Filing of Clinical Trial Application (CTA) in Prostate Cancer
Expected in Q4 2012
QUEBEC CITY, Oct. 2,
2012 /PRNewswire/ - Aeterna Zentaris Inc. (NASDAQ: AEZS)
(TSX: AEZ) (the "Company") today announced that preclinical
data on its oral prostate cancer vaccine candidate, AEZS-120, were
presented over the weekend at the 32nd Congress of the
Société Internationale d'Urologie, which is being held in
Fukuoka, Japan. The presentation
underlined the feasibility of an oral therapeutic vaccination
approach against prostate cancer. Furthermore, safety pharmacology
and toxicology data suggest that the profile of AEZS-120 is similar
to the approved carrier strain and, therefore, pave the way for
Phase 1 clinical testing.
Juergen Engel, PhD,
President and CEO at Aeterna Zentaris, commented, "Now that we have
completed the preclinical development program for AEZS-120, we look
forward to filing a Clinical Trial Application in Europe during this quarter, in order to
initiate a Phase 1 clinical trial in prostate cancer with this
novel oral anticancer vaccine."
Summary and Conclusions
The production, release, pharmacology, safety and
toxicology program was conducted in agreement with the regulatory
authorities and successfully finalized:
- The proof of concept has been shown in a tumor-challenge mouse
model using the anticipated clinical application schedule;
- Biosafety and biodistribution studies did not reveal a
different safety profile compared to the carrier strain;
- Pharmacological and toxicological studies did not reveal
differences to the approved carrier strain;
- In all, the non-clinical studies suggest that the safety and
toxicological profile of AEZ-120 is similar to the approved carrier
strain S. typhi Ty21a, which has already been safely applied in
more than 250 million doses;
- GMP material for clinical use has been produced and released;
and CTA filing for Phase 1 clinical study is planned in 4Q
2012.
The poster titled, "Preclinical Proof of Concept
and Characterization of AEZS-120, a Therapeutic Oral Prostate
Cancer Vaccine Candidate Based on Live Recombinant Attenuated
Salmonella", J. Fensterle, B. Bergmann, P. Schmidt, M. Teifel,
J. Engel, T. Rudel, W. Goebel, and U. Rapp, can be viewed by
clicking on the following link.
About AEZS-120
AEZS-120 is a live recombinant oral tumor vaccine
candidate based on Salmonella typhi Ty21a as a carrier
strain. Salmonella typhi Ty21a is an approved oral typhoid
vaccine which has been safely applied in more than 250 million
doses. The principle of AEZS-120 is based on the recombinant
expression of prostate specific antigen fused to the B subunit of
cholera toxin and a secretion signal in the presence of the
Escherichia coli type I hemolysin secretion system. The
proprietary system allows the secretion of the antigen, together
with an immunological adjuvant which has been demonstrated to be
required for optimal induction of CD8 T-cell responses by
recombinant Salmonella based bacterial vaccines. The
proof-of-concept was demonstrated for the mouse homologue of
AEZS-120 in a mouse tumor-challenge model. In general, by varying
the antigen and/or the carrier, this proprietary platform
technology should be suitable for virtually any therapeutic or
prophylactic vaccine indication with a favorable cost of goods
expectation in large scale.
About Aeterna Zentaris
Aeterna Zentaris is an oncology and endocrinology
drug development company currently investigating treatments for
various unmet medical needs. The Company's pipeline encompasses
compounds at all stages of development, from drug discovery through
to marketed products. For more information please visit
www.aezsinc.com.
Forward-Looking Statements
This press release contains forward-looking
statements made pursuant to the safe harbour provisions of the U.S.
Securities Litigation Reform Act of 1995. Forward-looking
statements involve known and unknown risks and uncertainties that
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 risk that safety and efficacy
data from any of our Phase 3 trials may not coincide with the data
analyses from previously reported Phase 1 and/or Phase 2 clinical
trials, 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
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, unless
required to do so by a governmental authority or by applicable
law.
SOURCE AETERNA ZENTARIS INC.