OvaRex(R)-Induced T Cells Correlated with Clinical
Benefit in Recurrent Disease Trials
WALTHAM, Mass., April 5 /PRNewswire-FirstCall/ --
AltaRex Corp. (AXO.TO, ALXFF.OTC) announced today that it will make an oral
presentation of clinical results from an integrated analysis of two OvaRex(R)
clinical studies in recurrent ovarian cancer at the American Association for
Cancer Research (AACR) meeting in San Francisco. Birgit Schultes, Ph.D.,
Executive Director of Research at AltaRex, will discuss data regarding T cell
activation and correlated clinical benefit during the "Cancer Vaccines"
symposium on Sunday April 7. In the reported studies, OvaRex(R) is active in
recurrent disease, tumor burden is not impacting the frequency or quality of
immune responses and OvaRex(R) is able to induce cellular responses to CA125
and autologous tumor cells. The T cell responses are correlated with a
significant (p=0.0026) increase in time to disease progression.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The two open-label phase II studies featured in the presentation at AACR
were designed to evaluate immune response induction and clinical outcome for
recurrent ovarian cancer patients as a result of immunotherapy (13-patient
study, Dr. Thomas Ehlen) or combined chemo-immunotherapy (20-patient study,
Dr. Alan Gordon) with OvaRex(R) MAb. Primary results of the individual
studies have previously been reported by AltaRex (March 2001 and March 2002,
respectively). Both studies focused on the induction of cellular responses to
CA125 and autologous tumor and also investigated OvaRex(R) activity in the
recurrent disease setting.
The integrated analysis demonstrates:
-- Clinical Response at First Assessment:
* After four administrations of OvaRex(R) (week 12-13), 7 of 26 evaluable
patients (27%) achieved a clinical response (3 no evaluable disease, 2
complete response, 2 partial response).
-- Cellular Immune Response:
* 86% of the patients with clinical response (6 of 7) had CA125- and/or
tumor-specific T cell immune responses.
* 59% of the patients evaluable for cellular response (13 of 22)
developed CA125- and/or tumor-specific T cell immune responses.
* T cell responses were generally maintained on combined treatment
(Gordon study) with OvaRex(R) and second-line chemotherapy (platinum,
paclitaxel, Doxil(R)).
-- Humoral Immune Response:
* Of the patients evaluable for humoral response, 71% (22 of 31)
developed robust antibody responses to the constant (HAMA) region, and
60% (18 of 30) to the variable region (Ab2) of OvaRex(R) MAb.
-- Time to Progression and Survival Benefit:
* T cell responders to CA125 and/or autologous tumor demonstrated a
significant benefit over non-responders in median time to progression;
60 weeks for responders (n=13) versus 10.7 weeks for non-responders
(n=9), p=0.0026. Median survival has not yet been reached for
responders (n=13) while median survival for non-responders (n=9) is 38
weeks.
-- Safety:
* OvaRex(R) infusions were well tolerated. There was no drug related
toxicity and adverse events were non-specific and Grade 2 or less.
"There are two important findings from the recurrent disease studies,"
commented Christopher Nicodemus, M.D., Senior Vice President of Clinical
Research and Development at AltaRex. "First, we are able to activate T cell
immunity concurrent to chemotherapy and second, this T cell immunity is
associated with a positive clinical outcome. These findings point to the
future development potential of OvaRex(R) in conjunction with chemotherapy.
This is in addition to the use of OvaRex(R) alone in the period following
front-line therapy. We believe that immune modulation with antibody
treatments such as OvaRex(R) are a promising non-toxic addition to standard
treatment."
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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Related links:
http://www.altarex.com
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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
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CONTACT:
Peter Gonze, Operations-Investor Relations,
+1-781-672-0138, ext. 1503, pgonze@altarex.com, Sondra Henrichon,
Investor Relations, +1-781-672-0138, ext. 1510,
shenrichon@altarex.com
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