Encouraging trend observed in overall survival
QUÉBEC CITY, June 7
/PRNewswire-FirstCall/ - Aeterna Zentaris Inc. (TSX: AEZ; Nasdaq:
AEZS), (the "Company"), a late-stage drug development company
specialized in oncology and endocrine therapy, today announced that
it presented positive efficacy and safety data for its doxorubicin
targeted conjugate compound, AEZS-108, in ovarian cancer. The
presentation was made by Prof. Günter Emons, Chairman, Department
of Obstetrics & Gynaecology Georg-August University Göttingen,
Germany, during last Saturday's
poster session at the American Society of Clinical Oncology (ASCO)
Annual Meeting, being held through June 8,
2010 at McCormick Place in Chicago. AEZS-108 is currently in a Phase 2
trial conducted in Europe by the
German AGO Study Group (Study AGO-GYN5), in advanced ovarian and
endometrial cancer, with final results expected by year-end.
The poster (abstract #5035) entitled, "Phase 2 study of
AEZS-108, a targeted cytotoxic LHRH analog, in patients with LHRH
receptor positive platinum resistant ovarian cancer", G. Emons, S.
Tomov, P. Harter, J. Sehouli, P. Wimberger, A. Staehle, L. C.
Hanker, F. Hilpert, P. Dall, and C. Gruendker, for the AGO Study
Group, details the use of AEZS-108, a targeted cytotoxic drug in
which doxorubicin is linked to (D-Lys(6))-luteinizing
hormone-releasing hormone (LHRH), in women with histologically
confirmed taxane-pretreated platinum-resistant/refractory LHRH-R
positive advanced (FIGO III or IV) or recurrent ovarian cancer.
Patients received a recommended dose of 267 mg/m2 by intravenous
infusion over 2 hours, with retreatment every 3 weeks, for up to 6
courses. Response rate (RECIST and/or GCIG criteria) was defined as
primary endpoint. Secondary endpoints were safety,
time-to-progression (TTP) and overall survival (OS).
Results
42 patients with platinum-resistant ovarian cancer entered the
study. Efficacy included partial response in 5 patients (11.9%) and
stable disease for more than 12 weeks in 11 patients (26.2%). Based
on those data, a Clinical Benefit Rate (CBR) of 38% can be
estimated. Median time to progression (TTP) and overall survival
(OS) were 3.5 months (104 days) and 15.6 months (475 days),
respectively.
In all, tolerability of AEZS-108 was good and commonly allowed
retreatment as scheduled. Only one patient (2.4%) had a dose
reduction, and overall, 25 of 170 (14.7%) courses were given with a
delay, including also cases in which delay was not related to
toxicity. Severe (Grade 3 or 4) toxicity was mainly restricted to
rapidly reversible hematologic toxicity (leukopenia / neutropenia)
associated with fever in 3 cases. Good tolerability of AEZS-108 was
also reflected with only a few patients with non-hematological
toxicities of grade 3 (none with grade 4), including single cases
(2.4%) each of nausea, constipation, poor general condition, and an
enzyme elevation. No cardiac toxicity was reported.
"The efficacy of AEZS-108 in our study was encouraging,
considering that it only included patients resistant to prior
platinum- and taxane-based therapies", commented Prof. Günter
Emons. "In these patients, a clinical benefit rate of 38% and
particularly a median overall survival of over 15 months compare
favourably with results for drugs such as topotecan and pegylated
liposomal doxorubicin that are currently used in this setting.
Furthermore, the safety profile of AEZS-108 was relatively benign
with no unexpected findings and in particular, no cardiac
toxicity."
Juergen Engel, Ph.D., President
and CEO of Aeterna Zentaris added, "With these favourable results
in refractory ovarian cancer patients, we are now looking forward
to the data of our endometrial cancer study scheduled for the
fourth quarter."
Conclusion
- AEZS-108 was active and well tolerated in patients with heavily
pre-treated platinum and taxane resistant ovarian cancer;
- The safety profile confirmed the dose of 267 mg/m2;
- Hematological toxicity was rapidly reversible;
- Non-hematological toxicities were usually limited to lower severity;
- Tolerability and CBR compare favourably with topotecan and liposomal
doxorubicin;
- Overall survival is encouraging as all patients treated with AEZS-108
were platinum-resistant.
Copies of the abstract and the poster are currently available
and can be viewed on-line through the ASCO website:
http://www.asco.org/.
About Ovarian Cancer
Ovarian cancer is one of the most common gynaecologic
malignancies and the fifth most frequent cause of cancer death in
women, with most of the cases occurring in women between 50 and 75
years of age. Overall, ovarian cancer accounts for 4% of all cancer
diagnoses in women and 5% of all cancer deaths. Approximately
26,000 new cases and 17,000 deaths from this disease are estimated
in the European community every year (Source: Gynaecologic Oncology
2004; 92:819-26). The National Cancer Institute estimates that in
2009, in the United States alone,
there were 21,550 news cases of ovarian cancer and 14,600 related
deaths. A study of Gordon et al, JCO 2001;19:3312-22, compared
pegylated liposomal doxorubicin with topotecan showed overall
survival of 13.7 and 13.0 months, respectively, in the total study
population and 8.2 and 9.5 months, respectively, in the subgroup of
patients with platinum-resistant disease.
About AEZS-108
AEZS-108, a doxorubicin LHRH receptor targeted conjugate, is
currently in a Phase 2 trial in advanced ovarian and endometrial
cancer for which final results are expected before year-end.
AEZS-108 has been granted orphan-drug designation by the FDA and
has received a positive opinion for Orphan Medicinal Product
designation from the Committee for Orphan Medicinal Products (COMP)
of the European Medicines Agency, for the treatment of ovarian
cancer.
An Investigational New Drug (IND) in the U.S. is in place for
the treatment of bladder cancer.
About Aeterna Zentaris Inc.
Aeterna Zentaris Inc. is a late-stage drug development company
specialized in oncology and endocrine therapy. News releases and
additional information are available at www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking statements made
pursuant to the safe harbor provisions of the U.S. Securities
Litigation Reform Act of 1995. Forward-looking statements involve
known and unknown risks and uncertainties, which could cause the
Company's actual results to differ materially from those in the
forward-looking statements. Such risks and uncertainties include,
among others, the availability of funds and resources to pursue
R&D projects, the successful and timely completion of clinical
studies, the ability of the Company to take advantage of business
opportunities in the pharmaceutical industry, uncertainties related
to the regulatory process and general changes in economic
conditions. Investors should consult the Company's quarterly and
annual filings with the Canadian and U.S. securities commissions
for additional information on risks and uncertainties relating to
the forward-looking statements. Investors are cautioned not to rely
on these forward-looking statements. The Company does not undertake
to update these forward-looking statements. We disclaim any
obligation to update any such factors or to publicly announce the
result of any revisions to any of the forward-looking statements
contained herein to reflect future results, events or developments
except if we are required by a governmental authority or applicable
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SOURCE AETERNA ZENTARIS INC.