- Worldwide Ovarian Cancer Summit Conference -
WALTHAM, Mass., March 21 /PRNewswire/ -- AltaRex Corp.
(TSE: AXO, OTC: ALXFF), announced today, as part of a worldwide ovarian cancer
summit conference, that it has identified what it believes is a breakthrough
in understanding the correlation between circulating levels of ovarian tumor
marker CA 125 and OvaRex(R) efficacy in the Company's lead trial interim
analysis. The previously announced interim analysis of a 252 patient data set
indicated more than a doubling in time to relapse (TTR) for OvaRex(R) immune
responders versus non-responders. The new data from further interim review of
the lead trial indicate that, in high-risk patients (CA 125 >= 20 units/mL),
the proportion of patients with disease-free survival of at least
6 months is significantly higher (p=0.0397) in patients treated with OvaRex(R)
MAb (79%) compared to patients receiving placebo (39%). These new findings
are important for the overall analysis of the full 345 patients in the trial,
an analysis that will be conducted at the time of study unblinding in the
third quarter of this year.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The Company is also disclosing initial clinical laboratory findings from a
collaboration with Theresa Whiteside, Ph.D., of the University of Pittsburgh
that demonstrate an OvaRex(R) T cell specific response directed to the
patient's own extracted tumor tissue. This is a rare demonstration, the
Company believes, of drug activated T cells that are functional to promote
tumor killing.
Additionally, the Company will highlight that its reported findings point
to an overall benefit induced by OvaRex(R) MAb in ovarian cancer patients who
express CA 125, regardless of their stage of disease. The Company is
conducting three controlled trials to address directly the impact of
CA 125 levels, immune response and other parameters (covariates) on both
disease-free progression and survival. The Company already has clinical
results from a completed phase II trial (Vancouver) and from retrospective
clinical data (Germany) which demonstrate the relationship between CA 125 and
immune response and their correlation with survival benefit. An additional
ongoing phase II study in Dallas, exploring combined modality therapy
(OvaRex(R) administration prior to and during second line chemotherapy), has
also generated early data consistent with the Vancouver study.
Helene Harris Memorial Trust Conference
Robert Bast, MD, Vice President Translational Research at the M.D.
Anderson Cancer Center and co-discoverer of the ovarian cancer marker CA 125,
has assembled, at the Helene Harris Memorial Trust Conference in Houston,
leading scientific and medical experts to discuss the treatment of ovarian
cancer, including the role of CA 125. Jonathan Berek, MD, Ph.D., Professor &
Vice Chair, Chief of Staff at the UCLA Medical Center and the lead OvaRex(R)
trial principal investigator, is one of two keynote speakers and is presenting
today the OvaRex(R) clinical data in a broader session entitled "Immunological
Therapeutics". The second keynote speaker of that session is Dr. Jeffrey
Schlom, Chief of the Laboratory of Tumor Immunology and Biology at the
National Cancer Institute and a member of the Company's Scientific Advisory
Board.
Dr. Berek's Presentation of OvaRex(R) Clinical Data
With respect to Dr. Berek's presentation at this conference, AltaRex's
lead trial is one of the largest double-blind, placebo-controlled trials ever
conducted in ovarian cancer. The Company's review of the interim data
demonstrate a highly significant (p< 0.001) difference in time to relapse
(TTR) between high-risk (CA 125 >= 15 units/mL) and low-risk patients (CA 125
< 15 units/mL) treated with placebo. Importantly, the difference in TTR
between high-risk and low-risk patients treated with OvaRex(R) is not
significantly different, indicating a positive treatment effect. Most
importantly, in high-risk patients with a CA 125 >= 20 units/mL, the
proportion with disease-free survival of at least 6 months is significantly
higher (p=0.0397) in patients treated with OvaRex(R) MAb (79%) compared to
placebo (39%). These findings support the Company's planned covariate
analysis to evaluate efficacy of OvaRex(R) treatment in the full 345 patients
(low- and high-risk) who express the target antigen CA 125, to which OvaRex(R)
MAb is specific. The final statistical analysis plan, allowing for the kind of
interim analyses reported by the Company, was accepted by the U.S. Food and
Drug Administration (FDA) prior to the conduct of the interim review.
A similar prospective statistical analysis plan to evaluate OvaRex(R)
clinical efficacy in patients with elevated CA 125 levels was also included in
the design of the Company's second double-blind placebo-controlled trial, with
Dr. Michael Bookman of the Fox Chase Cancer Center as principal investigator.
The second study is fully enrolled and will be unblinded for the endpoint of
TTR in the second quarter of this year. This trial is designed to further
confirm the difference in TTR among patients deemed to be at high-risk for
recurrence, as reported today.
Further, the Company's randomized, open-label, 102 patient trial, with Dr.
Berek as principal investigator, will further determine the relationships
between CA 125, immune response and efficacy. This trial should also provide
by year-end important insight into the impact of dosing schedule on laboratory
and clinical outcomes.
Dr. Berek's Presentation of OvaRex(R) Laboratory Data
Dr. Berek will also review the new clinical laboratory findings, conducted
in collaboration with Dr. Whiteside, demonstrating a specific OvaRex(R) T cell
response that is directed to the patient's own (autologous) extracted tumor
tissue. Clinical materials used in these laboratory studies were obtained
from a clinical trial conducted by Dr. Alan Gordon and collaborators with U.S.
Oncology, Inc. The Company believes that this is a rare but valuable
demonstration of T cells that are activated by OvaRex(R) in the clinical
treatment setting and function to promote tumor killing. Results showing T
cell activation from OvaRex(R) administration in this U.S. study support
outcomes from a recently reported trial conducted by Dr. Thomas Ehlen at the
British Columbia Cancer Centre, which demonstrated activation of T cells
during OvaRex(R) administration correlating with prolonged progression-free
and overall survival in some patients.
Company Conclusions
"As important and remarkable as these findings are, it is important to
note that the placebo-controlled trials are still blinded to the Company and
are not fully completed," noted Richard Bagley, President and CEO of AltaRex.
"This interim review, conducted by an independent biostatistician, provides
insight into how to analyze final trial results. The Company has reported
mature survival and safety data from one prospective trial in recurrent
/refractory disease as well as favorable efficacy and safety data from long-
term follow-up of two retrospective analyses in recurrent disease.
Preliminary data reported from the second ongoing prospective trial in
recurrent disease are very promising. Important B cell and particularly T
cell activation data have been obtained in all of our trial analyses."
Additional information about AltaRex (TSE: AXO, OTC: ALXFF) research and
development, news and events can be found on its web site at http://www.altarex.com.
Clinical information can also 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. and at http://www.ovariancanada.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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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
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