• Agennix Inc., of Houston, said final results from its positive Phase II trial of talactoferrin alfa as a monotherapy in non-small-cell lung cancer showed that the drug improved overall patient survival over placebo in patients who had failed previous chemotherapy, meeting the primary endpoint. The trial enrolled 100 patients with Stage IIIb/IV disease to receive treatment in 14-week cycles for up to three cycles or until disease progression. In the 100-patient intent to treat population, median overall survival was 65 percent higher in the talactoferrin group (6.1 months) compared to placebo (3.7 months). In the evaluable 81-patient population, the median overall survival was 80 percent higher in the talactoferrin group (7.9 months) vs. the placebo group (4.4 months). Positive trends also were observed on the secondary endpoints, including progression-free survival and disease control rate. Data were presented at the Targeted Therapies for the Treatment of Lung Cancer meeting in Santa Monica, Calif. Agennix now plans to begin Phase III testing with talactoferrin in two NSCLC indications: as first-line treatment in combination with chemotherapy and as a monotherapy in patients who have failed two or more previous therapies. Talactoferrin has fast-track designation.

• Bionomics Ltd., of Melbourne, Australia, initiated treatment for the first patient in its Phase I trial of cancer drug BNC105, a vascular disrupting agent. The trial will enroll patients with advanced cancer who will be treated with BNC105 on days one and eight of a 21-day cycle, over two cycles. The primary objectives include the evaluation of safety and tolerability data, determination of the optimal dose and measuring antitumor activity.

• Bradmer Pharmaceuticals Inc., of Toronto, said Phase II data showed that its Neuradiab product candidate demonstrated a 42 percent increase in overall survival compared to a historical control of the current standard of care in 21 patients with newly diagnosed glioblastoma multiforme. Neuradiab was administered by patient-specific dosing as an adjunctive therapy to oral chemotherapy, surgery and external beam radiation. Results demonstrated a median overall survival of 90.6 weeks vs. the historical control of 64 weeks. Data were published in Neuro-Oncology. Bradmer is completing manufacturing and site approval processes prior to starting a Phase III program.

• Eurand NV, of Milan, Italy, reported positive results from a pilot study of EUR-1025, its once-daily oral formulation of ondansetron hydrochloride, which is marketed as Zofran by London-based GlaxoSmithKline plc for treating and preventing chemotherapy-induced nausea and vomiting. The study achieved its goal of producing a formulation with a similar pharmacokinetic profile to twice-daily Zofran in healthy volunteers. The extended-release properties of Eurand's technology resulted in a QD formulation with comparable delivery of drug to reference, and there were no serious adverse events reported.

• Osiris Therapeutics Inc., of Columbia, Md., said interim results at the one-year time point in the company's Phase I trial of Prochymal in heart attack patients continued to demonstrate a strong safety profile and to show statistically significant improvement in heart function. Results of the 53-patient study showed that the Prochymal treatment group achieved a statistically significant 5.2 point increase in left ventricular ejection fraction (based on magnetic resonance imaging) over baseline vs. the 1.8 point improvement seen in the placebo group. Data also indicated that patients with more severe myocardial infarction, defined as a baseline LVEF of 45 or less, demonstrated even greater effects, with the Prochymal group showing a 6.5 point improvement one-year post-treatment, compared to a 1.9 point increase in the placebo group. Based upon those results, the company has received FDA approval to start a Phase II trial.

• Pharmacopeia, of Princeton, N.J., completed patient recruitment in its Phase IIa study of PS433540, a dual-acting angiotensin and endothelin receptor antagonist, in patients with Stage I and Stage II hypertension. Results are expected in the second quarter. Data from earlier studies showed the drug producing statistically significant, dose-dependent increases vs. placebo in plasma-renin activity, as well as reductions in systolic and diastolic blood pressure in nonhypertensive healthy volunteers.