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

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

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

Columbia Laboratories Inc., of Livingston, N.J., completed the treatment phase of its pivotal Phase III study of Prochieve 8 percent (progesterone gel) to prevent recurrent preterm birth. The 669-patient study is designed to expand the Prochieve label beyond infertility and secondary amenorrhea. Preliminary safety data from the preterm birth study is expected in mid-February 2007. Exelixis Inc., of South San Francisco, initiated a Phase II trial of XL880 in gastric cancer. The trial will

A.P. Pharma Inc., of Redwood City, Calif., said it probably would not meet a previously announced target of a 2007 filing of its new drug application for APF530, due to a slower-than-expected rate of sites being activated in the ongoing 1,350-patient Phase III trial. About 80 percent of the planned 80 sites now are active. APF530, which contains the 5HT3 antagonist granisetron formulated with the company's Biochronomer bioerodible drug delivery system, is in development for the prevention of

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

Abraxis BioScience Inc., of Los Angeles, presented data at the 29th annual San Antonio Breast Cancer Symposium from an interim analysis of a randomized, head-to-head Phase II trial of Abraxane for injectable suspension vs. Taxotere injection concentrate, in the first-line treatment of metastatic breast cancer. The analysis showed that treatment with weekly Abraxane (100 and 150 mg/m[2]) increased tumor response rate by greater than 60 percent with less toxicity vs. Taxotere (100 mg/m[2]) given

Bradmer Pharmaceuticals Inc., of Toronto, met with the FDA regarding a proposed Phase III trial of Neuradiab, a monoclonal antibody conjugated to radioactive iodine for treating glioblastoma multiforme. Specific guidance received from the agency included simplifying and strengthening the study design to use an exploratory genomic marker to better understand how patients respond or fail to respond to conventional chemotherapy. The primary endpoint in the trial will be the median overall survival

Alexza Pharmaceuticals Inc., of Palo Alto, Calif., completed patient enrollment in its Phase IIb trial of AZ-001 (Staccato prochlorperazine), an inhalation product for acute treatment of migraine. The 400-patient study is testing the drug in three doses vs. placebo and has a primary efficacy endpoint of headache pain relief at two hours post-dose. Secondary endpoints include pain relief and other symptom assessments at various time points. Initial results are expected by the end of March 2007

Avicena Group Inc., of Palo Alto, Calif., started a chronic toxicology study of HD-02, its lead candidate for Huntington's disease. The study is expected to conclude during the second half of 2007, at which time Avicena intends to initiate a Phase III trial. HD-02 has orphan drug designation from the FDA. Biomira Inc., of Edmonton, Alberta, reached an agreement with the FDA on a special protocol assessment for the planned Phase III trial of Stimuvax for non-small-cell lung cancer. The

Amarillo Biosciences Inc., of Amarillo, Texas, announced that four clinical sites are ready to enroll patients in a Phase II study to test low-dose interferon alpha lozenges administered orally to HIV-positive subjects with oral warts. Durect Corp., of Cupertino, Calif., completed Phase I trials with a new product, DUR-843, which is intended to treat a persistent pain condition. The company said DUR-843 has the potential to provide advantages over existing pain medications, but did not

Acorda Therapeutics Inc., of Hawthorne, N.Y., said it will design and conduct an additional Phase III trial of Fampridine-SR in people with multiple sclerosis. The company expects to discuss with the FDA a study of the same or shorter duration as its MS-F203 study with a single criterion for efficacy, a consistent response on the timed 25-foot walk. Ambrilia Biopharma Inc., of Montreal, said the Phase I repeat-dose study with PPL-100, the company's lead protease inhibitor to treat HIV and