaluate safety, tolerability, immunogenicity and vaccine shedding in the nose. It will include 140 study participants who will be followed through the end of the subsequent RSV season or for 180 days after the final dose, whichever occurs later.

• Napo Pharmaceuticals Inc., of South San Francisco, said it reached an agreement with the FDA on a special protocol assessment for the design of its pivotal study of crofelemer for the treatment of chronic diarrhea in people with HIV/AIDS. The trial, also called the ADVENT study, will be carried out under FDA fast-track designation. The randomized, double-blind, parallel-group, placebo-controlled, two-stage, adaptive-design study will assess the efficacy and safety of oral crofelemer at twice-daily doses of 125 mg, 250 mg and 500 mg. An interim analysis will be completed after the dose-escalation stage of the trial, which will include 50 subjects per study arm. Stage II will continue until an additional 75 subjects are randomized to the chosen dose and placebo, providing for 125 patients on placebo and 125 patients on selected crofelemer dose. Crofelemer is extracted from Croton lechleri, a medicinal plant from several countries in South America. It is being developed in four indications.