FDA OKs Clinical Trial for Novel Neuroendocrine Carcinoma Drug


A phase 2 clinical trial will evaluate iadademstat for patients with relapsed or refractory high-grade neuroendocrine carcinoma.

The Food and Drug Administration (FDA) greenlit a phase 2 clinical trial evaluating iadademstat in patients with relapsed or refractory high-grade neuroendocrine carcinoma, a type of cancer that occurs in the hormone-releasing cells.

In the United States, approximately 22% to 27% of neuroendocrine carcinomas occur in the lung (small cell lung cancer), while the rest frequently occur in the gastrointestinal tract, and genitourinary systems, according to Oryzon Genomics, the manufacturer of iadademstat.

“Relapsed and refractory (neuroendocrine carcinomas) and small cell lung cancer carry a dismal prognosis and represent a major unmet medical need in oncology,” said Dr. Douglas V. Faller, the chief medical officer at Oryzon, in a press release.

“(Neuroendocrine carcinomas) have been shown to be dependent upon LSD1 for their growth and the survival of the tumor stem cells. We believe that our epigenetic therapeutic drug, iadademstat, in combination with selected other agents which have shown activity in these malignancies, represents a new approach to the treatment of NECs, with the potential to provide meaningful benefit to these patients."

Iadademstat is an oral drug (taken by mouth) that selective inhibits the LSD1 epigenetic enzyme, which, when overexpressed, has been associated with the development of aggressive cancers. It is being studied in other clinical trials for the treatment of acute myeloid leukemia.

The trial is being run in conjunction with Fox Chase Cancer Center in Philadelphia, where clinicians from Fox Chase will be conducting research trials, while Oryzon Genomics, the manufacturer of iadademstat, will provide the drug, funding and technical experience.

“(Neuroendocrine carcinomas) are difficult to diagnose and treat because these types of carcinomas behave differently depending on where they grow in the body,” said lead study author, Dr. Namrata Vijayvergia, from the Fox Chase Cancer Center, said in the release.

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