Basilea announces conclusion of BAL30072 phase I multiple ascending dose study
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Basilea Pharmaceutica AG /
Basilea announces conclusion of BAL30072 phase I multiple ascending dose study
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Basel, Switzerland, October 25, 2011 - Basilea Pharmaceutica Ltd. (SIX: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 (SIX: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.
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;
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[HUG#1557493]
Unternehmensinformation / Kurzprofil:
Datum: 25.10.2011 - 07:15 Uhr
Sprache: Deutsch
News-ID 79962
Anzahl Zeichen: 7571
contact information:
Town:
Basel
Kategorie:
Business News
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