BASEL, SWITZERLAND--(Marketwired - June 04, 2013) - Basilea Pharmaceutica AG /
Basilea presents first phase 1 data from its novel anti-cancer drug
ASCO conference. Processed and transmitted by Thomson Reuters ONE.
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Basel, Switzerland, June 4, 2013 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
reported today the presentation of interim data of its oncology drug
from its ongoing phase 1 study in patients with advanced solid tumors at
Annual Meeting of the American Society of Clinical Oncology (ASCO), held in
Chicago, Illinois (USA) from May 31 to June 4.
The presented data demonstrated that intravenously administered BAL101553
well tolerated at the doses studied thus far and provided first evidence of
anti-tumor activity. Among the 18 patients treated, one patient experienced
partial response (decrease in tumor lesion size) and an additional five
reported stable disease of which two patients showed stable disease for
than 16 weeks. The main side effects observed were nausea/vomiting and
blood pressure elevations which were well manageable. Dose escalation
to determine the maximum tolerated dose.
Pharmacokinetic profiles from the study indicated dose-proportionality;
pharmacodynamic analyses showed vascular disrupting and anti-proliferative
effects in post-treatment tumor biopsies.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented:
currently available anti-cancer drugs remains a major challenge in the
of cancer patients. These interim results from our investigational drug
BAL101553 are encouraging, with first evidence of anti-tumor activity in
patients who failed to respond to standard treatment. In addition, the
safety profile of BAL101553 is promising."
Dr. Heidi Lane, Head of Cancer Biology Basilea, added: "Once the maximum
tolerated dose is established, the study will be extended to enlarge
numbers and identify tumor types likely to respond to this novel anti-
compound. In parallel we are actively exploring novel biomarkers for
stratification to determine which patients will potentially benefit most
BAL101553 is a highly water-soluble pro-drug of Basilea's small molecule
BAL27862, a novel anti-cancer drug targeting the intracellular microtubule
network critical for tumor cell proliferation. It was previously shown that
drug has a dual mode of action directly attacking drug-refractory tumor
well as disrupting tumor blood supply.
|Poster on BAL101553 |
|A first-in-human (FIH) dose-escalation study of the safety, |
|pharmacokinetics (PK), and pharmacodynamics (PD) of intravenous |
|BAL101553, a novel microtubule inhibitor, in adult patients with advanced|
|solid tumors - A.H. CALVERT, M. GONZALEZ, S. GANGULI, M. NG, S. BENAFIF, |
|M. CAPELAN, R. GOLDSTEIN, K. SHAH, C. JARVIS, M. FLYNN, M. FORSTER, S. |
|ANDERSON, A. SCHMITT-HOFFMANN, H. LANE, M. ENGELHARDT, A.L. HANNAH, |
|A. TZANKOV, F. BACHMANN, L. R. MOLIFE, R. KRISTELEIT; A 2566 |
For further information please visit http://chicago2013.asco.org/.
Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and
the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the Company focuses on innovative pharmaceutical
the therapeutic areas of bacterial infections, fungal infections and
targeting the medical challenge of rising resistance and non-response to
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,
or achievements of Basilea Pharmaceutica Ltd. to be materially different
any future results, performance or achievements expressed or implied by
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
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Source: Basilea Pharmaceutica AG via Thomson Reuters ONE