Abbott Laboratories, of Abbott Park, Ill., obtained positive data in its Phase III REVEAL trial of Humira (adalimumab) in moderate to severe psoriasis. The 1,200-patient trial demonstrated the efficacy of Humira both on a short-term and sustained basis. The company plans to include these data, as well as positive findings from a previous Phase III psoriasis study with Humira, in U.S. and European regulatory applications to be submitted in the first half of this year. Humira currently is

Aastrom Biosciences Inc, of Ann Arbor, Mich., said the FDA granted orphan drug designation to its Tissue Repair Cells for use in the treatment of dilated cardiomyopathy, a disease of the heart. Aastrom's TRC-based products consist of a mixture of stem and progenitor cell populations, produced from a small amount of bone marrow taken from the patient. Apollo Life Sciences, of Sydney, Australia, has received results of Phase I toxicology trials of its oral insulin delivery technology, Oradel

Advanced Viral Research Corp., of Yonkers, N.Y., began a Phase II study using a topically applied spray formulation of AVR 118 as a wound healing agent. One cohort of patients will be treated after plastic surgery. The product will be applied to one of their wounds, and their second wounds will serve as an untreated control to determine if AVR 118 can accelerate the time taken for the wound to close and reduce or eliminate subsequent scar formation. A second cohort of patients will be treated

Crucell NV, of Lieden, the Netherlands, said it completed a Phase I study of the alum-adjuvanted formulation of its whole inactivated West Nile vaccine, which was manufactured using its PER.C6 technology. The trial in 47 subjects in Belgium demonstrated safety and tolerability. Cytos Biotechnology AG, of Zurich, Switzerland, said a placebo-controlled Phase IIa trial of the hypertension vaccine CYT006-AngQb showed a reduction in daytime blood pressure. The study was conducted in 72 patients

Altea Therapeutics Corp., of Atlanta, said results from Phase I studies of its basal insulin transdermal patch showed efficient, sustained and constant delivery of insulin at therapeutic levels. The data show efficient delivery of the applied dose of insulin and demonstrate favorable pharmacodynamics of transdermal insulin delivery when compared to a subcutaneous injection of a long-acting insulin analog. Results were presented at the Drug Delivery Partnerships conference in Las Vegas

Addex Pharmaceuticals SA, of Geneva, began a double-blind Phase IIa study in the U.S. of ADX10061 for smoking cessation. Smokers will receive the drug or placebo for seven weeks, with counseling. Endpoints include abstinence measures, nicotine craving and withdrawal, and mood scores. ADX10061 is a selective antagonist of the dopamine D1 receptor. Lexicon Genetics Inc., of The Woodlands, Texas, began a Phase I trial of LX1031, an oral drug candidate for irritable bowel syndrome and other

DOR BioPharma Inc., of Miami, said data from its pivotal Phase III trial showed that orBec (oral beclomethasone dipropionate) demonstrated continued survival benefit when compared to placebo in patients with gastrointestinal graft-vs.-host disease one year after randomization. Overall 18 patients (29 percent) in the orBec group and 28 patients (42 percent) in the placebo group died within one year. Those results were published in an on-line edition of Blood. MediciNova Inc., of San Diego

Allon Therapeutics Inc., of Vancouver, British Columbia, said AL-208 advanced into the randomized portion of its Phase II trial for treating the mild cognitive impairment that can occur following coronary artery bypass graft surgery. The initial portion of the study assessed safety in patients. Now the product's effect on cognitive function will be tested against placebo. The company selected the 300-mg dose, the highest dose studied, for further testing. BioMS Medical Corp., of Edmonton

Bionovo Inc., of Emeryville, Calif., began enrollment in a pharmacokinetics trial to further evaluate its lead drug candidate, MF101, which is designed to treat the symptoms of menopause. The product also is being tested in Phase II trial in 217 postmenopausal women, which began in October. Penwest Pharmaceuticals Co., of Danbury, Conn., began a Phase I study of Nalbuphine ER, a nalbuphine hydrochloride extended-release tablet formulation being developed for pain. The trial will evaluate the

Alexza Pharmaceuticals Inc., of Palo Alto, Calif., completed patient enrollment in its Phase IIa trial of AZ-004 (Staccato loxapine), an inhalation candidate for acute treatment of agitation in schizophrenic patients. The study involved 120 subjects, with the primary aim of assessing the safety and efficacy of a single dose, as determined by the change in the PANSS Excited Component scale. Initial results from the trial are expected in the second quarter. Anesiva Inc., of South San Francisco

Aastrom Biosciences Inc., of Ann Arbor, Mich., said the first two patients have been treated in its pivotal trial of Tissue Repair Cells (TRCs) for the treatment of osteonecrosis of the femoral head. The trial, conducted in Barcelona, Spain, was initiated following approval from Spanish regulators. The treatment approach will include the removal of the necrotic tissue from the interior of a patient's femoral head, followed by implantation of TRCs. The trial's primary endpoint is to eliminate or

ArQule Inc., of Woburn, Mass., completed dose-escalation in its Phase I trial of ARQ 197, an oral small-molecule inhibitor of the c-Met receptor tyrosine kinase, and identified the optimal dose, when given orally two weeks out of three, at 120 mg twice daily. The company plans to explore a continuous dosing schedule prior to starting Phase II testing in the second quarter. ArQule also reported that it completed patient enrollment in three Phase II trials with ARQ 501, a first-generation

Aida Pharmaceuticals Inc., of Hangzhou, China, has received approval from the State Food and Drug Administration of China to begin Phase II clinical trials of the genetic cancer treatment Rh-Apo2L, the Category A biopharmaceutical currently in development phase by the Company's subsidiary Shanghai Qiaer Biotechnology Co., Ltd. of Shanghai. The Phase II trials will analyze the effect of Rh-Apo2L on two types of tumors chosen from the following cancers: advanced inert lymphoma, malignant melanoma

BioMarin Pharmaceutical Inc., of Novato, Calif., said the first patient has been treated in the second, company-sponsored Phase II study with oral 6R-BH4 for symptomatic peripheral arterial disease. Commonly known as tetrahydrobiopterin, 6R-BH4 is an essential enzyme cofactor that is involved in the production of nitric oxide, a molecule that has been shown in clinical studies to play a key role throughout the cardiovascular system, including regulation of endothelial function. The company

Anthera Pharmaceuticals Inc., of San Mateo, Calif., said the FDA approved its investigational new drug application for its lead cardiovascular compound, A-002. Anthera will initiate a multicenter Phase II trial called PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) that will examine the effect of A-002 on secretory phospholipase A2 levels and other well established markers of inflammation and cardiovascular risk in patients with stable coronary artery disease due to

Aerovance Inc., of Berkeley, Calif., reported top-line results from a Phase IIa trial in asthma patients, showing that twice-daily use of inhaled Aerovant (IL-4 and IL-13 antagonist) reduced the severity of late asthmatic response by a statistically significant 72 percent compared to baseline, meeting the trial's primary endpoint. The product also met its secondary endpoint of decreasing the forced expiratory nitric oxide in patients, indication a reduction in airway inflammation. Amorcyte

Array BioPharma Inc., of Boulder, Colo., filed an investigational new drug application for ARRY-520, a kinesin spindle protein inhibitor that demonstrated tumor regression in preclinical models of human solid tumors and leukemias. Array plans to begin the Phase I study to evaluate the intravenously administered compound in patients with advanced cancer. The study will test safety, tolerability and pharmacokinetics, as well as examine indicators of therapeutic activity. BioSante Pharmaceuticals

Cytokinetics Inc., of South San Francisco, said the National Cancer Institute initiated a Phase II trial of ispinesib, a kinesin spindle protein inhibitor, as a second-line treatment for patients with renal-cell cancer. That study will enroll between 18 and 35 patients and will measure response rate as determined by the Response Evaluation Criteria in Solid Tumors (RECIST) as the primary endpoint. The NCI also started a Phase I trial to evaluate ispinesib as a monotherapy in about 30 pediatric

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