• Amgen Inc., of Thousand Oaks, Calif., said a Phase III trial of Aranesp (darbepoetin alfa) in previously untreated patients with extensive-stage small-cell lung cancer receiving chemotherapy demonstrated no statistically significant difference in risk of death or investigator-assessed progression-free survival. The randomized, double-blind, placebo-controlled study is a component of Amgen's ongoing pharmacovigilance program designed to evaluate the effect of Aranesp on long-term survival in anemic patients undergoing concomitant chemotherapy. The study was completed three months ahead of Amgen's post-marketing commitment, and the results were publicly announced and primary data were provided to the FDA in April 2007. Separately, Amgen presented Phase Ib data showing the tolerability of AMG 706 - an oral agent targeting VEGFR1-3 — administered in combination with carboplatin/paclitaxel and/or its Vectibix (panitumumab) in patients with advanced non-small-cell lung cancer.

• Avigen Inc., of Alameda, Calif., initiated a Phase II trial of AV650 (tolperisone HCl) in the treatment of spasticity associated with multiple sclerosis. The trial will evaluate the safety, tolerability and efficacy of AV650 in MS patients at doses up to 900 mg for one month followed by an open-label safety extension. The trial in Germany and other sites in Europe will include up to 150 MS patients suffering from spasticity. Tolperisone is an orally administered, centrally acting small molecule marketed in Europe and Asia for the treatment of neuromuscular spasticity and spasm.

• Biopure Corp., of Cambridge, Mass., said it recently met with the FDA to discuss the compassionate-use protocol submitted by the company in July. At the FDA's suggestion, the company intends to submit a protocol for a Phase II randomized trial for the treatment of autoimmune hemolytic anemia and other forms of hemolytic anemia, including alloantibody anemia but excluding sickle cell anemia. Hemopure has been used previously, on a compassionate-use basis, to treat patients with those conditions.

• Idera Pharmaceuticals Inc., of Cambridge, Mass., reported interim results from a Phase I trial of IMO-2055, a Toll-like receptor 9 agonist, in combination with gemcitabine and carboplatin in patients with advanced solid tumors. Data were from the Phase I portion of a Phase I/II trial. Interim data from 19 patients suggest the combination was feasible in those patients. The response rate, progression-free survival and overall survival rates were 5 percent, 4.1 months and 12.9 months, respectively.

• Introgen Therapeutics Inc., of Austin, Texas, and the Moffitt Cancer Center in Tampa, Fla., said they plan to begin a Phase II trial of INGN 225, Introgen's investigational immunotherapy product that delivers the p53 tumor suppressor, in patients with metastatic small-cell lung cancer. The randomized, controlled trial will enroll up to 80 patients, starting early next year. INGN 225 uses a patient's own cells to stimulate an anti-tumor immune response to fight cancer. The National Cancer Institute awarded a grant of about $1.3 million to fund the trial. Separately, data were presented from a previous Phase II trial that showed a 45 percent response rate in patients with platinum-resistant small-cell lung cancer who received chemotherapy following INGN 225.

• Iomai Corp., of Gaithersburg, Md., began dosing in a Phase I/II study that will assess the safety and dose-sparing capability of the company's immunostimulant patch when used in combination with an injected H5N1 influenza vaccine. The Iomai patch, which contains an immune-stimulating adjuvant, may generate an immune response with small amounts of vaccine antigen, potentially expanding the pandemic influenza vaccine supply. This trial is funded through a contract from the U.S. Department of Health and Human Services. The 500 trial subjects will be followed for safety, and immune responses to the pandemic vaccine will be evaluated.

• Johnson & Johnson, of New Brunswick, N.J., published results of a study on the use of Procrit (Epoetin alfa) in medical, surgical and trauma patients admitted to an intensive care unit, to determine whether the drug would decrease the number of critically ill patients who received a red blood cell transfusion after ICU admission. There was no significant difference in the percentage of patients who received a RBC transfusion between the Procrit and placebo groups. However, the hemoglobin increase was greater in the Procrit group. Despite the lack of transfusion reduction, the study showed treatment with Procrit significantly reduced mortality, particularly in trauma patients admitted to the ICU, J&J said. Results were published in the New England Journal of Medicine.

• Kosan Biosciences Inc., of Hayward, Calif., said it successfully reached a binding agreement with the FDA on the design of its TIME-1 clinical trial, a pivotal Phase III study of its Hsp90 inhibitor tanespimycin as a treatment for patients with multiple myeloma. Through the FDA's special protocol assessment process, they reached agreement on overall protocol design, primary efficacy endpoints and data analysis, as well as aspects of expected labeling. The registration program already has been initiated, and includes two studies: TIME-1 and TIME-2. TIME-1 will be conducted in first-relapse patients, and is expected to begin late this year or early next year. TIME-2, which is designed to be supportive of TIME-1, is a Phase II/III trial in patients with relapsed-refractory disease. That study already is enrolling patients.

• Nabi Biopharmaceuticals, of Boca Raton, Fla., said nine-month data from its ongoing Phase IIb trial of NicVAX (nicotine conjugate vaccine) demonstrated efficacy in supporting statistically significant and continuous abstinence rates by dose as well as by antibody response. The nine-month data also enabled Nabi to determine what it believes is the most effective dose and schedule for NicVAX and the antibody concentration threshold for clinical efficacy. Nabi plans to use the nine-month data to advance its partnership discussions surrounding NicVAX, which is designed to help smokers quit.

• OSI Pharmaceuticals Inc., of Melville, N.Y., said OSI Prosidion, its UK subsidiary, reported positive results from a metformin drug-interaction study in healthy volunteers with its dipeptidyl peptidase-IV inhibitor, PSN9301. Exposure to PSN9301 and metformin did not change to a clinically relevant extent when they were co-administered, compared with each therapy alone. A final commercial formulation of PSN9301 is being developed to support long-term, double-blind, placebo-controlled studies. PSN9301 is scheduled to enter a Phase IIb study in early 2008.

• Pfizer Inc., of New York, initiated a global Phase III trial to evaluate the efficacy and safety of sunitinib malate, in combination with erlotinib, in previously treated patients with advanced non-small-cell lung cancer. The randomized, double-blind trial in 956 patients is designed to compare the overall survival of patients taking the multi-kinase inhibitor sunitinib (Sutent) with the EGFR inhibitor erlotinib (Tarceva, Genentech Inc. and OSI Pharmaceuticals Inc.) to those taking erlotinib plus placebo. Secondary endpoints include progression-free survival, objective response rates, one-year survival, duration of response, adverse events and patient-reported outcomes.

• Plethora Solutions Holdings plc, of London, reported positive results from its blinded Phase II study of PSD597 in interstitial cystitis (IC) and painful bladder syndrome, with preliminary analysis showing that patients treated with the drug experienced a statistically significant improvement in their symptoms as measured by the Global Response Assessment, the primary endpoint. The 102-patient trial was designed to show both immediate and sustained relief of IC symptoms. PSD597 was found to be safe and well tolerated and devoid of systemic side effects. The company is following that trial with a voluntary, open-label study to collect further information on the longer-term treatment effect. Full data from both the blinded and open-label studies will be available later this year.

• Zealand Pharma A/S, of Copenhagen, Denmark, said it is advancing ZP1846 into Phase I trials in the U.S. ZP1846, a peptide that incorporates Zealand's SIP technology, is being developed as a therapy for the prevention and treatment of chemotherapy-induced diarrhea. The Phase I study will be a double-blind, placebo controlled, randomized trial evaluating safety and tolerability in healthy volunteers.

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