WALTHAM, Mass., July 27 /PRNewswire/ -- AltaRex Corp.
(TSE: AXO, OTC: ALXFF) today reported further results from its 55-patient
OvaRex(R) trial for ovarian cancer patients with biochemical relapse following
primary surgery and chemotherapy. The primary analysis for this phase II,
multicenter, double-blind placebo-controlled trial was designed to compare
time to disease relapse in patients who demonstrate an immune response to
OvaRex(R) MAb versus patients who do not. Importantly, results from the trial
provide, for the first time, validated Quality of Life data associated with
the administration of OvaRex(R) MAb as compared with placebo.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The trial, with Dr. Michael Bookman of the Fox Chase Cancer Center as
principal investigator, enrolled 55 asymptomatic ovarian cancer patients who
had a rising blood level of the CA125 antigen (biochemical relapse) but who
had no clinical evidence (measurable tumor) of disease progression on physical
examination or CT scan. This is currently a poorly served population because
the cancer can quickly progress and the role of additional cytotoxic
chemotherapy has not been established. Low patient enrollment made this phase
II trial underpowered for a definitive comparison between OvaRex(R) and
placebo on time to relapse. However, the placebo-controlled results provide
important confirmatory data regarding the safety and efficacy of OvaRex(R) MAb
and will comprise one of three primary supportive trials to the Company's lead
345 patient double-blind, placebo-controlled designated pivotal trial.
Results from the trial are:
Patients who generated a robust immune response to OvaRex(R) (55% of
patients) did significantly better with respect to their time to disease
relapse than those who did not (17 weeks vs. 7.5 weeks; p=0.0129).
Treatment with OvaRex(R) MAb was associated with an improvement in overall
time to relapse, although the difference did not reach statistical
significance (relative risk 0.81, 95% CI 0.42-1.53, p=0.51).
The adverse event profile for OvaRex(R) was benign and similar to placebo,
which the Company believes reflects the ease of administration and
tolerability of the therapy.
The study employed the FACT-O Quality of Life (QOL) instrument for
measuring the impact of both OvaRex(R) and placebo on five measures of
patients' overall well being. Importantly, quality of life to study exit was
well maintained with both placebo and OvaRex(R) MAb. For both the Functional
Well Being and Social/Family Well Being measures, there was a statistically
significant difference in favor of OvaRex(R) over placebo (p=0.049; p=0.008).
"I'm encouraged by the results from this trial, particularly with respect
to the now explored quality of life issues in a placebo-controlled setting,"
said Michael Bookman, MD, Fox Chase Cancer Center, and Principal Investigator.
"Any agent that has a positive impact on ovarian cancer patients with rising
CA125 levels and impending disease relapse, that is accompanied by a benign
safety profile and where no other agent is approved, is highly encouraging. I
look forward to the primary analysis of the designated pivotal study with its
much larger patient numbers."
More about AltaRex research and development of antigen-targeted anti-
cancer antibodies, 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. 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.
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 and early 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:
http://www.prnewswire.com/gh/cnoc/comp/128163.html
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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