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2014-04-07

Basilea Pharmaceutica AG: Basilea's oncology drug candidate BAL101553 demonstrates broad antitumor activity in treatment-resistant breast cancer models as pres

Basilea Pharmaceutica AG / Basilea's oncology drug candidate BAL101553
demonstrates broad antitumoractivity in treatment-resistant breast cancer
models as presented at AACR . Processed and transmitted by NASDAQ OMX
Corporate Solutions.The issuer is solely responsible for the content of this
announcement.
Basel, Switzerland, April 7, 2014

- Basilea Pharmaceutica Ltd. (SIX: BSLN) reported today that new data
demonstrating the broad activity of Basilea's novel oncology drug candidate
BAL101553 in pre-clinical models of human breast cancer, including models
resistant to standard agents used for the treatment of breast cancer, were
presented at the American Association of Cancer Research (AACR) Annual
Meeting in San Diego, California, USA.

BAL101553 is an investigational new intravenous and oral small-molecule drug
that arrests tumor cell proliferation and induces tumor cell death through a
destabilizing effect on microtubules, an intracellular network essential for
cell division. In addition, it demonstrates tumor-specific vascular
disruption activity, thus depriving tumors of nutrition. Its distinct effect
on microtubules, as well as its potent activity across numerous
drug-refractory tumor models, differentiates BAL101553 from
microtubule-targeting agents marketed today.

Prof. Achim Kaufhold, Basilea's Chief Medical Officer, commented: "Resistance
to currently available anti-cancer drugs remains a major challenge in the
treatment of cancer patients. BAL101553 demonstrated potent antitumor
activity in diverse drug-refractory breast cancer models alone and in
combination. Specifically, the significant enhancement of antitumor activity
of BAL101553 in combination with trastuzumab, a widely-used therapeutic
antibody for the treatment of breast cancer, is striking. These data
highlight the potential of BAL101553 for the treatment of breast cancer alone
and in combination." He added: "Following the recent successful completion of
Phase 1 clinical testing determining the maximum tolerated dose, Basilea
plans to start a Phase 2 program exploring BAL101553 as monotherapy in
patients with advanced solid tumors in the first half of 2014."

The presented data was generated in cooperation between Basilea and the group
of Prof. Sikic at Stanford University. BAL27862, the active moiety of the
prodrug BAL101553, demonstrated anti-proliferative activity in several breast
cancer cell lines, including multidrug-resistant lines that no longer respond
to, or are inherently resistant to, paclitaxel and vincristine, two standard
microtubule-targeting breast cancer therapies. Intravenous administration of
BAL101553 in an animal model of chemotherapy-refractory human breast cancer
led to a significantly reduced rate of tumor growth when compared to
paclitaxel and vincristine. Antitumor activity was also observed in breast
cancer models refractory to treatment with the therapeutic antibody
trastuzumab. The combination of BAL101553 with trastuzumab strikingly
exhibited enhanced antitumor activityversus
the single agents in a patient-derived trastuzumab-refractory model. This was
associated with a significant delay in tumor growth over an extended time
period.

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|Poster at the AACR Annual Meeting 2014 |
| * BAL101553 (prodrug of BAL27862): A unique microtubule destabilizer active |
| against drug refractory breast cancers alone and in combination with |
| trastuzumab - F. Bachmann, K. Burger, G. E. Duran, B. I. Sikic, H. A. Lane; |
| poster/abstract #831 |
---------------------------------------------------------------------------------

For further information please visitwww.aacr.org

About BAL101553

BAL101553 is a novel small-molecule anti-cancer drug candidate. The agent
directly attacks tumor cells by destabilizing microtubules that form an
intracellular network essential for cell division. In addition, it disrupts
tumor blood vessels depriving the tumor of nutrition.

The investigational drug has shown broadin-vitro
anti-proliferative activity in a panel of tumor models, including many that
are, as a result of diverse resistance mechanisms, not responsive to standard
microtubule-targeting agents, such as taxanes orvinca
-alkaloids. Recently, a dose-escalation Phase 1 was successfully completed and
the maximum tolerated dose has been established. In the study, first evidence
of clinical antitumor activity in solid tumor patients was observed and
reduced tumor cell proliferation and tumor vascularization were shown in
patient tumor biopsies post-treatment.

BAL101553 is a highly soluble prodrug of Basilea's BAL27862. The injectable
dosage form is formulated without potentially harmful solubilizers. In
addition, the prodrug is orally bioavailable.

About Basilea

Basilea Pharmaceutica Ltd. is headquartered in Basel, Switzerland, and listed
on the SIX Swiss Exchange (SIX: BSLN). Through the fully integrated research
and development operations of its Swiss subsidiary Basilea Pharmaceutica
International Ltd., the company focuses on innovative pharmaceutical products
in the therapeutic areas of bacterial infections, fungal infections and
oncology, targeting the medical challenge of rising resistance and
non-response to current treatment options.

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@basilea.com investor_relations@basilea.com |
-------------------------------------------------------------

This press release can be downloaded fromwww.basilea.com.

Press release (PDF)
http://hugin.info/134390/R/1774735/605051.pdf

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The issuer of this announcement warrants that they are solely responsible for the content, accuracy and originality of the information contained therein.
Source: Basilea Pharmaceutica AG via Globenewswire

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