ActoGeniX NV, of Ghent, Belgium, said Phase I pharmacokinetic data for AG013, an oral rinsing solution in development for the prevention of oral mucositis, showed that the liver AG013 bacteria adhered to the buccal mucosa and actively secreted protein locally, resulting in homogenous exposure to the entire mucosal surface up to 24 hours after administration. A Phase Ib study recently showed that AG013 provided initial efficacy data, including a 35 percent reduction in the duration of ulcerative

Eisai Inc., of Woodcliff Lake, N.J., reported results from a final pivotal Phase III trial, showing that once-daily, adjunctive perampanel improved seizure control and was acceptably tolerated in subjects 12 and older with refractory partial-onset seizures. Those data, as well as results from a long-term Phase III extension study, were published online in Epilepsia. Perampanel is designed to selectively target AMPA receptors, which are thought to play a central role in seizure generation and

Kineta Inc., of Seattle, said it received regulatory clearance in the Netherlands to initiate a first-in-human trial of ShK-186, an autoimmune drug candidate designed to inhibit the Kv1.3 potassium ion channel. ShK-186 was developed by modifying natural sea anemone-derived peptide inhibitors of Kv1.3. The initial Phase Ia trial aims to assess the safety, tolerability and pharmacokinetics of a single dose of ShK-186 in up to 60 healthy volunteers. (See BioWorld Today, Sept. 21, 2011.) Medivir

Advanced Cell Technology Inc., of Marlborough, Mass., added Scotland's NHS Lothian as a site for its Phase I/II trial testing retinal pigment epithelial cells derived from human embryonic stem cells in Stargardt's macular dystrophy. Ariad Pharmaceuticals Inc., of Cambridge, Mass., said the first subject has been dosed in a multicenter Phase I/II trial evaluating ponatinib in Japan. The investigational BCR-ABL inhibitor is being tested in patients with chronic myeloid leukemia who have failed

Evolva Holdings SA, of Reinach, Switzerland, said top-line results for the first 32 patients enrolled in the Phase IIa study testing EV-077, a reversible antagonist of isoprostanes and prostanoids, showed promising efficacy, indicating that the drug, when given orally twice daily to patients with Type II diabetes, provided antiplatelet activity, reduced exercise-induced proteinuria and increased forearm blood flow. Analysis also indicated that EV-077 was generally well tolerated, with adverse

Curis Inc., of Lexington, Mass., said Debiopharm Group, of Lausanne, Switzerland, began treating patients in the HALO Phase I/II study of orally administered heat-shock protein 90 inhibitor Debio 0932 in combination with chemotherapy regimens in patients with advanced stages of non-small-cell lung cancer. The primary objective is to determine the efficacy of Debio 0932 in combination with chemotherapy and also assess KRAS mutation status as a stratification factor. Once a recommended Phase II

Coronado Biosciences Inc., of Burlington, Mass., initiated the Phase II TRUST-I (TRichUris Suis ova Trial) study of Trichuris suis ova (TSO, CNDO-201) in patients with Crohn's disease. TSO, the microscopic eggs of the porcine whipworm, is an orally administered, natural immunomodulator that regulates T cells and inflammatory cytokines. The double-blind, placebo-controlled, U.S. multicenter study is designed to evaluate the safety and efficacy of TSO in approximately 220 patients with Crohn's

Meritage Pharma Inc., of San Diego, began a Phase II trial of oral budesonide suspension for eosinophilic esophagitis. The trial will be carried out at clinical centers in the U.S. specializing in gastrointestinal diseases. The double-blind, randomized, placebo-controlled trial will enroll 100 patients between 12 and 25 with confirmed EoE and problems swallowing food. Protalix BioTherapeutics Inc., of Carmiel, Israel, received clearance from the FDA to begin trials of PRX-102, a candidate for

Pfizer Inc., of New York, reported that the combination of its Torisel (temsirolimus) and bevacizumab (Avastin, Genentech Inc.) failed to demonstrate superiority to bevacizumab plus interferon-alfa-2a in progression-free survival in the Phase III INTORACT trial. The combination therapy was being evaluated as first-line treatment of patients with advanced renal cell carcinoma (RCC). The company is analyzing additional efficacy endpoints and safety data in both trial arms; the data will be

Genentech Inc., a South San Francisco-based member of the Roche Group, reported that Avastin (bevacizumab) plus radiation and temozolomide chemotherapy demonstrated a significant improvement in progression-free survival, a co-primary endpoint of the Phase III AVAglio study. Details will be presented at an upcoming medical meeting. Data for final overall survival, the other primary endpoint, are expected next year. Avastin is approved in the U.S. as a single therapy to treat adults with

Achillion Pharmaceuticals Inc., of New Haven, Conn., reported sustained viral response results of 85 percent to 100 percent from an ongoing multidose Phase II trial evaluating sovaprevir, a once-daily protease inhibitor, in combination with pegylated interferon plus ribavirin (P/R) in patients with genotype 1 hepatitis C virus (HCV). The trial regimen calls for 12 weeks of dosing with sovaprevir with P/R followed by an additional 12 weeks of P/R. Achillion also reported that enrollment began in

Affinium Pharmaceuticals Ltd., of Austin, Texas, completed recruitment in its multicenter Phase II trial evaluating oral AFN-1252 in acute bacterial skin and skin structure infections – the first human efficacy study conducted with a new class of antibiotics designed specifically to inhibit Staphylococcal fatty acid biosynthesis via the fatty acid synthase II system. The study is designed to confirm efficacy, safety and tolerability of oral AFN-1252 in patients with serious, suspected

AnaMar Medical AB, of Stockholm, Sweden, applied to the Medicines Agencies in Sweden and Germany to begin a Phase II study of its analgesic and inflammatory candidate. The study will attempt to show the efficacy of the drug as pain reliever for osteoarthritis, and is scheduled to begin autumn and winter of 2012 and run through March/April 2013. The trial will be carried out by Pharmaceutical Research Associates. Immunovaccine Inc., of Halifax, Nova Scotia, published positive results from a

Pfizer Inc., of New York, reported that a Phase IV study assessing the efficacy and safety of Toviaz (fesoterodine fumarate) in patients with overactive bladder met its primary endpoint of reducing urge urinary incontinence (UUI). The 14-week randomized, parallel-group, placebo-controlled, double-blind study assessed Toviaz in patients who had been taking Pfizer's Detrol LA (tolterodine tartrate extended release) 4 mg for two weeks and had less than 50 percent reduction in UUI episodes. Toviaz

Healthpoint Biotherapeutics, of Fort Worth, Texas, said that the results for its Phase IIb trial investigating the efficacy of HP802-247 in venous leg ulcers are published in The Lancet. The trial, which enrolled 228 subjects, was designed to determine the potential effectiveness of two cell concentrations and two dosing frequencies of HP802-247, when combined with standard care, compared to control plus standard care, in healing venous leg ulcers over a 12-week treatment period. HP802-247, the

Advanced Cell Technology Inc., of Marlborough, Mass., treated its fourth patient, or the first in a second cohort, in a Phase I/II trial for dry, age-related macular degeneration with its human embryonic stem cell-derived retinal pigment epithelial cells. The procedure was carried out at the Willis Eye Institute in Philadelphia. BioDelivery Sciences International Inc., of Raleigh, N.C., and Endo Health Solutions, of Chadds Ford, Pa., began a Phase III trial of BEMA Buprenorphine for chronic

Acetylon Pharmaceuticals Inc., of Boston, said it initiated enrollment in a Phase Ib trial of lead candidate rocilinostat (ACY-1215) in combination with Revlimid (lenalidomide, Celgene Corp.) and dexamethasone for the treatment of relapsed and relapsed/refractory multiple myeloma. Rocilinostat is an oral Class II histone deacetylase inhibitor selective for the intracellular enzyme HDAC6. The primary outcome is to establish the optimal dose of rocilinostat over a 28-day treatment cycle. Acetylon

Pfizer Inc., of New York, reported top-line results from the Phase III ORAL Start study of JAK inhibitor tofacitinib in moderate to severe active rheumatoid arthritis (RA). Data showed that the drug met the primary endpoints at both the 5-mg and 10-mg twice-daily doses. Tofacitinib was found to be superior to methotrexate, with statistically significant changes shown in inhibiting structural damage, as measured by change from baseline in modified Total Share Score, and in reducing signs and

GenSpera Inc., of San Antonio, Texas, said the FDA cleared the firm to start a Phase II trial of lead compound G-202 in prostate cancer patients who have failed prior hormonal therapy. The trial is expected to recruit up to 40 patients with chemotherapy-naïve, metastatic castrate-resistant prostate cancer. GenSpera's platform combines plant-derived cytotoxin thapsigargin with a prodrug delivery system designed to release the drug only within the tumor. Lixte Biotechnology Holdings Inc., of