AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial Cancers



    QUEBEC CITY, Feb. 12 /CNW Telbec/ - 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/m2 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/m2. At 160 mg/m2, six
patients had a total of 32 cycles and at 267 mg/m2, 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/m2 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.




For further information:

For further information: 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; www.aeternazentaris.com

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