Basilea provides update on isavuconazole phase 3 program
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Basilea provides update on isavuconazole phase 3 program
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* On track for first data from the SECURE and VITAL phase 3 studies in the
second half of this year
* Primary efficacy assessment in the ACTIVE phase 3 study moved to the end of
intravenous treatment
* Recruitment into VITAL study completed after enrollment of 150 patients
* Pediatric Investigation Plans agreed by EMA
Basel, Switzerland, July 17, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
provided an update today on the phase 3 program with the novel antifungal
isavuconazole that is being developed in collaboration with Astellas Pharma Inc.
Topline data from the SECURE and VITAL phase 3 studies are on track to be
available in the second half of 2013. The SECURE registration study evaluates
the safety and efficacy of once-daily isavuconazole versus twice-daily
voriconazole for the primary treatment of life-threatening invasive fungal
disease caused by Aspergillus species. The VITAL study is an open-label phase 3
study in the treatment of aspergillosis patients with pre-existing renal
impairment or with invasive fungal disease caused by emerging and often fatal
fungi. With 150 patients enrolled, the VITAL study has now completed
recruitment, which was extended beyond its initial target to further expand the
database on the use of isavuconazole in the primary treatment of emerging fungal
infections for which currently only limited treatment options exist. The data
from the SECURE and VITAL studies could form the basis of an initial filing in
the first part of 2014.
The ACTIVE phase 3 study is evaluating the safety and efficacy of intravenously
(i.v.) and orally administered isavuconazole versus i.v. caspofungin followed by
oral voriconazole in the treatment of invasive Candida infections. The study's
primary efficacy endpoint of overall response will be moved to the end of
intravenous treatment and assessed by a Data Review Committee. The previous
assessment at two weeks after i.v. and oral treatment will remain a secondary
efficacy endpoint. There are no changes in the overall operational study
conduct. The protocol change will facilitate the comparison to data obtained
from previous registration trials in invasive Candida infections. The study is
expected to continue to recruit in 2014.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "We are on
track to provide the first data from the SECURE and VITAL phase 3 studies in the
second half of this year. The move of the ACTIVE study outcome assessment time
point will facilitate the comparison of the efficacy of isavuconazole to the
data from previous registration trials investigating echinocandins. It reflects
the most recent thinking of health authorities on the design and analysis of
phase 3 clinical trials investigating antifungals for the treatment of invasive
yeast infections."
In addition, the European Medicines Agency has agreed to the Pediatric
Investigation Plans (PIP) of isavuconazole for the treatment of invasive
aspergillosis, mucormycosis and Candida infections in children.
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 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 emerging and often fatal molds
including those that cause mucormycosis. In clinical studies to date,
isavuconazole achieved predictable drug levels supporting reliable dosing and a
switch from once-daily intravenous to oral administration. The intravenous
formulation of isavuconazole, which is water-soluble, does not contain possibly
kidney damaging solubilizers and has the potential to be given to patients with
pre-existing renal impairment. In the U.S. isavuconazole has fast-track status
and was granted orphan drug designation for the treatment of invasive
aspergillosis.
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.
For further information, please contact:
+-------------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-------------------------------+--------------------------------+
| Peer Nils Schröder, PhD | Barbara Zink, PhD, MBA |
| Head Public Relations & | Head Corporate Development |
| Corporate Communications | |
| +41 61 606 1102 | +41 61 606 1233 |
| media_relations(at)basilea.com | investor_relations(at)basilea.com |
+-------------------------------+--------------------------------+
This press release can be downloaded from www.basilea.com.
Press release (PDF):
http://hugin.info/134390/R/1716817/570724.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
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Datum: 17.07.2013 - 07:16 Uhr
Sprache: Deutsch
News-ID 279050
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