Arovella Therapeutics Says FDA Accepts Investigational New Drug Application for Blood Cancer Drug Candidate

MT Newswires Live

01/29

Arovella Therapeutics (ASX:ALA) said the US Food and Drug Administration (FDA) accepted its investigational new drug application for its ALA-101 drug candidate to commence first-in-human clinical trials in patients with CD19-positive non-Hodgkin's lymphoma and leukaemia, according to a Thursday Australian bourse filing.

This will allow it to conduct its phase one trial in Australia via the clinical trial notification scheme rather than the "lengthier" clinical trial application pathway, per the filing. The planned study will assess the safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity of the candidate in patients with relapsed/refractory CD19-positive non-Hodgkin's lymphoma and leukaemia.

Its shares rose 2% in recent trading on Thursday.

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