AEterna Zentaris Presents Detailed Phase 1 Results for Anti-Cancer Compound AEZS-108 at ASCO Meeting



    
    AEZS-108 was well tolerated and anti-tumor activity was observed in 7 out
    of 13 patients treated with the highest dose levels

    Phase 2 trial in ovarian and endometrial cancers to be initiated before
    year end
    

    QUEBEC CITY, QC, June 4 /CNW Telbec/ - AEterna Zentaris Inc. (TSX: AEZ;
Nasdaq:   AEZS), a global biopharmaceutical company focused on endocrine therapy
and oncology, today announced that it presented a poster outlining detailed
Phase 1 results for its targeted cytotoxic luteinizing hormone-releasing
hormone (LHRH) analog, AEZS-108 (formerly named AN-152 and ZEN-008), in female
patients with cancers expressing LHRH receptors. Evidence of anti-tumor
activity was found at 160 mg/m(2) or 267 mg/m(2) doses of AEZS-108, where 7 of
13 patients showed signs of tumor response, including 3 patients with complete
or partial responses. The poster No.3571 titled, "Phase 1 study of ZEN-008
(AN-152), a targeted cytotoxic LHRH analog, in female patients with cancers
expressing LHRH receptors": G. Emons, M. Kaufmann, A. Gunthert, C. Grundker,
S. Loibl, V.I. Tzekova, M.T. Velikova, S. Tomov, H. Sindermann, J. Engel and
A.V. Schally, was presented Sunday, June 3, 2007 at the American Society of
Clinical Oncology's (ASCO) Annual Meeting currently being held in Chicago,
Illinois.
    David J. Mazzo, Ph.D., President and CEO of AEterna Zentaris commented,
"The outcome of this study with AEZS-108 is very encouraging as we are
preparing to initiate our Phase 2 trial in endometrial and ovarian cancers. We
believe that our targeted approach, including only patients with LHRH receptor
expressing tumors, is the key to both individual patient safety and clinical
benefit as well as the potential success of the upcoming trial."

    Details

    This open, multi-center, sequential group, dose-escalation Phase 1 study
assessed dose-limiting toxicities (DLTs), maximum tolerated dose (MTD), and
pharmacokinetics (PK) of AEZS-108 given once every three weeks in female
patients with cancers expressing LHRH receptors. Safety monitoring included
secretory function of the pituitary gland and cardiac function, while adverse
events were calculated according to the NCI Common Terminology Criteria for
Adverse Events (CTCAE). Tumor response was evaluated according to Response
Evaluation Criteria In Solid Tumors (RECIST) and by measuring tumor marker
levels (CA125). High performance liquid chromatography (HPLC) with
fluorescence detection was used for plasma PK of AEZS-108 and free
doxorubicin.
    Seventeen patients with LHRH receptor-positive ovarian, endometrial or
breast 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(2). At
160 mg/m(2), six patients had a total of 32 cycles and at 267 mg/m(2), seven
patients had a total of 27 cycles. Most of the patients had been pretreated
with various chemotherapies.

    Results

    Leucopenia/neutropenia of CTCAE Grade 4 was dose limiting in two of seven
patients at 267 mg/m(2). The patients recovered spontaneously from
hematoxicity without use of hematopoietic growth factors. The most frequently
observed non-hematological toxicities were alopecia, nausea and fatigue. Most
toxicities were of Grade I. Two patients at the dose levels of 160 and
267 mg/m(2) had a moderate allergic skin reaction (CTCAE Grade 2) during the
first infusion; subsequent cycles with anti-allergic pre-medication were
tolerated. No indication of cardiac toxicity or impairment of the pituitary
gland function was reported.
    Regarding tumor response, at 160 mg/m(2), one patient with ovarian cancer
showed the complete disappearance of a malignant lymph node (diameter 17 mm)
at the first follow-up and received a total of six treatment cycles. Another
patient showed stable disease for six cycles and one patient had stable
disease until cycle 5.
    At 267 mg/m(2) one patient with ovarian cancer had a partial response of
liver metastasis which was accompanied by a complete normalization of CA125
levels. Additionally, one patient showed complete CA125 tumor marker response
(no evaluable target lesions in this patient) and received six treatment
cycles. Finally, two patients showed stabilization of disease under treatment
with 267 mg/m(2) of AEZS-108 and were treated with five and six treatment
cycles, respectively. In one of these patients, an additional transient minor
tumor regression was observed.
    PK analyses showed dose-dependent plasma levels of AEZS-108 and only
minor (10-30%) release of doxorubicin.

    Conclusions

    
    - AEZS-108 was well tolerated by patients with gynecological tumors;
    - AEZS-108 is the first drug in a clinical study that targets the
      cytotoxic activity of doxorubicin specifically to LHRH-receptor
      expressing tumors;
    - Signs of anti-tumor activity were observed in 7 out of 13 patients
      treated with 160 or 267 mg/m(2) of AEZS-108, including 3 patients
      with complete or partial response; and
    - Recommended dose for further clinical studies will be 267 mg/m(2)
      given once every three weeks.
    

    Based on the Phase 1 results, the Company plans to initiate a Phase 2
trial with AEZS-108 in patients with LHRH-receptor expressing gynecological
tumors (advanced or recurrent ovarian and endometrial tumors) before year end.

    About Cytotoxic Conjugate 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 the LHRH receptor-positive
tumors. The binding of conjugate molecule 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 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. Statements that are not historical facts, including statements preceded
by, followed by, or that include the words "believes", "anticipates",
"intends", "plans", "expects", "estimates", "will," "may", "should",
"approximately", and the negative or other variations of those terms or
comparable terminology, are forward-looking statements. Such statements
reflect management's current views, intentions, strategies and plans and are
based on certain assumptions.
    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 ability of AEterna Zentaris to
implement its business strategies, the availability of funds and resources to
pursue R&D projects, the successful and timely completion of clinical studies,
the ability of AEterna Zentaris 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.




For further information:

For further information: Jenene Thomas, Senior Director, Investor
Relations & Corporate Communications, (908) 938-1475,
jenene.thomas@aeternazentaris.com; Paul Burroughs, Media Relations, (418)
652-8525, ext. 406, paul.burroughs@aeternazentaris.com

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