Vicuron Pharmaceuticals Announces Phase 3 Trial Results Demonstrate Superiority of Anidulafungin Versus Fluconazole in Invasive
07 Febbraio 2005 - 8:00AM
PR Newswire (US)
Vicuron Pharmaceuticals Announces Phase 3 Trial Results Demonstrate
Superiority of Anidulafungin Versus Fluconazole in Invasive
Candidiasis/Candidemia Study Meets Primary and Secondary Endpoints
KING OF PRUSSIA, Pa., Feb. 7 /PRNewswire-FirstCall/ -- Vicuron
Pharmaceuticals Inc. (Nasdaq: MICU; Nuovo Mercato: MICU) today
announced results from its Phase 3 clinical trial evaluating
anidulafungin for the treatment of invasive candidiasis/candidemia,
the most common hospital-acquired fungal infection. The study
compared anidulafungin to fluconazole, and was designed to show
non-inferiority. Anidulafungin was superior to fluconazole in the
primary endpoint, global response at the end of intravenous therapy
in the microbiological intent-to-treat population. Anidulafungin
also demonstrated non-inferiority or superiority in all secondary
endpoints, including responses at the two-week and six-week
follow-up visits after completion of therapy. Anidulafungin was
well tolerated in the study, with a side effect profile comparable
to fluconazole. "We believe these exciting results demonstrating
the superiority of anidulafungin will enable us to present
anidulafungin, if approved by the FDA, as an important new option
to battle invasive infections due to Candida," said George F.
Horner, III, President and Chief Executive Officer of Vicuron.
"Vicuron is on track to file a New Drug Application for invasive
candidiasis/candidemia in the third quarter of this year and to
complete submission of an amendment to the esophageal candidiasis
NDA in the second quarter." Invasive candidiasis and candidemia are
infections caused by Candida, which can invade various organs or
the bloodstream. Candida is the fourth most common cause of
bloodstream infections, and the most common fungal cause. Invasive
Candida infections are more common in people who are
immunocompromised, such as those with cancer, organ transplants or
burns. Such infections are associated with high mortality in these
critically ill patients. Clinical Trial Results Summary The
double-blind, multi-center, randomized Phase 3 trial studied a 100
mg daily dose of anidulafungin versus a 400 mg daily dose of
fluconazole in 256 patients with invasive candidiasis/candidemia.
Patients received daily intravenous (IV) infusions of either
anidulafungin or fluconazole for 10 to 42 days. The primary
endpoint was the global response at the end of IV therapy, which
required a successful clinical and a successful microbiological
response. Results from the study included: Success in the global
response at the end of IV therapy in the microbiological
intent-to-treat population was 75.6 percent (96/127) of patients
with anidulafungin and 60.2 percent (71/118) with fluconazole.
These results demonstrate statistical superiority (95 percent
confidence interval of the difference: 3.85, 26.99). The secondary
endpoint of successful global response at the two-week follow up
visit in the microbiological intent-to-treat population was
observed in 64.6 percent (82/127) of patients in the anidulafungin
arm and 49.2 percent (58/118) of patients in the fluconazole arm,
again demonstrating statistical superiority (95 percent confidence
interval of the difference: 3.14, 27.68). The secondary endpoint of
successful global response at the six-week follow up visit in the
microbiological intent-to-treat population was observed in 55.9
percent (71/127) of patients in the anidulafungin arm and 44.1
percent (52/118) of patients in the fluconazole arm demonstrating
non- inferiority (95 percent confidence interval of the difference:
-0.6, 24.28). Anidulafungin demonstrated comparable tolerability to
fluconazole in the study. "We are very encouraged by these results,
and hopeful that they will help us to provide a new tool for
physicians against invasive Candida infections," said David S.
Krause, M.D., Vicuron's Executive Vice President and Chief Medical
Officer. Conference Call Details Vicuron will host a conference
call today at 10:30 a.m. (Eastern Standard Time). To access the
live call or the archive via the Internet, log on to
http://www.vicuron.com/. Please connect to Vicuron's website at
least 15 minutes prior to the conference call to ensure adequate
time for any software download that may be needed to access the
webcast. Alternatively, please call 800-811-8830 (U.S.) or
913-981-4904 (international) to listen to the call. Telephone
replay is available from approximately one hour after the call
through February 14, 2005. To access the replay, please call
888-203-1112 (U.S.) or 719-457-0820 (international). The replay
access code is 1004288. About Anidulafungin Anidulafungin is a
product candidate made through chemical modification of a naturally
occurring molecule. 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
not shown 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 1
study when given in combination with cyclosporine, a leading
chronic immunosuppressive drug. About Vicuron Pharmaceuticals
Vicuron Pharmaceuticals is a biopharmaceutical company focused on
discovering, developing, manufacturing and commercializing vital
medicine for seriously ill patients. The company has two New Drug
Applications pending with the U.S. Food and Drug Administration for
its lead products, dalbavancin, a novel intravenous antibiotic for
the treatment of serious Gram-positive infections, and
anidulafungin, a novel antifungal agent. Vicuron'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 Novartis and Pfizer.
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 or
unsuccessful, that the timing of the filing of any new drug
application or any amendment to a new drug application might be
delayed, that clinical trials might indicate that a product
candidate is unsafe or ineffective, that the FDA might require
additional information to be submitted and additional actions to be
taken before it will make any decision, 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 the pipeline may not yield a new clinical
candidate or a commercial product, that a third party may not be
willing to license Vicuron's product candidates on terms acceptable
to it or at all, that competitors might develop superior
substitutes for Vicuron's products or market these competitive
products more effectively, that a sales force may not be developed
as contemplated and that one or more of Vicuron's 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 E. Blair
Schoeb of WeissComm Partners, +1-212-923-6737, or ; or Aline
Schimmel of Burns McClellan Inc., +1-212-213-0006, or , both for
Vicuron Pharmaceuticals Web site: http://www.vicuron.com/
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