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

An intravenous formulation of Nemonoxacin is set to enter the clinic this spring

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

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

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

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

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

AVI BioPharma Inc., of Portland, Ore., started a clinical program for the treatment of Duchenne's muscular dystrophy using its ESPRIT (Exon Skipping Pre-RNA Interference Technology) exon-skipping technology. The program is based on positive preclinical data amassed over the past two years, including collaborator studies published in the October 2006 issue of Neuromuscular Disorders and the February 2006 issue of Nature Medicine. The technology is designed to delete disease-causing gene

Dynavax Technologies Corp., of Berkeley, Calif., started a Phase I dose-escalation trial with its TLR9 agonist in combination with a standard chemotherapeutic regimen for metastatic colorectal cancer. The enrollment target of the trial is 15 patients, all of whom will have been previously treated for colorectal cancer but had a recurrence of the disease. The trial, which will be conducted at three centers in the U.S., is designed to identify the optimum dose and to yield safety and tolerability

4SC AG, of Martinsried, Germany, started a Phase IIa study with SC12267 for rheumatoid arthritis. The 120-patient study will take place at 12 centers in Germany, Poland and Serbia. The application process for Serbia and Poland still is under authority review. SC12267 is a new type of small-molecular active agent from the class of disease-modifying anti-rheumatic drugs, and works as a selective inhibitor in the biosynthesis of pyrimidine, which inhibits the proliferation of fast proliferating