• Alimera Sciences Inc., of Atlanta, and pSivida Ltd., of Perth, Australia, said an independent data safety monitoring board recommended the continuation of the Phase III trial of Medidur following a planned interim review. Medidur, a tiny, injectable device, is being studied as a way to deliver fluocinolone acetonide, a corticosteroid, to the retina for up to three years as a treatment for diabetic macular edema.

• Avicena Group Inc., of Palo Alto, Calif., said the FDA granted orphan drug designation to HD-02, the company’s proprietary drug candidate for Huntington’s disease. The company recently announced the publication of positive Phase I/II data for HD-02 in Neurology.

• Cell Therapeutics Inc., of Seattle, presented preliminary results of a Phase I/II clinical trial of pixantrone in 64 patients with relapsed aggressive non-Hodgkin’s lymphoma who had previously failed one or two prior chemotherapy regimens, including the CHOP regimen. The two-part study was designed to determine the maximum tolerated dose and evaluate the drug’s effectiveness in a combination known as CPOP, in which pixantrone replaces doxorubicin in the standard CHOP regimen. All patients on the study had received prior doxorubicin therapy and as such were at risk for developing severe cardiac toxicity with additional anthracycline therapy. The CPOP regimen was highly effective, with complete response/unconfirmed complete response rates of 41 percent (14 of 34 patients) and 43 percent (13 of 30 patients) and overall response rates of 71 percent (24 of 34 patients) and 77 percent (23 of 30 patients) in the Phase I and Phase II components of the study, respectively.

• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, started dosing in a Phase Ib/II proof-of-concept trial to evaluate PXD101, a small-molecule histone deacetylase inhibitor, in combination with Velcade (bortezomib) for relapsed, refractory multiple myeloma. Preliminary results from the open-label, multi-center study are expected by mid-2007. The goal of the Phase Ib portion of the trial is to establish the maximum tolerated dose of PXD101 in combination with Velcade in up to 30 patients who have failed at least two prior lines of therapy for multiple myeloma.

• Neurobiological Technologies Inc., of Emeryville, Calif., started its second Phase III study of Viprinex (Ancrod) in patients with acute ischemic stroke. The overall clinical development program for both trials will enroll 1,300 patients, divided equally between the two trials. The program will be global, recruiting patients in the U.S., Europe, the Pacific Rim and South Africa.

• Northwest Kinetics Inc., of Tacoma, Wash., entered a pivotal Phase I trial with DVC LLC, of Frederick, Md., a developer of vaccines, for evaluation of the Venezuelan equine encephalitis vaccine candidate V3526. VEE is a mosquito-transmitted viral disease that causes encephalitis in horses and humans. The trial will evaluate the safety, tolerability and immunogenicity of the vaccine candidate in healthy volunteers between the ages of 18 and 40. Clinical testing will continue into 2006.

• Novelos Therapeutics Inc., of Newton, Mass., filed an investigational new drug application with the FDA for NOV-205, its second clinical stage compound. The initial U.S.-based trial will evaluate NOV-205 as monotherapy for chronic hepatitis C patients who have failed pegylated interferon plus ribavirin therapy.