Enrollment completed for BLP25 liposomal vaccine.

2002 DEC 27 - (NewsRx.com & NewsRx.net) -- Biomira, Inc., (BIOM, BRA) announced that the company has completed enrollment of the planned 166 patients in its phase IIb clinical trial with BLP25 Liposomal vaccine.

There are now 168 patients enrolled into the trial. The controlled, randomized study involves patients with advanced non-small cell lung cancer (NSCLC) and enrollment was conducted at 13 sites in Canada and four in the United Kingdom. The trial began in August 2000. Final recruitment in the trial has been extended to allow a few previously identified patients the opportunity to be included in the trial. Enrollment for these identified patients is expected to close later this month.

Since the enrollment of patients in the trial began, two Data Safety Monitoring Board (DSMB) reviews have taken place, of the first 50 patients and the first 100 patients who had passed the primary treatment period. The DSMB, comprising experts in oncology who are not affiliated with the trial, recommended that the study continue as planned.

"This is another milestone for our company as we advance our product candidates toward potential commercialization," said Alex McPherson, MD, PhD, president, and CEO. "We believe this accomplishment continues to position Biomira as a leader in bringing forth novel immunotherapeutic approaches to the treatment of cancer through the development of cancer vaccines."

All patients in this trial were required to be stable or responding following completion of their first line standard chemotherapy for treatment of Stage IIIb and IV NSCLC. Patients were then randomized to BLP25 Liposomal vaccine, plus best supportive care or to best supportive care alone. Best supportive care can include local radiotherapy and second line chemotherapy, according to current standard clinical practice.

Objectives of this trial are to measure the safety and potential survival benefit of BLP25 Liposomal vaccine in patients with NSCLC. Secondary endpoints of the trial are quality of life and immune response. All cumulative efficacy data remain fully blinded to until the final analysis. The analysis is event driven and the timing is dependent on when clinical events occur. The required event level is expected by mid-2003 with the final analysis commencing thereafter.

BLP25 Liposomal vaccine is a synthetic MUC1 peptide vaccine. The BLP25 Liposomal vaccine incorporates a 25-amino acid sequence of the MUC1 ...