WALTHAM, Mass., Nov. 22 /PRNewswire-FirstCall/--
AltaRex Corp. (Toronto: AXO, OTC: ALXFF.PK) today announced an update to the
clinical development program for OvaRex(R) MAb, the Company's novel
immunotherapeutic approach to treat metastatic ovarian cancer. The updated
program was presented in Frankfurt, Germany at a joint meeting of the European
Organization for Research and Treatment of Cancer (EORTC), National Cancer
Institute (NCI), and American Association for Cancer Research (AACR).
Presented as a poster today at the Frankfurt meeting was an overview of
the final conclusions of the AltaRex-conducted OvaRex(R) phase II clinical
program and an outline of plans for continued global development by AltaRex
and its partners, including the following highlights:
-- In two double-blind, placebo-controlled trials as a single agent
following first-line therapy for late stage ovarian cancer, OvaRex(R)
MAb demonstrated the most benefit in a patient population defined by
favorable prognostic factors. In the lead phase IIb North American
study, OvaRex(R) treated patients with these favorable prognostic
factors demonstrated a near doubling in time to disease relapse as
compared with placebo patients with these favorable factors, 19.2
months in median time to disease relapse vs. 10.5 months, with side
effects comparable to placebo and no diminution in quality of life.
This population represented approximately 40% of the studied 342
patients. United Therapeutics, the Company's licensee for North
America and other territories, has advised the Company that it plans to
conduct a pivotal phase III program in the United States to confirm
these findings in this patient population. The program would be
initiated by the first quarter of 2003, subject to review by the Food
and Drug Administration and expected to be completed in the first half
of 2005.
-- In several open clinical trials, OvaRex(R) MAb also demonstrated
clinical activity and beneficial immune induction in recurrent ovarian
cancer, both as a single agent and in conjunction with chemotherapy.
In 33 patients treated with OvaRex(R) in some combination with
chemotherapy, T cell immune responses were generally maintained or
increased in the presence of second-line chemotherapeutics such as
platinum, paclitaxel, topotecan or liposomal doxorubicin. In 22
patients with measured T cell responses, T cell immune responders had a
significantly improved overall survival as compared with T cell non-
responders, median survival not yet reached vs. 51.9 wks, p=0.02.
With regard to one OvaRex(R) chemoimmunotherapy open trial already
completed with Dr. Alan Gordon of U.S. Oncology as principal
investigator, the abstract has been selected for express plenary oral
presentation at the Society for Gynecological Oncology (SGO) Annual
Meeting being held January 31 - February 4, 2003 in New Orleans.
"AltaRex is pleased that United Therapeutics expects to conduct a
comprehensive U.S. phase III pivotal program following primary therapy, or the
consolidation setting, based on our phase II results," commented Richard E.
Bagley, President and CEO of AltaRex. "We believe that the breadth of the
opportunity with OvaRex(R) MAb is also indicated by the potential of OvaRex(R)
in combination with chemotherapy in patients with platinum-sensitive relapsed
disease, and have established the objective of confirming this observation in
a clinical trial in Europe. AltaRex has submitted a phase II protocol to the
EORTC for consideration in this regard. This will be further supported by
OvaRex(R) treated, relapsed patients from the U.S. conducted phase III
program. Our enthusiasm for the combination of OvaRex(R) and chemotherapy in
these patients has been heightened by the acceptance of our completed
chemoimmunotherapy trial for plenary oral presentation at SGO as well as by
the laboratory data reported at the Society for Biological Therapy, supporting
the use of OvaRex(R) with chemotherapy to enhance T cell killing."
Additional information about AltaRex Corp. can be found on the Company
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; 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 and dependence on
any alliance partners; 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; 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:
Trudy Chimko
Corporate Communications
(781) 672-0138
investor@altarex.com
SOURCE AltaRex Corp.
 back to top
Related links:
http://www.altarex.com
Company News On-Call:
http://www.prnewswire.com/comp/128163.html
CONTACT:
Trudy Chimko, Corporate Communications for
Altarex, +1-781-672-0138, investor@altarex.com
|
