Encouraging data observed in overall survival and tolerability
Company has requested Parallel Scientific Advice from FDA and EMA for pivotal trial
QUÉBEC CITY, Sept. 14, 2011 /CNW Telbec/ - Aeterna Zentaris Inc.
(NASDAQ: AEZS) (TSX: AEZ) (the "Company") earlier today, presented
positive final Phase 2 efficacy and safety data for its targeted
cytotoxic luteinizing hormone releasing hormone (LHRH) analog,
AEZS-108, in advanced endometrial cancer. The trial, chaired by Prof.
Günter Emons, Chairman, Department of Obstetrics & Gynaecology,
Georg-August University Göttingen, Germany, was conducted by the German
AGO Study Group and centers in Bulgaria. The presentation was made by
Pauline Wimberger, M.D., Assistant Director, Gynaecology and Obstetrics
Clinic, University of Duisburg-Essen, Germany, during a poster session
at the 17th International Meeting of the European Society of Gynaecological Oncology
(ESGO) currently being held in Milan, Italy.
"The safety and efficacy of AEZS-108 in our study on advanced
endometrial cancer was very encouraging", commented Dr. Wimberger.
"Although used as a single agent treatment only, AEZS-108 achieved good
response rates and disease stabilization. Personally, I was impressed
to see three responses in the five patients treated at my institution,
including one long-lasting complete response."
Juergen Engel, Ph.D., President and CEO of Aeterna Zentaris added, "We
would first like to thank Dr. Wimberger and all those involved in this
trial for their dedicated work which is now being presented to the
international gynaecological community. We are very excited about these
final results achieved with AEZS-108 alone, which compare favourably
with those usually seen with more aggressive and less well tolerated
combination regimens for endometrial cancer. On this basis, we have
requested Parallel Scientific Advice from both the FDA and the EMA for
the further pivotal development of AEZS 108 in this indication in the
The poster (abstract #247) entitled, "AGO-GYN 5 - (Phase II) with AEZS-108, a targeted cytotoxic LHRH analog in
patients with LHRH receptor positive endometrial cancer", Wimberger P, Gorchev G, Hanker L, Stähle A, Hristamian A, Beckmann MW,
Dall P, Gründker C, Hilpert F, Sehouli J, Harter P, Taskova V, Emons G,
details the use of AEZS-108, the Company's targeted cytotoxic analog in
which doxorubicin, a well known chemotherapeutic agent, is linked to
[D-Lys(6)]-LHRH, in women with histologically confirmed LHRH-R positive
advanced (FIGO III or IV) or recurrent endometrial cancer. Patients
received AEZS-108 by intravenous infusion at a dose of 267 mg/m2, once every 3 weeks. The primary endpoint was the response rate as
defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
Secondary endpoints included safety, time-to-progression (TTP) and
overall survival (OS).
In all, of 43 patients treated with AEZS-108, 39 were evaluable for
efficacy. Efficacy confirmed by independent response review included 2
complete responses (CR), 10 partial responses (PR), and 17 patients
with disease stabilization (SD). Based on those data, the estimated
Overall Response Rate (ORR = CR+PR) was 30.8% and the Clinical Benefit
Rate (CBR = CR+PR+SD) was 74.4%. Responses in patients previously
treated with chemotherapy included 1 CR, 1 PR and 2 SDs in 8 of the
patients with prior use of platinum/taxane regimens. Median TTP and OS
were 7 months and 13.7 months, respectively.
Overall, tolerability of AEZS-108 was good and commonly allowed
retreatment as scheduled. Only one patient had a dose reduction, and
less than 10% of treatment courses were postponed, including more than
half of the cases in which the delay was not related to toxicity.
Severe (Grade 3 or 4) toxicity was mainly restricted to rapidly
reversible leukopenia and neutropenia, associated with fever in only 1
patient who had been treated only 3 weeks after a surgery. Good
tolerability of AEZS-108 was also reflected by a low rate of severe
non-hematological possibly drug-related adverse events which included
single cases each of nausea, diarrhea, fatigue, general health
deterioration, creatinine elevation, and blood potassium decrease. No
cardiac toxicity was reported.
AEZS-108 at a dosage of 267 mg/m2 every 3 weeks was active and well tolerated in patients with
Hematological toxicity was rapidly reversible, and non-hematological
toxicities were usually not severe, causing few deviations from
The objective response rate of 30.8% compares well with those of single
agent platinum or taxane treatment; responders included patients
pre-treated with platinum/taxane combination.
In addition, the rate of stable disease was 43.6%, resulting in a
Clinical Benefit Rate of 74.4%.
The overall survival after single agent AEZS-108 is similar to that
reported for modern triple combination chemotherapy, but was achieved
with lower toxicity.
To consult a copy of the poster, please click here.
About Endometrial Cancer
This year, the American Cancer Society estimates that more than 43,000
cases of endometrial cancer - tumors in the lining of the uterus and
the glands of the endometrium - will be diagnosed in the United States.
Symptoms can include unexplained vaginal bleeding, painful urination,
painful intercourse and soreness in the pelvic area. There is no
routine test to identify endometrial cancer. Treatment options include
surgery, radiation therapy, hormone therapy and chemotherapy; however,
there are new treatments in development that work by targeting and
destroying cancerous cells.
AEZS-108 represents a new targeting concept in oncology using a hybrid
molecule composed of a synthetic peptide carrier and a well-known
chemotherapy agent, doxorubicin. AEZS-108 is the first intravenous drug
in a clinical study that directs the chemotherapy agent specifically to
LHRH-receptor expressing tumors, resulting in more targeted treatment
with less damage to healthy tissue. The product has successfully
completed Phase 2 studies for the treatment of endometrial and ovarian
cancer, and is also in Phase 2 trials in prostate and bladder cancer. A
pivotal trial in endometrial cancer is expected to be initiated by the
end of 2011. AEZS-108 has been granted orphan-drug designation by the
FDA and orphan medicinal product designation from the EMA for the
treatment of ovarian cancer. Aeterna Zentaris owns the worldwide rights
About Aeterna Zentaris Inc.
Aeterna Zentaris is a late-stage oncology drug development company
currently investigating potential treatments for various cancers
including colorectal, multiple myeloma, endometrial, ovarian, prostate
and bladder cancer. The Company's innovative approach of "personalized
medicine" means tailoring treatments to a patient's specific condition
and to unmet medical needs. Aeterna Zentaris' deep pipeline is drawn
from its proprietary discovery unit providing the Company with constant
and long-term access to state-of-the-art therapeutic options. For more
information please visit www.aezsinc.com.
This press release contains forward-looking statements made pursuant to
the safe harbour provisions of the U.S. Securities Litigation Reform
Act of 1995. Forward-looking statements involve known and unknown risks
and uncertainties that 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 risk that safety and efficacy data
from any of our Phase 3 trials may not coincide with the data analyses
from previously reported Phase 1 and/or Phase 2 clinical trials, 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 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, unless required to do so by a governmental authority or
by applicable law.
SOURCE AETERNA ZENTARIS INC.
For further information:
Ginette Beaudet Vallières
Investor Relations Coordinator
(418) 652-8525 ext. 265
Director of Communications
(418) 652-8525 ext. 406