Vicuron (NASDAQ:MICU)
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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/