• Advaxis Inc., of North Brunswick, N.J., dosed the first patients in a Phase I/II trial of Lovaxin C, a Listeria-based therapeutic cancer vaccine. The trial is expected to enroll about 20 cervical cancer patients and last about six months, with safety as its primary objective.

• Amazon Biotech Inc., of New York, submitted to the FDA its protocol to test AMZ0026 as an antiviral and immuno-modulating agent in HIV subjects treated with HAART (highly active anti-retroviral therapy). The study's design includes 32 non-symptomatic patients, with half to continue their current HAART regimen without change and the other half to receive AMZ0026 along with the HAART regimen. Treatment will last six months, with monitoring of T-cell increases, HIV plasma viral load decreases and improvements in quality of life. In parallel, the company plans to conduct a placebo-controlled study in non-symptomatic, non-treated HIV patients.

• Avicena Group Inc., of Palo Alto, Calif., initiated patient dosing for a research study aimed at comparing the bioavailability of creatine monohydrate and creatine ascorbate. Researchers at McMaster University Medical Centre will seek to determine which formulation is best suited for increasing muscle and brain levels of creatine. About 30 healthy subjects will be enrolled, and Avicena expects findings from the study to direct ongoing work in the area of creatine transporter defect.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, started patient dosing in a phase Ib/II trial using CTCE-9908, the company's lead cancer product, to investigate the safety and ability to reduce the spread of cancer in up to 30 humans after several doses. A previous Phase I trial showed the compound safe and well tolerated after a single dose.

• Corcept Therapeutics Inc., of Menlo Park, Calif., completed patient enrollment in Study 07, one of three Phase III studies evaluating Corlux (mifepristone) for psychotic features of psychotic major depression. The trial is covered by a special protocol assessment from the FDA. The primary endpoint is the proportion of patients with at least a 50 percent improvement in the Brief Psychiatric Rating Scale Positive Symptom Subscale (BPRS PSS) at both day seven and day 56, a responder analysis. Patients must have had at least mild psychotic symptoms (BPRS PSS greater than or equal to 12) to enter the study and will be hospitalized if clinically necessary. BPRS PSS assessments also will be made at days 14, 28 and 42.

• EntreMed Inc., of Rockville, Md., began a Phase I trial to evaluate the safety, tolerability, pharmacokinetics and clinical benefit of its new tubulin-binding agent, ENMD-1198, in advanced cancer patients. The study is expected to enroll patients whose disease has failed to respond to existing therapies or where no approved therapy is available. ENMD-1198, a new chemical entity based on a modified chemical structure of 2-methoxyestradiol (2ME2), is designed to decrease metabolism while retaining 2ME2's multiple mechanisms of action: inducing apoptosis, binding microtubules and inhibiting HIF-1alpha.

• Javelin Pharmaceuticals Inc., of Cambridge, Mass., said preliminary results of a pilot Phase II study of Intranasal Ketamine in 60 patients with moderate to severe pain following bunion surgery failed to demonstrate statistical significance. Data showed total pain relief scores over three hours (TOTPAR3) ranging from 44 through 54 mm hours in patients given the active drug, compared to 36.3 mm hours in those given placebo. Javelin said it is analyzing the data to move forward with overall Phase II development.

• Metabolic Pharmaceuticals Ltd., of Melbourne, Australia, completed recruitment in a Phase IIb obesity trial of AOD9604 called the OPTIONS study, which is designed to assess weight loss at lower doses of the product than previously tested. In the trial, 536 subjects have been enrolled and are receiving either placebo or one of three different doses of the oral tablet during 32 weeks of treatment. The trial is expected to be completed in December, ahead of schedule. Results will be reported in March.

• Myriad Genetics Inc., of Salt Lake City, began a Phase I trial of MPC-0920, an orally available direct thrombin inhibitor. The trial will enroll healthy volunteers in a single, escalating-dose format to determine its safety, dose range and pharmacokinetics. Dose escalation will continue until a blood clotting time that is several times higher than normal and sufficient to ensure clinical use in thrombotic conditions is reached.

• Pharmaxis Ltd., of Sydney, Australia, said it would expedite the initiation of a Phase III program for Bronchitol in cystic fibrosis following successful end-of-Phase II meetings with the FDA and European regulators. Phase II data demonstrated a significant improvement in lung function in cystic fibrosis patients treated with Bronchitol, so the company plans to begin two pivotal Phase III trials with the same endpoint used in Phase II, lung function as assessed by FEV1. The product has orphan drug status for treating cystic fibrosis in both the U.S. and Europe.

• Regeneron Pharmaceuticals Inc., of Tarrytown, N.Y., disclosed positive preliminary results from its Phase I trial of its Vascular Endothelial Growth Factor Trap in patients with the neovascular form of age-related macular degeneration (wet AMD). In addition to meeting its primary endpoints of safety and tolerability at all dose levels, VEGF Trap showed positive preliminary efficacy results, and the company is starting a Phase II trial in wet AMD. The data from the Phase I study were presented at the 2006 Association for Research in Vision and Ophthalmology's annual meeting.

• Samaritan Pharmaceuticals Inc., of Las Vegas, completed a 10-day monotherapy Phase II trial of SP01A as an adjunct therapy in 34 treatment-experienced HIV patients who are failing current antiviral therapy. Preliminary results from the study are expected at the shareholders meeting May 31. The company also reported that it started enrolling patients for the second part of its Phase II trial, which will evaluate SP01A in a total of 60 patients in a 28-day monotherapy study.

• SIGA Technologies Inc., of New York, began Phase I trials of its lead candidate, SIGA-246, an antiviral for smallpox. The study will evaluate the product's safety and pharmacokinetics as different dosages in healthy volunteers. SIGA expects to collect data from the trial within the next month.

• Tanox Inc., of Houston, reported 48-week data from its Phase II trial of TNX-355 in HIV, showing that patients who received either study dose of TNX-355 in combination with an optimized background regimen (OBR) maintained a considerably greater reduction in viral load than patients who received placebo plus OBR. Results also demonstrated that those receiving TNX-355 and OBR experienced a statistically significant increase in CD4+ cells, compared to those in the placebo/OBR arm. The data are consistent with the 24-week data reported in October. Despite those results, the company's stock fell more than 10 percent Tuesday on lower-than-expected revenues for the first quarter. Tanox reported a net loss of $5.2 million, or 12 cents per share, for the three months ending March 31, lower than analysts' estimates of $11.1 million, or 10 cents per share. Its stock was downgraded by Boston-based Leerink Swann, from "outperform" to "marketperform." Shares (NASDAQ:TNOX) closed at $14.12, down $1.44. (See BioWorld Today, Oct. 27, 2005.)

• Telik Inc., of Palo Alto, Calif., started ASSIST-5, an international Phase III trial that will compare treatment with the combination of Telik's Telcyta, a small-molecule prodrug that is activated by GST P1-1, and Doxil (doxorubicin, from Johnson & Johnson, of New Brunswick, N.J.) to treatment with Doxil alone in women with platinum refractory or resistant ovarian cancer. Telik plans to enroll about 244 women with 122 randomized to each treatment arm. Trial endpoints include objective response rate, progression-free survival and overall survival.