• 4SC AG, of Planegg-Martinsried, Germany, has completed patient recruitment for the Phase IIa clinical trial with its drug candidate SC12267 for the treatment of rheumatoid arthritis. In the three-tiered and placebo-controlled study, patients will be given two doses of SC12267 per day over a three-month period and tested for tolerance and clinical efficacy. The study is being carried out in 13 centers in Germany, Poland and Serbia. Results are expected for the fourth quarter of 2007.

• Aastrom Biosciences Inc., of Ann Arbor, Mich., said the first critical limb ischemia patient was treated in its Phase IIb trial of its Vascular Repair Cell product. The prospective, controlled, randomized, double-blinded trial is expected to enroll 120 patients at up to 20 sites, randomized into two patient groups, to evaluate the safety and efficacy of the treatment.

• Accentia Biopharmaceuticals Inc., of Tampa, Fla., reported findings from a 16-week interim analysis of blinded data from the first 50 patients in the ongoing Phase III trial of SinuNase for chronic sinusitis. Patients in the trial were randomized 1:1 to receive SinuNase or placebo. The company said approximately 42 percent of all patients reported resolution of one or both cardinal symptoms of chronic sinusitis, the primary endpoint of the trial, and 47 percent had improved endoscopy scores for intranasal polyposis. Accentia anticipates completing enrollment of the target 300 patients this summer and providing data before the end of the year.

• Alteon Inc., of Montvale, N.J., initiated a Phase II trial of the glutathione peroxidase mimetic ALT-2074 in diabetic patients with a haptoglobin 2-2 variant that put them at high risk for cardiovascular complications. The 60-patient dose-escalating trial will evaluate ALT-2074's ability to lower inflammatory cardiovascular biomarkers.

• Avicena Group Inc., of Palo Alto, Calif., has selected the optimal dose of HD-02, its drug candidate for the treatment of Huntington's Disease. The dose was determined in an open-label dose escalation study in a range of doses from 10 to 40 grams per day. The full scope of the data will be presented after the results have been peer reviewed. Based on the findings, Avicena and its collaborators have developed a double-blind, placebo-controlled Phase III trial expected to begin in early 2008. That trial will be one of the single largest trials for Huntington's patients, with external funding to be announced.

• Biovest International Inc., of Worcester, Mass., a majority-owned subsidiary of Accentia Biopharmaceuticals Inc., reported findings from a six-year interim analysis of blinded data from 122 patients in an ongoing Phase III trial of BiovaxID for non-Hodgkin's lymphoma. Patients were randomized 2:1 in favor of BiovaxID. Approximately 40 percent of the evaluable patients remained disease-free from 40 months to almost 70 months. Applications for accelerated conditional approval of the personalized cancer vaccine in the U.S. and Europe are planned for submission in mid-2008.

• Cephalon Inc., of Frazer, Pa., said a European Phase III trial of Treanda (bendamustine) in chronic lymphocytic leukemia met its primary endpoint of overall response rate. Details will be released by the end of the year, and the data will form the basis of a new drug application (NDA) filing in the third quarter. A Phase III trial of the drug in indolent non-Hodgkin's lymphoma remains on schedule to support an NDA filing in the fourth quarter. Cephalon acquired Treanda through its potential $200 million buy-out of Salmedix Inc. (See BioWorld Today, May 16, 2005.)

• Cylene Pharmaceuticals Inc., of San Diego, initiated a single-agent Phase II trial of its lead ribosomal RNA biogenesis inhibitor, quarfloxin (CX-3543), in patients with chronic lymphocytic leukemia. Quarfloxin is a small molecule derived from the fluoroquinolone class designed to selectively target a DNA protein complex that is amplified in cancer cells, leading to inhibition of ribosomal RNA biogenesis and induction of apoptotic cell death. The open-label trial is expected to include up to 25 patients with CLL whose leukemia has progressed on prior treatment with a purine analog and a monoclonal antibody.

• Cytochroma Inc., of Markham, Ontario, reported positive data from a Phase I trial of CTA018 Injection. The initial top-line results showed CTA018 was safe and well tolerated. Complete study results are expected in August. The recently completed trial was an open label, placebo-controlled, randomized study of CTA018 Injection administered to 20 healthy volunteers. Safety was evaluated after single doses of up to 180 mcg. Placebo and two strengths of CTA018, 90 mcg and 180 mcg, were subsequently studied during repeated dose administration. No drug-related adverse events were reported.

• Cytogen Corp., of Princeton, N.J., reported updated data from a Phase I dose escalation study evaluating Quadramet (samarium Sm-153 lexidronam injection) in combination with bortezomib (Velcade, Millennium Pharmaceuticals, Inc.) in patients with relapsed multiple myeloma. Results showed the combination was tolerable and of 32 evaluable patients, 15 achieved a response or stabilization. Of these, six responded to the combination regimen, with three achieving a complete response and three achieving a minor response. Of the 15 patients who achieved either a response to treatment or stabilization of their disease, nine had previously failed treatment with bortezomib. The data were presented at the 11th International Myeloma Workshop in Kos, Greece.

• Millennium Pharmaceuticals Inc., of Cambridge, Mass., presented data from four clinical trials showing that Velcade (bortezomib) in combination with various other cancer drugs improved survival and generated complete responses in first-line treatment of multiple myeloma. In one trial, patients on Velcade combined with adriamycin and dexamethasone had 100 percent survival after one year and 95 percent after two years. Data from a Phase III trial of Velcade in front-line treatment of multiple myeloma are expected around the end of the year. Velcade is approved for refractory treatment of multiple myeloma and mantle cell lymphoma. The data were presented at the 11th International Myeloma Workshop in Kos, Greece.

• Omrix Biopharmaceuticals Inc., of New York, said it completed patient enrollment in its Fibrin Patch Phase I trial being conducted in Israel. The Fibrin Patch, which combines medical device and biological components, is designed for the management and control of bleeding on active bleeding sites. It is being developed with Ethicon Inc., a Johnson & Johnson company.

• Pfizer Inc., of New York, said it initiated a Phase III trial to evaluate the safety and efficacy of Sutent (sunitinib malate), in combination with a standard chemotherapy regimen, in patients with metastatic colorectal cancer. The study of the multi-kinase inhibitor will include 700 patients and evaluate the product with the FOLFIRI chemotherapy regimen vs. that regimen alone. The trial is enrolling patients in Europe, Canada, Asia and South America.

• Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., and Wyeth Pharmaceuticals, of Madison, N.J., reported positive results from a three-month open-label extension study of subcutaneous methylnaltrexone for the treatment of opioid-induced constipation in patients with advanced illness. Forty-two patients received subcutaneous methylnaltrexone in the previous double-blind MNTX 302 study, and then entered this open-label extension study. For these 42 patients, the mean laxation response rates (laxation within four hours) were 45.5 percent during the first month, 57.7 percent in the second month, and 57.3 percent in the third and final month. For the remaining 40 patients who had first received placebo in the MNTX 302 study prior to entering the extension study, laxation response rates were 48.3 percent during the first month, 47.6 percent in the second month, and 52.1 percent in the third and final month. Subcutaneous methylnaltrexone was generally well-tolerated and the most common adverse event reported was mild to moderate abdominal pain. The results were presented at the Multinational Association of Supportive Care in Cancer Symposium in St. Gallen, Switzerland.

• Protalex Inc., of New Hope, Pa., said it began a Phase Ib study of PRTX-100 in healthy volunteers. The additional study is designed to gain more detailed information on biomarkers, which will allow for more optimized patient selection and targeting in a Phase II study. That study is expected to include rheumatoid arthritis patients and start in early 2008. Separately, the company plans to begin a trial in Australia later this year in idiopathic thrombocytopenic purpura patients. PRTX-100 is a purified form of the Staphylococcal bacterial protein known as Protein A.

• Speedel Holding AG, of Basel, Switzerland, said it successfully completed a Phase IIa proof-of-concept clinical trial with the renin inhibitor SPP635 for the treatment of hypertension. SPP635 was safe and well tolerated over the four-week study week period in the 35-patient trial, which showed a significant reduction in systolic blood pressure vs. placebo. Based on the results, the company is planning a Phase II trial in a population of diabetic patients with mild to moderate hypertension.

• Surface Logix Inc., of Boston, has begun a Phase IIa trial for SLx-2101 in patients with secondary Raynaud's disease. SLx-2101 is a long-acting PDE-5 inhibitor being developed to manage diseases associated with vascular dysfunction such as Raynaud's, a vasospastic disorder of small blood vessels leading to a marked reduction of blood flow to areas such as the fingers and toes. The trial is a single European center, randomized, double-blind, placebo-controlled, crossover pilot study of 20 patients with secondary Raynaud's disease. The trial will examine the safety, tolerability and pharmacodynamic profile of repeat oral doses of SLx-2101 once daily for up to 14 days.

• Titan Pharmaceuticals Inc., of South San Francisco, has completed enrollment in a randomized, double-blind Phase IIb clinical study of Spheramine in the treatment of advanced Parkinson's disease. A total of 71 patients were treated in the study. Spheramine is being developed in collaboration with Bayer Schering Pharma AG, of Berlin. Results from the study are expected to be available in the third quarter of 2008. Results from a previous open label study in six patients showed an average 48 percent improvement in motor function over baseline at one year after treatment.

• Transition Therapeutics Inc., of Toronto, said an exploratory Phase IIa trial indicated treatment with the gastrin-based therapy E1-I.N.T. showed sustained reductions in blood glucose control parameters, including haemoglobinA1C, for six months post-treatment. The Type II diabetes patients enrolled in the study were using metformin with or without thiazolidinediones. They were treated with E1-I.N.T. daily for four weeks. TTI plans to pursue a larger Phase II study to optimize dosing regimens. Novo Nordisk A/S, of Bagsvaerd, Denmark, has an exclusive license to the E1-I.N.T. product.

• Ziopharm Oncology Inc., of New York, reviewed previously presented interim data from two ongoing Phase II trials of ZIO-101 (darinaparsin) in multiple myeloma. ZIO-101, a small molecule organic arsenic formulation, is also in Phase II trials for liver cancer and hematological cancers. The company also presented new preclinical data indicating that ZIO-101 may have activity in myeloma patients who have failed treatment with arsenic trioxide. The data were presented at the 11th International Myeloma Workshop in Kos, Greece.