FDA approves IND application for resminostat in liver cancer

(PresseBox) ( Martinsried, )
4SC AG (4SC, FWB Prime Standard: VSC) has received an "investigational new drug" (IND) approval from the US Food and Drug Administration (FDA) to carry out a clinical trial with resminostat in combination with sorafenib, the standard first-line therapy for patients with advanced liver cancer (hepatocellular carcinoma, HCC).

Enno Spillner, CEO of 4SC, said: "The FDA's approval of our IND application is a major milestone in developing our epigenetic compound resminostat into a globally available drug for the first-line therapy of liver cancer patients. Back in 2014, our partner Yakult Honsha started a Phase II HCC trial in Japan, and we expect the trial's results to be available later this year. On this basis, we would then be able to conduct initial clinical activities with resminostat in the USA."

About liver cancer (liver cell carcinoma, hepatocellular carcinoma, HCC)
With around 748,000 new cases each year, liver cancer is the fifth most common type of cancer worldwide and the third most frequent tumor-related cause of death. In the past three decades alone, the number of new cases has almost doubled. Liver cancer often remains undetected until it reaches an advanced stage, resulting in only a slim chance of recovery. The tyrosine kinase inhibitor sorafenib is the only approved drug-based first-line therapy for patients with advanced liver cancer which has been shown to offer a survival benefit in clinical trials.

About Resminostat
Resminostat (4SC-201) is an oral histone deacetylase (HDAC) inhibitor with an innovative epigenetic mechanism of action that potentially enables the compound to be deployed as a novel, targeted tumor therapy for a broad spectrum of oncological indications, both in monotherapy and in combination with other cancer drugs. Like other epigenetic therapies, resminostat can modify transcription of genes in cancer cells and, thereby, reprogram the phenotypes of such cancer cells. Additionally, resminostat has immunotherapeutic effects by activating natural killer cells or suppressing unspecific immunosuppression in tumors. Resminostat is assumed to be able to halt tumor progression and induce tumor regression. Furthermore, due to its epigenetic mode of action resminostat is assumed to develop additional synergetic effects when combined with classical cancer therapies. This process can counteract certain tolerance and resistance mechanisms which tumor cells often develop against cancer drugs. On the whole, a reinforcing positive therapeutic effect is expected to be achieved through a combination of traditional cancer drugs with a well-tolerated epigenetic compound such as resminostat.

Resminostat has been investigated by 4SC and its Japanese partner Yakult in a broad clinical campaign comprising liver cancer (hepatocellular carcinoma, HCC), Hodgkin's Lymphoma (HL), colorectal cancer (CRC), non-small-cell lung cancer (NSCLC), and pancreatic and biliary tract cancer. In several phase I and phase II trials, resminostat has already demonstrated very good safety and tolerability, alongside promising indications of efficacy. In addition to the agreement with Yakult Honsha, a licensing and development partnership is in place with Menarini in the Asia Pacific (APAC) region excluding Japan. 4SC aims to agree additional partnerships for resminostat and is currently in preparations of a randomized, controlled Phase II trial in the indication of advanced cutaneous T-cell lymphoma (CTCL) in Europe that will be funded by 4SC itself.

Forward-looking information
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.
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