• Cell Therapeutics Inc., of Seattle, said interim Phase II/III data indicated pixantrone-based combination therapy resulted in complete or partial responses in the first-line treatment of aggressive non-Hodgkin's lymphoma, but with fewer severe side effects than seen in patients on doxorubicin-based combination therapy. Specifically, pixantrone-treated patients achieved a threefold reduction in the incidence of severe heart damage, clinically significant reductions in infections and thrombocytopenia, and a significant reduction in febrile neutropenia. The ongoing trial is anticipated to complete enrollment of 280 patients in 2008, but if a planned interim analysis of a second Phase III trial later this year is positive, the company may present both datasets to the FDA. Shares of Cell Therapeutics (NASDAQ:CTIC) gained 16 cents Wednesday, to close at $4.52.

• Geron Corp., of Menlo Park, Calif., initiated a Phase I/II trial of GRNVAC1, its telomerase cancer vaccine, in patients with acute myelogenous leukemia in complete remission. The vaccine is produced from a patient's blood using a process that generates dendritic cells containing RNA coding for the protein component of telomerase. The study's primary objective is to evaluate the safety and feasibility of a prime-boost vaccination regimen that extends the duration of telomerase immunity. Secondary objectives are to evaluate the immune response to GRNVAC1 and to explore the effects of vaccination on minimal residual disease and relapse rates.

• Inspire Pharmaceuticals Inc., of Durham, N.C., said it plans to initiate three pivotal Phase III trials and a six-month intranasal toxicology study with epinastine nasal spray in allergic rhinitis. Based on an End-of-Phase II meeting with the FDA, Inspire intends to conduct two of the Phase III trials in seasonal allergic rhinitis and one in perennial allergic rhinitis. The first seasonal trial will start in the fourth quarter, with results anticipated in the second quarter of 2008, while the other two Phase III trials will begin in 2008.

• Medicure Inc., of Winnipeg, Manitoba, said two-year follow-up data from a heart attack trial of the glycoprotein IIb/IIIa inhibitor Aggrastat (tirofiban hydrochloride) were published in the Journal of the American College of Cardiology. Patients treated with Aggrastat plus a sirolimus-eluting stent had significantly lower cumulative incidence of death, myocardial infarction or target vessel revascularization than patients receiving Reopro (abciximab, Centocor Inc.) plus a bare-metal stent. Data from a larger trial are expected in early 2008. Medicure licensed Aggrastat, which is approved for acute coronary syndrome, from MGI Pharma Inc., of Bloomington, Minn. (See BioWorld Today, Aug. 10, 2006.)

• Peregrine Pharmaceuticals Inc., of Tustin, Calif., has submitted a clinical protocol with the drug controller general of India for a Phase II trial of bavituximab in combination with chemotherapy in patients with non-small-cell lung cancer. The multicenter trial is expected to begin enrolling patients once the protocol regulatory review is completed. The trial has a two-stage design with up to 49 patients to assess overall response rate to the combination of bavituximab and chemotherapy. Secondary objectives include measuring time to tumor progression, duration of response, overall patient survival and safety parameters.

• Portola Pharmaceuticals Inc., of South San Francisco, reported positive Phase II data on its lead compound, PRT054021, an oral Factor Xa inhibitor, showing that the drug was safe, effective and well tolerated for the prevention of venous thromboembolic events in patients undergoing total knee replacement surgery. The proof-of-concept study was designed to evaluate two doses of PRT054021 vs. enoxaparin event rates in recent comparable studies. Results showed that the incidence of VTE was 20 percent, 15 percent and 10 percent in the low-dose group of PRT054021, the high-dose group of PRT-54021 and the enoxaparin group, respectively. Data were reported at the Congress of the International Society on Thrombosis and Haemostasis in Geneva. Portola expects to move PRT054021 into Phase III development in VTE prevention in the first half of 2008.

• Progen Pharmaceuticals Ltd., of Brisbane, Australia, announced the design of its upcoming Phase III trial of PI-88 in liver cancer. The trial will begin recruiting a total of 800 patients with hepatocellular carcinoma later this year in North America, Europe and Asia. The study's primary endpoint will be disease-free survival. At the completion of that trial, Progen expects to have a package to register PI-88 in more than a dozen countries and to expand the drug in additional indications.

• Starpharma Holdings Ltd., of Melbourne, Australia, has begun a U.S. trial to assess the safety and acceptability of SPL7013 Gel (VivaGel)) in sexually active young women. The Microbicide Trials Network is leading the study, funded by the National Institutes of Health. VivaGel is being developed as a vaginal microbicide for the prevention of HIV and genital herpes. The study is being conducted at the University of South Florida and the University of Puerto Rico. The study will enroll 40 sexually active, HIV-negative women ages 18 to 24. Participants will be randomly assigned to one of two study groups. One group will apply VivaGel twice a day for two weeks and the other will apply a placebo gel.

• Talecris Biotherapeutics Inc., of Research Triangle Park, N.C., presented data on the human plasma-derived thrombolytic Plasmin (TAL-05-00018) at the International Society for Thrombosis and Haemostasis congress. Phase I data showed the dose-related thrombolytic effect of Plasmin without an increase in dose-related adverse events, while a preclinical trial demonstrated reperfusion in a stroke model. The company also said its Phase I/II revascularization trial has enrolled three patients, and it continues work on a recombinant version of Plasmin, TAL-6003, designed to optimize fibrin binding and fibrinolytic potency.

• Tracon Pharmaceuticals Inc., of San Diego, has started treatment of the first cancer patient in a Phase I trial with TRC093, a first-in-class humanized monoclonal antibody that inhibits angiogenesis and tumor cell growth by binding cleaved collagen. The compound is being developed in oncology and age-related macular degeneration under a license agreement with Micromet Inc., of Bethesda, Md. The Phase 1 trial is designed to assess the safety, tolerability and pharmacokinetics, as well as preliminary antitumor activity, of TRC093 in patients with advanced cancer.

• Vical Inc., of San Diego, has begun enrollment of the 20th hematopoietic stem cell transplant recipient in the company's Phase II trial of a DNA vaccine against cytomegalovirus. After the recipient's two-month follow-up visit, an independent data safety monitoring board will conduct an interim evaluation of safety data for all subjects enrolled in the trial. The double-blind, placebo-controlled Phase II trial is designed to compare safety of the vaccine against placebo in approximately 80 matched, related donor/recipient pairs scheduled for hematopoietic stem cell transplants.

• YM BioSciences Inc., of Mississauga, Ontario, reported positive secondary endpoint data from its 99-patient, randomized, placebo-controlled, multicenter Phase IIb trial with AeroLEF, an inhaled-delivery composition of free and liposome-encapsulated Fentanyl. For the first dose administered, 59 percent of patients reported a pain intensity score of less than or equal to 1 (mild pain or no pain) at the end of the dosing period compared to 27 percent with placebo. The percentage of patients reporting a pain relief score of more than or equal to 2 (moderate, lots or complete relief) at the end of the dosing period with AeroLEF was 60 percent, compared to 32 percent with placebo. YM previously announced that this trial had successfully achieved its primary endpoint, the summed pain intensity.

• Ziopharm Oncology Inc., of New York, reported positive interim data from an ongoing Phase II study of ZIO-201 (isophosphoramide mustard) in advanced sarcoma patients. The trial, which has enrolled 39 patients, showed data from the first 10 evaluable patients. Of those, one has a partial response (21 weeks and ongoing) and four have stable disease. ZIO-201 was shown to be well tolerated at the Phase II dose, with no significant bone marrow suppression, alopecia (hair loss) or neurotoxicity. Based on that data, reported at the European Society of Medical Oncology in Lugano, Switzerland, enrollment has been expanded to include additional patients.