• Advanced Magnetics Inc., of Cambridge, Mass., said it expects to announce top-line data this summer from its fourth and final Phase III trial of ferumoxytol as an intravenous iron replacement in chronic kidney disease. Pending positive results, a new drug application filing is planned for the fourth quarter of 2007. Last month, the company raised $162.9 million through a public offering. (See BioWorld Today, May 24, 2007.)

• Alseres Pharmaceuticals Inc., of Hopkinton, Mass., said the FDA authorized an increase in the dose level of Cethrin to 9 mg in the company's ongoing Phase I/IIa study for the treatment of acute spinal cord injury (SCI). In April, the company announced that dosing at the 9 mg level had begun in Canadian trial sites under a Canadian clinical trial application. Patients with acute SCI are enrolled in the open-label study at sites across Canada and the U.S. Previous dose groups included in the study were 0.3 mg, 1 mg, 3 mg and 6 mg. By the end of the third quarter, the company plans to meet with regulatory authorities to review its plans for its proposed Phase IIb/III clinical study, and anticipates beginning that study by the end of the year or early 2008.

• Chelsea Therapeutics International Ltd., of Charlotte, N.C., initiated a bioequivalence study to determine a comparable dose range for its new disodium composition of CH-1504. Results are expected late in the third quarter and will guide the design of a Phase II study in rheumatoid arthritis, expected to begin in the fourth quarter. CH-1504 is a metabolically inert antifolate designed to improve upon the safety and potency of methotrexate.

• Columbia Laboratories Inc., of Livingston, N.J., said its vaginally-administered lidocaine for dysmenorrhea was well tolerated in a 42-patient, multidose pharmacokinetic study. An institutional review board has approved the company's plan to conduct a Phase II crossover study. In February, Columbia's shares lost more than two-thirds of their value after the company's progesterone gel failed to reduce the incidence of preterm birth in a Phase III study. (See BioWorld Today, Feb. 6, 2007.)

• CytRx Corp., of Los Angeles, reported data from the open-label extension study following its Phase IIa trial of arimoclomol in amyotrophic lateral sclerosis. Arimoclomol dosed at 100 mg three times daily for six months was well tolerated and resulted in a trend toward slower decline in several disease progression markers compared to historic controls. Subject to FDA clearance, CytRx plans to start a Phase IIb trial later this year with a four-fold arimoclomol dose increase and also may conduct a second efficacy trial, possibly in parallel with the Phase IIb trial.

• Durect Corp., of Cupertino, Calif, said Endo Pharmaceuticals Inc., of Chadds Ford, Pa., has begun a Phase II clinical program to evaluate the conversion of patients being treated with various opioids to sufentanil patches using Durect's Transdur technology. Durect reported positive results from an initial Phase II clinical study using patches. The sufentanil patch is intended to provide chronic pain relief for up to seven days from a single application, compared to the three days of relief provided with currently available opioid patches.

• Gentium SpA, of Como, Italy, reported results from an ongoing Phase I/II trial of Defibrotide in combination with melphalan, prednisone and thalidomide in relapsed or refractory multiple myeloma showed a major response rate, including complete and partial remission, was 53 percent after a median of three cycles. Data from 19 evaluable patients showed one complete response, one near complete response and seven partial responses. Results from a separate preclinical study showed that Defibrotide demonstrated the ability to significantly down-regulate heparanase gene expression and activity in myeloma cell lines in a dose-dependent manner, and that the drug decreases the myeloma cell invasion through the Matrigel matrix in vitro by 50 percent. Those data were presented at the International Myeloma Workshop in Kos, Greece.

• Isotechnika Inc., of Edmonton, Alberta, completed patient enrollment in its Phase IIb trial assessing ISA247 for the prevention of kidney graft rejection following transplantation. Of the 332 patients enrolled, 148 patients already completed the required six months of treatment. The company expects to have the last patient complete the six months of active treatment before the end of the year. Health Canada has granted a no objection letter allowing patients who already have completed 12 months of ISA247 treatment to continue therapy through to commercialization of the drug.

• Oncolytics Biotech Inc., of Calgary, Alberta, has begun patient enrollment in its U.S. Phase II trial to evaluate the intravenous administration of Reolysin in patients with sarcomas that have metastasized to the lung. The trial (REO 014) is an open-label, single agent study to measure tumor responses and duration of response, and to describe any evidence of antitumor activity of intravenous, multiple dose Reolysin in patients with bone and soft tissue sarcomas metastatic to the lung.

• Pharmacyclics Inc., of Sunnyvale, Calif., reported preliminary results from two ongoing Phase II trials supporting the potential use of Xcytrin (motexafin gadolinium) injection in combination with Alimta (pemetrexed, Eli Lilly & Co. Inc.) and in combination with Taxotere (docetaxel, Sanofi-Aventis Group) as a second-line treatment for non-small-cell lung cancer patients who failed at least one platinum-based chemotherapy regimen. In the first study, 17 of 27 evaluable patients (85 percent) receiving Xcytrin and Alimta have achieved stabilization of their tumors, with 10 of the 17 sill on treatment for up to nine cycles. Median survival time and median time to progression have not yet been reached. In the second study, 13 of 14 evaluable patients receiving Xcytrin and Taxotere have achieved stabilization of their tumors, with four still on treatment. The median survival time in that trial is 8.2 months and the median time to progression is 8.7 months. Data were presented at the International Lung Cancer Congress in Wailea, Hawaii.

• Pharmos Corp., of Iselin, N.J., said patient screening has begun in its Phase IIa trial of its topical NanoEmulsion drug delivery technology formulated with 3 percent diclofenac. The trial will compare the safety and analgesic efficacy of the diclofenac NE cream with placebo in approximately 126 subjects with knee osteoarthritis. Up to eight sites in Israel will participate in the double-blind, randomized, placebo-controlled, parallel group study.

• PrimeCell Therapeutics LLC, of Sydney, Australia, said preliminary results of a 25-patient trial that involved implanting autologous bone marrow stem cells into spinal cord injury patients showed that 15 patients (60 percent) could stand, up 10 patients (40 percent) could walk on the parallels with braces, seven (28 percent) could walk without braces and four (16 percent) could walk with crutches. No adverse events were observed. PrimeCell, which focuses on germ-line stem cell reprogramming, provided research support and preclinical studies for the trial.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., initiated a proof-of-concept Phase II trial of SCV-07 as a sole agent to treat hepatitis C virus. The company plans to enroll about 30 patients infected with HCV genotype I who previously responded to treatment with interferon-alpha and ribavirin but subsequently relapsed. Those patients will be randomized into three cohorts of escalating doses, and will receive daily subcutaneous injections of SCV-07 or placebo. The trial's objective is to demonstrate the drug's effect on hepatitis C viral load, as well as on other measures of immune response. Data are expected in the first quarter of 2008.

• Vasogen Inc., of Mississauga, Ontario, said the FDA has strongly recommended the company conduct a confirmatory study to support a pre-market approval filing for Celacade for the treatment of chronic heart failure. The FDA also recommended that the company consider using a Bayesian statistical approach to design the confirmatory trial, which involves a trial methodology that allows use of prior trial results with a confirmatory study to obtain additional information regarding efficacy and safety and has the potential to substantially reduce the number of patients required for a confirmatory study, as well as the cost and duration. Results from a previous Phase III ACCLAIM trial showed that in a subgroup of patients it reduced the risk of death or first cardiovascular hospitalization by 39 percent, and significantly reduced the risk of death or first cardiovascular hospitalization by 26 percent.

• YM BioSciences Inc., of Mississauga, Ontario, said the FDA has cleared its investigational new drug application for AeroLEF, an inhaled-delivery composition of free and liposome-encapsulated fentanyl in development for moderate to severe pain, including cancer pain. AeroLEF is being developed as a non-invasive delivery system to enable patients to self-titrate. YM plans to initiate an open-label Phase II trial designed to expand the target patient population and, in parallel, is planning an end of Phase II meeting with the FDA to seek agreement on the design of the Phase III program. The Phase II study will recruit up to 50 postsurgical patients across three sites in the U.S.