SAN FRANCISCO, May 12 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC) of
Waltham, MA is presenting promising interim results today from its lead
345-patient OvaRex(R) double-blind placebo- controlled clinical trial for
ovarian cancer, a trial at the foundation of the Company's OvaRex(R) MAb
registration plans. The results (abstract #837) of this cornerstone trial are
being presented at the 37th Annual Meeting of the American Society of Clinical
Oncology (ASCO) in San Francisco by co-principal investigator for the study,
Dr. Jonathan Berek, M.D., Ph.D., Professor & Vice Chair at the UCLA Medical
Center.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
Highlighted in the ASCO presentation is the Company's recent discovery of
what it believes is a breakthrough in understanding the correlation between
circulating levels of the ovarian tumor marker CA 125 and OvaRex(R) MAb
efficacy. Specifically:
* At initiation of the trial, the CA 125 levels of participants were in an
assumed normal range for the patient population. One of the most
important observations reported is that patients on the high end of this
range are at significant increased risk of disease relapse. It is this
high risk population where OvaRex(R) MAb is proving to be most
beneficial.
* The proportion of high risk patients in the 252-patient dataset with
disease free survival of 6 months is significantly higher (p=0.0397) in
patients treated with OvaRex(R) MAb (79%) compared to patients receiving
placebo (39%).
In addition to CA 125 levels, Dr. Berek's presentation will feature the
positive impact on relapse free survival of other factors discovered in
OvaRex(R) clinical trial analyses and immunology studies. These factors
include B cell, cytolytic T cell (CTL) and T helper cell immune responses. In
this interim lead trial analysis, 50% of patients developed a specific immune
response to OvaRex(R) MAb that directly correlates with clinical benefit.
In addition to the lead trial interim analysis, the Company has analyzed
final data from two Phase II OvaRex(R) trials. These results demonstrate
that, in late-stage ovarian cancer patients with recurrent disease, treatment
with OvaRex(R) MAb can provide comparable efficacy to "salvage"
chemotherapies, but without the associated toxicities.
The Company's analysis of the primary endpoint of time to disease relapse
for all 345 patients in the lead trial is scheduled to begin in the third
quarter of this year. Clinical data from this trial, along with five other
complementary and supporting trials, will form the basis for a simultaneous
filing for product approval with both the U.S. and Canadian regulatory
authorities. This filing is anticipated to begin by year end, assuming the
timely scale-up of cell culture manufacturing and the completion of the
necessary pharmacokinetic trial to establish product comparability.
About ASCO
The Annual Meeting of the American Society of Clinical Oncology is
considered the premiere event in clinical oncology worldwide. The Meeting
draws substantial attendance from outside the U.S., which adds to the
Meeting's prestige as well as to the forum in which research and treatment
advances are presented. Clinical trials research presented at ASCO's Annual
Meeting embodies the most significant progress made each year in the war on
cancer and provides oncology professionals with the best information available
on the most recent advances in cancer research, prevention, and treatment.
About AltaRex
AltaRex Corp. is focused on the research, development and
commercialization of antigen-targeted antibody-based cancer therapies,
utilizing monoclonal antibodies as immunotherapeutic agents for the treatment
of certain late-stage cancers. OvaRex(R) MAb targets the tumor associated
antigen CA 125 and is in the final stages of clinical evaluation for ovarian
cancer with commercialization expected in the United States, assuming timely
regulatory approval, in 2002. Clinical data reported to date evidence a
prolongation in time to relapse and/or survival in the treatment of ovarian
cancer, without the toxicities seen with chemotherapy. BrevaRex(R) MAb
targets the tumor associated antigen MUC1 and has successfully completed a
Phase I safety and immunology study. The Company plans to initiate a Phase
I/II clinical study of BrevaRex(R) MAb for the treatment of multiple myeloma
this year. ProstaRex(TM) MAb targets the tumor associated antigen PSA and has
successfully demonstrated robust immune responses in preclinical study.
More about AltaRex research and development, 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. Clinical trial
information can be found at http://www.centerwatch.com . 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 . Additional information
about multiple myeloma can be found at 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, completion of clinical trials,
patient enrollment rates, uncertainty of pre-clinical, retrospective and early
clinical trial results, which may not be indicative of results that will be
obtained in ongoing or future clinical trials, the establishment of
manufacturing processes and new corporate alliances, the timely development,
regulatory approval 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 201-369-3467
Company News On-Call:
http://www.prnewswire.com/comp/128163.html or fax,
800-758-5804, ext. 128163
CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex, 781-672-0138,
ext. 5110, or shenrichon@altarex.com; or Wayne Hendry, Investor
Relations of The Equicom Group, Inc, for AltaRex, 416-815-0700,
ext. 238, or whendry@equicomgroup.com
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