4SC AG (Frankfurt, Prime Standard: VSC), a drug discovery and development company focused on autoimmune and cancer indications, today announced the treatment of the first patient in a Phase II study evaluating resminostat (4SC-201), an oral pan-histone-deacetylase (HDAC) inhibitor in relapsed or refractory Hodgkin's Lymphoma (HL) patients.
In this open-label, single-arm, Simon-design two-stage Phase II study entitled 'SAPHIRE', resminostat will be given orally at a dose of 600mg daily for five consecutive days, followed by a nine day treatment free period ('5+9' dosing schedule). In the main phase of the trial, patients will receive treatment for six cycles (12 weeks). Disease assessments will be performed after treatment cycles three and six by computed tomography in combination with positron emission tomography (PET/CT), as recommended by the International Working Group (IWG) criteria for the evaluation of HL. Patients showing response or stable disease at the end of the main treatment phase may continue to the follow-up phase and can remain on medication for up to one year. The trial will conclude when the last patient remaining will have completed one year of therapy, develops progressive disease or discontinues treatment for other reasons. The study is expected to enrol 33 patients across 10 sites in Poland, Romania and the Czech Republic.
The primary endpoint of the study is to determine the ORR (objective overall response rate) of resminostat in patients who are refractory to first line treatment or have relapsed after responding to first line therapy. The secondary endpoints include assessment of PFS (progression free survival), TTP (time to progression), DOR (duration of response) and OS (overall survival), as well as the analysis of safety and tolerability of the treatment.
Dr Bernd Hentsch, Chief Development Officer of 4SC, commented: 'We are very pleased to have commenced this Phase II trial with our HDAC inhibitor resminostat in relapsed or refractory Hodgkin's Lymphoma. HDAC inhibitors have recently shown particularly promising efficacy in lymphoma indications and we look forward to the results resminostat will deliver in this proof of concept study. We have now delivered the second strategic development goal for resminostat by starting this Proof-of-Concept trial in an haematological tumour indication, having already initiated a Phase II study in hepatocellular carcinoma. We continue to evaluate further tumour indications and potential combinations of resminostat with standard chemotherapeutic agents and plan to commence a further clinical study later this year.'
More information about the trial can be found on www.clinicaltrials.gov.
About Hodgkin's Lymphoma Hodgkin's Lymphoma (HL) - formerly known as Hodgkin's Disease - is a cancer of the lymphatic system, which is part of the immune system. The disease is characterised by the prevalence of the Reed-Sternberg cell. In this disease lymphatic cells grow abnormally and then spread beyond the lymphatic system, which eventually compromises the immune system's ability to fight infection. HL represents one main type of cancer of the lymphatic system. Another type, the class of non-Hodgkin's lymphomas, is, however, far more common. Symptoms of HL include the painless swellings of the lymph nodes, spleen or other tissue, as well as fever, weight loss or night sweats. Therapy options for HL depend on the stage of the disease and number and regions of lymph nodes affected. The first line treatment of HL after the initial diagnosis consists of chemotherapy and/or radiation, achieving cure rates of up to 80%. Standard of care for patients with refractory or relapsing disease after initial therapy comprises salvage chemotherapy followed by high-dose chemotherapy and autologous stem cell transplantation. Disease progression is monitored by computed tomography (CT) in combination with magnetic resonance imaging (MRI) or positron emission tomography (PET). In particular the recent incorporation of functional imaging with PET scanning into disease evaluation has provided significant additional information on the outcome of patients with relapsed HL. For patients exhibiting a complete response after salvage chemotherapy, 5 year progression free survival (PFS) is 79%, but this number drops to 59% for patients only exhibiting partial responses and drops further to 17% for patients resistant to second line therapy regimens. Since there is no standard of care in patients with resistant/refractory HL, there is an especially high need to develop novel therapies for these patients.
About resminostat (4SC-201)
4SC-201 or resminostat is an oral pan-histone-deacetylase (HDAC) inhibitor. HDAC inhibitors modify the DNA structure of tumour cells to cause their differentiation and programmed cell death (apoptosis) and are therefore considered to offer a mechanism of action that has the particular potential to halt tumour progression and induce tumour regression. Resminostat is currently in a Phase II study as a second line treatment for advanced hepatocellular carcinoma (HCC), the most frequent form of liver cancer. Recently, in a completed Phase I trial in patients with various different cancer types, stable disease was achieved in over 50% of the patients, whilst the treatment was well tolerated and showed a positive, differentiating pharmacological profile to other drugs in this class.
About 4SC
4SC AG (ISIN DE0005753818) is a drug discovery and development company focused on autoimmune and cancer indications. 4SC-101, a small molecule, is in a Phase IIb study in rheumatoid arthritis as well as in a Phase IIa exploratory study in inflammatory bowel disease. The company's lead oncology compound, resminostat (4SC-201), a pan-histone-deacetylase inhibitor, is in two Phase II trials in hepatocellular carcinoma (HCC) and Hodgkin's Lymphoma (HL). Two further oncology compounds 4SC-203 and 4SC-205 are due to commence Phase I trials. Drug candidates are developed 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.
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| 4SC AG |
| Yvonne Alexander, IR & PR |
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| Stefan Riedel |
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Contacts:
4SC AG
Yvonne Alexander, 089-700 763 - 0
yvonne.alexander@4sc.com
andrea.aigner@4sc.com
