Biomira initiates Phase 1 trial of PX-478 in patients with advanced metastatic cancers

    EDMONTON, Aug. 28 /CNW/ - Biomira Inc. (Nasdaq: BIOM) (TSX: BRA) today
announced that the first patient has been enrolled in a Phase 1 clinical trial
of PX-478 in patients with advanced metastatic cancer. PX-478 is a novel small
molecule compound designed to inhibit the activity of hypoxia inducible factor
(HIF)-1 alpha, a transcription factor that controls the expression of a number
of genes important for growth and survival of cancer cells. Genes regulated by
HIF-1 alpha contribute to diverse functions such as new blood vessel growth
(angiogenesis), use of glucose for energy, and protection against apoptosis
(programmed cell death).
    "HIF-1 alpha plays a critical role in the response of cancer cells to low
oxygen levels, stimulating processes that increase oxygen concentrations and
allow tumors to grow and thrive," said Dr. Lynn Kirkpatrick, Ph.D., Chief
Scientific Officer of Biomira. "In our preclinical studies, PX-478 produced
significant tumor regression and growth delay in a wide variety of models of
human cancers, including lung, breast, prostate, colon, kidney, pancreas, and
ovarian cancers. We believe this is the first small molecule agent to enter
clinical trials that directly lowers levels of HIF-1 alpha protein in tumors."
    The Phase 1 trial is expected to enroll up to 36 patients with advanced
solid tumors or lymphoma who have failed or are intolerant of standard
therapy. PX-478 will be administered orally on days 1 through 5 of a 21-day
cycle. Primary objectives of the study include establishment of a maximum
tolerated dose, evaluation of safety, and analyses of pharmacodynamic and
pharmacokinetic profiles of PX-478. Other objectives are to evaluate the
effects of PX-478 on tumor blood flow and vascular permeability as measured by
DCE-MRI, and to evaluate the anti-tumor activity of PX-478 in patients with
advanced malignancies.
    "We are very excited about the potential for PX-478 as an anti-cancer
compound with broad potential application," said Dr. Robert L. Kirkman, MD,
President and Chief Executive Officer of Biomira. "We are also pleased with
the progress of our pipeline, as demonstrated by the initiation of this trial
on schedule. This is our second small molecule compound to enter clinical
development, and we expect to file an investigational new drug (IND)
application for PX-866, a third small molecule, by the end of 2007. Together
with PX-12, currently in Phase 2 development, the advancement of these
compounds reflects our significant progress in creating value from our
acquisition of ProlX Pharmaceuticals less than one year ago."

    About PX-478

    PX-478 is a potent inhibitor of HIF-1 alpha, a protein target whose
levels are elevated in a wide range of tumors. The protein is a key factor in
the response of a cancer cell to hypoxia (lack of oxygen), including the
angiogenic cascade that allows tumors to establish new blood vessels essential
to their survival and growth. Inhibition of angiogenesis is a validated
approach to treating cancer.
    In preclinical studies, PX-478 demonstrated marked antitumor activity
when delivered orally, showing tumor regression and long growth delay, both of
which correlated to the HIF-1 alpha levels of the tumor models. The wide
variety of models that showed sensitivity to PX-478 presents a large potential
market for this product candidate. The ability to combine PX-478 with
radiation therapy may further expand the opportunities for this novel
compound. The PX-478 preclinical development work was partially supported by a
grant from the U.S National Institutes of Health Small Business Innovation
Research program.

    About Biomira

    Biomira is a biotechnology company specializing in the development of
innovative therapeutic products for the treatment of cancer. Biomira's goal is
to develop and commercialize novel synthetic vaccines and targeted small
molecules that have the potential to improve the lives and outcomes of cancer

    Forward Looking Statements

    This press release contains forward-looking statements, including,
without limitation, statements related to the pre-clinical and clinical
development of PX-478, PX-12 and PX-866; the therapeutic and commercial
potential of PX-478, PX-12 and PX-866; the filing of an investigational new
drug application for PX-866 and the timing thereof; and future clinical
development plans. Any statements contained in this press release that are not
statements of historical fact may be deemed to be forward-looking statements.
Words such as "believes", "anticipates", "plans", "expects", "will",
"intends", "potential", "possible" and similar expressions are intended to
identify forward-looking statements. These forward-looking statements are
based upon Biomira's current expectations. Forward-looking statements involve
risks and uncertainties. Various factors could cause actual results to differ
materially from those projected in forward-looking statements, including those
predicting the clinical development of PX-478, PX-12 and PX-866; the
therapeutic and commercial potential of PX-478, PX-12 and PX-866; the filing
of an investigational new drug application for PX-866 and the timing thereof;
and future clinical development plans. There can be no guarantee that the
results of earlier trials will be predictive of either safety or efficacy in
future trials. Biomira expressly disclaims any obligation or undertaking to
release publicly any updates or revisions to any forward-looking statements
contained herein to reflect any change in the Company's expectations with
regard thereto or any change in events, conditions or circumstances on which
any such statements are based.

For further information:

For further information: Investor and Media Relations Contact: Julie
Rathbun, Rathbun Communications, (206) 769-9219,

Organization Profile


More on this organization

Custom Packages

Browse our custom packages or build your own to meet your unique communications needs.

Start today.

CNW Membership

Fill out a CNW membership form or contact us at 1 (877) 269-7890

Learn about CNW services

Request more information about CNW products and services or call us at 1 (877) 269-7890