BASEL, SWITZERLAND--(Marketwire - December 14, 2012) - Basilea Pharmaceutica AG /
Basilea reports recruitment completion of phase 3 pivotal study of
isavuconazole, an agent for the potential primary treatment of invasive and
life-threatening fungal infections
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Basilea Pharmaceutica Ltd. ("Basilea",
SIX:BSLN) and its partner Astellas Pharma Inc. ("Astellas") announced today
patient recruitment for the isavuconazole phase 3 registration study SECURE
been completed. Isavuconazole is an investigational intravenous (i. v.) and
broad-spectrum antifungal being jointly developed by Basilea and Astellas.
The SECURE study is a global double-blind randomized phase 3 study,
evaluate the safety and efficacy of once-daily isavuconazole versus
twice-daily voriconazole for up to 84 days of therapy in the primary
treatment of invasive
fungal disease caused by Aspergillus species or other filamentous fungi.
hundred and twenty-seven (527) patients were enrolled in the study. Acute
invasive fungal infections are serious, life-threatening diseases
with high mortality. The primary endpoint of this non-inferiority study is
all-cause mortality through day 42. Basilea and Astellas expect that
results of this
study will be available in the second half of 2013.
In addition, enrollment into the VITAL study, an open-label phase 3 study
isavuconazole in the treatment of aspergillosis patients with pre-existing
impairment or patients with invasive fungal disease caused by rare but
fatal molds, yeasts or dimorphic fungi has achieved the targeted
100 patients and will continue to recruit to further expand the data base
use of isavuconazole in the treatment of the diverse rare mold infections.
ACTIVE study, a double-blind randomized phase 3 study evaluating the use of
isavuconazole i. v. and oral versus caspofungin i. v. followed by oral
voriconazole for the treatment of candidemia and other invasive Candida
infections, will likely continue to recruit into 2014.
"Invasive Aspergillus infections cause life-threatening disease in patients
undergoing chemotherapy, bone marrow transplantation and other
patients. Current pre-clinical and clinical data suggest that isavuconazole
have the potential to overcome certain limitations of current treatment
We are pleased to have achieved this important milestone together with our
partner Astellas, of completing recruitment in the SECURE study, the
aspergillosis trial ever conducted," said Prof. Achim Kaufhold, Chief
Officer at Basilea.
Isavuconazole is an investigational intravenous and oral broad-spectrum
antifungal. In collaboration with Astellas Pharma Inc., isavuconazole is
investigated in phase 3 clinical studies for the treatment of severe
fungal infections. The drug demonstrated excellent in-vitro and in-vivo
of a broad range of yeasts (such as Candida species) and molds (such as
Aspergillus species) as well as in-vitro activity against less prevalent
often fatal molds such as Mucorales spp. In clinical studies, isavuconazole
achieves predictable drug levels allowing reliable dosing and a switch from
intravenous administration to a convenient once-daily oral dose.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical
the therapeutic areas of bacterial infections, fungal infections and
targeting the medical challenge of rising resistance and non-response to
This communication expressly or implicitly contains certain forward-looking
statements concerning Basilea Pharmaceutica Ltd. and its business. Such
statements involve certain known and unknown risks, uncertainties and other
factors, which could cause the actual results, financial condition,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future results, performance or achievements expressed or implied by
forward-looking statements. Basilea Pharmaceutica Ltd. is providing this
communication as of this date and does not undertake to update any
forward-looking statements contained herein as a result of new information,
events or otherwise.
This press release can be downloaded from www.basilea.com.
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE