• Astex Therapeutics, of Cambridge, UK, began dosing first patients in a Phase I/IIa trial of its investigational cancer drug, AT9283. Astex discovered AT9283, a potent inhibitor of Aurora kinases, using its innovative fragment-based drug discovery technology, Pyramid. The company's lead product, AT7519, already is in a Phase I trial at sites in the U.S. and the UK.

• CV Therapeutics Inc., of Palo Alto, Calif., said top-line results from its MERLIN TIMI-36 study of Ranexa (ranolazine) would be released in the first quarter of next year. If the primary endpoint is met, the drug could get a broader label, for treating acute coronary syndromes and secondary prevention. In addition, if treatment with Ranexa in this study is not associated with an adverse trend in death or arrhythmia compared to placebo, that safety database could support approval as a first-line chronic angina therapy, even if the primary endpoint is not met. The trial will proceed to its close-out phase, followed by unblinding and analysis of the data, now that the required number of endpoints have accumulated. The study's duration was event driven, and its protocol pre-specified that it would conclude after at least 730 major cardiovascular events and 310 deaths from any cause.

• CytRx Corp., of Los Angeles, said arimoclomol was shown to be safe and well tolerated at all three doses tested in its Phase IIa trial in patients with amyotrophic lateral sclerosis. Based on results, CytRx plans to initiate a Phase IIb trial with arimoclomol for the treatment of ALS in the first half of 2007. Data showed 84 patients with ALS entered the trial, with seven withdrawing prior to completion of dosing. No statistically significant treatment-related increases in adverse events were reported, and arimoclomol-treated patients reported fewer asthenia adverse events than the patients receiving placebo. One of the secondary endpoints was an analysis of pharmacokinetics, and additional secondary endpoints of the trial included a preliminary evaluation of the disease progression markers, the Revised ALS Functional Rating Scale (ALSFRS-R) and vital capacity (VC). Arimoclomol did not show a statistically significant change in disease progression as measured by those markers. The company's stock (NASDAQ:CYTR) fell 48 cents, or 26.2 percent, to close at $1.35.

• EntreMed Inc., of Rockville, Md., began a Phase I study with its clinical-stage drug candidate, MKC-1, in patients with hematological malignancies. The study will be conducted at the University of Texas MD Anderson Cancer Center in Houston. MKC-1 is also being evaluated in a Phase II study in patients with metastatic breast cancer.

• EpiCept Corp., of Englewood Cliffs, N.J., said Myriad Genetics Inc., of Salt Lake City, reported positive clinical results for Azixa, a compound discovered by EpiCept and licensed to Myriad as part of an exclusive, worldwide development and commercialization agreement. Based on the results, Myriad intends to initiate Phase II trials for the drug this fall, triggering a milestone payment to EpiCept.

• Indevus Pharmaceuticals Inc., of Lexington, Mass., is discontinuing a Phase II trial of pagoclone in premature ejaculation after an interim analysis revealed insufficient efficacy. No further work in this space is planned, but the company plans to advance the drug into a Phase III trial in the first half of next year for the treatment of persistent developmental stuttering.

• InterMune Inc., of Brisbane, Calif., applied to begin clinical trials of ITMN-191, an orally available hepatitis C virus protease inhibitor, in France. If approved, InterMune will begin Phase I testing of ITMN-191, which was developed in collaboration with Array BioPharma Inc., of Boulder, Colo.

• MacuSight Inc., of Union City, Calif., initiated a Phase I study of its lead product in patients with diabetic macular edema. The trial, which will enroll 30 patients, is designed to evaluate the safety and tolerability of MacuSight's formulation of sirolimus (rapamycin) when administered in various doses through two different types of ocular injections. As a result of MacuSight's recent product development milestones, the company has secured an additional $8 million in Series A funding from its existing investors. That brings the total of the company's financing to date to $26 million, it said.

• MDS Nordion, of Ottawa, Canada, received approval from the FDA to begin a clinical trial for a noninvasive cancer therapy called TheraSphere. The trial, expected to begin in October, will enroll up to 150 patients with secondary liver cancer. TheraSphere involves tiny radioactive glass beads that attack cancerous tumors in the liver, while minimizing the impact on the patient's healthy tissues, it said.

• Novexel, of Paris, began Phase I testing of NXL101, a small-molecule antibiotic that works as a bacterial topoisomerase/gyrase inhibitor. The company's development plans include both intravenous and oral dosage formulations of the compound, the first in a new class of antibacterials to treat hospital-based infections caused by Gram-positive pathogens.

• Orexigen Therapeutics Inc., of San Diego, said top-line Phase III results for the company's lead obesity compound, Contrave, demonstrated significant advantages in weight loss in a 24-week trial, which will continue unblinded for an additional 24 weeks. Contrave is a proprietary combination of bupropion, a dopamine and norepinephrine reuptake inhibitor, with one of several different doses of naltrexone, an opioid antagonist used to treat various addictive disorders.

• Sanofi Pasteur, the vaccines business of the Sanofi-Aventis Group, of Paris, began its first clinical study of a new generation of seasonal influenza vaccine produced using cell culture technology. It's part of a contract awarded by the Department of Health and Human Services to accelerate cell culture-based flu vaccines. The Phase I trial will include 100 healthy adults between 18 and 64. Half will receive the cell-based vaccine and the other half a traditional egg-based control vaccine. This vaccine was developed using PER.C6 cell culture technology from Crucell NV, of Leiden, the Netherlands. Separately, Crucell's Quinvaxem liquid pentavalent vaccine received prequalification status from the World Health Organization. It was co-developed with Novartis AG, of Basel, Switzerland.

• UCB SA, of Brussels, Belgium, voluntarily suspended Phase III dosing of epratuzumab in lupus following a routine quality assurance audit of the manufacturing facilities of its partner on the product, Immunomedics Inc., of Morris Plains, N.J. Then the FDA placed a clinical hold on the studies, as did one European country. The nature of the problem wasn't disclosed, though UCB said it is working with Immunomedics to address these observations. The companies' partnership dates to earlier this year. (See BioWorld Today, May 11, 2006.)

• VioQuest Pharmaceuticals Inc., Basking Ridge, N.J., dosed the first patient in its Phase I/IIa trial of VQD-001, sodium stibogluconate (SSG), for evaluation of solid tumors, at the MD Anderson Cancer Center. VQD-001 has shown in preclinical studies to specifically inhibit protein tyrosine phosphatases. The trial is a Phase I/IIa, open-label, dose escalation study to evaluate VQD-001 in combination with interferon alpha-2b for patients with advanced malignancies.

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