--Phase II Trial Shows a Doubling in Progression Free Survival in a
Well-Defined Population--
EDMONTON, Alberta, June 2 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSX: AXO, OTC: ALXFF) ("AltaRex" or the "Company") announced
today that Jonathan Berek, MD, Chief of the Division of Gynecologic Oncology
UCLA's Jonsson Cancer Center in Los Angeles, presented results of a phase II
trial of OvaRex(R) (oregovamab) at the 39th annual meeting of the American
Society of Clinical Oncologists (ASCO) in Chicago. The results of this
placebo-controlled trial in stage III/IV ovarian cancer patients identified a
population that exhibited a strongly favorable outcome. In this group of
patients, median time to disease relapse for OvaRex(R) treated patients (n=34)
was 24 months, versus 10.8 months for placebo (n=33) treated patients
(p=0.06).
(Logo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The study was a randomized Phase II multi-center trial assessing the
ability of OvaRex(R) to influence time to progression for advanced ovarian
cancer patients with no evidence of disease and normalized CA125 following
front-line surgery and chemotherapy. Currently there is no approved therapy
for patients in this treatment period. The study population was typical of
this cancer population, and the treatment arms were well balanced. One
hundred forty-five (145) patients were randomized into the study. The
clinical outcome favored OvaRex(R) treatment, 13.3 versus 10.3 months in
placebo treatment (p=ns), for the primary outcome of time to relapse, as
measured by the investigator or independent endpoint monitoring committee.
Further analysis of the data revealed a well-defined population that
demonstrated a dramatic clinical benefit as compared to placebo. This group
is characterized by patients with optimal surgical cyto-reduction, a favorable
CA125 response to chemotherapy, and no evidence of disease following
chemotherapy. Patients with less favorable outcome and response to surgery
and chemotherapy did not appear to benefit from the treatment following front-
line chemotherapy. The side effect profile for OvaRex(R) treatment was
similar to placebo, unlike most cancer therapeutics, which can have
significant toxicity.
"These results, if confirmed in the currently enrolling phase III trials,
will address a significant unmet medical need with the promise of an important
new therapeutic approach for women with advanced ovarian cancer," said Dr.
Jonathan Berek, the Principal Investigator of the study.
Unither Pharmaceuticals, a wholly-owned subsidiary of United Therapeutics
Corporation and our strategic partner and licensee for OvaRex(R), recently
announced the initiation of two identical pivotal Phase III clinical trials,
called IMPACT I and II, being conducted at centers throughout the United
States. OvaRex(R) MAb is an investigational immunotherapeutic monoclonal
antibody being developed for the treatment of stage III/IV advanced ovarian
cancer following successful completion of front-line therapy. A list of
participating sites in the IMPACT I and II trials may be obtained by accessing
http://www.clinicaltrials.gov and entering the keyword: OvaRex.
Ovarian cancer, the deadliest of women's reproductive cancers, is the
fifth leading cause of cancer deaths among U.S. women, occurring in 1 out of
57 women. The American Cancer Society estimates that this year, in the United
States, there will be 25,400 new cases of ovarian cancer diagnosed, and 14,300
American women will die from this disease. Overall, the five-year survival
rate for stage III/IV disease is estimated to be 31%. Although most patients
initially respond to surgery and chemotherapy completely, the relapse rate is
estimated to be approximately 85%. Once relapse occurs, there is no known
curative therapy.
In April 2002, United Therapeutics signed an exclusive license with
AltaRex Corp. for OvaRex(R) and four other monoclonal antibody immunotherapies
(antibodies that activate a patient's immune response to treat cancer) that
were being developed for treatment of ovarian, prostate, lung, breast,
multiple myeloma and other forms of cancer. "This strategic partnership with
United Therapeutics represents an important milestone for AltaRex in bringing
its lead Product OvaRex(R) to the marketplace,"said Dr. Noujaim, President and
CEO of the Company.
AltaRex Corp. is focused on the research, development and
commercialization of foreign antibodies that modulate the immune system for
the treatment of certain cancers and other diseases where there exists an
unmet medical need. Additional information about AltaRex Corp. can be found on
its website at 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 the Company's need for capital; the risk that
the Company can not raise funds on a timely basis on satisfactory terms or at
all; the need to obtain and maintain corporate alliances, such as the alliance
with United Therapeutics Corporation, and the risk that the Company cannot
establish corporate alliances on a timely basis, on satisfactory terms, or at
all; changing market conditions; uncertainties regarding the timely and
successful completion of clinical trials and 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 and/or its
collaborators will file for regulatory approval on a timely basis;
uncertainties as to when, if at all, the FDA and other similar regulatory
agencies will accept or approve regulatory filings for the Company's products;
the need to establish and scale-up manufacturing processes, uncertainty as to
the timely development and market acceptance of the Company's products; the
risk that the claims allowed under any issued patent owned or licensed by the
Company will not be sufficiently broad to protect the Company's technology,
that any patents issued to the Company will not be sustained if challenged in
court proceedings or otherwise or that third parties will be able to develop
products or processes that do not infringe valid patents owned or licensed by
the Company, 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 Company does not assume any obligation to update
any forward-looking statement.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE
INFORMATION CONTAINED HEREIN
Contact:
Rob Salmon
Chief Financial Officer
(780) 989-6708
rsalmon@altarex.com
SOURCE AltaRex Corp.
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http://www.altarex.com
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CONTACT:
Rob Salmon, Chief Financial Officer for
AltaRex Corp., +1-780-989-6708, rsalmon@altarex.com
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