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

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

Arpida Ltd., of Basel, Switzerland, reported positive results from its first Phase III trial of iclaprim, showing that the primary efficacy endpoint of statistical noninferiority compared to Zyvox (linezolid, Pfizer Inc.) in the clinical cure rate at the test-of-cure visit in patients with skin and skin structure infections. Data from the ASSIST-1 study showed that the overall clinical cure rates for the intent-to-treat population of 497 patients were 85.5 percent and 91.9 percent iclaprim and

AEterna Zentaris Inc., of Quebec, plans to begin a Phase III program with cetrorelix in benign prostatic hyperplasia (BPH) before the end of the year. A first study, involving about 600 patients, will assess the ability of an intermittent dosage regimen of the luteinizing hormone-releasing hormone antagonist in providing prolonged improvement in BPH-related signs and symptoms. The primary efficacy endpoint of this first placebo-controlled study is absolute change in the International Prostate

Biothera, of Eagan, Minn., initiated a Phase I/II trial of Imprime PGG in combination with G-CSF for mobilization of bone marrow stem cells into the peripheral blood in normal human subjects. The study's objective is to determine whether that combination is better than G-CSF alone for enhancing stem cell mobilization. Biothera anticipates completing the enrollment of 56 subjects by the end of the year. Dyax Corp., of Cambridge, Mass., completed the double-blind portion of its pivotal Phase

Aradigm Corp., of Hayward, Calif., said results of a Phase IIa trial of inhaled hydroxychloroquine (HCQ) in patients with moderate-persistent asthma did not meet the pre-specified clinical efficacy endpoints. The trial was funded by Tucson, Ariz.-based APT Pharmaceuticals Inc., and APT and Aradigm plan to continue data analysis to decide whether to pursue additional work on inhaled HCQ. No serious adverse events were reported, either related to the drug or Aradigm's AERx delivery system

Celtic Pharmaceutical Holdings LP, of Hamilton, Bermuda, and Neurobiological Technologies Inc., of Emeryville, Calif., said an interim report of an open-label extension study in a Phase III program of Xerecept (corticorelin acetate injection) showed that, of 20 subjects, 11 had reduced their dexamethasone dosage during the four-week study, and two took no concomitant dexamethasone. Improvement or resolution of steroid-related conditions was observed in eight of 18 (45 percent) of subjects with

Aegerion Pharmaceuticals Inc., of Bridgewater, N.J., said interim results from an ongoing Phase II trial of its cholesterol management compound, AEGR-733, in combination with Zetia (ezetimibe, Schering-Plough Corp.), show that patients receiving both achieved an LDL reduction of 35 percent after four weeks. Patients treated with Zetia alone achieved a 20 percent reduction. As a monotherapy, AEGR 733 was found to reduce mean LDL-C 19 percent and 28 percent in patients who received the 5-mg dose

Advanced Viral Research Corp., of Yonkers, N.Y., filed an amendment with the FDA to its existing investigational new drug application to expand the use of its product, AVR118, to include topical and intralesional therapy, which could be used in treating dermatologic conditions. AVR118 is a cytoprotective agent in development for cachexia-related disorders and has shown topical wound healing properties in animal models. Dyax Corp., of Cambridge, Mass., said findings from its 77-patient EDEMA2

Anacor Pharmaceuticals Inc., of Palo Alto, Calif., started dosing patients in a Phase IIb study of ANO128, a topical anti-inflammatory candidate for atopic dermatitis. The trial is expected to enroll 200 patients between the ages of 2 and 17 with moderate forms of the disease who will receive ANO128 or a placebo cream twice a day for six weeks. Researchers plan to assess efficacy using a 6-point static global assessment scale. Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia

Inspire Pharmaceuticals Inc., of Durham, N.C., reported results of a 28-day Phase II study of denufosol inhalation solution in cystic fibrosis patients, ages 5 to 7, showing that both the 20-mg and 60-mg doses of the drug given three times daily were well tolerated, with a safety profile similar to placebo. Data were presented at the 2006 North American Cystic Fibrosis Conference in Denver. Inspire has initiated the first of two planned Phase III trials to evaluate 60 mg of denufosol vs

Ariad Pharmaceuticals Inc., of Cambridge, Mass., reported additional positive efficacy data on AP23573, an mTOR inhibitor, from further analysis of its ongoing Phase II trial in metastatic and/or unresectable bone and soft-tissue sarcomas. Sixty-one patients in the 212-patient trial who had clinical-benefit response with AP23573 - defined as tumor regression or disease stabilization - had a progression-free survival rate at six months of 70 percent, which nearly tripled that of the overall