- Clinical Benefit Consistently Demonstrated in Well-Defined Population -
WALTHAM, Mass., March 15 /PRNewswire-FirstCall/ --
AltaRex Corp. (AXO.TO, ALXFF.OTC) announced today the release of expanded
clinical efficacy data from its two completed placebo-controlled OvaRex(R)
(oregovomab) trials for the treatment of advanced ovarian cancer, as well as
early immunological results from its third well-controlled study.
Jonathan Berek, M.D., Chief of the Division of Gynecologic Oncology at
UCLA School of Medicine and co-principal investigator of the Company's lead
OvaRex(R) trial, will be presenting the OvaRex(R) development program and
trial results at the annual meeting of the Society of Gynecologic Oncologists
(SGO), being held March 16-20 in Miami. In a post-graduate course being held
at the SGO meeting, Dr. Berek is using OvaRex(R) MAb as the primary example of
the promise that immunotherapy holds for the future treatment of gynecologic
malignancies. Also at the SGO meeting, Alan Gordon, M.D., Director of Research
and Gynecologic Oncology for U.S. Oncology in Dallas, will be presenting
primary results of a 20-patient "chemo-immunotherapy" study of OvaRex(R), for
which he is the principal investigator. The results will be the subject of a
separate press release and will be introduced by Dr. Gordon during SGO poster
sessions March 17-18.
With regard to the Company's lead 345-patient OvaRex(R) trial, a
statistical model (Cox Proportional Hazard Ratio) for the well-defined
population demonstrates a 41% reduced risk of relapse for OvaRex(R)-treated
patients as compared with placebo, a result that is statistically significant
(p=0.0313). A decreased risk of relapse of greater than 25% is generally
considered clinically significant by practicing physicians. As previously
reported, several prognostic factors, including CA125 at initiation of study
treatment, identify a well-defined population that benefits significantly from
treatment with OvaRex(R) MAb.
Also being presented today is a 12-month progression free survival
analysis of the well-defined population. 62% of OvaRex(R)-treated patients
with detectable levels of CA125 at first dose remained progression free versus
41% of patients on placebo (p=0.0449). 65% of OvaRex(R)-treated patients with
high normal baseline CA125 of >9.5 U/mL at first dose remained progression
free versus 18% of patients on placebo (p=0.0012). These findings are
particularly important, given that patients with high normal baseline CA125
are considered to be at higher risk for early disease relapse.
In light of these findings, the Company undertook new analyses of time to
disease relapse and progression free survival from its 55-patient controlled
trial. Unlike patients in the lead trial, those involved in this study were in
"biochemical relapse" on entry into the study, as defined by elevated CA125
levels but no measurable tumor. Therefore, 6-month rather than 12-month
progression free survival is a significant landmark in this more advanced
disease population. As reported today, in a similar well-defined population
representing about 42% of patients, the OvaRex(R) group experienced a 60%
increase in time to disease relapse versus placebo (10.8 months for OvaRex(R)
versus 6.9 months for placebo), and 6-month progression free survival of 75%
versus 36% (OvaRex(R) versus placebo). While these outcomes are not
statistically significant (largely due to smaller trial size), they
demonstrate consistency and will provide a positive contribution to the
integrated analysis that will form the basis of the Company's planned
OvaRex(R) Biologics License Application (BLA) for U.S. Food and Drug
Administration approval of OvaRex(R) MAb.
Importantly, for purposes of registration and clinical practice, all
OvaRex(R) studies to date demonstrate a benign safety profile. The placebo-
controlled trials also show that OvaRex(R) impact on quality of life is no
different than placebo.
Initial data from a third well-controlled study is also being presented by
Dr. Berek today. All 102 patients in this ongoing dosing study receive
OvaRex(R) on one of three different schedules. This phase II trial was
designed to determine ideal dosing frequency. Results indicate that more
frequent dosing can speed up induction of immune responses, but that similar
responses are induced with the same number of injections, independent of
dosing schedule. Of the 102 patients enrolled in this study, the Company has
determined that 30 meet the well-defined population criteria from the lead
study. Therefore, the Company is considering an amendment to the dosing
frequency trial that would enroll an additional 90 patients who also meet the
well-defined criteria. This would give the Company trial results from an
additional 120 active patients in the well-defined population, providing an
interim efficacy analysis in a timeframe in which the OvaRex(R) BLA would be
under review.
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 corporate alliances 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, 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 will file for
regulatory approval on a timely basis, uncertainties as to when, if at all,
the FDA will accept or approve the Company's regulatory filings for its
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
SOURCE AltaRex Corp.
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CONTACT: Peter Gonze, Operations, Investor Relations, +1-781-672-0138, ext. 1503, pgonze@altarex.com, or Sondra Henrichon, Investor Relations, +1-781-672-0138, ext. 1510, shenrichon@altarex.com, both of AltaRex Corp
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