- Updates Results and Registration Strategy -
ORLANDO, Fla., May 21 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSX: AXO, OTC: ALXFF.PK) of Waltham, MA announced that final
results of its OvaRex(R) (oregovomab) 345-patient study were presented
yesterday at the 38th annual meeting of the American Society of Clinical
Oncology (ASCO) by Thomas Ehlen, M.D. (Vancouver Cancer Center), co-principal
investigator of the North American clinical trial. The results of this
placebo-controlled study of OvaRex(R) antibody-based immunotherapy in stage
III/IV ovarian cancer patients have established that patients with optimal
surgical debulking and sensitivity to platinum chemotherapy are most likely to
achieve clinical benefit from OvaRex(R) treatment in the adjuvant setting
following front line treatment (the "watchful waiting" period).
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The ASCO presentation highlighted both previously announced and new
analyses of study results in well-defined populations of the 345-patient
study. As previously reported, the results demonstrate a statistically
significant prolongation (10 months, p=0.0290) in time to disease relapse for
OvaRex(R)-treated patients (as compared to placebo) in a well-defined patient
population (29% of patients in the study), and also demonstrate a 41% reduced
risk of relapse for OvaRex(R)-treated patients (as compared to placebo). This
population was identified by an analysis of several pre-defined prognostic
risk factors known to heavily influence early relapse.
Yesterday's presentation further highlighted new analyses that involve the
most influential prognostic factors and demonstrate a six- to nine-month
prolongation in time to disease relapse for OvaRex(R) -treated patients (as
compared to placebo) in 33%-48% of the 345 patients in the study. These well-
defined populations demonstrate a 19-29% reduced risk of relapse for OvaRex(R)
patients (as compared to placebo). A decreased risk of relapse of 20-25% is
generally considered clinically significant by practicing physicians. These
new analyses are important for considering the broadest enrollment criteria
for a confirmatory study, and notably, they were achieved with similar safety
profiles for OvaRex(R) and placebo and without negative impact on quality of
life.
The management of patients who are outside the well-defined populations,
generally patients who are less responsive or refractory to primary therapy or
those who have relapsed disease, may necessitate the use of OvaRex(R) in
conjunction with other therapeutic modalities. Favorable preliminary data on
the clinical application of OvaRex(R) concurrent with chemotherapy in relapsed
disease was recently presented (March 18) at the annual meeting of the Society
of Gynecological Oncologists (SGO), and was subsequently reported (April 5) at
the annual meeting of the American Association of Clinical Research (AACR).
This data comes from a 20-patient open label chemo-immunotherapy study, in
which OvaRex(R) T cell responders demonstrate a significant benefit over non-
responders in time to disease progression (p<0.0001) and survival (p=0.008).
In a second presentation at ASCO today, May 21, early data from a 102-
patient OvaRex(R) dosing regimen study is being highlighted by Michael Method,
M.D., Director of Oncology Services for St. Joseph's Regional Medical Center
in Indiana. In this study, three dosing regimens are being compared for
immune responder time to relapse and safety, including the dosing regimen used
in the 345-patient study. Results to date indicate that the dosing schedule
used in the 345-patient study is optimal for generating humoral and cellular
responses.
The Company and its expert advisors believe that the composite clinical
data has established a target population and dosing regimen for a confirmatory
trial, to be conducted by United Therapeutics Corporation as part of their
OvaRex(R) registration plan as appropriate following a program review with the
U.S. Food and Drug Administration.
"We believe that the data presented at the SGO, AACR and now ASCO
establish a firm foundation for successfully advancing the OvaRex(R)
development program," commented Richard E. Bagley, President and CEO of
AltaRex. "The results confirm the promise of the Company's novel foreign
antibody-based approach for treating cancer, and a provide a basis for
addressing registration of OvaRex(R) worldwide."
AltaRex Corp. is focused on the research, development and
commercialization of antibody-based antigen-targeted therapies for life
threatening diseases, utilizing foreign monoclonal antibodies as
immunotherapeutic agents. AltaRex has established proprietary expertise for
the use of antigen-binding agents, specifically foreign monoclonal antibodies,
to alter patients' immune system responses in a therapeutically beneficial
manner. OvaRex(R), BrevaRex(R), ProstaRex(TM), GivaRex(TM) and AR54 are being
developed in collaboration with United Therapeutics Corporation for North
America and many regions worldwide. OvaRex(R) is also being developed with
Dompe Farmaceutici, FAES, Genesis Pharma and Medison Pharma. AltaRex
currently retains all rights to its five-product cancer antibody portfolio for
the majority of member nations of the European Union. For more information
about the Company, please visit the AltaRex 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 and 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 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, 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
Contact:
Sondra Henrichon
Investor Relations and Corporate Communications
(781) 672-0138 ext. 1510
shenrichon@altarex.com
SOURCE AltaRex Corp.
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CONTACT:
Sondra Henrichon, Investor Relations and
Corporate Communications of AltaRex Corp., +1-781-672-0138, ext.
1510, shenrichon@altarex.com
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