Vicuron (NASDAQ:MICU)
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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/