WALTHAM, Mass., July 12 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC)
today reported positive long-term safety and survival results from an
OvaRex(R) MAb (oregovomab) clinical trial involving 44 previously treated
patients in Germany with recurrent ovarian cancer. Patients were referred for
OvaRex(R) treatment to the Clinic of Nuclear Medicine at the University of
Frankfurt by Dr. Volker Moebus, then at the University of Ulm. Patient
follow-up continued to April, 2001.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
This is the Company's first OvaRex(R) study to report long-term survival
and safety results. In the population of patients with recurrent ovarian
cancer, the common expectation for survival is less than one year from
recurrence. Twenty-five (56%) of patients in this Moebus study survived more
than one year and 15 patients (34%) survived more than two years from first
treatment. Among the 15 patients with survival greater than two years, five
(11%) survived five years or longer from first treatment. Four of 44 patients
are still alive as of April 2001 (survival ranging from five to eight years
after first treatment, and seven to thirteen years from diagnosis). As a
result of long-term survival, more than 20 patient years of drug exposure
history was obtained, and the safety profile was generally benign.
These newly reported results are consistent with the Company's recently
completed prospective recurrent disease study of 13 patients conducted by Dr.
Thomas Ehlen at the Vancouver Cancer Center. In that study, roughly half of
the patients survived approximately 12 months with three patients (23%)
surviving two years or greater, and two of the three patients were still alive
at data cut-off. A benign safety profile was also consistent with the current
reported findings.
The U.S. Food and Drug Administration has designated OvaRex(R) MAb as a
Fast Track candidate, a status which can provide for priority review, an
opportunity for filing a "rolling" Biologics License Application (BLA), and
for accelerated approval on the basis of phase II/IIb trial results (including
surrogate efficacy endpoints) with a post-approval commitment to additional
study. The Company expects to initiate the filing of a rolling BLA at the end
of 2001 or early 2002 with its clinical data from four OvaRex(R) trials
(designated by lead investigator(s)): this Moebus study of 44 patients with
recurrent disease, the Ehlen study of 13 patients with recurrent disease, the
Bookman study of 55 patients with subclinical relapse and the lead pivotal
Berek/Ehlen study of 345 patients in watchful waiting. Two trials are now
completed and reported (Ehlen, Moebus), a final report from a third completed
trial (Bookman) is imminent, and the primary endpoint results of the lead
pivotal trial (interim results already reported) will occur in the fourth
quarter of this year.
Additional supporting data will be filed in the first half of 2002. This
includes data from a chemotherapy/OvaRex(R) study of 20 patients with
recurrent disease (Dr. Gordon as lead investigator), a dose response study of
102 patients in watchful waiting (Dr. Berek as lead investigator) and a 24-
patient pharmacokinetic study to establish equivalence between ascites-based
and cell culture-based manufacturing. Assuming successful scale-up
manufacturing by Abbott Laboratories and the successful and timely completion
of the aforementioned studies, the Company believes that U.S. approval of
OvaRex(R) MAb could follow late next year or early 2003 with commercialization
in the first half of 2003.
More about AltaRex research and development of antigen-targeted anti-
cancer antibodies, clinical trials, news and events can be found on its web
site at http://www.altarex.com. AltaRex Corp. is traded on the Toronto Stock
Exchange under the symbol AXO, and over-the-counter in the United States under
the symbol ALXFF. Additional information about ovarian cancer can be found at
http://www.nci.nih.gov, http://www.ovarian.org, http://www.ovariancancer.org and at
http://www.ovariancanada.org. Information about multiple myeloma can be found at the
http://www.multiplemyeloma.org.
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 pre-
clinical, retrospective and early 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 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 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
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:
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CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex Corp.,
781-672-0138, ext. 1510, or shenrichon@altarex.com; or Wayne
Hendry, Investor Relations of The Equicom Group, Inc.,
416-815-0700, ext. 238, or whendry@equicomgroup.com
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