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

BioMS Medical Corp., of Edmonton, Alberta, said a monitoring board recommended continuation of its pivotal Phase II/III MAESTRO-01 trial of MBP8298 in patients with secondary progressive multiple sclerosis. The move followed a planned interim safety analysis of the first 100 patients in the 550-patient study who completed 12 months of treatment. The next interim analysis, targeted for mid-2008, will look at both safety and efficacy in the first 200 patients who have completed 24 months of

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

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

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

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

Active Biotech AB, of Lund, Sweden, and Chelsea Therapeutics International Ltd., of Charlotte, N.C., performed the first human micro-dosing trial of an I-3D compound, ABR-224050, to determine the pharmacokinetic characteristics of the drug in humans. The study, conducted in healthy volunteers, demonstrated that the compound appears well suited for once-daily oral administration, and also that it has a half-life of around 60 hours, though that is significantly shorter than that of Arava, from

Biogen Idec Inc., of Cambridge, Mass., and PDL BioPharma Inc., of Fremont, Calif., said the ongoing Phase II study of daclizumab, known as the CHOICE trial, met its primary endpoint in relapsing multiple sclerosis patients being treated with interferon beta. Specifically, patients receiving daclizumab 2 mg/kg subcutaneously every two weeks showed a significant reduction in the number of new or enlarged gadolinium-contrast-enhancing lesions (Gd-CELs) at week 24. Based on those data, the

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

Pharmaxis Ltd., of Sydney, Australia, said a Phase II trial of Bronchitol in children with cystic fibrosis closed its enrollment phase after entering 25 subjects, fewer than the 42 originally expected. The number was revised following a review of the trial and because of a shortage of volunteers at the two UK sites. Children in the trial are completing three months of treatment with each of three different therapies - Bronchitol alone, both Bronchitol and Pulmozyme (domase alfa, Genentech Inc