Basilea reports positive results from first clinical phase I study with its novel antibiotic BAL30072
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Basilea Pharmaceutica AG /
Basilea reports positive results from first clinical phase I study with its
novel antibiotic BAL30072
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Basel, Switzerland, May 25, 2011 - Basilea Pharmaceutica Ltd. (SIX:BSLN)
reported today positive top-line results from the first clinical phase I study
with its antibiotic BAL30072 which is being developed for the treatment of
infections caused by multidrug-resistant Gram-negative bacteria. BAL30072 was
safe and well tolerated in this single-ascending-dose study.
The double-blind randomized clinical phase I study investigated the safety,
tolerability and pharmacokinetics of single ascending doses of BAL30072 in
healthy volunteers. BAL30072 was safe and well tolerated at all dose levels. It
displayed dose-proportional plasma levels as well as linear pharmacokinetic
properties. Detailed study results will be presented at upcoming scientific
conferences.
"We are delighted with the good safety and tolerability of BAL30072 demonstrated
in this first study in man, which is in line with our preclinical observations,"
said Dr. Anthony Man, CEO of Basilea Pharmaceutica Ltd. "These results support
the potential of BAL30072 as a new treatment option for severe and life-
threatening infections caused by multidrug-resistant Gram-negative bacteria,
where currently very limited therapeutic options exist. We are committed to
addressing the significant medical challenge arising from the rapid global
spread of new emerging Gram-negative superbugs and we will be further advancing
the phase I program with this promising drug this year."
Clinically important multidrug-resistant Gram-negative pathogens such as
Pseudomonas aeruginosa, Acinetobacter spp., Klebsiella spp. and Enterobacter
spp. are associated with prolonged hospital stays, higher healthcare costs and
increased mortality. These pathogens may cause serious and life-threatening
infections such as sepsis, severe lung or complicated urinary tract infections.
In a recent study which involved thousands of patients in intensive care units
around the world, Gram-negative pathogens were found in about 60 percent of
patients tested positive on bacterial infections.
About BAL30072
BAL30072 is a novel siderophore (iron-binding) sulfactam antibiotic with a
unique mode of action, conferring potent bactericidal activity against a broad
range of multidrug-resistant Gram-negative pathogens such as Pseudomonas
aeruginosa or Acinetobacter spp., as demonstrated in in vitro and in vivo
models. BAL30072 is stable towards many types of bacterial beta-lactamase
enzymes which inactivate most of the currently marketed beta-lactam
antibiotics. This stability covers many of the extended-spectrum beta-
lactamases (ESBLs) as well as carbapenemases and metallo-beta-lactamases such as
New Delhi metallo-beta-lactamase 1 (NDM-1). A clinical phase I multiple-
ascending-dose study with BAL30072 is anticipated to start in the second half of
2011.
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed on
the SIX Swiss Exchange (SIX:BSLN). Its 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 severe chronic hand eczema unresponsive to potent topical
corticosteroids, in Denmark, Finland, France, Germany, Switzerland and the
United Kingdom and has appointed distributors for Toctino® in other selected
European markets, Canada, Israel and Mexico. Furthermore, 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 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 methicillin-resistant Staphylococcus aureus (MRSA),
and many clinically important Gram-negative bacteria such as Pseudomonas spp.
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, Ph.D. | Barbara Zink, Ph.D., 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.
--- End of Message ---
Basilea Pharmaceutica AG
Grenzacherstrasse 487
P.O Box Basel Switzerland
Listed: Freiverkehr in Börse Stuttgart,
Freiverkehr in Börse Berlin,
Open Market (Freiverkehr) in Frankfurter Wertpapierbörse,
Freiverkehr in Bayerische Börse München;
Press release (PDF):
http://hugin.info/134390/R/1518503/455010.pdf
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE
[HUG#1518503]
Unternehmensinformation / Kurzprofil:
Datum: 25.05.2011 - 07:16 Uhr
Sprache: Deutsch
News-ID 54959
Anzahl Zeichen: 7706
contact information:
Town:
Basel
Kategorie:
Business News
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