The randomized, double-blind, placebo-controlled, multicenter Phase II trial, which is designed to include about 126 subjects, is expected to begin enrolling patients before the end of the year and is part of the company's December 2009 collaboration with Pfizer Inc., of New York, to develop MultiStem for the treatment of inflammatory bowel disease
Pfizer Inc., of New York, reported data showing that 57 percent of ALK-positive advanced non-small-cell lung cancer patients treated with crizotinib (PF-02341066), an investigational oral anaplastic lymphoma kinase (ALK) inhibitor, had either a complete or partial response to treatment
Cytheris SA, of Paris, initiated a Phase II HIV trial combining immunomodulatory agent CYT107 with the integrase inhibitor Isentress (raltegravir, Merck & Co. Inc.) and the CCR5 inhibitor Selzentry (maraviroc, Pfizer Inc
The research was carried out as a collaboration among scientists at Pfizer Inc., of New York, Proteostasis Therapeutics Inc., of Cambridge, Mass., the University of Dundee, Duke University and Metabolon
Argos Therapeutics Inc., of Durham, N.C., reported interim Phase II data showing that AGS-003 plus Sutent (sunitinib, Pfizer Inc.) resulted in median progression-free survival of 14.9 months for intermediate risk and six months for poor risk renal cell carcinoma patients
Palatin intends to meet with the FDA to discuss trial designs for further testing, including a proposed Phase II trial of subcutaneous bremelanotide as a monotherapy and in combination with a PDE5 inhibitor such as Viagra (sildenafil, Pfizer Inc.) in men with erectile dysfunction who are not responsive or are inadequately responsive to PDE5 inhibitor therapies alone
Patients will be treated with varespladib or placebo once daily in combination with Lipitor (atorvastatin, Pfizer Inc.) As per a special protocol assessment, the primary endpoint will be a reduction in major adverse coronary events defined by recent FDA draft guidance to include cardiovascular death, nonfatal myocardial infarction, nonfatal stroke or documented unstable angina with objective evidence of ischemia requiring hospitalization
Of those, three have had stable disease for six months or longer, including a renal-cell carcinoma patient previously resistant to mTOR inhibitor Torisel (temsirolimus, Pfizer Inc.) Data were presented at Cambridge Healthtech Institute's Next-Gen Kinase Inhibitors Oncology & Beyond conference in Cambridge, Mass
and Pfizer Inc., both of New York, said they agreed to stop the Phase III AVERROES trial of anticoagulant apixaban in patients with atrial fibrillation because a predefined interim analysis revealed clear evidence of a clinically important reduction in stroke and systemic embolism compared to aspirin in AF patients considered intolerant of or unsuitable for vitamin K antagonist therapy
Pfizer Inc., of New York, said results from a Phase III study demonstrated that Macugen (pegaptanib sodium) significantly improved vision in patients with diabetic macular edema, a complication of diabetes that is a leading cause of blindness in people of working age
Pfizer Inc., of New York, reported final results from a Phase III trial of Sutent (sunitinib malate) in patients with advanced pancreatic neuroendocrine tumors, showing that the drug more than doubled progression-free survival compared to placebo
Inhibitex Inc., of Atlanta, said partner Pfizer Inc., of New York, initiated recruitment for a 408-patient Phase I trial of a three-antigen Staphylococcus aureus vaccine (SA3Ag) in healthy adults...Trubion Pharmaceuticals Inc., of Seattle, said partner Pfizer Inc., of New York, initiated a Phase II trial of SBI-087 (PF-05230895), a next-generation, humanized small
PEG-SN38, or EZN-2208, is a pegylated form of SN38, the active metabolite of Camptosar (irinotecan HCl injection, Pfizer Inc.) It also is being studied in a Phase II trial in metastatic colorectal cancer
Pfizer Inc., of New York, said it discontinued a Phase III trial of figitumumab (CP-751,871, as a first-line treatment in patients with advanced non-adenocarcinoma non-small-cell lung cancer after an independent data safety monitoring committee showed that the addition of the drug to paclitaxel plus carboplatin would be unlikely to meet the primary endpoint of improving overall survival compared to paclitaxel plus carboplatin alone
It was statistically noninferior to Zyvox (linezolid, Pfizer Inc.) for all clinical test-of-cure and short-term follow-up endpoints