-- Outlines Next Steps Toward Announcing Results --
WALTHAM, Mass., Sept. 4 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC)
announced today that the Company has reached a major milestone in its
OvaRex(R) clinical development program -- the completion for primary analysis
of the Company's designated pivotal 345-patient OvaRex(R) trial. Primary
results from the trial will form the foundation of the Company's Biologics
License Application (BLA) with the U.S. Food and Drug Administration (FDA) for
marketing approval of OvaRex(R) MAb. Submission of the BLA is expected by the
Company to begin by year end or early in 2002, assuming the timely scale-up of
cell culture manufacturing to establish product comparability.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
With the patient treatment now complete for this lead trial, an Endpoint
Monitoring Board (EMB) will independently assess time to disease relapse
surrogate endpoints on individual patients' case record forms (CRFs) over the
course of the next two to three months. Once the EMB has completed its
assessment, the database will be locked for statistical analysis and the trial
will be unblinded to reveal OvaRex(R) MAb versus placebo patient data.
Statistical analyses will then be conducted and trial results announced prior
to initiating the OvaRex(R) BLA.
"The completion of this pivotal OvaRex(R) trial nearly four years after
trial launch is itself a victory for the Company all involved parties. We've
gained important information about the role of CA125 -- the antigen targeted
by OvaRex(R) MAb -- and about the safety profile of OvaRex(R) and its ability
to induce clinically beneficial immune responses in certain ovarian cancer
patients," noted Richard Bagley, President and CEO of AltaRex. "We now look
forward to the opportunity to engage the FDA in discussion regarding our
findings from this 345-patient trial and smaller supporting trials, and to our
ensuing BLA for OvaRex(R)."
The 345-patient Phase II/IIB OvaRex(R) trial was conducted at 51 sites in
the U.S. and Canada and enrolled patients in an advanced stage of ovarian
cancer referred to as "watchful waiting", following first-line treatment of
surgery and chemotherapy. Currently, there are no therapeutic options for
patients at this stage of disease. Primary endpoints of the trial are time to
disease relapse and safety, comparing patients receiving OvaRex(R) MAb versus
placebo. Patients will continue to be followed for survival. Interim results
from the trial are positive, as most recently reported in the Company's press
release issued May 12, 2001.
AltaRex expects that clinical data from this lead trial, along with five
complementary and supporting trials, will form the basis for a "rolling" BLA
submission for OvaRex(R) MAb. Due to the Fast Track designation granted
OvaRex(R) MAb by the FDA, the Company is able to seek approval for the product
based on Phase II/IIb trial results with surrogate endpoints for survival,
rather than typically required Phase III trial results.
More about AltaRex research and development of antigen-targeted anti-
cancer antibodies, clinical trials, news and events can be found on its web
site at http://www.altarex.com. AltaRex Corp. is traded on the Toronto Stock
Exchange under the symbol AXO, and over-the-counter in the United States under
the symbol ALXFF. Additional information about ovarian cancer can be found at
http://www.nci.nih.gov, http://www.ovarian.org., http://www.ovariancancer.org and at
http://www.ovariancanada.org. Information about multiple myeloma can be found at the
http://www.multiplemyeloma.org.
This news release contains forward-looking statements that involve risks
and uncertainties, which may cause actual results to differ materially from
the statements made. For this purpose, any statements that are contained
herein that are not statements of historical fact may be deemed to be forward-
looking statements. Without limiting the foregoing, the words "believes,"
"anticipates," "plans," "intends," "expects" and similar expressions are
intended to identify forward-looking statements. Such risks and uncertainties
include, but are not limited to our need for capital and the risk that the
Company can not raise funds on a timely basis on satisfactory terms or at all,
changing market conditions, uncertainties regarding the timely and successful
completion of clinical trials, patient enrollment rates, uncertainty of pre-
clinical, retrospective, early and interim clinical trial results, which may
not be indicative of results that will be obtained in ongoing or future
clinical trials, whether the Company will file for regulatory approval on a
timely basis, uncertainties as to when, if at all, the FDA will approve the
Company's regulatory filings for its products, the need to establish and
scale-up manufacturing processes, the need to obtain and maintain corporate
alliances, uncertainty as to the timely development and market acceptance of
the Company's products, uncertainty as to whether patents will issue from
pending patent applications and, if issued, as to whether such patents will be
sufficiently broad to protect the Company's technology, and other risks
detailed from time-to-time in the Company's filings with the United States
Securities and Exchange Commission and Canadian securities authorities.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE
INFORMATION CONTAINED HEREIN
SOURCE AltaRex Corp.
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Related links:
http://www.altarex.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
http://www.prnewswire.com/gh/cnoc/comp/128163.html
CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex Corp.,
+1-781-672-0138 ext. 1510, shenrichon@altarex.com; or Wayne
Hendry, Investor Relations of The Equicom Group Inc,
+1-416-815-0700 ext. 238, whendry@equicomgroup.com
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