AEterna Zentaris Announces Positive Results for Phase 2 Study with LHRH-Receptor Targeted Cytotoxic Conjugate AEZS-108 in Endome
24 Novembro 2009 - 10:00AM
PR Newswire (US)
Primary efficacy endpoint has been met for patients with
advanced-stage or recurrent endometrial cancer QUEBEC CITY, Nov. 24
/PRNewswire-FirstCall/ -- AEterna Zentaris Inc. (NASDAQ: AEZS; TSX:
AEZ) (the "Company"), a global biopharmaceutical company focused on
endocrine therapy and oncology, today announced positive efficacy
data from a Phase 2 study with its targeted cytotoxic peptide
conjugate, AEZS-108 (formerly AN-152), in patients with advanced or
recurrent endometrial cancer. In a personalized health care
approach, the study selected patients with tumors expressing
luteinizing hormone-releasing hormone (LHRH) receptors, the key
element in the targeting mechanism of AEZS-108. Under the
coordination of Prof. Gunter Emons, MD, Chairman of the Department
of Obstetrics & Gynaecology at the University of Gottingen,
Germany, this open-label, multi-center and multi-national Phase 2
study AGO-GYN 5, is being conducted by the German AGO Study Group
(Arbeitsgemeinschaft Gynakologische Onkologie/Gynaecological
Oncology Working Group; http://www.ago-ovar.de/), in cooperation
with clinical sites in Europe. Preliminary Results A preliminary
evaluation has shown that the study AGO-GYN 5 met its predefined
primary efficacy endpoint of 5 or more responder patients with
endometrial cancer. The study is currently ongoing, and responders,
as well as patients with stable disease after completion of
treatment with AEZS-108, will be followed to assess the duration of
progression-free survival and, ultimately, overall survival.
Detailed analyses of the study results will be presented at
forthcoming scientific conferences. Juergen Engel, Ph.D., President
and Chief Executive Officer at AEterna Zentaris stated, "We are
pleased with the progress of this Phase 2 program. Along with the
recently disclosed positive results for the ovarian cancer
indication, the good news for the endometrial cancer indication
provides us with an even stronger basis to take the next steps in
the development of AEZS-108 in gynaecological cancers." About
AEZS-108 and its Phase 2 program AEZS-108 represents a new
targeting concept in oncology using a cytotoxic peptide conjugate
which is a hybrid molecule composed of a synthetic peptide carrier
and a well-known cytotoxic agent, doxorubicin. The design of this
product allows for the specific binding and selective uptake of the
cytotoxic conjugate by LHRH-receptor positive tumors. The binding
of AEZS-108 to cancerous cells that express these receptors,
results in its accumulation and preferential uptake in the
malignant tissue. In a Phase 2 study program entitled, "The
antitumoral activity and safety of AEZS-108 (AN-152), a LHRH
agonist linked doxorubicin in women with LHRH-receptor positive
gynaecological tumors", patients with tumors expressing LHRH
receptors are administered an intravenous infusion of 267 mg/m2 of
AEZS-108 over a period of 2 hours, every Day 1 of a 21-day (3-week)
cycle. The proposed duration of the study treatment is 6, 3-week
cycles. Study AGO-GYN 5 is performed with 14 centers of the German
Gynaecological Oncology Working Group (AGO;
http://www.ago-ovar.de/), in cooperation with 3 clinical sites in
Europe. The program was planned to include up to 82 evaluable
patients, up to 41 with a diagnosis of platinum-resistant and
taxane-pretreated ovarian cancer, (for which positive results were
disclosed on November 2, 2009) and up to 41 with advanced or
recurrent endometrial cancer. For both indications, patient
recruitment was planned in 2 stages, with 21 and 20 patients,
respectively, and the primary efficacy endpoint at the end of stage
2 was defined as 5 or more patients with partial or complete tumor
responses according to Response Evaluation Criteria in Solid Tumors
(RECIST) and/or Gynaecologic Cancer Intergroup (GCIG) guidelines.
Secondary endpoints include time to progression, survival, toxicity
as well as adverse effects. About Endometrial and Ovarian Cancer
Cancer of the endometrium is the most common gynaecologic
malignancy and accounts for 6% of all cancers in women. The
majority of the cases occur in postmenopausal women, with the
largest number of women developing their cancers during their sixth
decade. Approximately 38,000 new cases and 9,000 deaths from this
disease are estimated annually in Europe (Source: Annals of
Oncology 2004; 15:1149-50). 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). About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a global biopharmaceutical company focused
on endocrine therapy and oncology, with proven expertise in drug
discovery, development and commercialization. News releases and
additional information are available at http://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 law.
DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Investor Relations:
Ginette Vallieres, Investor Relations Coordinator, (418) 652-8525
ext. 265, ; Media Relations: Paul Burroughs, Director of
Communications, (418) 652-8525, ext. 406,
Copyright