WALTHAM, Mass., Oct. 24 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC)
announced that OvaRex(R) MAb, the Company's lead product in late stage
development for the treatment of advanced ovarian cancer, has been selected
for discussion today during a special session on gynecologic cancer therapy at
the 11th annual European Cancer Conference (ECCO 11) in Lisbon, Portugal. The
presentation marks the first opportunity for the Company to present to the
collective European oncology community its findings on the relevance of
circulating levels of the tumor associated antigen CA125 both as an indicator
of impending progression of ovarian cancer and as a target for OvaRex(R) MAb.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The selection of OvaRex(R) MAb for the special session at ECCO II
recognizes an extensive body of clinical data demonstrating that OvaRex(R) MAb
can induce robust immune responses not only during "quiet" periods of the
disease ("watchful waiting") -- where there are no approved treatment options
and where the OvaRex(R) program has primarily focused -- but also when
administered in conjunction with salvage chemotherapy.
The poster and accompanying discussion will be presented by Christopher
Nicodemus, M.D., Senior Vice President of Clinical Research and Development at
AltaRex. The presentation examines the connection between circulating levels
of the ovarian cancer antigen CA125, clinical course of disease and the
therapeutic activity of the OvaRex(R) treatment. An interim analysis of
252 patients from the Company's lead designated pivotal 345-patient study in
"watchful waiting" ovarian cancer demonstrated that, when an immune response
is stimulated (51% of treated patients), there is a significant impact on time
to disease progression (median 18 months vs. 7.9 months; p<0.001 logrank
test). This correlation between immune response and clinical efficacy was
further confirmed in the final analysis of a second well-controlled trial of
55 patients in "biochemical relapse" (rising CA125, no measurable tumor) where
52% of OvaRex(R)-treated patients generated an immune response and experienced
a significant increase in their time to progression (median 3.4 months vs.
1.6 months; p=0.0129 logrank test). The collective data from the Company's
six ongoing or completed clinical trials point to immune responses (as
measured by HAMA and Ab2) as surrogates for sustained T cell immunity (T
helper and cytotoxic T lymphocytes or CTLs) and for a clinically meaningful
impact on time to disease progression and, potentially, prolonged survival.
Dr. Nicodemus will also discuss early clinical data from a concurrent
OvaRex(R)/second-line chemotherapy study conducted in the United States that
demonstrate successful activation of the immune system (induction of
functional T cells that react to CA125 and the patient's own tumor) when
OvaRex(R) MAb was administered after surgery and then concurrent with
chemotherapy.
Early findings from this study demonstrate that OvaRex(R) MAb did not
diminish the effect of salvage chemotherapy and vice versa, and that patients
were still able to mount robust immune responses even in recurrent disease.
Robust HAMA and/or Ab2 responses were measured in 71% of evaluable patients,
while T helper and cytolytic T cell responses were measured in 63% of
evaluable patients.
"The results from the OvaRex(R)/second-line chemotherapy trial are
particularly exciting since they support safety and activity of the drug to
enhance immunity even when integrated with the standard treatments of surgery
and chemotherapy. The data from this trial and other completed trials
present new opportunities for clinical development and potential broader
applications of OvaRex(R) MAb with standard surgery and chemotherapy
treatments, now commonly used around the world for management of this
disease," commented Dr. Nicodemus.
ECCO is recognized as a primary multidisciplinary forum for the discussion
of oncology, providing a platform for interaction and exchange between
experimental and clinical oncologists and cancer nurses. The scientific
program is focused on the exchange of experience and knowledge in oncology
research, treatment and care.
AltaRex Corp. is focused on the research, development and
commercialization of foreign antibodies as immunotherapeutics for the
treatment of late-stage cancer. The Company's lead product OvaRex(R) MAb
targets the tumor associated antigen CA125 and is being studied in advanced
ovarian cancer. The Company expects to initiate its first Biologics License
Application (BLA) for regulatory approval of OvaRex(R) MAb by the U.S. Food
and Drug Administration (FDA) early in 2002, assuming timely scale-up of cell
culture manufacturing. There are no approved treatment options for patients
in the remission period ("watchful waiting") of ovarian cancer, prior to
disease recurrence. While salvage chemotherapy is approved for recurrent
disease, toxicities associated with use of these agents warrant the
investigation of new more benign treatments, including those capable of
"priming" the immune system prior to the initiation of chemotherapy, and those
capable of maintaining immune responses even in the presence of chemotherapy.
The compilation of OvaRex(R) data from six clinical studies in over
500 ovarian cancer patients in both watchful waiting and recurrent disease is
expected to form the basis of the OvaRex(R) BLA, for which AltaRex will seek
priority review and full and/or accelerated approval.
More about AltaRex research and development of antigen-targeted
anti-cancer antibodies, clinical trials, news and events can be found on the
website http://www.altarex.com .
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
Company News On-Call:
http://www.prnewswire.com/comp/128163.html
CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex Corp.,
+1-781-672-0138, ext. 1510, or shenrichon@altarex.com; or Wayne
Hendry of Equicom Group Inc., +1-416-815-0700, ext. 238, or
whendry@equicomgroup.com
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