details of prima's presentation at asco

Thanks Boiler for the link to the ASCO sire with details of the sessions.Maybe it isn't an individual presentation but it still all good publicity for the company and as was mentioned the focus will be on immunotherapies this year so prima will be in the spotlight!


Here is the abstract of PRR's phase 2b being presented at the ASCO conference on Monday with details of the 4 hour session allocated for this;

"A randomized, open-label phase IIb study of maintenence therapy with a MUC-1 dendritic cell vaccine in patients with epithelial ovarian cancer in first or second remission."

Time: Monday June 7, 8:00 AM to 12:00 PM
Location: S Hall A2
Sub-category: Vaccines
Category: Developmental Therapeutics - Clinical Pharmacology and Immunotherapy
Meeting: 2010 ASCO Annual Meeting

Citation: J Clin Oncol 28:7s, 2010 (suppl; abstr TPS171)

Abstract:
Background: MUC-1 is a highly immunogenic antigen that is widely expressed in epithelial ovarian carcinoma (EOC) making it an ideal target for vaccine therapy. Prior phase I and II studies conducted in Australia of the MUC-1 dendritic cell vaccine (CVac) in heavily pretreated, advanced disease patients showed minimal toxicities and prolonged disease stabilization. The purpose of this trial is to determine the safety and efficacy of a MUC-1 dendritic cell vaccine (CVac) in ovarian cancer patients who are in clinical remission after first or second-line therapy.

Methods: Women with stage III or IV ovarian, fallopian tube, or primary peritoneal carcinoma who have had a complete response (CR) based on clinical and radiologic studies after first or second-line chemotherapy will be eligible for this study. Planned sample size is 60 patients. The first 6 patients will be treated with CVac open-label to ensure consistency of manufacturing.

The next 54 patients will be randomized 1:1 to CVac or standard of care (observation). Patients receiving vaccine will undergo leukopheresis followed by in vitro loading of dendritic cells with MUC-1. They will receive a total of 10 intradermal vaccine administrations over 52 weeks (every 4 weeks x 7, then every 8 weeks x 3).

Clinical assessments will be every 4 weeks and radiologic assessments will be every 12 weeks.

Primary endpoints are the safety of CVac in this population and effect on progression-free survival (PFS).

Secondary endpoints are effect on overall survival (OS) and immunologic parameters, including MUC-1 antibodies and intracelluar cytokine assays.



Author(s): H. J. Gray, A. A. Secord, M. L. Anderson, G. DelPriore, N. E. Tchabo, J. S. Berek; University of Washington/Fred Hutchinson Cancer Research Center, Seattle, WA; Duke University Medical Center, Durham, NC; Baylor College of Medicine, Houston, TX; New York Downtown Hospital, New York, NY; Atlantic Health Carol G. Simon Cancer Center, Morristown, NJ; Stanford Cancer Center, Stanford, CA