BASEL, SWITZERLAND--(Marketwire - October 25, 2011) -
Basilea Pharmaceutica AG /
Basilea announces conclusion of BAL30072 phase I multiple ascending dose
study
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Basilea Pharmaceutica Ltd. (SWISS: BSLN)
announced today that it has concluded the second phase I study with its
novel
sulfactam antibiotic BAL30072 for the potential treatment of life-
threatening
multidrug-resistant Gram-negative infections.
Basilea has completed the double-blind, randomized, placebo-controlled
dose-
ranging study in healthy volunteers assessing the pharmacokinetics, safety
and
tolerability of BAL30072 after multiple ascending doses of intravenous
infusions. The drug was clinically well tolerated with no significant
clinical
adverse events. The limiting factor for the highest dose regimen tested was
transiently elevated liver enzyme levels.
"Having established the maximum dose of this particular dosing regimen we
will
now optimize alternative dosing regimens including combinations. Co-
administration of BAL30072 with other antibiotics such as the penem class
follows the observation that combinations extend the excellent spectrum of
activity of BAL30072 against multidrug-resistant Gram-negative infections,
involving Pseudomonas, Acinetobacter and Enterobacteriaceae even further,"
said
Prof. Achim Kaufhold, Chief Medical Officer of Basilea Pharmaceutica Ltd.
The multiple ascending dose study was initiated following the successful
completion of the single ascending dose phase I trial, in which BAL30072
was
well tolerated and displayed dose-proportional pharmacokinetic properties.
Following the analyses of the pharmacokinetic data obtained in the
multiple-
ascending dose study and the completion of ongoing preclinical studies such
as
PK/PD modeling in animals, Basilea plans to expand the phase I program in
2012
to include studies evaluating additional dosing regimens of BAL30072 mono
and
combination therapies in preparation to entering phase II studies of
BAL30072 in
patients with Gram-negative infections in 2013.
BAL30072 is a novel sulfactam antibiotic that in in vitro and in vivo
models
demonstrated potent bactericidal activity against a broad range of
multidrug-
resistant Gram-negative pathogens such as Pseudomonas or Acinetobacter
species.
It overcomes bacterial resistance by several mechanisms and is not easily
destroyed by bacterial beta-lactamase enzymes, such as extended-spectrum
beta-
lactamases (ESBLs), carbapenemases and the recently characterized New Delhi
metallo-beta-lactamase 1 (NDM-1), which cause resistance against many
currently
marketed antibiotics.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SWISS: BSLN). Basilea Pharmaceutica International's
fully
integrated research and development operations are focused on antibiotics,
antifungals and oncology drugs, as well as on the development of
dermatology
drugs, targeting the medical challenge of resistance and non-response to
current
treatment options in the hospital and specialty care setting.
Basilea is currently marketing Toctino® (alitretinoin), the only
approved
treatment for adults with severe chronic hand eczema unresponsive to potent
topical corticosteroids, in Denmark, Finland, France, Germany, Norway,
Switzerland and the United Kingdom and has appointed distributors for
Toctino®
in other selected European markets, Canada, Israel, Mexico and the Republic
of
Korea. A phase III clinical program on alitretinoin for the treatment of
severe
chronic hand eczema is ongoing in the U.S.
For its phase III compound isavuconazole, a potential best-in-class azole
antifungal for the treatment of life-threatening invasive fungal
infections, the
company has entered into a license, co-development and co-promotion
agreement
with Astellas Pharma Inc.
In addition, Basilea is developing ceftobiprole, a late-stage novel anti-
MRSA
(methicillin-resistant Staphylococcus aureus) broad-spectrum cephalosporin
antibiotic, for the first-line treatment of potentially life-threatening
resistant bacterial infections. Ceftobiprole has a broad coverage of both
Gram-
positive bacteria, including MRSA, and many clinically important Gram-
negative
bacteria such as Pseudomonas spp.
Basilea's BAL30072, a novel antibiotic for the treatment of resistant Gram-
negative infections, and the oncology drug BAL101553 for the treatment of
drug-
resistant cancers are in phase I clinical testing.
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/1557493/480868.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1557493]
