• Amgen Inc., of Thousand Oaks, Calif., said Phase II data show that, in patients with symptomatic heart failure and anemia, Aranesp (darbepoetin alfa) was well tolerated and effectively raised hemoglobin. Results from a prespecified pooled analysis, including those data and data from a second Phase II study presented in March, show that treatment with Aranesp may decrease the risk of heart failure hospitalization and all-cause mortality, and improve symptoms. The results require confirmation from a large, Phase III trial, which Amgen recently launched. There are no approved treatments addressing the effects of anemia associated with symptomatic heart failure.

• Celgene Corp., of Summit, N.J., said its wholly owned subsidiary, Celgene International Sarl, disclosed data from two multi-centered, randomized, double-blind, placebo-controlled Phase III pivotal studies evaluating lenalidomide (Revlimid) plus dexamethasone in previously treated patients with multiple myeloma, at the 11th Congress of the European Hematology Association in Amsterdam. Updated results from the pivotal trial (MM-010) reported overall survival (p=0.03) in addition to median time to disease progression (p<0.0001). As of June 2006, median overall survival in the trial in patients treated with lenalidomide plus dexamethasone had not been reached as compared to 20.6 months with dexamethasone plus placebo. The clinical data from the pivotal North American Phase III trial (MM-009) reported overall survival (p=0.0001) in addition to median time to disease progression (p<0.0001). Celgene also offered data from a multi-center, single-arm open-label Phase II study evaluating single agent lenalidomide in patients with relapsed and refractory aggressive non-Hodgkin's lymphoma. Preliminary results were from 25 patients ages 45-80 (median age 63) who had received a median of 2.5 prior treatments (range: 1-6 treatments), given 25 mg of Revlimid orally once daily for 21 days in the cycle. Sixteen patients with aggressive NHL were evaluable for tumor assessment, of which there were five (31 percent) who experienced objective responses.

• ChemGenex Pharmaceuticals Ltd., of Melbourne, Australia, said data reported at the European Hematology Association meeting in Amsterdam supported the use of Ceflatonin (homoharringtonine, or HHT) in chronic myeloid leukemia patients who have developed resistance to Gleevec or other tyrosine kinase inhibitors. Of the 15 patients evaluated, 11 achieved a complete hematologic response after a median of two courses of HHT given in single or combination therapy. The responders included one patient with accelerated phase chronic myeloid leukemia and five with bcr-abl point mutations, which can be associated with resistance to imatinib mesylate and other tyrosine kinase inhibitors. Only one of six who had a detected bcr-abl mutation in the study did not respond to HHT therapy.

• Cytogen Corp., of Princeton, N.J., said interim results from a Phase I trial of Quadramet (samarium Sm-153 lexidronam injection) in combination with bortezomib (Velcade, Millennium Pharmaceuticals Inc.) in patients whose multiple myeloma had relapsed following prior treatment indicated that the combination regimen, known as VELSAM, was well tolerated at doses studied and demonstrated antitumor activity. Fifty percent of patients experienced a response or achieved stable disease. Results were presented at the 11th Congress of European Hematology. Quadramet is indicated for the relief of pain in patients with confirmed osteoblastic metastatic bone lesions that enhance on radionuclide bone scan.

• Lorus Therapeutics Inc., of Toronto, plans to investigate GTI-2040 as a single-agent in patients with high-grade myelodysplastic syndrome and acute myeloid leukemia. The study will be sponsored by the National Cancer Institute Cancer Therapies Evaluation Program under the clinical trials agreement with Lorus. GTI-2040 is an antisense oligonucleotide complementary to the R2 component of ribonucleotide reductase, an activity that is essential for DNA synthesis and tumor growth.

• Micromet Inc., of Carlsbad, Calif., said preliminary Phase I data reported at the European Hematology Association meeting in Amsterdam showed that MT103 had no dose-limiting toxicities in the first three cohorts (0.5 up to 5 mg/m2/24 h). Pharmacodynamic effects have been observed at 5 and 15 mg/m2/24 h, with complete depletion of malignant B cells as well as significant T-cell expansion in the majority of patients. Three out of five patients receiving 15 mg/m2/24 h for at least two weeks showed clinical responses assessed by central radiology; one had a complete tumor response and two showed partial responses. The product, also called MEDI-538, is in development for non-Hodgkin's lymphoma with MedImmune Inc., of Gaithersburg, Md.

• NovaCardia Inc., of San Diego, said Phase II results reported at the Heart Failure 2006 Congress in Helsinki, Finland, showed that KW-3902 exhibited significant diuretic activity over a six-hour period after the beginning of administration, and also resulted in increased hourly urine volume, with relatively preserved kidney function, over a nine-hour period compared to placebo. The findings were from two separate studies of the drug, an adenosine A1 receptor antagonist in development for congestive heart failure.

• Sinovac Biotech Ltd., of Beijing, disclosed Phase I preliminary results with its inactivated pandemic avian influenza vaccine, showing good immunogenicity, with a sero-positive rate of 78.3 percent, which exceeds the criteria for assessment of vaccines established by Committee for Proprietary Medicinal Products of the European Union. The project is sponsored and supported by Ministry of Science and Technology, and is co-developed by the Chinese Centers for Disease Control and Prevention and Sinovac.

• Synthetic Blood International Inc., of Costa Mesa, Calif., signed a letter of intent with the Mexican government's Institute of Social Security (IMMS) confirming its agreement to conduct a clinical study of Oxycyte in cardiopulmonary bypass surgical procedures to support market approval in Mexico. The agreement calls for Synthetic Blood to fund a 50-patient trial and to work with the IMMS, through a Mexican partner. Oxycyte is a perfluorocarbon therapeutic oxygen carrier and blood substitute.

• The Immune Response Corp., of Carlsbad, Calif., completed the first stage of enrollment of drug-na ve HIV patients in a Phase II study being conducted in Italy. The trial has enrolled 31 returning patients from a previous trial and 54 new patients. It is examining IR103, a second generation immunotherapy, as a first-line treatment for drug-na ve HIV-infected individuals not yet recommended for antiretroviral therapy. Approval has been attained to expand the study with another 50 patients. Eventually, more than 200 patients will be enrolled in two parallel studies with sites in Italy, France, Canada and the UK.

• Viral Genetics Inc., of Azusa, Calif., said results of its 137-patient TNP-001 clinical trial of VGV-1, conducted in South Africa, were consistent with the company's four prior prospective clinical studies of VGV-1. They confirm immunological bioactivity and antiviral properties, while also suggesting that the optimal dose has not yet been identified and requires further study. Specifically, the results indicate that a proportion of patients receiving eight weeks of treatment and no additional anti-HIV therapy experienced a decrease in viral load at day 150 that diminished at day 240. Viral load did not show statistically significant changes during treatment, or afterward at day 90, day 120 or day 240.

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