-- Manufacturing Comparability and OvaRex(R)/Chemotherapy Phase II Studies --
WALTHAM, Mass., May 5 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF) announced today the results of an
OvaRex(R) phase II comparability trial designed to compare immunologic,
pharmacokinetic, and safety profiles of product resulting from two
manufacturing processes. These results were to have been presented by Dr.
James Levin of Unither Pharmaceuticals at the American Association of Cancer
Research (AACR) meeting in Toronto, which has been rescheduled for July.
Unither Pharmaceuticals, a wholly-owned subsidiary of United Therapeutics, has
licensed OvaRex(R) and other monoclonal antibody products from AltaRex. Dr.
Birgit Schultes of AltaRex was also scheduled to make a presentation at the
AACR meeting regarding favorable clinical immunological data supporting the
feasibility of OvaRex(R) and chemotherapy for the treatment of relapsed
ovarian cancer. Abstracts of both presentations have been already published in
the 2003 Proceedings of the American Association for Cancer Research.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The comparability study was undertaken to compare OvaRex(R) derived from
mouse ascites fluid (used in most of the phase II/IIb clinical trials) to
OvaRex(R) manufactured utilizing a protein-free cell culture process. The
cell culture manufactured OvaRex(R) is being used in the ongoing pivotal phase
III IMPACT I and II trials as well as certain other ongoing phase II trials in
the United States being conducted by Unither Pharmaceuticals. In the
comparability trial, no significant differences in pharmacokinetic,
immunologic, or safety profiles could be detected between the two versions of
OvaRex(R). Commercial supply of OvaRex(R) MAb is expected to be manufactured
utilizing the cell culture process.
Dr. Schultes' data reports the feasibility of administering chemotherapy
concurrent with OvaRex(R) treatment. Chemotherapy did not abrogate the
ability of OvaRex(R) to generate an immune response nor abrogate the
previously established immune response. Interestingly, T cell responses
increased during concomitant chemotherapy in 4 of 8 patients (to CA125) and 3
of 5 patients (to autologous tumor). This data has important implications for
the design of future clinical trials in the front-line setting where
chemotherapy following surgery is the standard of care, and in the recurrent
setting where chemotherapy alone is the standard of care.
AltaRex Corp. is focused on the research and development of antigen-
targeted monoclonal antibodies, or antibody-based immunotherapy, for the
treatment of certain late stage cancers and other diseases with significant
unmet medical needs. The Company's lead product, OvaRex(R) for advanced
ovarian cancer, is in a U.S. phase III clinical program being conducted by the
Company's licensee, Unither Pharmaceuticals, a wholly owned subsidiary of
United Therapeutics. OvaRex(R) targets the tumor associated antigen CA125 and
BrevaRex(R) targets MUC1. The Company has completed a phase I study of
BrevaRex(R). AltaRex also has reported using its ProstaRex(TM) MAb to induce
T cells in laboratory studies to a circulating prostate cancer antigen, PSA.
ProstaRex(TM) is in preclinical development. Further clinical development of
BrevaRex(R) and/or ProstaRex(TM) is under consideration by Unither
Pharmaceuticals and, along with OvaRex(R), comprise licensing or other
opportunities in AltaRex's retained markets.
The Company's present and limited research is focused on an early stage
disease target, human carcinoma antigen, in collaboration with Egenix while at
the same time conducting proof of principal experiments for applying the
technology platform to allergy and infectious diseases as well as altered
delivery mechanisms to enhance the desired immunogenic effect.
Additional information about AltaRex 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 and http://www.clinicaltrials.gov.
Additional information about ovarian cancer can be found at http://www.nci.nih.gov,
http://www.ovariancanada.org and at http://www.ovarian.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 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:
Robert Newman
Vice President, Business Operations
(781) 672-0138 ext. 1502
bnewman@altarex.com
SOURCE AltaRex Corp.
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Related links:
http://www.altarex.com
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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:
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CONTACT:
Robert Newman, Vice President, Business
Operations of AltaRex, +1-781-672-0138, ext. 1502,
bnewman@altarex.com
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