Clinical Experience on AEterna Zentaris' Impavido(R) Published in Clinical Infectious Diseases
November 15 2004 - 7:33AM
PR Newswire (US)
Clinical Experience on AEterna Zentaris' Impavido(R) Published in
Clinical Infectious Diseases Results support the therapeutic
utility of Impavido(R) in immunocompromised HIV-infected patients
with recurrent leishmaniasis QUEBEC, Nov. 15 /PRNewswire-FirstCall/
-- AEterna Zentaris Inc. (TSX: AEZ; Nasdaq: AEZS) today announced a
publication in the peer-reviewed Clinical Infectious Diseases
Journal demonstrating the therapeutic utility and favourable
tolerability of oral miltefosine (Impavido(R)) as initial and
maintenance treatment of recurrent visceral leishmaniasis, an
opportunistic life- threatening infection also known as black
fever, in immunocompromised HIV- infected patients. The results
come from a compassionate use program of oral miltefosine in 39 HIV
infected patients, all with parasitologically verified
leishmaniasis, who had failed at least one and as many as nine
prior courses of standard therapy for leishmaniasis and were
receiving antiviral combination therapy for HIV. The initial
response and initial cure rates for miltefosine were shown to be
64% and 41%, respectively, a significant positive finding in this
tough-to-treat patient population that currently lacks treatment
alternatives. All currently existing drug treatments for
leishmaniasis have a high rate of relapse and, unlike miltefosine,
are for parenteral (injection) use. Miltefosine was generally
well-tolerated, with no dose-limiting side effects or adverse
interactions with antiviral therapy, even when used for extended
periods of maintenance treatment for up to two years. The most
frequently observed side effects in this study were
gastrointestinal and included vomiting, nausea and diarrhea.
Miltefosine's safety and tolerability profile compares favourably
to that of other treatment modalities, which can be associated with
treatment-limiting side effects such as kidney toxicity. "The
results of this study continue to support the use of Impavido(R) as
a much-needed treatment alternative that combines the convenience
of oral use with favourable efficacy and tolerability for patients
with leishmaniasis," said Prof. Jurgen Engel, Executive Vice
President, Global R&D and Chief Operating Officer at AEterna
Zentaris. "Leishmaniasis is becoming a growing problem in countries
in Southern Europe where, until recently, it was not considered
endemic. Immunocompromised patients, in particular, are at an
increased risk for this life-threatening disease, with
approximately 25%-70% of leishmaniasis cases in Southern Europe
being associated with HIV infection." Impavido(R) is currently
marketed in India through cooperation with German Remedies (a
member of Zydus Cadila) and has been submitted for registration in
Germany, Pakistan and Colombia. It is the first orally-
administered therapy for visceral and cutaneous leishmaniasis, a
parasitic infection which affects millions of people and is,
according to WHO, endemic in 88 countries in the world. It is
estimated that annually 1-1.5 million people are newly infected and
a total of 12 million people are infected. The cure rate of
Impavido(R) is 95%, even in patients resistant to antimony-based
standard therapy. Leishmaniasis is transmitted by sand flies. The
symptoms of visceral leishmaniasis include fever, spleen and liver
enlargement, blood deficiencies, bleeding of mucous membranes, and
severe weight loss. If left untreated, visceral leishmaniasis can
lead to death within 0.5-2 years. About AEterna Zentaris Inc.
AEterna Zentaris Inc. is a biopharmaceutical company focused in
oncology and endocrine therapy. Its extensive portfolio, from drug
discovery to marketed products, includes cetrorelix and perifosine.
Cetrorelix, an LHRH antagonist already marketed for in vitro
fertilization under the brand name Cetrotide(R), is also in
advanced clinical development for the treatment of uterine myoma,
endometriosis and benign prostatic hyperplasia (BPH). Perifosine,
an orally-active AKT inhibitor, is in several Phase II trials for
multiple cancers. AEterna Zentaris also owns 60% of Atrium
Biotechnologies Inc., which develops, manufactures and markets
active ingredients, specialty fine chemicals, cosmetic and
nutritional products for the cosmetics, chemical, pharmaceutical
and nutritional industries. News releases and additional
information about AEterna Zentaris are available on its new Web
site 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. DATASOURCE: AETERNA
ZENTARIS INC. (FORMERLY/ANCIENNEMENT - LES LABORATOIRES AETERNA
CONTACT: Media Relations, Paul Burroughs, (418) 652-8525 ext. 406,
; U.S. Investor Relations, Lippert/Heilshorn & Associates, Kim
Golodetz, (212) 838-3777, ; Investor Relations, Jacques Raymond,
(418) 652-8525 ext. 360, ; Europe, Dr. Mathias Pietras, +49 69
42602 3423, To request a free copy of this organization's annual
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