AEterna Zentaris Reaches 2nd Stage of Patient Recruitment for Phase 2 Trial in Ovarian Cancer with the Innovative LHRH Receptor Targeted Conjugate, AEZS-108

    QUEBEC CITY, Oct. 2 /CNW Telbec/ - AEterna Zentaris Inc. (NASDAQ:   AEZS;
TSX: AEZ), a global biopharmaceutical company focused on endocrine therapy and
oncology, today reported that it has entered the second stage of patient
recruitment for its Phase 2 trial in ovarian cancer with AEZS-108, a
luteinizing hormone-releasing hormone (LHRH) agonist linked to doxorubicin.
The decision to enter the second stage of patient recruitment was taken
following recent first stage data reporting two partial responses (PR) among
patients with a diagnosis of platinum-resistant ovarian cancer. The trial is
part of a Phase 2 program in gynaecological cancers for which patient
enrolment began in December 2007. The open-label, non-comparative multi-center
Phase 2 program will treat up to 82 women with LHRH-receptor positive ovarian
and endometrial cancerous tumors. The primary endpoint for the program is the
partial or complete tumor response rate according to Response Evaluation
Criteria in Solid Tumors (RECIST) and/or Gynaecologic Cancer Intergroup (GCIG)
guidelines. The program is being conducted in 15 centers in Europe under the
supervision of lead investigator, Prof. Gunter Emons, M.D., of the
Georg-August-University, Institute of Gynaecology and Obstetrics in Gvttingen,
    Paul Blake, M.D., Senior Vice President and Chief Medical Officer of
AEterna Zentaris commented, "We are encouraged by the early signal of
potential efficacy of our lead oncology compound, AEZS-108, for patients
suffering from ovarian cancer. We believe that specifically targeting
LHRH-receptor expressing tumors using doxorubicin is key to achieving
increased clinical benefit for these patients. Finally, we look forward to
disclosing full results during the next few months, as they will be pivotal in
formulating the next steps in the clinical development of this novel agent."
    Juergen Engel, Ph.D., President and CEO of AEterna Zentaris stated,
"These results confirm the early signals of anticancer activity we have seen
in our phase 1 study with this new targeting concept we developed in
collaboration with the Nobel Prize laureate Dr. Andrew V. Schally."

    About the Phase 2 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", this European open-label, non-comparative multi-center
Phase 2 program has as its primary endpoint, the partial or complete tumor
response rate according to RECIST and/or GCIG guidelines. Secondary endpoints
include time to progression, survival, toxicity as well as adverse effects.
The program 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 are 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. Further information on the program is available at

    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
    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 seven 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 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 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

    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

    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: Investor Relations: Dennis Turpin, Senior Vice
President and CFO, (418) 652-8525 ext. 242,; Media
Relations: Paul Burroughs, Director of Communications, (418) 652-8525 ext.

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