WALTHAM, Mass., Jan. 31 /PRNewswire-FirstCall/ --
AltaRex Corp. (AXO.TO, ALXFF.OTC) today announced positive and statistically
significant overall results from further analysis of its 345-patient OvaRex(R)
combined U.S. and Canadian phase IIb trial in metastatic late stage ovarian
cancer. As previously disclosed, the primary analysis had demonstrated
statistically favorable results for OvaRex(R) treatment in a well-defined
population in the U.S. study and non-significant results in the Canadian
study.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The Company has been engaged in further analysis of the disparity between the
results seen in Canada and the U.S. In the combined studies, after excluding
patients with prognostic factors for early relapse, as well as patients who
are platinum insensitive, there is a favorable outcome for median time to
relapse (TTR) for OvaRex(R) treatment as compared with placebo, 20.7 months
for OvaRex(R) (N=71) vs. 13.5 months for placebo (N=77). Further, when also
considering tumor antigen levels at initiation of treatment, the outcome is
highly statistically significant, OvaRex(R) 20.7 months (N=31) vs. placebo
10.2 months (N=33), p=0.0174. Similarly, for this population with available
tumor antigen, an analysis of relapse-free survival (at 12 months from
initiating treatment) is also highly statistically significant for OvaRex(R)
treatment, 61% vs. 27% for placebo, p=0.011.
The goal of the phase IIb trial was to evaluate the efficacy of OvaRex(R)
to provide clinical benefit as adjunctive treatment after optimal disease
control provided by primary surgery and chemotherapy. Optimal disease control
can be measured by multiple factors, including the amount of disease remaining
after primary tumor-reductive surgery and the reduction in the CA125 tumor
marker after initiation of chemotherapy, as well as by the ability of a
patient to remain relapse-free for a period of six months following six cycles
of platinum-based therapy (platinum sensitive). These factors are predictive
of early relapse. In the initial analysis, the observed differences in these
factors between patients enrolled in the Canadian and U.S. trials appeared to
explain the difference in results between the two countries.
As previously reported, a large number of Canadian patients (both
OvaRex(R) and placebo groups) entered the study having known risk factors for
early relapse. Further analysis now indicates that 38% of patients in the
OvaRex(R) Canadian treatment group were platinum resistant (relapsed after
completion of primary chemotherapy and prior to receiving 4 doses of study
drug), compared to a rate of only 23-25% in the U.S. OvaRex(R) treatment group
as well as in each placebo group.
Richard E. Bagley, President and CEO of AltaRex, commented, "With the new
results, the Company will follow through on an analysis of the phase IIb trial
as both a composite study and as separate trials. We believe that our results
warrant filing for approval, particularly as we have two additional trials
ongoing." Mr. Bagley also noted, "There is an interesting precedent of an
accelerated approval in ovarian cancer involving circumstances not unlike our
own, as abstracted from the FDA summary basis of approval."
The U.S. Doxil(R) application (for ovarian cancer patients refractory to
paclitaxel and platinum-based chemotherapy) consisted of three open-label
single arm trials of a total of 176 patients, 145 evaluable. The company
sponsoring the Doxil(R) studies also had supportive data from interim results
of a phase III randomized study in 44 patients. With regard to the phase II
trials, two were conducted in the U.S., one in Europe. The primary endpoint
was objective tumor response rate. In the two Doxil(R) U.S. studies, response
rates were approximately 22% and 17%, while in Europe, 0%. On a combined
basis it was 14%. An excerpt from the FDA Advisory Committee stated:
" ... we looked at a variety of factors to explain why the results from 30
and 47 E were not consistent with the results from the other two trials. In
looking at some of these factors, we noted that there were indeed a couple of
differences between the patients in these trials and patients in the other
trials. For example, the baseline CA125 was somewhat larger ... . Patients
who left trial in general left the trial for death or progressive disease
rather than toxicity ... . Nonetheless, these patients are included in our
overall analysis of response rates."
Of particular relevance to the OvaRex(R) registration program, Doxil(R)
was approved for the treatment of refractory ovarian cancer in June of 1999
primarily on the basis of the study results described above and with a post-
approval commitment to conduct further study. AltaRex expects to file its
phase IIb study with the results of two additional well-controlled studies and
two open studies.
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 or additional analyses of completed 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, 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
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Company News On-Call:
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CONTACT:
Peter Gonze, Senior Vice President,
Operations and Investor Relations, +1-781-672-0138, ext. 1503,
pgonze@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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