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Biomira Initiates Phase II Pilot Study Of BLP25 Vaccine.
2001 NOV 14 - (NewsRx.com & NewsRx.net) -- Biomira Inc. (BIOM, BRA) has initiated of a Phase II clinical trial evaluating BLP25 vaccine in patients with prostate cancer.
The study is designed to test active specific immunotherapy with BLP25 vaccine as a treatment for patients who have recurrent disease following radical prostatectomy for prostate cancer. The primary endpoint of the trial is to reduce or stabilize prostate-specific antigen (PSA) values in patients with rising PSA post-radical prostatectomy. PSA is believed to be a useful tumor marker that is associated with the presence of prostate cancer, and is used to monitor a patient's recurrence or progression. Immune response and safety will be measured as secondary endpoints.
The trial is expected to enroll approximately 20 patients. Patients will have undergone radical prostatectomy for treatment of prostate cancer at least six months prior to study entry. Under the lead investigator, Dr. Scott North, from the Alberta Cancer Board, Cross Cancer Institute in Edmonton, patients will receive a low dose of cyclophosphamide and then 1000 micrograms of BLP25 vaccine once a week for eight weeks. Patients may receive maintenance treatments every six weeks thereafter until completion of the trial. Patients will be evaluated for serum PSA status over a one-year period.
"This trial has been designed ...
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