• Active Biotech AB, of Lund, Sweden, and Ipsen SA, of Paris, said the Phase III study of tasquinimod in prostate cancer is fully enrolled, with more than 1,200 randomized patients. That achievement triggers a €10 million (US$12.9 million) milestone payment from Ipsen to Active Biotech. The study is testing tasquinimod in patients with metastatic castrate-resistant prostate cancer, with radiological progression-free survival as the primary endpoint and overall survival as a secondary endpoint.

• AOP Orphan Pharmaceuticals AG, of Vienna, Austria, said it plans to initiate a Phase III study to support European marketing authorization of a monopegylated interferon alpha 2b candidate (AOP2014/P1101) for the treatment of polycythemia vera. AOP Orphan licensed rights to the program for development and commercialization in the field of myeloproliferative disorders in Central Europe, CIS and the Middle East from Pharmaessentia Corp., of Taiwan. Based on positive Phase II data, the pivotal study will begin in early 2013.

• Eleven Biotherapeutics Inc., of Cambridge, Mass., said it started a Phase Ib trial to test EBI-005, its lead ophthalmic protein product, in patients with dry eye disease. The study, which will enroll up to 80 subjects and will determine safety as the primary endpoint, is expected to complete in the first half of 2013. EBI-005 is a rationally designed topical protein designed to inhibit the interleukin-1 receptor.

• Inovio Pharmaceuticals Inc., of Blue Bell, Pa., reported interim Phase I data showing that a single dose of its H1N1 universal SynCon flu vaccine followed with a dose of a seasonal flu vaccine generated protective immune responses in 40 percent of trial subjects, compared with a 20 percent response rate in elderly patients who received the seasonal flu vaccine alone. The 50-patient study is ongoing.

• Neuralstem Inc., of Rockville, Md., presented Phase I data at the International Symposium on ALS/MND in Chicago from its spinal cord transplantation of neural progenitor cells in patients with amyotrophic lateral sclerosis, showing that researchers were able to establish the long-term survival of the transplanted spinal cord stem cells in autopsied patients. The company also said it received a grant from the National Institutes of Health to cover a majority of the costs of an upcoming Phase II study.

• Patrys Ltd., of Melbourne, Australia, said it completed initial treatment of the first group of three patients in its Phase I/IIa PAT-SM6 multiple myeloma trial. Each patient received four doses of the lead antibody candidate at a dose of 0.3 mg/kg, and no significant safety issues have been observed or reported to date. Full data from that first cohort will be available in the first quarter of 2013.

• Portola Pharmaceuticals Inc., of South San Francisco, said it started a Phase II study testing the safety and effectiveness of PRT4445, its universal antidote for Factor Xa inhibitor anticoagulants, in healthy volunteers who have been given approved and investigational Factor Xa inhibitors, including the oral drug Eliquis (apixaban, Bristol-Myers Squibb Co. and Pfizer Inc.) and Portola's own betrixaban. Multiple cohorts are planned for the study, which is expected to be completed in 2013. The first cohort will test PRT4445, a recombinant protein, with apixaban to evaluate further the safety of the drug and the dose required to reverse the anticoagulant effect of apixaban.

• Protalix BioTherapeutics Inc., of Carmiel, Israel, said the first patient was treated in its Phase I/II trial of PRX-102, a plant cell-expressed, chemically modified recombinant alpha-galactosidase-A enzyme in development as a long-term enzyme replacement therapy for patients with Fabry disease. The study is designed to evaluate the safety, tolerability, pharmacokinetics and exploratory efficacy parameters of PRX-102 in adult Fabry patients. About 18 patients will be enrolled. After completion of the study protocol, patients will have the option to continue to receive PRX-102 in an open-label extension trial.

• Spinifex Pharmaceuticals Pty., of Melbourne, Australia, said the first patients were treated in its Phase II study of EMA401 in chemotherapy-induced peripheral neuropathy (CIPN). The open-label biomarker study is designed to provide proof of concept of the use of the angiotensin II Type II receptor antagonist in CIPN. About 50 patients who have received either taxane or platinum chemotherapy for any cancer type are expected to be enrolled. The primary endpoint is the change in mean spontaneous pain intensity score between baseline and the last week of 28 days of dosing using the Numeric Pain Rating Scale. Secondary endpoints will include changes in nerve characteristics in skin biopsies taken from the calf pre-treatment and after EMA401 treatment at day 29.

• Trius Therapeutics Inc., of San Diego, said it reached its enrollment objective of 658 patients in the last of its two Phase III trials of tedizolid phosphate (TR-701) for the treatment of acute bacterial skin and skin structure infections. The pivotal study, designated ESTABLISH 2, is designed to examine the efficacy and safety of a six-day course of treatment given once daily vs. 10-days of Zyvox (linezolid, Pfizer Inc.) given twice daily. Top-line data are expected in early 2013. Trius reported positive data last year for its first Phase III study, ESTABLISH 1. (See BioWorld Today, Dec. 20, 2011.)