• Adventrx Pharmaceuticals Inc., of San Diego, has completed patient enrollment in its marketing-enabling study of ANX-530 (vinorelbine emulsion), a novel, emulsion formulation of vinorelbine tartrate, which is marketed under the brand name Navelbine. It is an anticancer agent approved for advanced non-small-cell lung cancer as a single agent or in combination with cisplatin. The study is a crossover comparison of ANX-530 and Navelbine, with a primary endpoint of pharmacokinetic equivalence. The safety of a single dose of ANX-530 is being evaluated as a secondary endpoint. The company said the FDA has indicated that if the study demonstrates bioequivalence between ANX-530 and Navelbine, that would provide sufficient clinical data to support the submission of an NDA.

• Alacrity Biosciences, of Laguna Hills, Calif., reported that its dry-eye treatment, ALTY-0501, demonstrated statistically significant advantages over vehicle in its ability to control signs and symptoms of dry eye in a Phase II study. The study used the controlled adverse environment chamber to measure dry-eye patients' ability to withstand a stressful drying environment, and patient diaries to measure the severity of their dry-eye symptoms. Patients were randomized to receive ALTY-0501 or its vehicle four times each day over the course of a 56 day study. Patients who received ALTY-0501 demonstrated statistically significantly lower scores following CAE exposure for fluorescein staining of the total cornea - a measure of damage to the ocular surface - than those who received vehicle (p < 0.05) on day 28.

• Amarin Corp. plc, of London, said it intends to begin a series of clinical trials with AMR 101 in dyslipidemia, the first of which will start by the end of this year. The firm also plans to begin investigation of new compounds from its existing development portfolio for the treatment of metabolic syndrome and dyslipidemia. AMR 101 is believed to impact on a number of biological factors in the body such as anti-inflammatory mechanisms, cell membrane composition and plasticity, triglyceride levels and regulation of glucose metabolism.

• Anesiva Inc., of South San Francisco, said it will conduct two Phase III clinical trials of Adlea, a long-acting, nonopiate analgesic drug candidate designed to provide pain relief for weeks to months after a single local application during a surgical procedure. The trials will examine the product in patients undergoing total-knee replacement surgery and in bunionectomy surgery. Both trials are expected to begin in the first half of 2008. Results of a Phase II trial of 40 patients undergoing bunionectomy surgery suggested that Adlea 1,000 mcg was superior to placebo. A second Phase II trial evaluated three dose levels of Adlea in 185 patients undergoing bunionectomy surgery. All three dosage levels of Adlea were shown to be well tolerated without safety concerns. In addition to the two Phase III trials, Anesiva plans to initiate a Phase II trial in patients undergoing arthroscopic shoulder surgery and a Phase II/III trial in patients with osteoarthritis of the knee.

• Antigenics Inc., of New York, said that the Brain Tumor Research Center at the University of California, San Francisco has initiated a Phase II clinical trial of Oncophage (vitespen), Antigenics' investigational patient-specific cancer vaccine, for the treatment of recurrent glioma. The primary objective of the investigator-sponsored study is to evaluate overall survival in glioma patients receiving Oncophage vaccination. Preliminary Phase I results showed that Oncophage vaccination was associated with significant tumor-specific immune response in all 12 treated patients from baseline. Updated results from Phase I of this study will be presented at the American Association for Cancer Research-National Cancer Institute-European Organization for Research and Treatment of Cancer conference on Oct. 25. Oncophage has been granted fast-track and orphan drug designations from the FDA in metastatic melanoma and renal cell carcinoma.

• Canopus BioPharma Inc., of Los Angeles, said it has begun a 30-patient Phase II clinical trial for its new HIV-1 anti-viral therapy, SpirH. SpirH is being studied to determine its potential to delay the onset of full-blown AIDS when used as a monotherapy in early stage infection. Canopus BioPharma's research to date shows that SpirH is effective against all strains of the HIV-1 virus, including strains from Africa, Thailand, Brazil and the U.S. The Phase II trial is examining whether SpirH is effective in delaying the onset of full-blown AIDS. The drug will be administered to patients both as a monotherapy and in association with conventional antivirals to augment their effectiveness.

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., said the first patient has been dosed in a trial to evaluate the safety and pharmacokinetics of bavituximab in patients co-infected with HCV and HIV. The open-label, dose-escalation study will involve about 24 patients chronically infected with HCV and HIV. Subjects will receive ascending dose levels of bavituximab weekly for up to eight weeks. HCV and HIV viral titers and other biomarkers will be evaluated, although they are not formal study endpoints.

• Pharmion Corp., of Boulder, Colo., and MethylGene Inc., of Montreal, have initiated a Phase I trial evaluating MGCD0103, an isotype-selective histone deacetylase inhibitor (HDACi) product candidate, in combination with Taxotere (docetaxel; Sanofi-Aventis) in patients with solid tumors. In the first portion of the trial, MGCD0103 will be given orally, three times per week for three weeks in combination with Taxotere, which will be administered on day one of each three-week cycle. Key objectives for that portion of the study are to evaluate safety, maximum tolerated dose and to define optimal dosing for the second phase of the study. The second portion of the trial will assess the safety of the drug combination, quantification of tumor responses and measurement of the pharmacodynamic and pharmacokinetic characteristics. The trial may enroll up to 50 patients and is expected to take 12 to 18 months.

• Proteolix Inc., of South San Francisco, and South Texas Accelerated Research Therapeutics, of San Antonio, have begun enrollment in a Phase I trial to study Proteolix's investigational drug carfilzomib (PR-171). The trial is evaluating carfilzomib, a novel proteasome inhibitor, in patients with recurrent or advanced solid tumors. The Phase Ib portion of the study is a dose-escalation study to determine the maximum dosing when administered intravenously in patients with solid tumors. Additional patients will be enrolled in Phase II and stratified according to disease type, including non-small-cell lung cancer, small cell lung cancer, ovarian cancer and renal cancer.

• Salvat, of Barcelona, Spain, has completed enrollment in a dose-finding Phase II trial of SVT-40776 for the treatment of overactive bladder. The double-blind, placebo-controlled, multicenter trial includes 332 patients with overactive bladder at 77 sites in 11 countries. During the four-week study, patients are randomized into one of five treatment arms, which include one placebo, one active control (Tolterodine, 4 mg once daily) and three SVT-40776 groups (once-daily administration). The primary endpoint is the mean change from baseline to last day of treatment in the number of micturitions per day. The trial also will generate tolerability data.

• VioQuest Pharmaceuticals, of Basking Ridge, N.J., has completed enrollment in its Phase I open-label dose escalation trial of its investigational drug, Lenocta), (sodium stibogluconate) for the treatment of solid tumors. Lenocta is an inhibitor of SHP-1 and SHP-2. Inhibition of those enzymes results in the up-regulation of the response to immunologic stimuli (cytokines) and inhibition of mitogenesis.

• Zealand Pharma AS, of Denmark, said it received a milestone payment from Wyeth Pharmaceuticals, of Collegeville, Pa., for the advancement of the first orally available gap junction modifier ZP1609 (GAP-134) into Phase I clinical trials in the U.S. It is the second gap junction modifier developed by Zealand that Wyeth advanced into clinical trials. ZP1609 (GAP-134) has shown pharmacological effects in animal models of both ventricular and atrial arrhythmias, and with its oral formulation, the molecule represents a novel paradigm for the potential chronic prevention of cardiac arrhythmias.