WALTHAM, Mass., Jan. 23 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) confirmed today that Unither
Pharmaceuticals ("Unither"), a wholly owned subsidiary of United Therapeutics,
has initiated an OvaRex(R) (oregovomab) phase III pivotal trial program to
treat advanced ovarian cancer. The Company believes that the two phase III
trials being conducted by Unither in the United States, supported by the
Company's completed and planned phase II studies, will form the basis for an
OvaRex(R) registration program for both North America and Europe.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
On April 17, 2002, AltaRex entered into an exclusive license agreement
with Unither Pharmaceuticals for its cancer antibody portfolio for North
America, Japan, and other territories with a focus on the lead OvaRex(R)
product. Unither Pharmaceuticals conducted an in-depth review of the OvaRex(R)
clinical program with respect to a registration plan for the United States,
including meeting with representatives from the Center for Biologics
Evaluation and Research (CBER) of the U.S. Food and Drug Administration for an
end-of-phase II meeting. Unither has notified AltaRex that the 240-day initial
assessment period contemplated under the agreement has been completed and that
the planned U.S. phase III pivotal trial program has been initiated.
Each of Unither's two identical trials will be conducted in the United
States in Stage III/IV ovarian patients who have successfully completed
primary treatment of surgery and chemotherapy. Treatment will continue until
disease relapse, a time period where there are no approved treatment options.
Consequently, the studies will be double-blind, placebo-controlled and will
each enroll 177 patients randomized 2:1 active versus placebo. Patient
enrollment has commenced and the Company expects that Unither will have fully
enrolled these trials within the next 15 months with results by mid-2005.
OvaRex(R) MAb has been granted Orphan Drug status in the U.S. and Europe and
Fast Track designation in the U.S.
During the Unither 240-day evaluation period, AltaRex and its European
partners have developed plans for European registration of OvaRex(R) MAb that
would center on the Unither program with support from the Company's completed
and planned phase II trials. The Company continues in a dialogue with the
European Organization for Research and Treatment of Cancer (EORTC) on a
possible OvaRex(R) phase II trial conducted by AltaRex and its partners as
further phase II support in relapsed ovarian cancer, an indication with
approved treatment options.
Ovarian cancer is the most serious form of gynecologic cancer, affecting
one of every 55 women, and killing 40 women in the United States every day.
Incidence and outcomes are similar in Europe. Ovarian cancer is referred to
as the "Disease that Whispers" because vague symptoms and the difficult
location of the ovaries lead to 75% of diagnoses being made late, when the
disease has reached an advanced metastatic stage. While first-line treatment
of surgery and chemotherapy usually results in temporary remission, recurrence
of advanced stage disease is almost inevitable and the 5-year survival rate
remains very low.
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 the Company 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 our 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 or the proposed alliance with the EORTC, 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:
Robert Newman
Vice President Business Operations
(781) 672-0138
investor@altarex.com
SOURCE AltaRex Corp.
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Company News On-Call:
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Photo Notes: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 /Web site:
http://www.altarex.com
CONTACT:
Robert Newman, Vice President Business
Operations of AltaRex Corp., +1-781-672-0138,
investor@altarex.com
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