BASEL, SWITZERLAND--(Marketwire - June 30, 2011) - Basilea Pharmaceutica AG /
Basilea initiates first-in-human study with its novel anti-cancer drug
BAL101553
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Basel, Switzerland, June 30, 2011 - Basilea Pharmaceutica Ltd. (SWISS: BSLN) today
announced the start of the first clinical study with its anti-cancer drug
BAL101553. The open-label phase I study will determine the safety,
tolerability
and pharmacokinetic profile of BAL101553, a novel microtubule-targeting
agent
which has demonstrated anti-cancer activity in many drug-resistant tumor
models.
Cancer remains a significant challenge in healthcare despite progress in
the
development of agents with anti-tumor activity. Specifically, there is an
increasing medical need for novel agents with new mechanisms of action that
overcome tumor resistance against current therapies.
BAL101553 - a novel anti-cancer drug with unique properties
BAL101553 is a highly water-soluble prodrug of the synthetic small molecule
BAL27862 that allows intravenous and oral administration without
solubilizing
excipients associated with adverse effects. BAL27862 arrests tumor cell
proliferation and induces tumor cell death through a characteristic
destabilizing effect on microtubules that is distinct from other anti-
cancer
agents also directed against the microtubule network. Anti-tumor activity
has
been demonstrated across a broad panel of solid tumor models, including
those
resistant against conventional microtubule-targeting drugs such as taxanes
or
Vinca alkaloids.
The phase I open-label, dose-escalation study investigates safety,
tolerability
and pharmacokinetics of intravenous BAL101553 to establish dose and
administration schedule for phase II studies. The study includes adult
patients
with advanced solid tumors who have failed standard therapy or for whom no
effective standard therapy is available.
"There is a high need for novel anti-cancer therapies to treat patients
whose
cancers are resistant to current agents such as taxanes," said Dr. Anthony
Man,
CEO of Basilea Pharmaceutica Ltd. "BAL101553 is a novel small-molecule drug
active against a well-validated cancer cell target and showing broad anti-
tumor
activity in preclinical models. We are delighted to see this innovative
anti-
cancer drug move into clinical development to broaden our hospital-focused
product portfolio."
About Basilea
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
listed on
the SIX Swiss Exchange (SWISS: 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, Norway, 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.
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/1527031/462735.pdf
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[HUG#1527031]
