Vicuron Pharmaceuticals Announces Phase III Results of Anidulafungin Combination Regimen for Treatment of Invasive Aspergillosis
March 24 2004 - 6:30AM
PR Newswire (US)
Vicuron Pharmaceuticals Announces Phase III Results of
Anidulafungin Combination Regimen for Treatment of Invasive
Aspergillosis KING OF PRUSSIA, Pa., March 24 /PRNewswire-FirstCall/
-- Vicuron Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today
announced results from a Phase III trial evaluating the company's
lead product anidulafungin, a novel antifungal therapy, in
combination with liposomal amphotericin B (LAmB) for the potential
treatment of invasive aspergillosis infections. Aspergillosis is an
opportunistic fungal infection acquired by patients with weakened
immune systems and is frequently fatal. "These results demonstrate
that we can combine these two treatments to fight invasive
aspergillosis infections without increasing side effects," said
Raoul Herbrecht, MD, Department of Hematology and Oncology, Hopital
de Hautepierre, Strasbourg, France, and lead investigator in the
study. "Anidulafungin's distinct mechanism of action,
broad-spectrum activity and novel route of elimination make it a
particularly attractive therapy for use in combination antifungal
treatments." "In addition to providing important evidence that
combining anidulafungin with an amphotericin agent is
well-tolerated as first line therapy, these data confirm previous
and other data that the pharmacokinetic profile of anidulafungin
makes it well-suited for potential combination strategies to fight
deadly invasive fungal diseases," said Timothy Henkel, M.D., Ph.D.,
Vicuron's Chief Medical Officer. Previous in vitro studies have
shown compelling results demonstrating anidulafungin's additive or
synergistic effect in combination with a variety of other
antifungal agents. Results from another study evaluating the
concomitant use of anidulafungin and voriconazole, an increasingly
important agent for the treatment of aspergillosis, will be
presented at an international medical meeting later this year.
Study Details and Results The non-comparative, multi-center, global
trial enrolled 30 patients with probable or proven invasive
aspergillosis. Study patients were administered both LAmB at 3-5 mg
per kg daily and anidulafungin intravenously at 100 mg daily, with
an initial loading dose of 200 mg of anidulafungin on day one. The
95 percent confidence interval of the global response rate ranged
from 12 to 49 percent. The combination was well tolerated with few
drug-related serious adverse events. Adverse event and laboratory
values at the end of the study were consistent with those expected
for a critically ill patient population with invasive
aspergillosis. About Anidulafungin Anidulafungin is a naturally
occurring molecule that has been significantly improved through
chemical modification. In vitro studies have demonstrated that
anidulafungin combines both the potency and killing effects of the
polyene class (e.g. amphotericin B) without the resistance problems
found with the azole class (e.g., fluconazole). Anidulafungin is a
broad- spectrum agent, and has been demonstrated to be highly
potent in vitro against the fungi responsible for several serious
fungal infections. Preclinical studies have shown that five-minute
exposure to anidulafungin in vitro kills more than 99 percent of
Candida, including fluconazole-resistant strains. Anidulafungin has
no cross-resistance with azoles or amphotericin, and in the
laboratory it has proven very difficult to develop resistance to
anidulafungin. Anidulafungin also was well tolerated in a Phase I
study when given in combination with cyclosporine, the leading
chronic immunosuppressive drug. About Vicuron Vicuron
Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing vital
medicine for seriously ill patients in North America and Europe.
The company has filed a New Drug Application with the U.S. Food and
Drug Administration for its lead product, anidulafungin, a novel
antifungal agent. The company's other lead product, dalbavancin, a
novel intravenous antibiotic for the treatment of serious
Gram-positive infections, is in Phase III clinical trials. The
company's versatile research engine integrates industry-leading
expertise in functional genomics, natural products discovery,
mechanism-based drug design and combinatorial and medicinal
chemistry. These approaches are yielding promising novel and
next-generation compounds, many of which are in the later stages of
preclinical development. In addition, the company has research and
development collaborations with leading pharmaceutical companies,
such as Pfizer and Novartis. Forward-Looking Statements This news
release contains forward-looking statements that predict or
describe future events or trends. The matters described in these
forward-looking statements are subject to known andunknown risks,
uncertainties and other unpredictable factors, many of which are
beyond Vicuron's control. Vicuron faces many risks that could cause
its actual performance to differ materially from the results
predicted by its forward-looking statements, including the
possibilities that clinical trials and the results thereof might be
delayed, that the timing of the filing of any new drug application
might be delayed, that subsequent clinical trials might indicate
that a product candidate is unsafe or ineffective, that any filed
new drug application may not be approved, that ongoing proprietary
and collaborative research might not occur or yield useful results,
that a third party may not be willing to license our product
candidates on terms acceptable to us or at all, that competitors
might develop superior substitutes for their products or market
them more effectively, that a sales force may not be developed as
contemplated and that one or more of its product candidates may not
be commercialized successfully. The reports that Vicuron files with
the U.S. Securities and Exchange Commission contain a fuller
description of these and many other risks to which Vicuron is
subject. Because of those risks, Vicuron's actual results,
performance or achievements may differ materially from the results,
performance or achievements contemplated by its forward- looking
statement. The information set forth in this news release
represents management's current expectations and intentions.
Vicuron assumes no responsibility to issue updates to the
forward-looking matters discussed in this news release. DATASOURCE:
Vicuron Pharmaceuticals Inc. CONTACT: Dov A. Goldstein, M.D. of
Vicuron Pharmaceuticals Inc., +1-610-205-2312, or ; or Ian
McConnell of WeissCom Partners, +1-415-362-5018, or ; or E. Blair
Schoeb of Burns McClellan Inc., +1-212-213-0006, or , both for
Vicuron Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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