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4SC announces positive top line data from clinical Phase I trial with epigenetic cancer drug 4SC-202 in patients with haematological tumours at ASCO
The first-in-man, open-label, dose-escalating, multi-centre, exploratory study evaluated safety, pharmacokinetics and pharmacodynamics of 4SC-202 in 24, heavily pre-treated, patients with advanced stages of haematological malignancies. The compound was studied in doses from 25 mg up to 400 mg total daily dose of 4SC-202 using various dosing schemes.
The drug showed promising signs of efficacy, both in terms of long-term disease stabilisation of heavily pre-treated cancer patients and in terms of tumour shrinkage and objective radiological response. There was one complete remission (CR) and one partial remission (PR). 50% of patients (12 out of 24) had disease stabilisation and time on study medication for more than 100 days, 13% were stabilised for over a year, and one patient could be stabilised for more than 2 years. The patient with the CR has been on the trial now for over 16 months, with both study treatment and CR still ongoing to date.
4SC-202 was generally safe and well tolerated in the doses tested. Due to the clean safety profile, no formal DLT (dose limiting toxicity) or MTD (maximum tolerated dose) could be determined. A recommended dose of 200 mg 4SC-202 once daily or twice daily in a 14+7 dosing scheme (14 days treatment, 7 days rest) was established.
The compound showed a favourable pharmacokinetic profile achieving potentially efficacious and well tolerated levels of 4SC-202 in patients. As for pharmacodynamics, the study showed promising biomarker responses including HDAC inhibition and a regulation of genes associated to the WNT signalling pathway in patient blood samples.
4SC will fully evaluate the data after final completion of the trial. In parallel, 4SC will investigate in particular WNT and HH related tumour indications for a possible Phase II development, and will also engage in talks with pharmaceutical partners interested in further development of the compound.
Enno Spillner, Chief Executive Officer of 4SC, said: "We are highly excited about the clinical Phase I top line results with our second epigenetic drug candidate 4SC-202. In the study 4SC-202 showed very good safety and highly promising signs of efficacy in heavily pre-treated patients with haematological tumours. We will now carry on our efforts on a Phase II development plan which we would like to pursue together with a potential pharmaceutical partner."
Details of the Presentation at ACSO:
Abstract No.: 8559
Poster Title: First-in-human study of 4SC-202, a novel oral HDAC inhibitor in advanced hematologic malignancies (TOPAS study)
Time/location: Monday, 2 June 2014, 1:15 pm - 5:00 pm CDT, S Hall A2
Type: General Poster Session
Session: Lymphoma and Plasma Cell Disorders
Authors: Bastian von Tresckow1, Mariele-E. Goebeler2, Walter Erich Aulitzky3, Dennis A. Eichenauer1, Cyrus Sayehli2, Liza Bacchus3, Stefan Gundermann2, Bernhard Hauns4, Anna Mais5, Bernd Hentsch4, Hella Kohlhof4, Eunice Braz4, Rolf Krauss4, Babett Krauss4, Roland Baumgartner4, Daniel Vitt4, Andreas Engert1;
1University Hospital of Cologne, Cologne, Germany;
2University Hospital of Wuerzburg, Wuerzburg, Germany;
3Robert Bosch Hospital, Stuttgart, Germany;
44SC AG, Planegg-Martinsried, Germany;
5formerly 4SC AG, now Novartis, Basel, Switzerland;
4SC-202 is 4SC's second epigenetic drug candidate in clinical development, showing markedly different properties compared to the company's other epigenetic drug resminostat thus possessing an individual and unique therapeutic profile. 4SC-202 is an orally administered selective inhibitor of LSD1 and HDACs 1, 2, and 3 with a unique combination of anti-cancer mode of actions, namely epigenetic regulation and targeting of cancer stem cells. 4SC-202 has been shown to inhibit the Hedgehog (HH) and WNT signalling pathways in cancer cells via epigenetic modifications, thereby provoking the inhibition of properties of cancer stem cells. The Hedgehog and WNT signalling pathways play an important role in cancer development and progression.
Cautionary statement regarding forward-looking statements
This press release contains certain forward-looking statements. Any forward-looking statement applies only on the date of this press release. By their nature, forward-looking statements are subject to a number of known and unknown risks and uncertainties that may or may not occur in the future and as a result of which the actual results and performance may differ substantially from the expected future results or performance expressed or implied in the forward looking statements. No warranties or representations are made as to the accuracy, achievement or reasonableness of such statements, estimates or projections, and 4SC AG has no obligation to update any such information or to correct any inaccuracies herein or omission herefrom which may become apparent.
The Group managed by 4SC AG (ISIN DE0005753818) discovers and develops targeted, small-molecule drugs for treating diseases with high unmet medical needs in various cancer and autoimmune indications. These drugs are intended to provide innovative treatment options that are more tolerable and efficacious than existing therapies, and provide a better quality of life. The Company's pipeline comprises promising products that are in various stages of clinical development. 4SC's aim is to generate future growth and enhance its enterprise value by entering into partnerships with leading pharmaceutical and biotech companies. Founded in 1997, 4SC had a headcount of 64 employees (55 FTEs) at 31 March 2014. 4SC AG has been listed on the Prime Standard of the Frankfurt Stock Exchange since December 2005.
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