FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
For the month of February 2008
AETERNA ZENTARIS INC.
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1405, boul. du Parc-Technologique
Quebec, Quebec
Canada, G1P 4P5
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports
under cover of Form 20-F or Form 40-F.
Form 20-F / / Form 40-F /X/
Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934
Yes / / No /X/
If "Yes" is marked, indicate below the file number assigned to the registrant in
connection with Rule 12g3-2(b): 82-
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DOCUMENTS INDEX
DOCUMENTS DESCRIPTION
1. Press Release dated February 12, 2008: AEterna Zentaris Reports First
Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in
Ovarian and Endometrial Cancers
[LOGO]
AETERNA ZENTARIS INC. 1405 du Parc-Technologique Blvd.
Quebec (Quebec) Canada G1P 4P5 T 418 652-8525 F 418 652-0881
www.aeternazentaris.com
PRESS RELEASE
For immediate release
AETERNA ZENTARIS REPORTS FIRST PATIENTS TREATED WITH ANTI-CANCER COMPOUND
AEZS-108 IN PHASE 2 TRIAL IN OVARIAN AND ENDOMETRIAL CANCERS
QUEBEC CITY, CANADA, FEBRUARY 12, 2008 - AEterna Zentaris Inc. (NASDAQ: AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported that dosing of AEZS-108, a luteinizing
hormone-releasing hormone (LHRH) agonist linked to doxorubicin, has commenced in
its Phase 2 trial in gynaecological cancers for which patient enrolment had
begun in December 2007. This open-label, non-comparative multi-center Phase 2
trial will treat up to 82 women with LHRH-receptor positive ovarian and
endometrial cancerous tumors. The primary endpoint for the trial will be the
partial or complete tumor response rate according to Response Evaluation
Criteria in Solid Tumors (RECIST) and/or Gynaecologic Cancer Intergroup (GCIG)
guidelines. The trial is being conducted in 15 centers in Europe under the
supervision of lead investigator, Prof. Gunter Emons, M.D., of the
Georg-August-University, Gottingen Institute of Gynaecology and Obstetrics in
Gottingen, Germany.
David J. Mazzo, Ph.D., President and CEO of AEterna Zentaris
commented, "We are excited to have started dosing patients in our Phase 2 trial
with AEZS-108, our highest priority oncology compound. We believe that our
approach targeting only patients with LHRH-receptor expressing tumors using
doxorubicin is key to both potential increased individual patient safety and
potential augmented clinical benefit, while ultimately providing us results that
will be pivotal in formulating the next steps in the clinical development of
this novel agent."
ABOUT THE PHASE 2 TRIAL
Entitled, "THE ANTITUMORAL ACTIVITY AND SAFETY OF AEZS-108 (AN-152), A LHRH
AGONIST LINKED DOXORUBICIN IN WOMEN WITH LHRH-RECEPTOR POSITIVE GYNAECOLOGICAL
TUMORS", this European open-label, non-comparative multi-center Phase 2 trial
will have as its primary endpoint the partial or complete tumor response rate
according to RECIST and/or GCIG guidelines. Secondary endpoints will include
time to progression, survival, toxicity as well as adverse effects. The trial
will include up to 82 patients (up to 41 with a diagnosis of platinum-resistant
ovarian cancer and up to 41 with disseminated endometrial cancer). Patients will
be administered an intravenous infusion of 267 mg/m (TO THE POWE OF 2) of
AEZS-108 over a period of 2 hours at a constant rate, every Day 1 of a 21-day
(3-week) cycle. The proposed duration of the study
treatment is six, three-week cycles. The planned study period is approximately
24 months. Further information on the trial is available at
www.clinicaltrials.gov.
PRIOR PHASE 1 TRIAL RESULTS
On June 3, 2007 positive results of an open, multi-center, sequential group,
dose-escalation Phase 1 study in various gynaecological cancers were presented
at the American Society of Clinical Oncology's (ASCO) Annual Meeting in Chicago,
Illinois. 17 patients with LHRH-receptor positive gynaecological cancers were
recruited. AEZS-108 was administered by intravenous infusion over two hours at
dosages of 10, 20, 40, 80,160 and 267 mg/m (TO THE POWE OF 2). At 160 mg/m (TO
THE POWE OF 2), six patients had a total of 32 cycles and at 267 mg/m (TO THE
POWE OF 2), seven patients had a total of 27 cycles. Most of the patients had
been pretreated with various chemotherapies.
The study showed that AEZS-108 was well tolerated by patients with
gynaecological tumors. Furthermore, AEZS-108 is the first drug in a clinical
study that targets the cytotoxic activity of doxorubicin specifically to
LHRH-receptor expressing tumors. Finally, signs of anti-tumor activity were
observed in three out of 13 patients treated with 160 or 267 mg/m (TO THE POWE
OF 2) of AEZS-108, including three patients with complete or partial response.
ABOUT AEZS-108
AEZS-108 is a targeted 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 in the malignant tissue. This binding is followed by
internalization and retention of the cytotoxic drug, doxorubicin, in the cells.
Therefore, since they target specific cells, cytotoxic conjugates are postulated
to be less toxic, have less side-effects and are more effective IN VIVO than the
respective non-conjugated/non-linked cytotoxic agents in inhibiting tumor
growth.
ABOUT OVARIAN AND ENDOMETRIAL 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 diagnosis 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: GYNECOLOGIC ONCOLOGY, VOLUME 92, ISSUE 3, MARCH 2004, PAGES 819-826)
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 the sixth decade. Approximately 38,000 new cases and 9,000 deaths from
this disease are estimated annually in Europe.
(Source: ANNALS OF ONCOLOGY 15:1149-1150, 2004)
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
www.aeternazentaris.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 requested by a
governmental authority or applicable law.
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CONTACTS
Jenene Thomas
Senior Director, Investor Relations & Corporate Communications
(908) 626-5509
jthomas@aezsinc.com
Paul Burroughs
Media Relations
(418) 652-8525 ext. 406
pburroughs@aezsinc.com
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
AETERNA ZENTARIS INC.
Date: February 12, 2008 By: /s/Mario Paradis
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Mario Paradis
Senior Vice President, Administrative and
Legal Affairs and Corporate Secretary