Vicuron Pharmaceuticals Completes Enrollment in Phase III Clinical Trial of Anidulafungin for Invasive Candidiasis/Candidemia
September 09 2004 - 7:30AM
PR Newswire (US)
Vicuron Pharmaceuticals Completes Enrollment in Phase III Clinical
Trial of Anidulafungin for Invasive Candidiasis/Candidemia KING OF
PRUSSIA, Pa., Sept. 9 /PRNewswire-FirstCall/ -- Vicuron
Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato) today announced
that the company has completed enrollment in its Phase III clinical
trial of anidulafungin for invasive candidiasis/candidemia. "We are
pleased to have completed enrollment ahead of schedule," said
George F. Horner III, President and Chief Executive Officer of
Vicuron. "With a growing number of immunocompromised patients in
the hospital, particularly those with cancer, the incidence of
life-threatening, invasive fungal disease is rising. We look
forward to releasing the results of this study in the first quarter
of next year." The double-blind, randomized Phase III trial of more
than 250 patients was designed to study the safety and efficacy of
a 100 mg daily dose of anidulafungin preceded by an initial 200 mg
loading dose of anidulafungin versus fluconazole in invasive
candidiasis/candidemia. Patients received daily intravenous (IV)
infusions of either anidulafungin or fluconazole for 10 to 42 days.
The primary endpoint is global assessment of clinical and
microbiological responses at the end of IV therapy. 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 major
countries in Europe. In May 2004, Vicuron received an approvable
letter from the FDA for its lead product anidulafungin for the
treatment of esophageal candidiasis. 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 and unknown 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 by the FDA, 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 Hala Bashir
of WeissCom Partners, +1-212-204-2080, or ; or Aline Schimmel of
Burns McClellan Inc., +1-212-213-0006, or , both for Vicuron
Pharmaceuticals Inc. Web site: http://www.vicuron.com/
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