WALTHAM, Mass., June 21 /PRNewswire-FirstCall/--
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) updated shareholders yesterday at the
Company's Annual General Meeting in Toronto. AltaRex President and CEO,
Richard E. Bagley, reported on the Company's strategic direction, which has
been refocused as a result of the Company's exclusive licensing agreement with
a wholly-owned subsidiary of United Therapeutics Corporation with respect to
OvaRex(R) and four other product candidates of the Company.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
A review to date of the OvaRex(R) program by United Therapeutics has been
conducted with input sought from leading clinical oncologists and
gynecologists as well as regulatory consultants. United Therapeutics has
disclosed its intention, subject to further counsel from the U.S. Food and
Drug Administration (FDA), to conduct a randomized pivotal trial initiated by
the first quarter of next year. As part of the ongoing evaluation, United
Therapeutics has also explored various manufacturing alternatives consistent
with the conduct of this new trial. During this evaluation period, United
Therapeutics has assumed remaining OvaRex(R) development, manufacturing and
commercialization responsibilities and expenses, including personnel, for the
licensed territories.
Consistent with these activities by United Therapeutics, AltaRex has
worked closely with Dompe Farmaceutici to explore opportunities for OvaRex(R)
in the European markets. As antibodies are regulated on a centralized basis
in Europe and in light of favorable responses from certain country experts
regarding the manufacturing comparability program, AltaRex is pursuing
aggressively an OvaRex(R) collaboration for Northern European markets. Such a
collaboration in Northern Europe would make the Company better able to
integrate United Therapeutic's efforts for North American registration of
OvaRex(R) with those in Europe. The companies with which AltaRex has
distribution arrangements for OvaRex(R) in Southern Europe and the Middle East
are committed, if necessary, to fund the study of up to 60 patients in the
aggregate for regulatory filing purposes.
As the great majority of present OvaRex(R)-related expenses have been
assumed by United Therapeutics, the Company has focused its reduced staffing
on its patents, the development of further therapeutic applications, and
business development. The Company believes that the results of its OvaRex(R)
trials to date validates its technology platform of using foreign antibodies
to alter immune responses for clinical benefit and without significant
toxicities. The Company's small group of scientists has considerable
expertise in antigen presentation and dendritic cell biology. With a growing
base of both this scientific expertise and breadth of intellectual property,
the Company believes that it can pursue research collaborations both within
and outside the cancer field without significant additional staff and
increases in operating expense.
"Given our current arrangements with United Therapeutics, Dompe
Farmaceutici, Genesis Pharma and Medison Pharma, combined with the Company's
growing patent estate led by our U.S.-issued OvaRex(R) patent and the recent
European Patent Office's intent to grant a patent for OvaRex(R), we believe
that AltaRex is well-positioned to capitalize on its novel technology
worldwide. We expect that moving forward, both our oncology products and our
science and intellectual property position will be the main drivers of
licensing and other revenue opportunities," commented Mr. Bagley. "We've
single-handedly developed our lead product OvaRex(R) through phase II studies
and will have successfully licensed the product for the majority of markets
worldwide. We believe that these milestones support our proprietary
technology platform, and we look forward to expanding this potential further,
not only beyond ovarian and other cancer indications, but to underserved
disease areas where market potential - and potential patient benefit - remain
high."
Additional information about AltaRex research and development, clinical
trials, news and events can be found on the Company website 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, 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
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/comp/128163.html
CONTACT:
Robert Newman, VP Business Operations of
AltaRex Corp., +1-781- 672-0138, investor@altarex.com
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