WALTHAM, Mass., Feb. 3 /PRNewswire-FirstCall/ --
AltaRex Corp. (TSE: AXO, OTC: ALXFF.PK) announced today that Dr. Alan Gordon
of U.S. Oncology and Texas Oncology PA of Dallas, Texas presented updated
survival data from a 20 patient OvaRex(R) (oregovamab) phase II trial
conducted by AltaRex yesterday at the opening oral plenary session of the
Society for Gynecological Oncology (SGO). The results demonstrated that in
this study there was a correlation between OvaRex(R)-induced T cell responses
and prolonged survival in platinum-sensitive patients with recurrent
epithelial ovarian cancer.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The objectives of the study were to evaluate immune responses and clinical
outcomes from concurrent OvaRex(R) and chemotherapy treatment. The
conclusions were that OvaRex(R) MAb induced multifaceted antigen-specific
immune responses even when combined with chemotherapy and that patients with a
T cell response survived significantly longer than those without a T cell
response. Induction of T cells by OvaRex(R), which occurred in 61% of the
patients, was associated with a significant survival advantage, with median
survival for T cell responders not reached (64% still alive at 140 weeks)
versus 51.9 weeks for T cell non-responders (p=0.002; hazard ratio 0.157
[0.009-0.347]).
The Company believes that the high frequency of beneficial OvaRex(R)-
induced immune responses seen in the study in conjunction with chemotherapy
strongly supports additional evaluation and has initiated discussions with the
European Organization for the Research and Treatment of Cancer (EORTC) in that
regard. Further, in a recent publication in the New England Journal of
Medicine by Zhang et al., the authors report on their immunohistochemical
analysis of tumor infiltrating lymphocytes in 186 frozen tumor specimens
obtained from primary debulking surgery of FIGO III and IV ovarian cancer
patients. The paper, entitled "Intratumoral T cells, Recurrence and Survival
in Epithelial Ovarian Cancer", makes several observations relevant to
OvaRex(R) immune induction and the survival benefit reported at SGO:
-- Patients with advanced ovarian cancer have significantly longer overall
and progression-free survival if there are tumor-infiltrating
lymphocytes present (p<0.001).
-- Significantly longer survival was also observed among the patients in
which a complete response to primary therapy (optimal debulking and
adjuvant chemotherapy) occurred and the tumor was infiltrated by
lymphocytes (p<0.001); the five-year overall survival rate was 74% among
these patients whose tumors contained T-cells and 12% among those with
no T cells.
-- Among patients with a complete response to primary therapy, the presence
or absence of T cells (p<0.001) and the extent of residual tumor
(p<0.001) correlated with overall survival but tumor grade, histologic
type, inclusion or non-inclusion of paclitaxel in the chemotherapeutic
regimen, and age did not.
The finding from the Zhang paper regarding optimal debulking is addressed
by Unither Pharmaceuticals, the Company's licensee for North America, Japan
and other territories, in their pivotal double-blind placebo-controlled U.S.
phase III trials where the target population is advanced ovarian cancer
patients whose primary therapy resulted in optimal debulking, chemo-responsive
disease, and CA125 in the normal range. This population was identified from
the previously reported AltaRex phase IIb trial in 345 patients.
With regard to Europe, AltaRex continues a dialogue with the EORTC
regarding the conduct of a phase II trial in patients with recurrent disease
who were previously optimally debulked and had chemo-sensitive disease (>6
month progression free survival). This study is intended to further elucidate
Dr. Gordon's observations regarding the synergistic effect of immunotherapy
and chemotherapy on T cell induction and resulting survival benefit.
AltaRex Corp. is focused on the research, development and
commercialization of foreign antibodies that modulate the immune system for
the treatment of certain cancers and other diseases where there exists an
unmet medical need. 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 or the proposed alliance with the EORTC, 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, such as the trial results referred to in this
release, 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
investor@altarex.com
SOURCE AltaRex Corp.
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Related links:
http://www.altarex.com
Photo Notes:
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:
http://www.prnewswire.com/gh/cnoc/comp/128163.html
CONTACT:
Robert Newman, Vice President, Business
Operations of AltRex, +1-781-672-0138, investor@altarex.com
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