Cougar Biotechnology Inc., of Los Angeles, enrolled the first patient in a Phase I study of CB3304 (noscapine), an oral inhibitor of microtubule dynamics. The compound will be administered daily to patients with relapsed or refractory multiple myeloma. Cougar licensed rights to CB3304 in 2004 from Emory University. Crucell NV, of Leiden, the Netherlands, and Aeras Global TB Vaccine Foundation in Rockville, Md., started a Phase I BCG-Ad35 prime-boost trial of an AdVac-based tuberculosis

Corcept Therapeutics Inc., of Menlo Park, Calif., started a Phase III trial of Corlux, its cortisol receptor antagonist, in endogenous Cushing's syndrome. The FDA indicated earlier this year that the 50-patient open-label study might provide a reasonable basis for a new drug application submission. Corlux previously received orphan drug designation for Cushing's, a disease caused by prolonged exposure of the body's tissues to high levels of cortisol. CuraGen Corp., of Branford, Conn., and

Ablynx NV, of Ghent, Belgium, reported final positive results from a Phase I study of ALX-0081, an anti-thrombotic therapeutic, showing that the drug was safe and well tolerated at all doses tested in 40 healthy male volunteers, with no dose-limiting toxicities or serious adverse events. ALX-0081, a Nanobody targeting von Willebrand Factor, is in development to reduce the risk of thrombosis in patients with acute coronary syndrome and thrombotic thrombocytopenic purpura. Ablynx intends to start

BioMS Medical Corp., of Edmonton, Alberta, said a independent data safety monitoring board has reviewed data from the on-going MAESTRO-03 U.S. pivotal Phase III clinical trial of MBP8298 for the treatment of secondary progressive MS and recommended that the trial continue. More than 133 patients have been enrolled in the trial and an interim safety and efficacy analysis will be performed on data when they have completed 24 months of the trial Ceregene Inc., of San Diego, said long-term follow

Arpida Ltd., of Basel, Switzerland, initiated a Phase II trial of the intravenous antibiotic iclaprim in hospital-acquired pneumonia, ventilator-associated pneumonia and health care-associated pneumonia. The randomized, double-blind study will compare iclaprim to vancomycin and should be completed next year. Arpida also said a Phase I study with oral iclaprim resulted in no serious adverse events. Finally, Arpida said it plans to submit the first modules of its new drug application for

Astion Pharma AS, of Copenhagen, Denmark, said it has started enrolling patients for three pivotal Phase III studies of ASF-1057 for the treatment of seborrheic dermatitis, an inflammatory dermatological disease affecting the upper skin layers that is characterized by a red, greasy and scaly eczema that typically occurs on the face, chest or scalp. Two of the pivotal placebo-controlled studies are designed to document the effect of ASF-1057, glycerol monocaprylate formulated in a base cream

Catalyst Pharmaceutical Partners Inc., of Coral Gables, Fla., announced positive initial top-line results from an investigator-initiated Phase II double-blind, placebo-controlled trial, demonstrating that vigabatrin is effective for the treatment of cocaine addiction. Catalyst's lead compound, CPP-109, is bioequivalent to vigabatrin. The 103-subject trial is the first randomized, double-blind, placebo-controlled clinical trial studying vigabatrin's effectiveness in treating cocaine addiction

Adventrx Pharmaceuticals Inc., of San Diego, completed enrollment of a targeted 32 patients in its single-arm, Phase II trial of ANX-510 (CoFactor) plus 5-fluorouracil (5-FU) for breast cancer. CoFactor is the active metabolite of leucovorin and is intended to boost the efficacy and decrease the toxicity of 5-FU. Data are expected in the second quarter of 2008. A Phase IIb trial in colorectal cancer missed its primary endpoint earlier this year, and a Phase III colorectal cancer trial with 5-FU

Avicena Group Inc., of Palo Alto, Calif., reported positive Phase II data from its combination trial involving AL-08, a second-generation drug candidate for amyotrophic lateral sclerosis. The trial's purpose was to determine which drug used in combination with AL-08 would yielded the most favorable results, either minocycline or celecoxib, as measured by neuroprotective capacity. Results showed that patients taking the AL-08/celecoxib showed a smaller mean decline in ALS-Functional Score

Acorda Therapeutics Inc., of Hawthorne, N.Y., completed enrollment in its Phase III trial of Fampridine-SR in multiple sclerosis. That 240-patient trial is designed to evaluate the drug's efficacy in improving walking ability. Data are expected in the second quarter of 2008. Alpharma Inc., of Bridgewater, N.J., reported positive results from its 500-patient, pivotal Phase III trial of ALO-01, an abuse-deterrent, extended-release opioid, which demonstrated significant pain relief, meeting the

Barrier Therapeutics Inc., of Princeton, N.J., announced positive results of a safety, dose escalation study with its oral antifungal agent pramiconazole. No clinically relevant changes were seen in any of the 32 healthy volunteers dosed with up to 6 g of pramiconazole given over a five-day period, as compared to placebo. The study measured cardiac parameters, including QT/QTc interval, liver and kidney function, and several other blood chemistry parameters. The total of 6 g administered over

Avant Immunotherapeutics Inc., of Needham, Mass., said new data from a large European trial, published in The Lancet, showed that London-based GlaxoSmithKline plc's rotavirus vaccine, Rotarix, is effective against the five most commonly circulating rotavirus types (G1, G2, G3, G4 ad G9). Those virus types are responsible for more than 98 percent of rotavirus gastroenteritis disease in Europe during the first two years of life. The protection afforded by the vaccine's two-dose schedule in

Cell Therapeutics Inc., of Seattle, said its wholly-owned subsidiary, Systems Medicine LLC, revealed preliminary data from a Phase I trial combining brostallicin with cisplatin in solid tumors. Of the first 21 patients treated in the Phase I dose-escalation trial, 14 experienced stable disease and half of those 14 patients had durable stable disease for more than six cycles of therapy. Phase II trials are planned combining Brostallicin, a synthetic, second-generation DNA minor groove binder

Arpida Ltd., of Basel, Switzerland, reported data from a Phase I trial exploring the possible interaction between its intravenous iclaprim and warfarin, an agent used for the prophylaxis of thrombosis and embolism. The study, which involved 24 healthy volunteers, found that intravenous iclaprim had no significant effect on the pharmacokinetics and pharmacodynamics of warfarin, and results confirmed the safety and tolerability profile of iclaprim. Arpida expects to include those data in the new

BioAlliance Pharma SA, of Paris, has completed patient enrollment in the pivotal Phase III trial for Loramyc for the treatment of oropharyngeal candidiasis. The trial will include 540 patients enrolled by 40 specialist clinical centers in the U.S., Canada and South Africa. The trial results are expected in the first half of 2008. The company plans to file a market authorization application in the second half of next year, subject to the FDA's regulatory requirements. Peregrine Pharmaceuticals

Aeterna Zentaris Inc., of Quebec City, said it has completed enrollment of its European multi-center Phase II trial in non-small-cell lung cancer with perifosine, a first-in-class, oral signal transduction inhibitor. The randomized, double-blind, placebo-controlled trial will assess the efficacy and safety of a 150 mg daily dose of perifosine when combined with radiotherapy in 160 patients with inoperable Stage III NSCLC. Patients will receive perifosine daily for 5 to 6 weeks, starting seven

Allos Therapeutics Inc., of Westminster, Colo., initiated patient enrollment in a Phase I trial of its targeted chemotherapeutic agent RH1 in patients with advanced solid tumors or non-Hodgkin's lymphoma. In the dose-escalation study, up to 60 patients will receive a three-hour intravenous infusion of RH1 administered once every 21 days. Archemix Corp., of Cambridge, Mass., started a Phase IIa trial of ARC1779, which is designed to test the drug's safety and efficacy as an anti-thrombotic in

Akesis Pharmaceuticals Inc., of San Diego, said the FDA accepted its investigational new drug application for AKP-020, a vanadium compound, in Type II diabetes. Screening already has begun for patients in a Phase IIa trial measuring the drug's efficacy using the euglycemic-hyperinsulinemic clamping procedure. The company expects to dose the first patient before the end of the year. AtheroGenics Inc., of Atlanta, said it stopped testing the highest dose of AGI-1067 (300 mg) in its ongoing

CV Therapeutics Inc., of Palo Alto, Calif., said data from a preclinical study of the selective adenosine A1 agonist tecadenoson, in combination with a low dose of the beta blocker metoprolol, showed increased rate control compared to either agent alone (p<0.05) in an animal model of atrial fibrillation. Tecadenoson also demonstrated effective rate control at rest and during exercise in the preclinical model. Tecadenoson is in an ongoing Phase II study as a potential rate control agent for