Redundant but for archival purposes. Nice summary for an exciting 2003.
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Biomira awaits phase III Theratope vaccine results
2002-12-12 06:12 PT - News Release
Dr. Alex McPherson reports
BIOMIRA HIGHLIGHTS MILESTONES FOR 2003 PHASE III THERATOPE VA ...
Biomira has released its milestones and plans for moving forward in 2003. Milestones include the final analysis of the phase III trial of Theratope vaccine in women with metastatic breast cancer. The final analysis is expected toward the end of the first half of 2003. Biomira is also expected to have data on both the Theratope vaccine phase II colorectal study and the BLP25 Liposomal vaccine trial in prostate cancer toward mid-2003. Finally, data from the BLP25 Liposomal vaccine phase IIb study in non-small-cell lung cancer (NSCLC) are expected in the third quarter of 2003.
"When you look at our programs, we are a company with a long history in examining the immunological and clinical analysis of MUC1 and associated carbohydrate epitopes as target antigens in solid cancer tumours. I believe Biomira has several value drivers in place for 2003. These include growth potential, our two lead product candidates in late-stage development, and a strong and established corporate alliance with Merck KGaA of Darmstadt, Germany. We feel these are essential ingredients necessary to grow the company and it is our intention to do our utmost to build shareholder value in the coming year," said Dr. Alex McPherson, MD, PhD, president and chief executive officer.
Biomira affected a cost-reduction program in 2002, which allows the company to focus on its two lead product candidates, while further savings were seen with the reduction in costs related to the Theratope vaccine phase III trial. By the first quarter of 2003, the company is targeting to extend its cash reserves to the end of 2004.
Theratope vaccine
In March, 2001, Biomira completed enrolment of the controlled, randomized and double-blinded phase III Theratope vaccine trial, enrolling 1,030 women in 10 countries in more than 120 clinical sites. The trial was stringently designed with respect to powering and appropriate safeguards. Comprehensive phase I and II safety data from over 400 patients were also critical in the development of the design.
As reported in Stockwatch Sept. 19, 2002, Biomira reported that the independent Data Safety Monitoring Board (DSMB) conducted the fifth planned review of all the available safety and efficacy data, and stated it had "no safety concerns at all and recommend that the trial continue to final analysis." The DSMB also said it had "no safety concerns with continuing the present programs or initiating new trials under the current development plan." This, in the company's opinion, seemed to underscore the potential effectiveness of the product. The phase III trial was originally designed with the strongest opportunity to show a survival advantage at the final analysis, with stricter hurdles set for the interim analysis.
The timing of the final survival analysis is event driven and is expected to commence toward the end of the first half of 2003. The p-value set for the interim survival analysis was 0.0145, while the p-value for survival at the final analysis will be at a level of 0.0357. Biomira and Merck KGaA remain blinded to the data from the interim analysis, and have no indication how close the data came to meeting the stringent predetermined statistical analysis hurdles at this earlier interim review.
A phase II trial using Theratope vaccine in women with metastatic breast cancer who are being treated with aromatase inhibitors, a type of hormonal therapy, or Faslodex (fulvestrant), an estrogen-receptor antagonist, is currently enrolling patients in the United States. The trial is expected to enroll 95 women and enrolment should continue throughout 2003. The study's primary objective is to determine the response of the immune system in these metastatic breast cancer patients. A secondary objective is to determine the safety and tolerability of Theratope vaccine when used in conjunction with aromatase inhibitors or fulvestrant. This trial is not designed to formally evaluate efficacy.
The phase II pilot study of Theratope vaccine in patients with metastatic colorectal cancer completed enrolment this fall, and data expected in the first half of 2003 should demonstrate the safety of the vaccine and the antibody response of patients treated with Theratope vaccine when given in combination with first line chemotherapy.
BLP25 Liposomal vaccine
Biomira's second lead product candidate is BLP25 Liposomal vaccine. BLP25 Liposomal vaccine incorporates a synthetic 25-amino-acid sequence of the MUC1 cancer mucin, incorporated into a synthetic liposomal delivery system that also includes potent immune enhancers. The liposome is intended to enhance recognition of the cancer antigen by the immune system and facilitates better delivery. BLP25 Liposomal vaccine is a therapeutic vaccine designed to induce an immune response in cancer cells expressing MUC1.
A randomized, controlled phase IIb study of BLP25 Liposomal vaccine completed enrolment of 171 patients with NSCLC earlier this month at sites in both Canada and the United Kingdom. Since the enrolment of patients in the trial began, two DSMB reviews have taken place, of the first 50 patients and the first 100 patients who had passed the primary treatment period. The DSMB, consisting of experts in oncology who are not affiliated with the trial, recommended that the study continue as planned.
Objectives of the phase IIb trial are to measure the safety and potential survival benefit of BLP25 Liposomal vaccine in patients with NSCLC. Secondary end points of the trial are quality of life and immune response. All cumulative efficacy data remain fully blinded 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, likely in the third quarter of 2003.
A pilot study involving BLP25 Liposomal vaccine in 16 patients with prostate cancer was also fully enrolled in 2002. The study is designed to test active specific immunotherapy with BLP25 vaccine as a treatment for patients with rising prostate-specific antigen (PSA) postradical prostatectomy. The primary end point of the trial is to reduce or stabilize PSA values in these patients. PSA is believed to be a useful tumour 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 end points. Data are expected in the first half of 2003.
Future direction
With sufficient cash to sustain the company's two lead product candidates through 2003 and with clinical data expected in all areas currently under clinical testing, Biomira believes the essential ingredients are in place to take advantage of a strong market opportunity.
Merck KGaA
Biomira is collaborating with Merck KGaA of Darmstadt, Germany, on the development of Theratope vaccine and BLP25 Liposomal vaccine. Founded in 1668, Merck KGaA has positioned itself to be on the cutting edge of cancer research with an oncology portfolio based on four technology platforms -- monoclonal antibodies, vaccines, immunocytokines and angiogenesis inhibitors.
WARNING: The company relies upon litigation protection for "forward-looking" statements. |
