AEterna Zentaris Inc., of Quebec City, began the first Phase III study of cetrorelix in benign prostatic hyperplasia (BPH). The one-year, placebo-controlled trial will assess an intermittent dosage regimen of the luteinizing hormone-releasing hormone (LHRH) antagonist compound in providing prolonged improvement in BPH-related signs and symptoms. The primary efficacy endpoint is measuring absolute change in the International Prostate Symptom Score (IPSS) between baseline before beginning

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

Achillion Pharmaceuticals Inc., of New Haven, Conn., said it presented data validating the clinical antiviral activity of one of its NS4A antagonists, ACH-806, for treating hepatitis C virus infection. In the first presentation of human antiviral activity, a monotherapy study showed a mean change in HCV RNA (log10) at day five was a decrease of 0.91 from baseline for treated subjects vs. an increase of 0.05 for placebo subjects. Achillion also presented data on the synergy with other classes of

Anthera Pharmaceuticals Inc., of San Mateo, Calif., started enrolling patients with stable coronary artery disease in its Phase II trial of A-002, an inhibitor of secretory phospholipase A2 (sPLA2). The PLASMA (Phospholipase Levels And Serological Markers of Atherosclerosis) study will randomize about 200 subjects to receive either placebo tablets or one of four orally active doses of A-002 for eight weeks. The study's goal will be to determine A-002's ability to target sPLA2, enzymes that lead

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

Immtech Pharmaceuticals Inc., of New York, initiated a Phase IIb trial of the oral agent pafuramidine maleate to treat patients with uncomplicated malaria caused by Plasmodium falciparum. The primary objective is to establish a dose to be studied as monotherapy in a subsequent Phase III trial. The trial also will explore the treatment efficacy of the combination of pafuramidine and artesunate. Immtech separately is conducting a Phase II trial of pafuramidine for malaria prevention. The new

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

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

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

Adherex Technologies Inc., of Research Triangle Park, N.C., started a Phase I trial of the combination of systemic ADH-1 plus isolated limb infusion melphalan in melanoma. The study is expected to enroll up to 25 patients with N-cadherin positive melanoma and will explore escalating doses of ADH-1 to define dose-limiting toxicities, determine the maximum tolerated dose and assess initial efficacy of the combination treatment. It is expected to conclude in the second half of 2007. Allon

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

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

7TM Pharma A/S, of Horsholm, Denmark, began a Phase I/II trial of TM30339, an obesity agent derived from the company's discovery program on Y4 receptor selective agonists. The company said TM30339 mimics a natural satiety signal from the gastrointestinal tract involved in the regulation of food intake. Adherex Technologies Inc., of Research Triangle Park, N.C., said an investigator presented data from Adherex's European Phase Ib/II study of single-agent ADH-1 in solid tumors. Data from 30

Allon Therapeutics Inc., of Vancouver, British Columbia, said a Phase Ib trial of AL-108 met all its objectives. The trial confirmed that AL-108 was safe and well tolerated in 32 healthy elderly subjects after seven days of dosing. It also demonstrated favorable pharmacokinetic data. AL-108 is being evaluated in a Phase II efficacy trial in Alzheimer's disease, a trial for which enrollment is expected to be completed by the end of 2007. BioLineRx Ltd., of Jerusalem, reported preclinical data

Alkermes Inc., of Cambridge, Mass., said it completed enrollment in a Phase I/II trial of ALKS 29, an oral compound for the treatment of alcohol dependence. Alkermes is not disclosing the nature of the compound. The multicenter, randomized, double-blind, placebo-controlled trial is designed to assess the safety and efficacy of ALKS 29 in about 150 subjects with alcohol dependence. Alkermes expects to provide top-line results from the study in the first half of 2007. AOP Orphan Pharmaceuticals