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
. Processed and transmitted by Thomson Reuters ONE.
The issuer is solely responsible for the content of this announcement.
Basilea Pharmaceutica Ltd. ("Basilea",
SIX:BSLN) and its partner Astellas Pharma Inc. ("Astellas") announced today
that
patient recruitment for the isavuconazole phase 3 registration study SECURE
has
been completed. Isavuconazole is an investigational intravenous (i. v.) and
oral
broad-spectrum antifungal being jointly developed by Basilea and Astellas.
The SECURE study is a global double-blind randomized phase 3 study,
designed to
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.
Five
hundred and twenty-seven (527) patients were enrolled in the study. Acute
invasive fungal infections are serious, life-threatening diseases
associated
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
of
isavuconazole in the treatment of aspergillosis patients with pre-existing
renal
impairment or patients with invasive fungal disease caused by rare but
often
fatal molds, yeasts or dimorphic fungi has achieved the targeted
recruitment of
100 patients and will continue to recruit to further expand the data base
on the
use of isavuconazole in the treatment of the diverse rare mold infections.
The
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
immunocompromised
patients. Current pre-clinical and clinical data suggest that isavuconazole
may
have the potential to overcome certain limitations of current treatment
options.
We are pleased to have achieved this important milestone together with our
partner Astellas, of completing recruitment in the SECURE study, the
largest
aspergillosis trial ever conducted," said Prof. Achim Kaufhold, Chief
Medical
Officer at Basilea.
About isavuconazole
Isavuconazole is an investigational intravenous and oral broad-spectrum
antifungal. In collaboration with Astellas Pharma Inc., isavuconazole is
being
investigated in phase 3 clinical studies for the treatment of severe
invasive
fungal infections. The drug demonstrated excellent in-vitro and in-vivo
coverage
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
but
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.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
and
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd. the company focuses on innovative pharmaceutical
products in
the therapeutic areas of bacterial infections, fungal infections and
oncology,
targeting the medical challenge of rising resistance and non-response to
current
treatment options.
Disclaimer
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,
performance
or achievements of Basilea Pharmaceutica Ltd. to be materially different
from
any future results, performance or achievements expressed or implied by
such
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,
future
events or otherwise.
This press release can be downloaded from www.basilea.com.
Press release (PDF):
http://hugin.info/134390/R/1664857/540108.pdf
This announcement is distributed by Thomson Reuters on behalf of
Thomson Reuters clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1664857]
