Basilea announces clinical study agreement with Adult Brain Tumor Consortium to explore BAL101553 in newly diagnosed glioblastoma
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Basilea Pharmaceutica AG /
Basilea announces clinical study agreement with Adult Brain Tumor Consortium to
explore BAL101553 in newly diagnosed glioblastoma
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The issuer is solely responsible for the content of this announcement.
* The Adult Brain Tumor Consortium (ABTC) is designed to develop more
effective treatments for malignant brain tumors. It is funded by the US
National Cancer Institute (NCI).
* The ABTC will conduct a clinical phase 1 study to determine the safety and
tolerability of Basilea's novel tumor checkpoint controller BAL101553 in
newly diagnosed glioblastoma patients.
Basel, Switzerland, June 12, 2017 - Basilea Pharmaceutica Ltd. (SIX: BSLN)
announced today that it has entered into a clinical study agreement with the
Adult Brain Tumor Consortium (ABTC). The consortium will conduct a clinical
phase 1 study to determine the safety and tolerability of the oral formulation
of Basilea's novel anticancer drug candidate BAL101553 in combination with
standard radiation in patients with newly diagnosed glioblastoma who have a
reduced sensitivity to standard chemotherapy due to an unmethylated MGMT
promoter. MGMT promoter methylation status is an important molecular genetic
biomarker in glioblastoma.
Prof. Achim Kaufhold, Chief Medical Officer of Basilea, said: "There is a
critical medical need for new agents in the treatment of patients with
glioblastoma with an unmethylated MGMT promoter. Today these patients have fewer
therapeutic options than those with a methylated MGMT promoter and a worse
disease prognosis. We are very pleased to be working with the ABTC to
potentially provide an urgently needed new treatment modality for fighting brain
cancer in this patient group."
The ABTC is designed to develop more effective treatments for malignant brain
tumors. It has 11 brain tumor centers at leading universities across the United
States. It is funded by the US National Cancer Institute (NCI).
Glioblastoma is the most common primary brain tumor and one of the most lethal
types of cancer. The incidence of glioblastoma is approximately 3 patients per
100,000 in the United States.(1) Median survival of about 15 months from
diagnosis has been reported for adult glioblastoma patients receiving standard-
of-care treatment,(2) with a 5-year survival rate of 5%.(1) It is estimated that
approximately 55% of newly diagnosed glioblastoma patients have an unmethylated
MGMT promoter, and these patients have a worse prognosis than those with a
methylated MGMT promoter.(3)
The dose escalation phase 1 study will be conducted at ABTC member sites in the
United States, coordinated by the Johns Hopkins University's School of Medicine.
The majority of the study costs will be borne by the ABTC. The study is
anticipated to start in the third quarter of 2017.
About BAL101553
Basilea's small molecule oncology drug candidate BAL101553 (the prodrug of
BAL27862)(4) is being developed as a potential therapy for diverse cancers.
BAL101553 is currently undergoing clinical phase 1/2a evaluation in patients
with advanced solid tumors or glioblastoma (brain cancer). 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.(5, 6, 7) BAL101553
efficiently distributes to the brain, with anticancer activity in glioblastoma
models.(8, 9, 10) The active moiety BAL27862 binds the colchicine site of
tubulin with distinct effects on microtubule organization,(11) resulting in the
activation of the "spindle assembly checkpoint" which promotes tumor cell
death.(12)
About Basilea
Basilea Pharmaceutica Ltd. is a biopharmaceutical company developing products
that address the medical challenge of 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
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.
About ABTC
The Adult Brain Tumor Consortium (ABTC) is a multi-institutional consortium,
consisting of investigators at renowned institutions across the United States.
It is funded by the US National Cancer Institute (NCI). The consortium performs
innovative, multidisciplinary phase 1 - 2 clinical trials that focus
predominantly on adult patients with grade IV gliomas (glioblastoma multiforme).
The ABTC has demonstrated that clinical trials are not only possible in this
challenging tumor type, but represent the best hope for making further progress
against this devastating disease. For more information visit
www.abtconsortium.org.
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 Q. T. Ostrom et al. CBTRUS statistical report: primary brain and central
nervous system tumors diagnosed in the United States in 2007-2011. Neuro-
Oncology 2014 (16, Suppl 4), iv1-iv63
2 R. Stupp et al. Radiotherapy plus concomitant and adjuvant temozolomide for
glioblastoma. New England Journal of Medicine 2005 (352), 987-996
3 M. E. Hegi et al. MGMT gene silencing and benefit from temozolomide in
glioblastoma. New England Journal of Medicine 2005 (352) 997-1003
4 R. Bergès et al. The novel tubulin-binding checkpoint activator BAL101553
inhibits EB1-dependent migration and invasion and promotes differentiation of
glioblastoma stem-like cells. Molecular Cancer Therapeutics 2016 (15), 2740-2749
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 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)
8 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
9 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
10 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
11 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
12 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/2112345/803409.pdf
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Source: Basilea Pharmaceutica AG via GlobeNewswire
Unternehmensinformation / Kurzprofil:
Datum: 12.06.2017 - 07:15 Uhr
Sprache: Deutsch
News-ID 547303
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