- Conducts OvaRex(R) Mini-Symposium at ASCO Site -
WALTHAM, Mass., May 14 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC)
will conduct an OvaRex(R) mini-symposium this evening for participants of the
Meeting of the American Society of Clinical Oncology (ASCO) regarding
OvaRex(R) clinical trial progress. Presenting in San Francisco are OvaRex(R)
investigators Jonathan Berek, M.D., Ph.D. of the UCLA School of Medicine,
Thomas Ehlen, M.D. of the Vancouver Cancer Center and Volker Mobus, M.D., of
the Stadts Klinik, Frankfurt a.M., Germany, in addition to the Company's
physicians.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
Dr. Berek will highlight lead clinical trial interim results as presented
at ASCO on Saturday, May 12, 2001 while Drs. Ehlen and Mobus will comment on
their findings regarding completed phase II trials. The Company will
summarize all OvaRex(R) clinical and immunology data to date, particularly
demonstration of T cell responses generated by OvaRex(R) MAb to patients' own
tumor tissue.
The Company will also highlight preliminary findings from its recently
completed phase II randomized double-blind placebo-controlled trial involving
55 (27 active, 28 placebo) patients with subclinical disease recurrence
(elevated CA 125 but with no evidence of tumor) following successful primary
therapy of surgery and chemotherapy. This trial is in the very early stages
of analysis. It was a particularly challenging trial to enroll, as the
patients knew they were months from relapse and were therefore reluctant to
risk receiving placebo. The trial was closed to enrollment at half of its
intended size and therefore, it is underpowered for traditional statistical
analysis. The analysis plan calls for an initial focus on the role of the
tumor associated antigen CA 125 and on the ability of OvaRex(R) to induce
specific immune responses in patients. Patients in the trial will continue to
be followed (one year later) for survival and quality of life.
The initial findings indicate that measurements of CA 125 at baseline are
strongly predictive of patient time to disease relapse, a finding also
observed in the interim analysis of the lead 345-patient phase IIb trial. In
addition, immune response rates are consistent with previously reported
studies and, importantly, OvaRex(R) MAb immune responders:
-- Evidence a 3-fold improvement on time to relapse (TTR) if HAMA is > =
5000 ng/mL;
-- Evidence a 2-fold improvement in TTR if Ab2 is > = 100 ng/mL, and
-- There is a statistically significant difference (p < 0.05) for immune
responders versus non-responders for both of these pre-defined efficacy
outcomes.
"These preliminary findings of baseline CA 125 as a predictor of time to
relapse, along with the clinical benefit of being an OvaRex(R) immune
responder, are particularly exciting in light of the interim results of our
lead trial," commented Richard E. Bagley, President and CEO of AltaRex. "This
55-patient trial will play a strong supporting role to the lead 345-patient
trial, and is one of five complementary trials to be submitted to the U.S. and
Canadian regulatory authorities, along with final manufacturing comparability
data."
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 under accelerated provisions, 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 T and B cell
immune responses in preclinical study.
Additional information about AltaRex research and development, 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 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, such as the results referred to above, 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.
 back to top
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 Corp.,
781-672-0138 ext. 1510, shenrichon@altarex.com; or Wayne Hendry,
Investor Relations of The Equicom Group, Inc, 416-815-0700 ext.
238, whendry@equicomgroup.com
|
