Bionovo Inc., of Emeryville, Calif., initiated its Phase I/II trial of BZL101, an oral drug designed to induce cancer cell apoptosis. The aim of the 80-patient study is to determine the maximum tolerated dose of the drug and to measure tumor response in women with advanced, measurable breast cancer who have not had more than two prior third-line cytotoxic treatments. EPIX Pharmaceuticals Inc., of Lexington, Mass., reported positive cognitive function results from its Phase Ib multiple

Addex Pharmaceuticals SA, of Geneva, said a Phase IIa proof-of-concept trial of ADX10059, its lead compound, met its primary endpoint in gastroesophageal reflux disease, and also showed statistically significant improvements in many of the secondary measures, including clinical GERD symptoms. The study enrolled 24 patients, who received placebo on day 1 and ADX10059 half an hour before each of three meals on day 2. The primary endpoint, the percentage of time that esophageal pH was greater than

Advanced Magnetics Inc., of Cambridge, Mass., reported positive results from two additional Phase III trials of ferumoxytol as an intravenous iron replacement therapeutic. Data from one trial in 303 non-dialysis-dependent chronic kidney disease patients randomized to receive either two doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks showed that the drug met all primary and secondary endpoints with statistical significance. The second study, which enrolled 750

AlphaVax Inc., of Research Triangle Park, N.C., began immunizing volunteers in trials to evaluate vaccines for cytomegalovirus (CMV) and influenza developed with the company's alphavaccine technology. In the first, they're receiving a human version of an alphavaccine that's shown to be effective in protecting against congenital CMV disease in a preclinical study. Results will be used to design future studies in target populations such as solid organ transplant recipients. In the second

Ambit Biosciences Corp., of San Diego, dosed the first patients in its Phase I trial of AC220 in acute myeloid leukemia. The study is expected to enroll between 20 and 40 patients with relapsed or refractory AML to receive AC220 daily via oral solution, beginning at 12 mg for 14 days and then increasing until the maximum tolerated dose is established. In addition to evaluating safety, tolerability and pharmacokinetics, the trial will measure pharmacodynamics by monitoring FLT3 receptor

Celgene Corp., of Summit, N.J., said preliminary results from a trial testing Revlimid (lenalidomide) in combination with low-dose dexmethasone (Decadron) in patients with newly diagnosed multiple myeloma suggests survival advantage in patients receiving that treatment regimen, as compared to those receiving Revlimid plus the higher, standard-dose of dexamethasone. Those results were reported by the Eastern Cooperative Oncology Group's Data Monitoring Committee. Cerimon Pharmaceuticals Inc

Cell Genesys Inc., of South San Francisco, disclosed final data from its second multicenter Phase II trial of GVAX immunotherapy for prostate cancer, which evaluated escalating doses of the immunotherapy in 80 patients with metastatic hormone-refractory prostate cancer. Additional follow-up of the 22 patients who received the dose that is comparable to that being employed in the company's ongoing Phase III program indicated that the median survival is 35 months. Four patients withdrew consent

Astellas Pharma, of Tokyo, and Theravance Inc., of South San Francisco, presented data from two Phase III trials in which telavancin compared favorably to standard therapy in the treatment of patients with complicated skin and skin structure infections, including those caused by Gram-positive organisms. The companies are partners on the drug, which is under FDA review. Astellas also said a trial of its drug Mycamine (micafungin sodium) compared favorably to standard therapy for Candida

Gen-Probe, of San Diego said its research test for the highly specific prostate cancer gene PCA3 in urine predicted the results of repeat biopsies more accurately than traditional prostate specific antigen testing, according to a study of 233 men published in the March issue of Urology. Researchers found that the risk of a positive repeat biopsy correlated with the PCA3 score. For example, among the 26 men in the study who had a PCA3 score of less than 5, only 12 percent had a positive repeat

Baxter International Inc., of Deerfield, Ill., announced final Phase I/II data for its adjuvant-free investigational pandemic H5N1 influenza vaccine. The Phase I/II study indicated that Baxter's H5N1 candidate vaccine is highly immunogenic at low doses, and induces substantial levels of cross-immunity against widely divergent H5N1 strains. The company plans to initiate an open-label, multicenter Phase III trial of the candidate vaccine in Europe to evaluate the safety and efficacy of the

Merck & Co. Inc., of Whitehouse Station, N.J., and H. Lundbeck A/S, of Copenhagen, Denmark, terminated ongoing late-stage trials of gaboxadol, a selective extrasynaptic GABA agonist for insomnia, after reporting that data from recently completed studies do not support further development. As a result of the data, Merck and Lundbeck ended their joint development program. NicOx SA, of Sophia Antipolis, France, said partner Pfizer Inc., of New York, started the first in a series of trials of PF

Ocera Therapeutics Inc., of San Diego, said a Phase II exploratory study of AST-120 in patients with active pouchitis was initiated at the Cleveland Clinic

Aeolus Pharmaceuticals Inc., of Laguna Niguel, Calif., finished analyzing results from its Phase I multiple-dose study of AEOL 10150, and said the clinical direction for the drug is under consideration, with the most likely targets for an efficacy study being lung cancer and/or head and neck cancer and amyotrophic lateral sclerosis. The 18-patient trial studied three doses of AEOL 10150 or placebo administered subcutaneously, and results showed that the drug was safe and well tolerated at doses

Abraxis BioScience Inc., of Los Angeles, will begin enrollment in two Phase I/II clinical trials to investigate the use of its nab-docetaxel (ABI-008), an albumin-bound chemotherapeutic for the treatment of hormone refractory prostate and metastatic breast cancer. Enrollment in the first study for hormone refractory prostate cancer is expected to begin in April, with the second Phase I/II trial in metastatic breast cancer starting in the second quarter of 2007. Both trials will be conducted at

Advanced Magnetics Inc., of Cambridge, Mass., completed enrollment in its final Phase III study with ferumoxytol in 230 dialysis-dependent chronic kidney disease patients, and expects to file a new drug application in the fourth quarter of this year. (See BioWorld Today, Nov. 20, 2006.) Avexa Ltd., of Victoria, Australia, reported positive Phase IIb data with apricitabine (ATC), a nucleoside reverse transcriptase inhibitor for HIV. The trial compared ATC's efficacy in reducing the viral load

Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, began a pivotal study in the U.S. of its Vascular Wrap paclitaxel-eluting mesh product. The trial will evaluate the safety and efficacy of the Vascular Wrap after surgical implantation with an ePTFE vascular graft in the upper extremity for hemodialysis vascular access. Angiotech intends to brand Vascular Wrap with its VaxSys ePTFE vascular graft as the VaxSys Synergy product. The study is expected to enroll 530 patients and

Amicus Therapeutics Inc., of Cranbury, N.J., completed enrollment in all ongoing Phase II studies of Amigal (migalastat hydrochloride, AT1001) in Fabry's disease. The four studies are examining various dose levels and frequencies of Amigal to determine the safety and tolerability as the primary objective. The secondary objective is to evaluate certain pharmacodynamic measures of treatment, including effects on alpha-galactosidase A and globotriaosylceramide levels in various cells and tissues

Neose Technologies Inc., of Horsham, Pa., gained FDA clearance to start trials with NE-180, a long-acting, glycoPEGylated erythropoietin for anemia in adult cancer patients with non-myeloid malignancies who are getting chemotherapy, and for anemia associated with chronic kidney disease, including patients on dialysis and patients not on dialysis. In Switzerland, NE-180 is already in a Phase II trial for oncology-related anemia. TorreyPines Therapeutics Inc., of La Jolla, Calif., said it will

Avigen Inc., of Alameda, Calif., said it received approval from the FDA to begin Phase II clinical development of AV650 (tolperisone), a new chemical entity in the U.S. Tolperisone is approved in several European Union member countries for the treatment of spasticity and muscle spasms. The Phase II trial will assess the safety, tolerability and initial efficacy, as well as AV650's lack of sedation, in spinal cord injury patients suffering from spasticity. The study will be a multicenter, double