Attention Business Editors:
Biomira Reports Enrolment Progress in Theratope(R) Vaccine Trial at Annual General Meeting
Company Makes Strides in All Major Cancer Programs
TORONTO, May 26 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSE, ME: BRA)
announced today its progress in the enrolment of patients with metastatic
breast cancer in its pivotal Phase III clinical trial with THERATOPE(R) cancer
vaccine. At its Annual Shareholder's Meeting today at 4 p.m., Toronto
Marriott Centre, the Company also discussed significant accomplishments of the
last year.
In the multinational THERATOPE(R) vaccine trial, Biomira is right on
target in ramping-up the study, having enrolled 101 patients to date. This
pivotal trial will involve 900 evaluable patients at approximately 75 sites
worldwide. The trial is the largest immunotherapy trial of its kind ever
conducted in metastatic breast cancer patients, providing the greatest
opportunity for obtaining statistically significant data which will be
critical in the approval and marketing of the product when the trial is
complete.
''We have gained a significant amount of momentum in enrolling this major
trial on schedule,'' said Alex McPherson, M.D., Ph.D., President and CEO. ''It
must be considered an accomplishment that we are off to a strong start. I
believe clinicians and patients are enthusiastic about THERATOPE(R) vaccine
and its potential to extend survival for patients.''
In other THERATOPE(R) vaccine-related news, investigators from the Fred
Hutchinson Cancer Research Center presented data from a retrospective
comparison study earlier this month at the American Society of Clinical
Oncology's (ASCO) 35th Annual Meeting. Analysis of the data suggest the chance
of death was more than two times greater among patients in a control group
receiving high-dose chemotherapy and autologous stem-cell transplant compared
to patients vaccinated with THERATOPE(R) vaccine after undergoing the same
procedure. The chance of relapse was approximately 1.7 times greater for
patients in the control group compared to those vaccinated.
''These data from Fred Hutchinson Cancer Center, combined with the
findings of our own Phase II trials, represent additional evidence that
THERATOPE(R) vaccine has the potential to be an effective treatment for breast
cancer,'' stated Dr. McPherson. ''This is a positive indication of the type of
results we may see emerge from our Phase III trial.''
In addition, published in the ASCO Proceedings were data from the
THERATOPE(R) vaccine Bridging Study, performed before the initiation of the
Phase III trial, to test the safety and immunogenicity of a new formulation of
the vaccine. A final analysis of the Bridging Study was completed by Biomira.
Blood samples from breast cancer patients treated in the Bridging Study were
compared with blood samples from breast cancer patients treated in the Phase
II trials in a blinded immunological test. The mean and median antibody
titres against the STn-bearing mucin OSM were higher in the patients treated
with the new formulation. The highest anti-OSM titres were found in patients
in the Bridging Study, 35% having IgG titres greater than or equal to the
highest titre achieved by only a single patient in the Phase II studies. This
is statistically significant (p equals 0.03).
In total, THERATOPE(R) vaccine has been tested in over 350 patients in
Phase I and Phase II clinical trials in the US, Canada and the United Kingdom.
It was well tolerated by study participants. In 1996 the Company reported the
results of Phase II breast cancer trials. In one study arm, THERATOPE(R)
vaccine-treated patients had a median survival rate of 26.5 months as compared
with 9.2 months for matched patients in a retrospective control group.
In 1998 Biomira also made significant headway with its second product
candidate, BLP25 for non-small cell lung cancer. In December 1998, the Company
announced it had fully enrolled a Phase I clinical trial with BLP25, a
protein-based synthetic vaccine that showed promise in preclinical
development. On schedule, Biomira completed a preliminary analysis of this
data, confirming BLP25 is both safe and triggers a cytotoxic T-lymphocyte
immune response against cancer cells. An outside panel of oncology experts
brought in to review the data concurred with the Company's preliminary
analysis of the Phase I data.
Together, THERATOPE(R) vaccine and BLP25 target the most common and
widespread human cancers, suggesting significant marketing potential.
On yet another front, Biomira signed an agreement with Biovector
Therapeutics of Toulouse, France, in September 1998 to co-develop the
Company's idiotypic vaccine against B-cell lymphoma. This novel treatment
involves the development of patient-specific vaccines. Plans call for the
start of human assurance that the Company's expectations are correct. All forward-looking
statements are expressly qualified in their entirety by this Cautionary
Statement.
-0- 05/26/1999
For further information: Company Investor Relations Contact: Jane Tulloch, (780) 490-2812; Media Contact: Brad Miles, (212) 477-9007, ext. 17; Investor Contact: Jonathan Fassberg, (212) 477-9007, ext. 16 |
