Corporate | 11 February 2010 07:45
4SC AG / Research Update
11.02.2010 07:45
Dissemination of a Corporate News, transmitted by
DGAP - a company of EquityStory AG.
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- Oral Eg5 kinesin spindle protein inhibitor to be evaluated in solid
tumour and malignant lymphoma patients -
Planegg-Martinsried, Germany - 11 February, 2010 - 4SC AG (Frankfurt, Prime
Standard: VSC) a drug discovery and development company focused on
autoimmune and cancer indications, today announced the first treatment in a
Phase I study evaluating 4SC-205, an oral Eg5 kinesin spindle protein
inhibitor, in patients with solid tumours or malignant lymphomas.
This first-in-man Phase I, open label, dose escalation trial, the 'AEGIS'
study, in patients to investigate the safety, tolerability,
pharmacokinetics, and pharmacodynamics of orally administered 4SC-205. Six
dosage cohorts (3+3 design) will be enrolled and patients will be treated
for two to three week treatment cycles with dosing on days one and eight of
each cycle. After six weeks of treatment patients will undergo radiological
disease assessments. Patients may remain on therapy beyond the initial two
therapy cycles as long as they tolerate the treatment and do not
demonstrate progressive disease. The study will be performed in two centres
in Germany and is expected to report results in 2011.
4SC-205 is an oral inhibitor of the kinesin spindle protein Eg5 (also known
as kinesin-5, KIF11), a motor protein that has been shown to be of crucial
importance for proper cell division (mitosis) by mediating chromosome
separation to the daughter cells. Inhibition of Eg5 leads to cell cycle
arrest by interfering with microtubules, a component of the mitosis
machinery, leading to apoptosis (programmed cell death). Other anti-mitotic
agents which directly target microtubules, such as taxanes, are used
extensively as chemotherapeutics, however, these also frequently lead to
severe peripheral neurological side-effects. In contrast, targeting Eg5 is
expected to provide an improved safety profile since its expression has
been described to be confined to actively dividing (proliferating) cells.
Therefore, 4SC-205 has the potential to generate a therapeutic effect
analogous to other anti-mitotic drugs yet avoiding peripheral nerve damage
commonly seen after taxane chemotherapy.
In preclinical studies 4SC-205 displayed encouraging anti-tumour activity
in several in vitro and in vivo models.
Dr Bernd Hentsch, Chief Development Officer of 4SC commented, 'With the
commencement of this trial, we have now extended our oncology pipeline to
include a third compound. This anti-mitotic agent, based on earlier
preclinical results, could be positioned in a variety of cancer
indications. Over the last twelve months 4SC has now established a strong,
clinical stage oncology franchise investigating multiple, innovative
approaches for the treatment of both solid and haematological cancers.'
More information about this trial can be found on www.clinicaltrials.gov.
For further information please contact:
4SC AG
Yvonne Alexander
Investor Relations & Public Relations
Tel: +49 (0) 89 70 07 63 66
yvonne.alexander@4sc.com
The Trout Group (USA)
Chad Rubin
Tel: +1 646 378 2947
crubin@troutgroup.com
Notes to Editor
About 4SC-205
4SC-205 is a small molecule inhibitor of the human kinesin spindle protein
Eg5 which is of crucial importance for proper cell division (mitosis). Eg5
interacts with microtubules, a component of the cellular mitosis machinery,
and mediates the segregation of the two spindle poles resulting in the
correct distribution of the chromosomes to the daughter cells. Inhibition
of Eg5 leads to cell cycle arrest in mitosis und subsequent programmed cell
death (apoptosis). Mitosis is the fundamental process leading to cell
division and tissue proliferation. The mitotic spindle apparatus has been
for decades a primary target for the development of anti-mitotic agents
such as the taxanes and vinca alkaloids which are broadly used in cancer
therapies as single chemotherapeutic agents or in combination. In
preclinical tests 4SC-205 has proven to be a particularly effective
inhibitor of tumour cell proliferation of various cancer origins, both in
vitro and in vivo.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company
focused on autoimmune and cancer indications. Vidofludimus (4SC-101), a
small molecule, is currently in a Phase IIb study in rheumatoid arthritis
and a Phase IIa exploratory study in inflammatory bowel disease. The
company's lead oncology compound, resminostat (4SC-201), a pan histone
deacetylase (HDAC) inhibitor, is in Phase II trials in hepatocellular
carcinoma and Hodgkin's lymphoma. Two further oncology compounds, 4SC-203
and 4SC-205 are in Phase I studies. 4SC develops drug candidates until
proof-of-concept in order to generate value creating partnerships with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties.
4SC was founded in 1997, has 93 employees, and is listed on the Prime
Standard of the Frankfurt Stock Exchange since December 2005.
For further information please visit www.4sc.com.
Legal Note
This document may contain projections or estimates relating to plans and
objectives relating to our future operations, products, or services; future
financial results; or assumptions underlying or relating to any such
statements; each of which constitutes a forward-looking statement subject
to risks and uncertainties, many of which are beyond our control. Actual
results could differ materially, depending on a number of factors.
11.02.2010 Ad hoc announcement, Financial News and Media Release distributed by DGAP.
Media archive at www.dgap-medientreff.de and www.dgap.de
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Language: English
Company: 4SC AG
Am Klopferspitz 19a
82152 Martinsried
Deutschland
Phone: +49 (0)89 7007 63-0
Fax: +49 (0)89 7007 63-29
E-mail: public@4sc.com
Internet: www.4sc.de
ISIN: DE0005753818
WKN: 575381
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Berlin, Düsseldorf, München, Stuttgart
End of News DGAP News-Service
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