• Eisai Europe Ltd., of Hatfield, UK, a division of Eisai Co. Ltd., of Tokyo, reported preliminary results from a Phase III pediatrics study, which showed that epilepsy treatment Zonegran (zonisamide) was more effective than placebo and was well tolerated in pediatric patients with partial-onset seizures treated with one or two other anti-epileptics. Results were presented at the International Epilepsy Congress in Rome. Zonisamide, which is used as adjunctive therapy to treat partial seizures in adult epilepsy patients, also is part of the fixed-dose combination of obesity candidate Empatic (zonisamide/bupropion) from San Diego-based Orexigen Therapeutics Inc., which has completed Phase II testing.

• Ferring Pharmaceuticals SA, of Saint-Prex, Switzerland, said data published in the September issue of the Journal of Urology showed that long-term use of Firmagon (degarelix), a gonadotropin-releasing hormone therapy approved in the U.S. and Europe in advanced prostate cancer, continued to be effective and well tolerated beyond three years. For patients who remained on the drug, prostate-specific antigen (PSA) suppression and the effects of PSA progression-free survival (PFS) remained consistent over the long term (42 months). In addition, the study looked at patients who crossed over from leuprolide to Firmagon after one year, with data at a median follow-up of 27.5 months showing that the risk of PSA PFS had decreased (p = 0.003).

• Hatchtech Pty. Ltd., of Melbourne, Australia, said it enrolled the first subjects in a Phase IIb study of DoOvo to treat head lice. The study will test two dose levels of a single application for efficacy, safety and tolerability compared to vehicle and will involve about 132 healthy subjects 2 years and older with head lice infestation. Hatchtech anticipates completing the study by the end of this year. DoOvo is a topical metalloprotease inhibitor.

• Keryx Biopharmaceuticals Inc., of New York, said the independent data safety monitoring board for the firm's pivotal Phase III X-PECT (Xeloda + Perifosine Evaluation in Colorectal cancer Treatment) study of perifosine (KRX-0401) in refractory advanced colorectal cancer completed a pre-specified interim safety and futility analysis and recommended the trial continue as planned. The study has completed enrollment, with more than 465 patients, and is being conducted under a special protocol assessment. About 360 events of death will trigger the unblinding of the study, which is designed to measure overall survival as the primary endpoint and overall response rate, progression-free survival and safety as secondary endpoints. Keryx licensed U.S. rights to perifosine, a PI3K/Akt pathway inhibitor, from partner Aeterna Zentaris Inc., of Quebec City. (See BioWorld Today, Aug. 4, 2009.)

• Medivir AB, of Huddinge, Sweden, said enrollment is completed in three Phase III studies of protease inhibitor TMC435, in development by partner Tibotec Pharmaceuticals, of Cork, Ireland, for hepatitis C virus (HCV). The trials are QUEST 1 and QUEST 2 in treatment-naïve HCV patients and the PROMISE study in the treatment-experienced relapse population. In all three trials, the duration of total treatment is response guided, and patients in the TMC435 arms are eligible to stop all treatment at week 24 if predefined response-guided criteria are met.

• NexBio Inc., of San Diego, said an article in Clinical Infectious Diseases showed that a bone marrow transplant patient who had progressive and worsening parainfluenza virus Type 3 infection, given DAS181, experienced improved respiratory status within one day of initiating treatment. By day three, the patient no longer required supplemental oxygen and pulmonary function tests showed an improvement in lung function. The patient was treated under an emergency investigational new drug application.

• QLT Inc., of Vancouver, British Columbia, said results of a Phase II study of its Latanoprost Punctal Plug Delivery System in subjects with ocular hypertension and open-angle glaucoma showed that, after two weeks of treatment, intraocular pressure (IOP) showed a statistically significant mean change from baseline of -6.2 mmHg, with 73 percent of subjects showing an IOP reduction vs. baseline of 5 mmHg or greater. Fifty-one percent showed a reduction of 6 mmHg or greater. The mean percentage change in IOP from baseline at two weeks was -24.3 percent. A total of 95 patients in the intent-to-treat population were included in the L-PPDs treatments in the study, which was designed to compare QLT's punctual plugs to daily administered Xalatan (latanoprost) eye drops.