Full-Life Technologies’ IND application for prostate cancer cleared by FDA

Betsy Goodfellow | May 30, 2024 | News story | Medical Communications |  Full-Life Technologies, IND, Oncology, prostate cancer 

Full-Life Technologies has announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) Application for its clinical trials of Ac-FL-020, its PSMA-targeted radiopharmaceutical for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The company intends to begin clinical trials throughout the US and globally during 2024.

The drug uses targeted alpha-radiotherapy to selectively attack cancer cells, therefore reducing the damage to healthy tissue. The drug has demonstrated a promising biodistribution profile through its preclinical models, and displayed robust anti-tumour activity un LNCaP xenograph mice, as well as having a favourable safety profile.

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Steffen Heeger MD MSc, chief medical officer at Full-Life Technologies, commented: “The IND application clearance is a significant regulatory milestone in our development plan for Ac-FL-020. This important step underscores our overall commitment to the therapeutic potential of radiopharmaceuticals and once again highlights the value of the team´s effort, dedication and cross-functional collaboration. We are excited to initiate the phase 1 clinical programme, which provides the first opportunity to gather human data on Ac-FL-020’s safety and anti-tumour activity.”

Betsy Goodfellow

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