SM,
Here's some news off the Pr wire to start the weekend off right.
THERATOPE(R) VACCINE DATA PUBLISHED AT AMERICAN SOCIETY OF CLINICAL
ONCOLOGY
Annual Meeting
Company Releases Final Bridging Trial Data
ATLANTA, May 15 /PRNewswire/ -- Biomira Inc. (Nasdaq: BIOM) (TSE, ME:
BRA) announced today results of the THERATOPE(R) vaccine Bridging Study
published in the 1999 American Society of Clinical Oncology (ASCO)
Annual Proceedings under Official Abstract 1761. Charles Vogel, MD,
FACP, of the Columbia Cancer Research Network, and colleagues reported
that in an interim analysis, the improved formulation of THERATOPE(R)
vaccine for metastatic breast cancer resulted in an enhanced immune
response against the target cancer antigen. Biomira also released today
final analysis of the Bridging Study.
Following several Phase II studies with THERATOPE(R) vaccine, Biomira's
researchers demonstrated that the strength of immune response to the
vaccine appears to be correlated with improved survival. On the heels
of these studies, the Company entered into a Bridging Study with an
enhanced formulation of its lead product candidate. Biomira entered
into a pivotal Phase III trial in late 1998 to enroll over 900 patients
at approximately 75 sites worldwide after initial results of the
Bridging Study suggested that the new formulation was as safe as the
earlier version of the drug.
Biomira has since completed analysis of data from the Bridging Study,
and today announced that the final data confirm the enhanced product is
more potent than the original formulation of THERATOPE(R) vaccine used
in the Phase II studies. 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=0.03).
"In the Phase II studies improved survival was seen for those patients
who achieved higher titres against OSM. This prompted the question:
can we improve THERATOPE(R) vaccine to induce higher titres in a
greater number of patients? The final bridging study data confirms that
the new formulation induces higher titres in a greater percentage of
patients. This validates our decision to use the improved formulation
in the Phase III study now underway," commented Dr. Grant MacLean,
Vice-President Clinical and Regulatory Affairs.
Also at ASCO, an investigator from the Fred Hutchinson Cancer Research
Center is presenting data suggesting that THERATOPE(R) vaccine
increases survival in ovarian and breast cancer patients following
high-dose chemotherapy and autologous stem cell rescue.
ASCO's 1999 Annual Meeting is currently ongoing at the Georgia World
Congress Center and is featuring over 150 scientific and educational
presentations, as well as an exhibition with over 250 industry
representatives. It is the largest professional meeting on clinical
data about new cancer therapies. |
