WALTHAM, Mass., March 18 /PRNewswire-FirstCall/ --
AltaRex Corp. (AXO.TO, ALXFF.OTC) announced today the positive primary results
of its recently completed 20-patient "chemo-immunotherapy" study of OvaRex(R)
for the treatment of relapsed ovarian cancer in a non-randomized setting.
Alan Gordon, M.D., Director of Gynecologic Oncology Research for U.S. Oncology
in Dallas and principal investigator of the study, is presenting these results
at the annual meeting of the Society of Gynecologic Oncologists (SGO), being
held March 16-20 in Miami.
The data presented demonstrate:
-- OvaRex(R) was well-tolerated and induced multiple antigen- and tumor-
specific immune responses;
-- T-cell responders demonstrated a highly statistically significant
benefit over non-responders in time to progression (p<0.0001) and survival
(p=0.008);
-- After four doses of OvaRex(R) (week 12), 5 of 15 evaluable patients
(33%) maintained or achieved a clinical response ( 2 NED, 2 CR, 1 PR);
-- 13 of these 15 evaluable patients continued on combined chemo-
immunotherapy and five of those patients (38%) experienced complete remission;
-- OvaRex(R)-induced immune responses were maintained in the presence of
this second-line chemotherapy;
-- 75% of patients are still alive and median survival for these patients
has not yet been reached.
The 20-patient phase II study combined OvaRex(R) immunotherapy with
approved chemotherapy to address several questions from within the gynecologic
community. First, would excessive tumor burden in relapsed disease prevent
meaningful clinical benefit from OvaRex(R) immunotherapy alone? Second, would
the use of cytotoxic chemotherapy to minimize the excessive tumor burden
suppress OvaRex(R)-induced immunity and/or would OvaRex(R)-induced immunity
interfere with the activity of subsequent chemotherapy?
The study demonstrated that the initial OvaRex(R) administrations can
induce robust immunity in the presence of tumor burden that can be maintained
during subsequent chemotherapy, and that the activity of chemotherapy can be
preserved when administered concurrently with OvaRex(R) MAb. Patients who had
OvaRex(R)-induced T-cell responses showed a statistically significant benefit
over non-responders in both time to disease progression (median not reached
for responders, 10.6 weeks for non responders, p<0.0001) and survival (median
not reached for responders, 27.6 weeks for non-responders, p=0.008).
At study entry, patients with relapsed disease and elevated tumor antigen
CA125 had to have experienced a prior six month period of disease
stabilization after initial platinum-based chemotherapy and had to have an
expected survival of at least three months. Four doses of OvaRex(R) were
administered over twelve weeks and patients then had the option to receive up
to two additional doses of OvaRex(R), to be administered one to four days
prior to second-line chemotherapy.
The objective of the trial was to induce robust tumor-specific immune
responses in patients with relapsed disease, thereby increasing the response
rate to second-line chemotherapy. Results demonstrated that, following four
administrations of OvaRex(R) MAb, both robust humoral responses (in 79% of
patients evaluated) and cellular responses (in 50% of patients evaluated) were
induced, including memory T helper cells, "killer" T cells (CTLs) and B-cells.
The T cell responses to tumor antigen CA125 were mainly a TH1 type response,
activating CTL rather than B cells for antibody production. Five of eight
patients tested (63%) had a T cell response to their own tumor (autologous).
With regard to the five of eight patients mounting T cell responses to
autologous tumor, four received subsequent chemotherapy and were disease-free
after completion of chemo-immunotherapy. T cell responses were increased
after chemo-immunotherapy in these five patients.
"Today's standard treatment of surgery and chemotherapy, though critically
important to reduce tumor mass, very rarely result in a cure. Thus, patients
generally relapse with more resistant disease, particularly in the case of
ovarian cancer," commented Dr. Gordon. "These study results are even more
provocative than I anticipated, demonstrating that even in relapsed disease,
and while coping with the rigors of chemotherapy, patients are able to mount
and maintain strong immune responses against CA125 and their tumors, without
further diminution of quality of life. It is satisfying as a clinical
investigator to witness two treatment approaches that combined, improve rather
than hinder clinical outcome. The resulting increases in time to disease
progression, and the early evidence of increased survival, represent an
encouraging step toward improved treatment of this horrible disease," added
Dr. Gordon.
For more information about the Company, please visit the recently updated
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
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