UPPSALA, SWEDEN - LIDDS AB (publ) has received approval from the Danish Medicines Agency (DKMA) to conduct its Phase I NZ-DTX-001 clinical trial. The Danish study is in addition to the Phase I NZ-DTX-001 clinical trial being conducted at the Karolinska University Hospital.
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.
For more information, please contact:
Monica Wallter, CEO, +46 (0)737 07 09 22, monica.wallter@liddspharma.com
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology: NanoZolid®. NanoZolid is superior to any drug delivery technology in its ability to provide a controlled and sustained release of active drug substances for up to six months. LIDDS has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in preclinical phase for cytostatics and immunoactive agents. LIDDS shares (LIDDS) are listed on Nasdaq First North. Redeye AB, Certifiedadviser@redeye.se, +46 (0)8 121 576 90, is a certified adviser to LIDDS. For more information, please visit www.liddspharma.com.
