AEterna Zentaris Reports First Patients Treated with Anti-Cancer Compound AEZS-108 in Phase 2 Trial in Ovarian and Endometrial C
February 12 2008 - 7:30AM
PR Newswire (US)
QUEBEC CITY, Feb. 12 /PRNewswire-FirstCall/ -- 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
http://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
http://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.
DATASOURCE: AETERNA ZENTARIS INC. CONTACT: Jenene Thomas, Senior
Director, Investor Relations & Corporate Communications, (908)
626-5509, ; Paul Burroughs, Media Relations, (418) 652-8525 ext.
406, ; http://www.aeternazentaris.com/
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