Corporate | 21 October 2008 08:57
4SC AG / Miscellaneous
Release of a Corporate News, transmitted by DGAP - a company of EquityStory
AG.
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• Very good tolerability and excellent pharmacological profile
• Completion of this phase I trial is expected shortly
• Various phase II efficacy studies planned for 2009
Planegg-Martinsried, Germany, 21 October 2008 - The Martinsried-based drug
discovery and development company 4SC AG (Frankfurt, Prime Standard: VSC)
announced today that the clinical phase I trial with the drug candidate
4SC-201, an innovative substance from the histone deacetylase (HDAC) class
of inhibitors, for the treatment of cancer has progressed very well. The
first available study results prove that 4SC-201 given orally can be
administered safely, is highly tolerable and shows a particularly
advantageous pharmacological profile. At advanced stages of the study,
different cancer types were seen to stabilise in several patients. In some
of these cases, with an optional, prolonged treatment with 4SC-201 that
went beyond the main therapy scheme, to date the treatment period has
already reached up to six months.
To date, 17 evaluable patients were treated in this phase I study. The aim
of this trial, which is being conducted at the Royal Marsden Hospital in
Sutton/England, is to evaluate the safety, tolerability and
pharmacokinetics of 4SC-201 upon oral administration, to determine the
maximum tolerated dose (MTD) and dose-limiting toxicity (DLT) and to
examine its pharmakodynamic and therapeutic efficacy. Patients who suffer
from a progressed solid tumour disease or from malignant lymphomas, and who
have received at least one previous standard therapy, or for whom no
standard therapy exists can be included in this trial.
The clinical trial is designed as a dose-escalation study, in which a
minimum of three patients per dose level are treated. If the medication had
been tolerated well by these patients, more patients are included in the
trial at the next higher dose level. This way, 4SC-201 was administered
orally, once daily, to at least three patients each for five days at
different doses (100 mg, 200 mg, 400 mg, 600 mg and 800 mg). After a
subsequent nine-day break from the treatment, another five-day
administration of the drug began. The resulting 14-day treatment cycle
(five + nine days) is repeated up to four times.
With evidence of a therapeutic benefit, the patient is subsequently offered
the option of continuing treatment with 4SC-201. Among the patients with
different tumour diseases included into this trial, three patients are
currently in continuing treatment beyond the four planned treatment cycles.
One of these patients has meanwhile reached already the twelfth treatment
cycle.
With all three patients in the 600 mg dose group, the disease was seen to
stabilise after eight weeks of treatment, i.e. after four cycles. In the
final planned and highest dose level of the trial, 800 mg daily, five
patients have been included to date, of which one patient has already
accepted the continuing treatment with 4SC-201 beyond the planned four
cycles. The conclusion of the trial at this dose level is expected shortly.
The pharmacokinetic profile of 4SC-201 observed upon oral administration
proves the substance behaves dose-proportionally. With a calculated serum
half-life of 4SC-201 being approximately three to four hours, its measured
serum concentrations are clearly above those described for other HDAC
inhibitory drugs. These findings confirm that 4SC-201 exhibits a
particularly advantageous pharmacokinetic behaviour also in humans. Thus it
is to be expected that this substance has a clearly optimised,
therapeutically beneficial window.
'The results available from this first clinical trial have far exceeded our
expectations,' said Dr. Bernd Hentsch, Chief Development Officer at 4SC AG.
'Above all, particularly in the advanced stage of the trial, the results
obtained give reason to hope that 4SC-201 shall deliver further clinical
progress with the efficacy studies in phase II and demonstrate a great
medical benefit.'
4SC AG shall present the initial results from this phase I trial between 22
and 24 October 2008 at two international conferences: 'Molecular Targets
and Cancer Therapeutics' (20th EORTC-NCI-AACR Symposium) in Geneva,
Switzerland, and 'HDAC Inhibitors: Targeting Oncolgy and Beyond' in Boston,
USA. The conclusion, and with it the final results of the Phase I trial,
are expected shortly. It is on this basis that the enterprise plans to
begin with different efficacy studies in clinical phase II trials in
different tumour diseases in the coming year.
About 4SC-201:
4SC-201 is an innovative substance from the histone deacetylase (HDAC)
class of inhibitors. It concerns one of the drug candidates, which 4SC AG
took over in July of this year from Nycomed, with the former designation
BYK408740. Compared with other cancer drugs, which also block the HDAC
enzyme, this candidate showed a particularly good pharmacokinetic profile
upon oral application in previous test series. In addition, a very good
safety profile and very good efficacy were observed with respect to its
broad anti-tumour activity in preclinical models.
About 4SC:
4SC AG (ISIN DE0005753818) has been listed in the Prime Standard of
Frankfurt Stock Exchange since 15 December 2005. Founded in 1997 and now
with a staff of 77 employees, the company develops novel drug candidates
against inflammatory diseases and cancer. 4SC AG utilises its patent
protected platform, to create a sustainable project pipeline of drug
candidates, which are to be developed up to clinical efficacy in early
clinical phases ('proof of concept') and subsequently partnered with the
pharmaceutical industry in return for advance and milestone payments as
well as royalties. There are currently eight projects in the development
pipeline and a rich pool of further discovery projects. Clinical phase IIa
for the first project for the treatment of rheumatoid arthritis has already
successfully been completed. An additional project for the treatment of
various cancers is currently completing a clinical phase I trial. Further
projects are in advanced pre-clinical stages.
Further information is to be found at 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.
For more information please contact us!
Bettina von Klitzing
Manager Investor Relations und Public Relations
4SC AG
Tel.: +49 (0) 89 70 07 63 - 0
Bettina.von.klitzing@4sc.com
21.10.2008 Financial News transmitted by DGAP
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Language: English
Issuer: 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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