Basilea starts continuous infusion phase 1/2a clinical study with oncology drug candidate BAL101553
(Thomson Reuters ONE) -
Basilea Pharmaceutica AG /
Basilea starts continuous infusion phase 1/2a clinical study with oncology drug
candidate BAL101553
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The issuer is solely responsible for the content of this announcement.
Basel, Switzerland, September 6, 2016 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that the first patient has been dosed in a new phase 1/2a
continuous infusion study with its tumor checkpoint controller BAL101553 in
patients with advanced solid cancers. Continuous infusion with portable pumps is
an established mode of drug administration used for the treatment of certain
cancers.
Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "We are
excited to start this phase 1/2a study with our novel tumor checkpoint
controller BAL101553. Continuous infusion could provide additional
administration flexibility beyond daily oral administration and weekly 2-hour
intravenous (i.v.) infusion. In cancer therapy, it is important to offer maximum
administration flexibility in order to optimize treatment for specific tumor
types and to synchronize treatment schedules in combination with other cancer
therapies."
The open-label, multicenter study is being conducted in Switzerland. It includes
adult patients with advanced solid tumors who failed standard therapy or for
whom no effective standard therapy is available. Study participants receive i.v.
BAL101553 administered as 48-hour continuous infusions.
About BAL101553
Basilea's small molecule oncology drug candidate BAL101553 (the prodrug of
BAL27862)(1) is being developed as a potential therapy for diverse cancers,
including tumor types unresponsive to standard therapeutics. BAL101553 is
currently undergoing clinical phase 1/2a evaluation in patients with advanced
solid tumors. It has shown evidence of clinical anti-tumor activity in a phase
1/2a study with weekly 2-hour i.v. dosing, during which the maximum tolerated
dose and the recommended phase 2 dose were established. In addition to the newly
initiated 48-hour continuous intravenous infusion phase 1/2a study, BAL101553 is
also currently being investigated in a dose-escalation phase 1/2a study with an
once-daily oral formulation. In preclinical studies, the drug candidate
demonstrated in-vitro and in-vivo activity against diverse treatment-resistant
cancer models, including tumors refractory to conventional approved therapeutics
and radiotherapy.(2, 3, 4) BAL101553 efficiently distributes to tumors and to
the brain, with anticancer activity in glioblastoma (brain cancer) models.(5,
6) The active moiety BAL27862 binds the colchicine site of tubulin with distinct
effects on microtubule organization(7), resulting in the formation of the
"spindle assembly checkpoint" which promotes tumor cell death.(8) Basilea's
approach to oncology includes the early evaluation of potential biomarkers,
which are already being tested in phase 1/2a clinical studies in order to
optimize dose selection and identify cancer patient groups more likely to
respond.
About Basilea
Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address increasing resistance and non-response to current treatment options
in the therapeutic areas of bacterial infections, fungal infections and cancer.
The company uses the integrated research, development and commercial operations
of its subsidiary Basilea Pharmaceutica International Ltd. to discover, develop
and commercialize innovative pharmaceutical products to meet the medical needs
of patients with serious and potentially life-threatening conditions. Basilea
Pharmaceutica Ltd. is headquartered in Basel, Switzerland and listed on the SIX
Swiss Exchange (SIX: BSLN). Additional information can be found at Basilea's
website www.basilea.com.
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:
+-------------------------------------------------------+
| Peer Nils Schröder, PhD |
| Head of Corporate Communications & Investor Relations |
| +41 61 606 1102 |
| media_relations(at)basilea.com |
| investor_relations(at)basilea.com |
+-------------------------------------------------------+
This press release can be downloaded from www.basilea.com.
References
1 J. Pohlmann et al. BAL101553: An optimized prodrug of the microtubule
destabilizer BAL27862 with superior antitumor activity. American
Association for Cancer Research (AACR) annual meeting 2011, abstract
1347; Cancer Research 2011, 71 (8 Supplement)
2 A. Broggini-Tenzer et al. The novel microtubule-destabilizing drug
BAL101553 (prodrug of BAL27862) sensitizes a treatment refractory
tumor model to ionizing radiation. EORTC-NCI-AACR symposium 2014,
abstract 202
3 G. E. Duran et al. In vitro activity of the novel tubulin active agent
BAL27862 in MDR1(+) and MDR1(-) human breast and ovarian cancer
variants selected for resistance to taxanes. American Association for
Cancer Research (AACR) annual meeting 2010, abstract 4412
4 F. Bachmann et al. BAL101553 (prodrug of BAL27862): A unique
microtubule destabilizer active against drug refractory breast cancers
alone and in combination with trastuzumab. American Association for
Cancer Research (AACR) annual meeting 2014, abstract 831
5 A. Schmitt-Hoffmann et al. BAL27862: a unique microtubule-targeted
agent with a potential for the treatment of human brain tumors. AACR-
NCI-EORTC conference 2009, abstract C233; Molecular Cancer
Therapeutics 2009, 8 (12 Supplement)
6 A. C. Mladek et al. The novel tubulin-binding 'tumor checkpoint
controller' BAL101553 has anti-cancer activity alone and in
combination treatments across a panel of GBM patient-derived
xenografts. American Association for Cancer Research (AACR) annual
meeting 2016, abstract 4781
7 A. E. Prota et al. The novel microtubule-destabilizing drug BAL27862
binds to the colchicine site of tubulin with distinct effects on
microtubule organization. Journal of Molecular Biology 2014 (426),
1848-1860
8 F. Bachmann et al. BAL101553 (prodrug of BAL27862): the spindle
assembly checkpoint is required for anticancer activity. American
Association for Cancer Research (AACR) annual meeting 2015, abstract
3789
Press release (PDF):
http://hugin.info/134390/R/2039784/760544.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 06.09.2016 - 07:15 Uhr
Sprache: Deutsch
News-ID 492718
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