-- Expects to Commence Pharmacokinetic Study --
WALTHAM, Mass., Jan. 9 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC),
a developer of foreign antibodies that activate the immune system to treat
cancer, today announced that its contract manufacturer has successfully filled
and lyophilized into vials the first lot of cell-culture-manufactured
OvaRex(R) antibody for use in the Company's planned human pharmacokinetic
study. As a result, the Company expects in the near future to file an
amendment to its Investigational New Drug submission for OvaRex(R) MAb with
the U.S. Food and Drug Administration (FDA) and to commence the trial roughly
one month thereafter.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
"This landmark milestone means that we now have our new cell-culture-
manufactured OvaRex(R) product available for the first time to take to the
clinic for human comparability testing," commented Richard E. Bagley,
President and Chief Executive Officer of AltaRex. "We believe that the
pharmacokinetic study will be a final step in our program to establish the
equivalency of our protein-free cell-culture-based process with the ascites-
based process that generated product used in our clinical trials."
The pharmacokinetic trial will be conducted in 24 patients in the United
States and Canada. This trial is expected to be completed in the second
quarter of this year. Upon completion, the results of this trial will be
submitted to the FDA as part of the Company's Biologics License Application
(BLA) for regulatory approval of OvaRex(R) MAb. The Company is in the process
of analyzing the results of several Phase II clinical trials of OvaRex(R) MAb,
including a primary analysis of its lead pivotal trial (phase IIb) in 345
patients which has been delayed by various issues principally stemming from
data collection and validation by the Company's external vendors.
As disclosed in connection with its recently completed C$12.6 million
Special Unit Offering, the Company has sufficient cash, cash equivalents and
short-term investments to fund its operations through the first quarter of
2002. In order to complete the clinical, manufacturing and regulatory
activities associated with the filing of a BLA, the Company will be required
to raise additional funding through public or private equity or debt financing
as market conditions permit or through strategic relationships with
pharmaceutical or biotechnology companies. The Company is pursuing
discussions with various companies and will seek to structure such
relationships to ensure the successful completion of its development program
for OvaRex(R) MAb while retaining a significant share of any profits resulting
from its commercialization.
More about AltaRex research and development of foreign antibodies that
activate the immune system, the Company's clinical trials, news and events can
be found 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 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
preclinical, 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 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 beyond the levels described in this release,
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 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/gh/cnoc/comp/128163.html
CONTACT:
Edward Fitzgerald, Senior Vice President and
Chief Financial Officer, +1-781- 672-0138, ext. 1504,
efitzgerald@altarex.com, or Sondra Henrichon, Director, Investor
Relations and Corp. Communications, +1-781-672-0138, ext. 1510,
shenrichon@altarex.com, both of AltaRex Corp.
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