Basilea initiates phase 1/2a oncology study with oral formulation of tumor checkpoint controller BAL101553
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Basilea Pharmaceutica AG /
Basilea initiates phase 1/2a oncology study with oral formulation of tumor
checkpoint controller BAL101553
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Basel, Switzerland, June 25, 2015 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today the start of a clinical phase 1/2a study with an oral
formulation of its anti-cancer drug candidate BAL101553. BAL101553 is a
microtubule-destabilizing small molecule, acting as tumor checkpoint controller
(TCC) as it promotes tumor cell death through activation of an important
checkpoint in cell proliferation.
The primary objective of the phase 1 study is to determine the maximum tolerated
dose (MTD) in adult patients with advanced or recurrent solid tumors who have
failed standard therapy or for whom no effective standard therapy is available.
BAL101553 capsules will be administered once daily. A subsequent phase 2a
extension of the study is planned to further evaluate the safety, tolerability
and the pharmacokinetic profile of daily oral BAL101553 at the MTD, and to
assess its anti-tumor activity. Furthermore, biomarkers will be explored in both
the phase 1 and phase 2a parts of the study to determine their potential utility
in identifying patients who are most likely to respond to treatment.
An intravenous (i.v.) formulation of BAL101553 is currently being investigated
in a separate phase 2a clinical study in cancer patients with advanced solid
tumors.
"Oral bioavailability of our anti-cancer compound BAL101553 may provide
advantages complementary to the i.v. formulation," said Prof. Achim Kaufhold,
Basilea's Chief Medical Officer. "The availability of an oral formulation of
BAL101553 offers increased flexibility with regard to both single agent and drug
combination treatment strategies across different tumor types and thus could
potentially broaden the options for the clinical development of this anti-cancer
drug candidate."
About tumor checkpoint controller BAL101553
BAL101553 is a water-soluble prodrug of Basilea's small molecule oncology drug
candidate BAL27862. The prodrug is available in oral and intravenous (i.v.)
formulations. The investigational drug is being developed for the treatment of
diverse cancers, including tumor types unresponsive or resistant to standard
therapeutics. BAL101553 showed first evidence of clinical anti-tumor activity in
the phase 1 part of an ongoing phase 1/2a i.v. study in solid tumor cancer
patients.[1]
BAL101553 destabilizes the microtubule network involved in cell proliferation
and has demonstrated its ability to stop tumor growth by a dual action on tumor
cell proliferation and tumor vascularization through a mechanism different from
conventional microtubule-targeting agents such as taxanes.
Data presented at the 2015 American Association of Cancer Research (AACR) Annual
Meeting in Philadelphia (USA) show that BAL101553 induces the formation of the
spindle assembly checkpoint (SAC), which promotes tumor cell death when the
microtubule spindle is not properly formed.[2] Furthermore, the presence of SAC
components, including BubR1, was shown to be associated with response to
BAL101553 in a range of tumor models. The data presented at AACR confirmed that
the sensitivity of human cancer cell lines to BAL101553 correlates with the
presence of an intact SAC, supporting the hypothesis that prediction of cancer
response to BAL101553 may lay in its tumor checkpoint control function. The
utility of SAC components as predictive biomarkers to identify patients likely
to respond to BAL101553 is being explored in the clinical program.
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 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:
+-----------------------------+--------------------------------+
| Media Relations | Investor Relations |
+-----------------------------+--------------------------------+
| Peer Nils Schröder, PhD | Barbara Zink, PhD, 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.
References
[1] L. R. Molife et al. Phase 1/2a trial of the novel microtubule inhibitor
BAL101553 in advanced solid tumors: Phase 1 completed. American Society of
Clinical Oncology (ASCO) annual meeting 2014, abstract 2562
[2] F. Bachmann, K. Burger, H. Lane. 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/1931218/694380.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
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