• Anacor Pharmaceuticals Inc., of Palo Alto, Calif., started dosing patients in a Phase IIb study of ANO128, a topical anti-inflammatory candidate for atopic dermatitis. The trial is expected to enroll 200 patients between the ages of 2 and 17 with moderate forms of the disease who will receive ANO128 or a placebo cream twice a day for six weeks. Researchers plan to assess efficacy using a 6-point static global assessment scale.

• Angiotech Pharmaceuticals Inc., of Vancouver, British Columbia, said results from its European first-in-man study of its Vascular Wrap paclitaxel-eluting products produced evidence of a reduced overall incidence of leg amputation and prolonged limb retention vs. the control group. The mean interval to amputation in the Vascular Wrap group was 156 days vs. 76 days in the control arm. The objectives of the 109-patient, two-year study were to assess the safety and clinical performance of the Vascular Wrap in combination with an ePTFE vascular graft following surgery to treat patients suffering advanced peripheral arterial disease in their lower limbs.

• ArQule Inc., of Woburn, Mass., said data from a Phase Ib trial of ARQ 501 in combination with docetaxel support previously announced findings that showed clinical tolerability and signs of antitumor activity in patients with a range of advanced solid tumors who had failed prior treatments. Data were presented at the 18th EORTC-NCI-AACR meeting in Prague, Czech Republic. ARQ 501 is in a Phase II program consisting of two monotherapy trials in leiomyosarcoma and head and neck cancer, and one combination trial with gemcitabine in pancreatic cancer.

• Callisto Pharmaceuticals Inc., of New York, said it began dosing in a multicenter, open-label Phase II trial of Atiprimod, an orally available small-molecule drug, for patients with low- to intermediate-grade neuroendocrine carcinomas including advanced carcinoid cancers, with metastatic or unresectable cancer. Participants will record their symptoms for two weeks to establish baseline before beginning the Atiprimod dosing. A maximum of 40 patients will be enrolled, and will be evaluated through a measure of target lesions and symptom relief.

• Cyclacel Pharmaceuticals Inc., of Short Hills, N.J., said preliminary results from a Phase I trial of sapacitabine (CYC682), an orally available nucleoside analogue, demonstrated that the product could be administered safely to patients with refractory solid tumors or lymphomas, and it might be active in several tumor types. The trial is part of a larger Phase I program consisting of three additional studies: two in patients with incurable solid tumors and one in patients with advanced leukemias and myelodysplastic syndromes.

• Exelixis Inc., of South San Francisco, said preliminary results from an ongoing Phase I trial of OX184, a small-molecule inhibitor of multiple receptor tyrosine kinases, showed that the drug was generally well tolerated, with no dose-limiting toxicities reported to date. As of Oct. 21, 21 patients had been enrolled, and three of the 18 evaluable patients had some improvement in disease measures. Those results were presented at the 18th EORTC-NCI-AACR meeting in Prague, Czech Republic. The company also presented updated Phase I results showing that XL647 was generally well tolerated and showed evidence of antitumor activity in patients with advanced solid tumors. Another Phase I trial showed that XL880 also was well tolerated and showed antitumor activity in advanced solid tumors. XL880 is being tested in Phase II in papillary renal-cell carcinoma.

• Gemin X Biotechnologies Inc., of Montreal, said Phase I data of GX15-070 confirmed direct, dose-dependent biological activity of the drug, a small molecule designed to inhibit Bcl-2, when administered as a single agent in patients with chronic lymphocytic leukemia, refractory solid tumors or lymphomas, myelodysplastic syndromes or acute myelogenous leukemia in a variety of dosing schedules. Clinical activity also was demonstrated by partial responses in CLL and follicular lymphomas, prolonged disease stabilization in large-cell lymphoma and hematological responses resulting in both red-blood cell and platelet-transfusion independence. Data were presented at the 24th annual Chemotherapy Foundation Symposium in New York.

• Genzyme Corp., of Cambridge, Mass., said results of a study comparing the outcomes of kidney transplant patients undergoing induction therapy showed that those treated with the company's Thymoglobulin (antit-thymocyte globulin [rabbit]) had a significantly reduced risk of acute rejection, acute rejection requiring antibody therapy and delayed graft function, graft loss and death vs. patients receiving basiliximab. The Thymoglobulin group had a 38.8 percent lower incidence of acute rejection and an 82.5 percent lower incidence of severe acute rejection. Data were published in the New England Journal of Medicine.

• Inflazyme Pharmaceuticals Ltd., of Vancouver, British Columbia, completed patient enrollment in its Phase IIb trial of IPL512,602 in moderate to severe asthma. The 218-patient CAPSICS (Control of Asthma Patients Symptomatic on Inhaled Corticosteroids) study is designed to evaluate the efficacy and safety of once-daily oral dosing of 20 mg of IPL512,602 against placebo. The company expects to conclude the trial in the first quarter of 2007, with top-line results released shortly thereafter.

• KaloBios Pharmaceuticals Inc., of Palo Alto, Calif., said it started a Phase I trial in Australia of KB002, an engineered human monoclonal antibody, for rheumatoid arthritis. The drug targets and neutralizes GM-CSF, the granulocyte macrophage colony-stimulating factor. The trial is a single-dose, dose-escalating, placebo-controlled, double-blind trial, which will enroll more than 30 rheumatoid arthritis patients at more than five medical centers in Australia. The trial will investigate whether the antibody is effective in patients who have become resistant to disease modifying anti-arthritis drugs and/or anti-TNF drugs.

• MethylGene Inc., of Montreal, said data from one of its Phase I trials of MGCD0103, a histone deacetylase (HDAC) inhibitor, showed that seven of 37 patients with advanced solid tumors enrolled in the study have had stable disease beyond two cycles. Preliminary data further support that the drug can inhibit HDAC activity in a dose-dependent manner and induce histone acetylation in peripheral blood cells. Data were presented at the 18th EORTC-NCI-AACR meeting in Prague, Czech Republic.

• Oncolytics Biotech Inc., of Calgary, Alberta, presented a poster at the EORTC-NCI-AACR meeting in Prague, Czech Republic, that covered more results from the firm's Phase I trial with Reolysin, a formulation of the human reovirus. Delivered systemically, the drug showed activity in patients with colorectal, bladder, prostate, pancreatic, endometrial and non-small-cell lung cancers, the company said, with generally mild toxicity.

• Oxford BioMedica plc, of Oxford, UK, said further data from an ongoing Phase II trial of TroVax, an immunotherapy cancer product, showed the drug was well tolerated and demonstrated antitumor activity in patients with renal-cell carcinoma, with one patient showing a complete response and two patients developing a partial response. Results from a second ongoing Phase II trial evaluating the product in prostate cancer demonstrated that TroVax-treated patients developed a strong 5T4-specific antibody response whether or not they received GM-CSF. Analysis of cytotoxic T-cell immune response stimulated by the drug in both trials is ongoing. Results were presented at the EORTC-NCI-AACR meeting in Prague, Czech Republic.

• Pharmacyclics Inc., of Sunnyvale, Calif., said preliminary results of a Phase II trial suggested that Xcytrin (motexafin gadolinium) injection might improve steriotactic radiosurgery treatment planning by enhancing magnetic resonance imaging and better defining the treatment field in patients with brain metastases from solid tumors. Nine of the evaluable 45 patients had brain metastases identified with Xcytrin that were missed with standard MRI procedures. Data were presented at the 48th American Society for Therapeutic Radiology and Oncology annual meeting in Philadelphia.

• Targacept Inc., of Winston-Salem, N.C., reported positive results from a Phase II trial of mecamylamine hydrochloride as an augmentation treatment for major depression. Data showed that patients receiving TRIDMAC (mecamylamine in combination with citalopram) demonstrated greater improvement on symptoms of depression over citalopram alone, as measured by group mean change from baseline on the Hamilton Depression Rating Scale. That result was statistically significant on an intent-to-treat basis and showed a strong trend on a per-protocol basis. In measuring the achievement of remission, the TRIDAC group was higher than the placebo/citalopram group, though the results were not statistically significant.

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