• Addex Pharmaceuticals SA, of Geneva, started a Phase IIa proof-of-concept study of its lead compound, ADX10059 in moderately severe dental anxiety, the third development program for the drug. ADX10059, a selective negative allosteric modulator of the metabotropic glutamate receptor 5, also is being tested in the acute treatment of migraine and for prevention of acid reflux in gastroesophageal reflux disease patients.

• Advaxis Inc., of North Brunswick, N.J., received confirmation that the Gynecologic Oncology Group, a clinical research group of the National Cancer Institute, agreed to conduct and help fund a future Phase II trial of Lovaxin C. The trial is expected to begin following completion of the company's ongoing Phase I/II study, which, to date, has finished enrolling and dosing patients with advanced, recurrent or progressive cervical cancer in the first two of four cohorts. Lovaxin C is a Listeria-based vaccine.

• Basilea Pharmaceutica Ltd., of Basel, Switzerland, began two Phase III trials of isavuconazole (BAL8557) in patients with invasive systemic fungal infections caused by yeasts and molds. The global program focuses on patients with invasive candidiasis including candidemia and patients with proven or probable aspergillosis. Both trials are double-blinded, randomized studies. One will compare isavuconazole to voriconazole for the primary treatment of invasive fungal disease caused by aspergillus species or other filamentous fungi, and the other will test it against a candin-based regimen in the treatment of candidemia and other invasive candida infections. Isavuconazole has fast-track status from the FDA.

• Crucell NV, of Leiden, the Netherlands, obtained approval to test its AdVac-based malaria vaccine, which is being developed in collaboration with the National Institutes of Allergy and Infectious Diseases. The company is ready to begin recruiting the expected 96 healthy volunteers for an upcoming Phase I dose-escalation study designed to test the vaccine. The trial will be funded by NIAID and will be conducted by researchers at Vanderbilt University, one of NIAID's Vaccine and Treatment Evaluation Units.

• Human Genome Sciences Inc., of Rockville, Md., initiated dosing in ACHIEVE 1, one of two pivotal Phase III trials of Albuferon (albinterferon alpha 2b) in combination with ribavirin in treatment-na ve patients with genotype 1 chronic hepatitis C. In October, HGS announced plans for the trial, which will randomize a minimum of 1,278 patients into three treatment groups: two groups to receive subcutaneously administered Albuferon once every two weeks (900 mcg or 1200 mcg), and an active control group to receive Pegasys once every week at a dose of 180 mcg. The primary endpoint is sustained virologic response. Albuferon is partnered with Basel, Switzerland-based Novartis AG under an exclusive, worldwide development and commercialization agreement signed in June. (See BioWorld Today, June 7, 2006, and Oct. 5, 2006.)

• InterMune Inc., of Brisbane, Calif., and partner, Basel, Switzerland-based F. Hoffmann-La Roche Ltd. received approval in Europe to initiate a Phase Ia trial of ITMN-191, an NS3/4A protease inhibitor, in chronic hepatitis C virus infection. The study will enroll about 74 healthy volunteers. InterMune expects to dose the first patient sometime in early January.

• MediciNova Inc., of San Diego, began a Phase II study of MN-221, its intravenous product candidate for status asthmaticus, an acute, long-lasting and severe asthma episode that does not respond to initial standard treatments and is potentially fatal. The randomized, dose-escalating crossover-design trial will involve 28 mild-to-moderate asthma patients who will receive a 15-minute intravenous infusion of MN-221 or placebo. Its primary endpoint will be the change from baseline in mean FEV1 (forced expiratory volume in 1 second) after a 15-minute infusion of MN-221, a highly selective Beta2-adrenergic receptor agonist.

• Prana Biotechnology Ltd., of Melbourne, Australia, began dosing in a Phase IIa trial of PBT2 in patients with early Alzheimer's disease. The PBT2-201-Euro trial is designed to enroll about 80 patients, all aged 55 or older, to randomly receive three months treatment with one of two oral dose levels of PBT2 or placebo. The efficacy endpoint will be PBT2's effect on cerebrospinal fluid and plasma biomarkers. Results are expected in the fourth quarter.

• Targacept Inc., of Winston-Salem, N.C., began a Phase II trial of the acute post-operative pain product TC-2696 to evaluate its analgesic effects following dental surgery. The randomized, double-blinded, single-dose study is expected to enroll about 150 molar extraction patients. It includes five arms: 10 mg, 25 mg and 50 mg of TC-2696, 400mg ibuprofen as a positive control and placebo. A Phase I, multiple ascending dose trial remains ongoing.

• Trillium Therapeutics Inc., of Toronto, said the FDA and the European Medicines Agency designated TTI-1612 an orphan drug for the prevention of necrotizing enterocolitis (NEC). The small, orally available recombinant protein has cytoprotective and anti-inflammatory effects and has shown efficacy in preclinical animal models of NEC and intestinal ischemia/reperfusion injury. Also, it may have additional use in treating other intestinal disorders such as short bowel syndrome, inflammatory bowel disease and chemotherapy-induced mucositis.