--Data from Completed, Prospective Study Presented at SGO Annual Meeting--
NASHVILLE, Tenn., March 6 /PRNewswire/ -- The results of a Phase II
OvaRex(R) study by AltaRex Corp., demonstrating that nearly half of the
OvaRex(R) MAb treated patients with advanced recurrent ovarian cancer survived
50 weeks or longer, were presented today at the 32nd Annual Meeting of the
Society of Gynecologic Oncologists. The poster session was presented by
Thomas G. Ehlen, M.D., FRCSC, lead investigator of the clinical trial at the
Vancouver Cancer Center in British Columbia. Patients participating in this
study were experiencing ovarian cancer which had relapsed after treatment
failure of multiple standard therapies.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
Thirteen patients with advanced recurrent ovarian cancer received
intravenous 2 mg infusions of OvaRex(R) MAb on an outpatient basis (five doses
over a 12-week period and then every three months until disease progression).
Six of 13 OvaRex(R) treated patients survived 50 weeks or longer from entry
into the trial. Over half of the patients enrolled in the study demonstrated
substantive immune responses following OvaRex(R) treatment. Among these
immune responders, one patient survived more than 18 months and two were still
alive, at last contact, at 20 and 24 months respectively. In addition,
OvaRex(R) MAb was well tolerated and treatment was easily managed in the
outpatient setting.
"For women with advanced ovarian cancer who have relapsed disease after
treatment with standard chemotherapeutic agents, the response benefit from
available drug treatment is commonly less than one year and is often
associated with significant toxicities," said Dr. Ehlen. "We need new
treatments that do not have the same side effects as currently used
chemotherapies, and so the clinical results from this and other completed or
ongoing trials with OvaRex(R) MAb are very encouraging."
"OvaRex(R) MAb is an antigen specific product rather than tumor specific,"
continued Dr. Ehlen. "It targets the antigen CA 125, which is produced by
most ovarian tumors but not recognized by the patient's immune system as a
threat since it is self-produced. OvaRex(R) binds to the circulating CA 125
and because of its foreign nature, it fools the body's own immune system,
including the T cells, into attacking the CA 125 and, in turn, the associated
ovarian tumor. Among the patients followed in our study, it was notable that
two patients with potent activation of immune T cells after the OvaRex(R)
treatment, were the same two patients who continue to survive years after
starting the protocol therapy."
"We believe that the frequent development of immune responses observed in
this study, correlated with evidence of prolonged stabilization of disease and
survival in some patients, provides further proof of principle for this
innovative approach to cancer treatment," commented Howard Fingert, M.D., Vice
President of Clinical Operations and Medical Director of AltaRex, "We are
pleased with the outcomes of this completed study, one of several prospective,
well-controlled trials sponsored by AltaRex in North America to evaluate the
safety and efficacy of OvaRex(R) MAb to support our upcoming U.S. regulatory
filing for ovarian cancer indications."
Ovarian Cancer--The Disease That Whispers
Ovarian cancer is the most serious form of gynecologic cancer, killing 40
women in the United States each day. Known as the "Disease that Whispers," an
estimated 75% of women with the disease are not diagnosed until it is in an
advanced stage (Stage III or IV) and has spread beyond the ovaries.
Currently, first-line treatment for ovarian cancer consists of surgery
followed by chemotherapy, which usually results in temporary remission.
Unfortunately, most patients will have a recurrence of the disease within 12
months.
There are no approved therapies for this "watchful waiting" period between
remission and recurrence of the cancer. Although there are some approved
products for patients who have had a recurrence of ovarian cancer, these
chemotherapies often are associated with possible serious side effects.
More than 23,000 new cases of ovarian cancer are estimated to be diagnosed
each year and more than 14,000 women will die from the disease in the United
States in 2001. Regular screenings, self-examinations and knowing family
history help women detect ovarian cancer early. The earlier the cancer is
diagnosed, the better chance for complete remission. Symptoms of ovarian
cancer include: abdominal pressure, bloating and discomfort; nausea,
indigestion, or gas; urinary frequency, constipation, or diarrhea; abnormal
bleeding; unusual fatigue; unexplained weight gain or loss; and shortness of
breath.
OvaRex(R) MAb
Currently, there are late stage (phase II, IIb) clinical studies underway
at 64 sites across North America involving OvaRex(R) MAb, developed by AltaRex
Corp. These studies involve patients in both the "watchful waiting" and
recurrent ovarian cancer indications. Worldwide, OvaRex(R) MAb has been
studied in more than 400 ovarian cancer patients. Results from completed and
ongoing OvaRex(R) trials demonstrate evidence of clinical benefit and indicate
that OvaRex(R) MAb is generally safe and well tolerated.
By the end of 2001, AltaRex expects to begin filing a Biologics License
Application (BLA) with the U.S. Food and Drug Administration (FDA) for
regulatory approval of OvaRex(R) MAb. OvaRex(R) MAb has already received
Orphan Drug status and Fast Track designation from the FDA, procedural
mechanisms allowing for approval on the basis of Phase II studies that are
followed by additional post-approval trials. AltaRex will seek approval of
OvaRex(R) MAb for treatment of both the "watchful waiting" and recurrent
ovarian cancer indications.
Additional information about AltaRex (Toronto: AXO, OTC: ALRXF) 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.,
781-693-1510, shenrichon@altarex.com
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