• Biother, of Eagan, Minn., said it completed a Phase I trial of Imprime PGG, its investigational drug for cancers and the enhancement of white blood cell mobilization and production. Results demonstrated a strong safety profile in 24 healthy volunteers following a single injection. The company plans to begin a Phase I study next month to generate additional safety data, including pharmacokinetic and pharmacodynamic data. Beyond that, Biothera expects to launch a Phase II program to include a series of trials featuring a combination of Imprime PGG and various monoclonal antibodies and growth factors to treat a number of indications.

• EntreMed Inc., of Rockville, Md., began a Phase II trial to test the safety and efficacy of Panzem NCD in combination with Avastin (bevacizumab, Genentech Inc.) in patients with locally advanced or metastatic carcinoid tumors. The study will be coordinated by Boston's Dana-Farber/Partners Cancer Care, a collaboration among The Brigham and Women's Hospital Inc., Dana-Farber Cancer Institute, Massachusetts General Hospital and the Beth Israel Deaconess Medical Center. Panzem NCD is a liquid nanocrystal formulation of Panzem (2ME2) designed to attack tumors by disrupting microtubules, by inducing apoptosis and by blocking blood vessels that feed tumors.

• GTx Inc., of Memphis, Tenn., started a proof-of-concept Phase II trial of ostarine. The trial is designed to evaluate the ability of ostarine, a selective androgen receptor modulator, to build muscle and to promote bone, as well as to assess its safety. The trial is a randomized, placebo-controlled, double-blind dose-finding study in 60 elderly men and 60 postmenopausal women who will receive one of four doses of ostarine or placebo orally each day for three months. Endpoints include measurements of bone, fat, muscle mass and performance. Clinical data should be available in the second half of this year.

• Hemispherx Biopharma Inc., of Philadelphia, said it procured the seasonal influenza vaccine it needs to execute a placebo vs. Ampligen immunopotentiation clinical trial. The Phase II study will be conducted in Australia. Recent preclinical studies suggest that Ampligen may offer increases in protective antibody levels of up to 100-fold, and may provide added cross-protection against variant avian influenza virus strains when co-administered with influenza vaccines.

• Mentor Corp., of Santa Barbara, Calif., initiated a Phase I study of its botulinum toxin Type A product, focused on treating pain associated with adult onset spasmodic toricollis/cervical dystonia. The safety and dose-escalation study will be a placebo-controlled, single-exposure study with four months of follow-up. Mentor established its botulinum toxin program through a licensing agreement with the Wisconsin Alumni Research Foundation in December 2003.

• Nereus Pharmaceuticals Inc., of San Diego, initiated a Phase I trial of NPI-0052, a small-molecule proteasome inhibitor aimed at solid tumors and lymphomas. The open-label study is expected to enroll about 50 patients with advanced solid tumors or refractory lymphomas to receive once-weekly, intravenous doses of the drug. The company anticipates starting another trial of NPI-0052 in patients with multiple myeloma in upcoming months.

• OxiGene Inc., of Waltham, Mass., said the FDA granted orphan drug designation to the company's lead vascular disrupting agent, Combretastatin A4P (CA4P), in ovarian cancer. CA4P is being evaluated in a Phase II trial in combination with the chemotherapy regimen of carboplatin and paclitaxel. Results previously reported from a Phase Ib study showed a 67 percent response rate to the combined CA4P plus chemotherapy treatment among with ovarian cancer who failed previous therapy.

• Polydex Pharmaceuticals Ltd., of Toronto, reported that 738 participants have been enrolled in its ongoing Phase III trials in Africa and India to evaluate its microbicide Ushercell (cellulose sulphate) in the prevention of HIV and other sexually transmitted diseases. Abstracts from the studies were presented at the Microbicides 2006 conference in Cape Town, South Africa.

• Provectus Pharmaceuticals Inc., of Knoxville, Tenn., said a second group of subjects has been treated in its Phase I trial of PV-10 (Provecta) for ablation of metastatic melanoma. Treatment was tolerated by all subjects, with no evidence of systemic or serious local side effects, and most subjects exhibited evidence of efficacy, ranging from tumor shrinkage to complete ablation. Based upon those results, the company expanded the scope of the study to include a third group to receive treatment for up to 20 melanoma lesions.

• TorreyPines Therapeutics Inc., of San Diego, completed a Phase I trial of tezampanel (NGX424), an AMPA/kainite (AK) receptor antagonist for acute migraine, and plans to move into a Phase II study during the second half of the year. The 110-subject study showed that the drug, administered subcutaneously, was well tolerated at single doses up to and including 100 mg, and pharmacokinetic findings showed that it was rapidly and completely absorbed. Tezampanel is designed to provide a non-opioid, non-vascular approach to managing migraine and other persistent pain.

• VasoGenix Pharmaceuticals Inc., of Lenexa, Kan., entered an agreement to use Cleveland Clinic's expertise in clinical cardiovascular research on the application of VasoGenix's drug, calcitonin gene-related peptide (CGRP), in heart failure. The clinic will prepare a protocol design for a Phase I/II trial, and will assist the company in discussions with the FDA.