On February 5, 2019 LIDDS AB (publ) reported that it has received approval from the Danish Medicines Agency (DKMA) to conduct its Phase I NZ-DTX-001 clinical trial (Press release, Lidds, FEB 5, 2019, View Source [SID1234555911]). The Danish study is in addition to the Phase I NZ-DTX-001 clinical trial being conducted at the Karolinska University Hospital.
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The aim of the dose escalation clinical trial is to assess the tolerability and safety of intratumoral injections of NanoZolid with docetaxel, a well established cytostatic used in the treatment of cancer with an estimated global market of over USD 1 billion.
LIDDS expects to enroll the first patients in the NZ-DTX-001 trial in Q1 2019.
-This Phase I study will be very exciting to follow. LIDDS aims to demonstrate that intratumoral injections with cytostatics are safe and we expect that following this study a wide range of different indications and NanoZolid combinations using chemotherapy drugs will emerge, says Monica Wallter, CEO.
-Our goal is to deliver drugs directly into the cancer tumor and thereby limit the severe side effects for cancer sufferers receiving systemic chemotherapy treatments which affect all cells in the body, says Monica Wallter.
LIDDS will now initiate a collaboration with a competent Phase I clinical site in Denmark.
NZ-DTX-001 study description:
A phase Ia/Ib, first-in-human, open label, multicenter, dose-escalation and dose-expansion study of a novel NanoZolid-docetaxel depot formulation (NZ-DTX Depot) given as an intratumoral injection in patients with advanced solid tumors.