Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.4SC has treated first patient in a Phase I TOPAS study evaluating 4SC-202 in patients with advanced hematological indications, including acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, myelodysplastic syndrome and lymphomas.
Subscribe to our email newsletter
4SC-202 is a benzamide type selective inhibitor of human class I histone deacetylases (HDAC) isoenzymes 1, 2 and 3.
TOPAS is a mono-centric, single arm, open-label dose escalation Phase I study designed to evaluate daily doses between 25 and 400mg of 4SC-202 in six dose cohorts.
Patients will be given 4SC-202 tablets once daily for 14 consecutive days (d1-14) in a 21-day treatment cycle (14+7 scheme).
The primary objective of the TOPAS study is to evaluate the safety, tolerability and pharmacokinetics of 4SC-202 and the associated determination of optimal doses and dosing regimens for patients with advanced hematological malignancies.
The secondary objectives include the assessment of the clinical anti-tumour activity with respect to tumour response, duration of response (DOR) and progression-free survival (PFS) of the patients.
4SC chief development officer Bernd Hentsch said with the commencement of the TOPAS study they have now advanced the second HDAC inhibitor to the clinical development stage and extended their oncology pipeline to a total of four compounds.