WALTHAM, Mass., Oct. 11 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC)
will announce today, as part of both the UBS Warburg and BioContact
biotechnology conferences, favorable early results from a concurrent
OvaRex(R)/second-line chemotherapy clinical trial in relapsed ovarian cancer
where prognosis is extraordinarily poor, and where salvage chemotherapy alone
provides limited clinical benefit. For patients at this stage of disease,
salvage chemotherapy typically has a response rate of only 15-25% with a
survival benefit of approximately one year. Dr. Alan Gordon of US Oncology in
Houston, Texas is the lead investigator of the 20 patient, fully enrolled
phase II open-label OvaRex(R) (oregovomab) study.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
A primary objective of the OvaRex(R) trial is to induce a robust tumor-
specific immune response, including chemotherapy-insensitive memory T and B
cells, in the 12 weeks prior to beginning second-line chemotherapy. Patients
had the option to continue on OvaRex(R) while also receiving chemotherapy. It
has been postulated in the oncology community that administration of
immunotherapy with chemotherapy can be problematic because chemotherapy could
actually suppress the immune response. In this trial, both robust humoral
(71% of patients evaluated) and cellular (63% of patients evaluated) immune
responses, including T helper cells and "killer" T cells (CTLs) that target
both the tumor associated antigen CA 125 and the patient's own tumor, were
induced following administration of OvaRex(R) MAb. Further, immune responses
were maintained, not compromised, in those patients receiving chemotherapy,
suggesting the possible additive benefit of OvaRex(R) treatment combined with
salvage chemotherapy. Fifteen of the 20 patients are still alive with median
estimated survival not yet calculable. The newly reported data suggest that
by augmenting the clinical response with OvaRex(R) MAb via activation of the
immune system, chemotherapy may become more effective without further
impacting quality of life.
Interestingly, as published this week in Nature Immunology online (9
October 2001, DOI: 10.1038/ni722), Dr. M.L. Albert and colleagues (Rockefeller
University) observed in vitro (laboratory) that the induction of T helper
cells is critical for the priming of "killer" T cells to the target tumor.
Concordant with Dr. Albert's observations, AltaRex in vitro data have shown
that OvaRex(R)-CA125 immune complexes presented by dendritic cells can
activate both T helper and CTLs. In light of the Nature Immunology
publication and the Company's laboratory observations, the clinical results
reported today that demonstrate the induction of T helper, CTLs and B cell
immune responses are intriguing. The Company believes this trial is the first
clinical demonstration in ovarian cancer of such T cell induction (T helper
and CTLs) to a patient's own tumor.
Appropriate to these findings in recurrent ovarian cancer, the Company has
entered into formal discussions with a major pharmaceutical company to conduct
a trial in which the possible benefit of a concurrent OvaRex(R)/first-line
chemotherapy treatment in stage III/IV ovarian cancer is explored, e.g.
following initial diagnosis and surgery. The objective of such a trial would
be to further extend the period of remission attained by using chemotherapy
alone by "priming" the immune system while it is conceivably at its strongest.
This trial would be initiated using new cell culture material in 2002
following the filing of the Company's OvaRex(R) Biologics License Application
(BLA) in the United States.
Richard E. Bagley, President and CEO of AltaRex will highlight the results
in his 11:20 a.m. presentation at the UBS Warburg Global Life Sciences
Conference in New York. The data are also included in today's 9:30 a.m.
presentation at BioContact Quebec in Quebec City.
The investing public is invited to participate in the UBS Warburg
presentation at 11:20 a.m. on Thursday, October 11, through a listen-only
conference call, by dialing 800-500-0177 (domestic) or 719-457-2679
(international). Replays will be available for up to four weeks following the
conference and can be accessed by dialing 888-566-0785 (domestic) or 402-220-
0102 (international).
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 has completed and reported results from several
controlled and open OvaRex(R) clinical trials and has initiated a primary
analysis of its pivotal 345-patient study. 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. 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
PRN Photo Desk, 888-776-6555 or 212-782-2840
Company News On-Call:
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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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