• Adherex Technologies Inc., of Research Triangle Park, N.C., received regulatory clearance from Health Canada to convert the dosing schedule of its Phase II study of single agent ADH-1 to once very week from once every three weeks. The trial is designed to evaluate the antitumor activity and tolerability of repeated doses of ADH-1 in patients with lung, esophageal, adrenocortical, renal and hepatocellular cancers whose tumors express the molecular target N-cadherin. Adherex anticipates completing the study in the second half of 2006.

• Amazon Biotech Inc., of New York, is designing a protocol to test AMZ0026 as an HIV drug to delay onset of full-blown AIDS. The study is designed to include 60 nonsymptomatic HIV-infected subjects who have not been recently treated with any AIDS medications. The subjects will receive AMZ0026 or placebo over a six-month treatment period, during which primary endpoint parameters will be monitored, including T-cell increases and the amount of HIV virus in the bloodstream.

• Biogen Idec Inc., of Cambridge, Mass., and Elan Corp. plc, of Dublin, Ireland, enrolled and dosed the first patients in the Tysabri (natalizumab) monotherapy safety extension study program in multiple sclerosis. Patients who previously participated in the Phase III trials and subsequent safety evaluation are eligible to be screened for entry in the open-label study. The companies voluntarily suspended Tysabri from the U.S. market and halted ongoing clinical trials last year based on reports of PML. Earlier this month, an FDA advisory committee unanimously recommended reintroduction of Tysabri as an MS treatment, and the FDA is expected to take action on or before June 28, 2006. (See BioWorld Today, March 9, 2006.)

• CuraGen Corp., of Branford, Conn., and TopoTarget A/S, of Copenhagen, Denmark, began dosing in a Phase I trial of PXD101 in combination with bortezomib (Velcade, Millennium Inc.) to treat patients with advanced malignancies, including solid tumors and lymphomas. The trial, which will include up to 36 patients, is being sponsored by the National Cancer Institute under a clinical trials agreement with CuraGen for PXD101 and under a cooperative research and development agreement with Cambridge, Mass.-based Millennium Pharmaceuticals Inc. for bortezomib. CuraGen and TopoTarget initiated a separate Phase Ib/II study last week of PXD101 plus Velcade to treat multiple myeloma.

• Elusys Therapeutics Inc., of Pine Brook, N.J., completed a Phase I study of its fast-track anthrax drug, Anthim, administered with and without ciprofloxacin. All subjects completed the 42-day trial, and no serious adverse events were found. The company said it initiated manufacturing scale-up to produce the drug in commercial quantities in preparation for possible U.S. government procurement under Project BioShield.

• Genaera Corp., of Plymouth Meeting, Pa., said new subset analysis of Phase II data of Evizon (squalamine lactate) suggested that the drug might benefit patients with wet age-related macular degeneration whose vision already has significantly deteriorated. The results, along with recently announced 24-week interim data, were presented at the IBC Third Annual Ocular Anti-angiogenesis Conference in Cambridge, Mass.

• Gentium SpA, of Villa Guardia, Italy, received its first Institutional Review Board approval to start a U.S. Phase III trial with Defibrotide to treat veno-occlusive disease (VOD) with multiple organ failure as a complication of stem cell transplantation. Data from the 80-patient, multicenter trial will be compared to a historical control group of 80 patients, with survival at day 100 as the primary endpoint. The trial will be conducted at about 20 U.S. cancer centers pending the IRB approval at each institution. Defibrotide has orphan drug status and fast-track designation in VOD from the FDA.

• GenVec Inc., of Gaithersburg, Md., began a Phase II study to evaluate TNFerade in patients with metastatic melanoma. The study will assess tumor response after four weeks of intratumoral injections of TNFerade plus concomitant radiation therapy in 29 patients with Stage III or IV metastatic melanoma who are ineligible for curative surgery or unlikely to benefit from other treatment options. Patients will be evaluated two months after the completion of therapy and followed for three years thereafter.

• Optimer Pharmaceuticals Inc., of San Diego, said Phase III trials of OPT-99 (prulifloxacin) for bacterial gastroenteritis are scheduled to begin in May. The company will conduct two international Phase III trials, one in the U.S., Mexico and Peru, and the other in India and Africa. Optimer said it hopes to file a new drug application with the FDA in mid-2007.

• PowderMed Ltd., of Oxford, UK, said pdpSC18, its dual-antigen encoding immunotherapeutic for hepatitis B entered Phase I trials to evaluate the drug’s safety and tolerability when administered by PMED, the company’s needle-free delivery technology, both in combination with lamivudine and as a monotherapy. The Phase I study will enroll patients at seven sites in Southeast Asia and the U.S., with results expected during 2007.

• PR Pharmaceuticals Inc., of Fort Collins, Colo., said healthy volunteers were dosed with PulmoLAR (2-methoxyestradiol) in a Phase I study. The double-blind, placebo-controlled trial is designed to assess the safety, tolerability and pharmacokinetics of a subcutaneous injection of PulmoLAR. The company is developing the drug to treat pulmonary arterial hypertension.

• Theratechnologies Inc., of Montreal, said TH9507 is the subject of a new clinical trial conducted by the University of Washington in Seattle and supported by the National Institutes of Health. The trial is investigating the effects of the drug on cognitive function in healthy older adults and older adults with mild cognitive impairment. About 160 male and female subjects will be enrolled in the randomized, double-blind, placebo-controlled trial. Theratechnologies is supplying TH9507, which is a stabilized analogue of human growth hormone releasing factor.

• YM BioSciences Inc., of Mississauga, Ont., said its partner, Oncoscience AG, of Wedel, Germany, was cleared by German authorities to start a Phase III trial of nimotuzumab in combination with radiation in children with inoperable pontine glioma. The trial is designed as a potential European registration study on the basis of a single-arm trial because of the absence of treatment options for children suffering from the disease. It will enroll 40 children with inoperable pontine glioma who will receive radiation concomitant with nimotuzumab.