Biomira Reports Progress at Biotechnology Industry Organization Conference
NEW YORK, Feb. 16 /CNW-PRN/ - Biomira Inc. (NASDAQ: BIOM) (TSE: BRA) today
presented at the Biotechnology Industry Organizations' second annual CEO &
Investor Conference, highlighting the Company's clinical and financing
developments.
``We now have three major cancer vaccine product candidates plus an immune
enhancer, Liposomal IL-2, in the clinic and up to U.S. $100 million in
financing potentially available to push our products through to
commercialization,' commented President and CEO Alex McPherson, MD, PhD, who
spoke at the conference today. ``Biomira is addressing the largest cancer
markets with innovative product candidates. THERATOPE(R) vaccine for
metastatic breast cancer is now in a pivotal Phase III trial, and BLP25 for
lung cancer is in Phase II testing. Our patient-specific vaccine for lymphoma,
co-developed with Biovector Therapeutics of Toulouse, France and the National
Cancer Institute (NCI), entered NCI-sponsored Phase I trials in the first half
of last year. We have a talented scientific staff and a strategically minded
and dedicated management team that should be credited with our progress and
success.'
At the conference, the Company reviewed its recently announced equity line
financing and the increase in the maximum dollar amount of such financing from
U.S. $36 million to a maximum of U.S. $100 million. The term of the equity
line has also been increased from 30 months to 42 months. No additional
shares of Biomira stock were needed to be reserved for issue, due to the
increase in valuation and liquidity of the Company's common stock. As Biomira
continues negotiations with potential partners, the equity line gives the
Company the ultimate flexibility of taking only the cash needed to develop its
product portfolio.
Dr. McPherson also announced that the Company expects to complete
enrolment of its Phase III THERATOPE(R) vaccine trial in the second half of
2000. The THERATOPE(R) vaccine Phase III trial will confirm whether the
vaccine, Biomira's lead product candidate, is effective in increasing patient
survival as suggested by data from several Phase II trials. This trial is
intended to include 900 evaluable patients with metastatic breast cancer.
Enrolment has been increasing steadily in recent months, with more than 370
patients currently participating.
The multinational study officially began enrolling patients in late 1998
with most of the approximately 75 original sites in the U.S., the U.K.,
France, Germany, Belgium, Spain and Canada accruing patients in 1999. Biomira
is in the process of adding approximately 30 new clinical sites to the trial,
including sites in Australia, New Zealand and Ireland, plus additional sites
in the U.S. and Europe. It is anticipated that there will shortly be more
than 100 sites worldwide enrolling patients.
In the original 75 active sites, the trial accrued an average of 41 new
patients per month over the last two months as the ramp-up continued. The
current recruitment pace is expected to increase with the addition of the new
study locations. In addition, in order to make the trial accessible to as
many women as possible, the Company made amendments to its clinical trial
protocol, allowing patients on hormonal therapy to participate and extending
the window of opportunity during which patients may enroll. As well, the
Company is attempting to ensure that patients on emerging first line
chemotherapy treatments can be incorporated into the trial.
The Company is also aggressively pursuing public relations efforts and
working with advocacy groups to make patients and their physicians aware of
the opportunity to be involved in a clinical trial with this investigational
product candidate. Investigators and patients have responded favorably to our
efforts, and the Company feels confident that the trial accrual rate will
increase even further with these new initiatives.
During today's presentation, Dr. McPherson also described plans Biomira is
aggressively pursuing for additional clinical trials with BLP25 vaccine. A
Phase I study with BLP25 vaccine provided safety, immunological and survival
data on 17 highly selected stage IIIb and stage IV non-small cell lung cancer
patients randomized to be treated with either 20 mg or 200 mg doses of the
vaccine. Preliminary immunology data demonstrated the induction of a
cytotoxic T-lymphocyte (CTL) response capable of killing tumor cells in five
out of the 12 evaluable non-small cell lung cancer patients from both arms of
the study. BLP25 vaccine was found to be well tolerated and relatively
non-toxic.
The median survival time of patients treated with the 20 mg dose regimen
was 5.4 months from the time of entry to the study. The Kaplan-Meier
projection of the median survival of the 200 mg dose regimen group is 14.7
months from the time of entry to the study, with three of the eight patients
(37.5%) still alive.
Biomira is now conducting a series of Phase II trials to optimize the
immune response against the BLP25 vaccine. The first stage of the Phase II
trial was a study utilizing a dosage of 1000 mg of BLP25, which has been shown
to induce a very strong CTL immune response in six out of eight patients to
date. To the Company's knowledge, this type of T-cell mediated cellular
immune response has never been previously achieved in human carcinoma
patients, nor was this level observed in the 20 mg or 200 mg patients in Phase
I. Patients are being followed to determine if this increased T-cell response
is reflected in an increased survival benefit. This type of immune response
is strongly associated with tumour rejection in many pre-clinical animal
models. Biomira is expecting to have survival data in the final quarter of
2000.
The Company is currently enrolling non-small cell lung cancer patients in
a second stage of the Phase II trial to determine whether the vaccine's
immunogenicity can be further enhanced when combined with Liposomal
Interleukin-2.
In a third research and development initiative, Biomira Inc. and its
co-developer, Biovector Therapeutics of Toulouse France, are conducting an
NCI-sponsored Phase I trial with an idiotypic vaccine for B-cell lymphoma.
This novel treatment uses vaccines that incorporate each patient's cancer
antigen into a Liposomal Interleukin-2 formulation, and is specific for each
individual patient. The vaccine is intended to trigger an immune attack
directed specifically to the lymphoma cells. Early clinical data indicate
that the autologous lymphoma vaccine is well tolerated and induces a potent
anti-lymphoma immune response.
The Biotechnology Industry Organization is a Washington, D.C.-based
organization that engages in lobbying, advocacy, communications and new
business development related to the biotech industry. Established in 1993,
today it includes more than 850 member companies. The goal of the CEO and
Investor Conference is to provide a unique and neutral forum where CEOs from
small, medium and large cap public companies and private firms planning to go
public can interact with investors and other members of the financial
community and the healthcare industry.
Biomira is a biotechnology company specializing in the development of
innovative therapeutic approaches to cancer management. The commitment to the
treatment of cancer currently focuses on the development of synthetic vaccines
and novel strategies for cancer.
This release may contain forward-looking statements. Various factors
could cause actual results to differ materially from those projected in
forward-looking statements, including those predicting the timing of clinical
trials, the efficacy of products or the availability of capital. Although the
Company believes that the forward-looking statements contained herein are
reasonable, it can give no assurance that the Company's expectations are
correct. All forward-looking statements are expressly qualified in their
entirety by this cautionary statement.
SOURCE Biomira Inc.
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