• Alexza Pharmaceuticals Inc., of Palo Alto, Calif., said its Phase IIa clinical trial of AZ-104 (Staccato loxapine) to treat patients with migraine headache met its primary endpoint. The primary efficacy endpoint was headache pain relief at two hours post-dose. Secondary efficacy endpoints included various additional measurements of pain relief, as well as effects on nausea, vomiting, phonophobia and photophobia. All results were considered statistically significant at the p < 0.05 level, and all analyses were made on an intent-to-treat basis.

• BioMS Medical Corp., of Edmonton, Alberta, said the independent data safety monitoring board for the Phase II MINDSET-01 trial of MBP8298 in patients with relapsing-remitting multiple sclerosis has completed a safety analysis and recommended that the trial continue. The 15-month trial is fully enrolled with 218 patients at 24 sites in six countries. The objectives of the study are to demonstrate safety and efficacy of MBP8298 vs. placebo as measured by relapse rate, MRI activity and disease progression.

• GTx Inc., of Memphis, Tenn., said toremifene citrate 80 mg reduced hot flashes in men with prostate cancer on androgen deprivation therapy (ADT), a secondary endpoint of the Phase III clinical trial evaluating the compound for treatment of multiple side effects of ADT for advanced prostate cancer. In an analysis of patients experiencing six or more hot flashes per day at baseline and not being treated with megestrol acetate (Megace), toremifene citrate 80 mg reduced the number of hot flashes by an average of 4.7 per day compared to a reduction of 1.6 hot flashes for placebo patients (p=0.03). The reduction among treated patients was durable for at least 12 months. Last week GTx reported data showing the product candidate works to reduce spinal fractures and other side effects from ADT sending its shares up more than 36 percent. (See BioWorld Today, Feb. 26, 2008.)

• HUYA Bioscience International, of San Francisco, has completed three Phase I clinical trial protocols in China of anti-arrhythmic compound, HBI-3000 (Sulcardine sulphate). The data supported a desirable safety profile at dose levels displaying indications of pharmacologic activity. HBI-3000 is being developed as a potential treatment for both atrial and ventricular arrhythmias.

• LifeCycle Pharma A/S, of Horsholm, Denmark, announced positive top-line results from a Phase II clinical trial for LCP-Tacro in stable kidney transplant patients. The company said data demonstrated that LCP-Tacro, a once daily immunosuppression drug, has a potential best-in-class profile when compared to the currently marketed twice-daily tacrolimus capsule, Prograf, by indicating Higher bioavailability by more than 40 percent, and improved pharmacokinetics, reduced variability (peak-to-trough ratio).

• NicOx SA, of Sophia Antipolis, France, has begun two large clinical pharmacology studies in the U.S. that will assess the blood pressure profile of naproxcinod compared to ibuprofen and naproxen. The primary objective of the studies is to assess the mean change from baseline in the average 24-hour systolic blood pressure, as well as to evaluate the general safety and tolerability of naproxcinod. Those separate studies, 12 and 16 weeks in duration, will recruit a total of around 420 osteoarthritis patients with controlled hypertension.

• Nventa Biopharmaceuticals Corp., of San Diego, has completed the safety and tolerability assessment of its third cohort of patients in a Phase I clinical trial of new HspE7 in patients with cervical intraepithelial neoplasia (CIN). The safety data from the cohort were normal and met the limits prescribed in the trial protocol, allowing advancement to the fourth cohort of patients in the study, which will be administered 500 mcg of HspE7 and 2,000 mcg of adjuvant. The dosing of the fourth cohort of patients is expected shortly.

• Pharmacopeia Inc., of Princeton, N.J., has begun a Phase IIb clinical study of PS433540, a dual-acting angiotensin and endothelin receptor antagonist being developed for hypertension and diabetic nephropathy. The randomized, double-blind, placebo and active-controlled, parallel-group study is designed to evaluate the compound's safety and efficacy at three different doses in subjects with Stage 1 and Stage 2 hypertension. The trial's primary objective is to compare the change from baseline in mean seated systolic blood pressure for each dose of PS433540 with placebo.

• PhytoMedical Technologies Inc., of Princeton, N.J., announced positive results from new tests of its anticancer compounds, which have demonstrated the ability to kill colon cancer cells and human glioblastoma cells related to brain cancer. The compounds are designed to bind more tightly to cancer cell DNA, preventing replication and killing the cancer cell DNA. In tests against a difficult-to-treat strain of human colon cancer cells, researchers observed a 50 percent or greater cancer cell kill rate using the compounds.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said data from all end-stage colorectal cancer patients from its Phase II trial showed Davanat administered in combination with 5-fluorouracil (5-FU), extended median survival by 6.7 months or 29 weeks after all other treatments were exhausted. The data for the 20 patients who completed the trial showed that three patients survived more than one year, two patients survived more than two years and one patient is still alive. The patients experienced total serious adverse events of 35 percent with only 10 percent drug related, compared with more than 70 percent SAEs reported for similar patient populations in similar trials.