Research & Development
FerGene reveals positive results from Phase three nadofaragene firadenovec clinical trial
9 December 2019 -

FerGene, a new gene therapy company formed by Ferring Pharmaceuticals and Blackstone Life Sciences, has revealed positive results from the pivotal Phase three clinical trial assessing nadofaragene firadenovec (rAd-IFN/Syn3), an investigational gene therapy intended for the treatment of high-grade, Bacillus Calmette-Guerin (BCG) unresponsive non-muscle invasive bladder cancer (NMIBC), it was reported on Friday.

FKD Therapies Oy (FKD) headed the development and regulatory filing of nadofaragene firadenovec, which has been studied in 33 centres across the United States in partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO_CTC). The results were revealed during the bladder cancer session at the Society of Urologic Oncology 20th Annual Meeting in Washington DC.

The Phase three study of 157 patients from the United States has met its primary endpoint with 53% of CIS ± Ta/T1 patients achieving a CR at three months, and 24% continuing to show a CR at 12 months. Moreover, the study also showcased expanded efficacy in this difficult to treat patient population with a 73% HGRF survival in patients with papillary disease at three months and 44% HGRF survival at 12 months. In the study, nadofaragene firadenovec was instilled directly into the patients' bladder every three months. All responses at 12 months were confirmed by protocol-mandatory five-point biopsies.

The US Food and Drug Administration (FDA) has validated FKD's Biologics License Application (BLA) and granted Priority Review for nadofaragene firadenovec, which previously received Fast Track and Breakthrough Therapy Designations.

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