UPPSALA, SWEDEN – LIDDS AB (publ) announced today that the systemic exposure of docetaxel after treating solid tumors with NanoZolid®-docetaxel is low and that the study demonstrated activity in both injected lesions and in systemic inflammatory markers. The results support further development of NanoZolid®-docetaxel.
In October 2021, LIDDS announced the closing of the NZ-DTX-001 Phase I study. It was demonstrated that NanoZolid® in combination with docetaxel was safe and well tolerated, reaching the primary endpoint of the trial. After further analysis it is also concluded that the systemic NanoZolid®-docetaxel exposure is low and that activity in injected lesions is observed. Patients receiving docetaxel showed activation of systemic inflammatory biomarkers including IFN-gamma, CXCL9 and CXCL10. These molecules are considered important for efficient recruitment and activation of immune effector cells and for creating a good environment for treatments with immune-modulating drugs such as check-point inhibitors. LIDDS intends to submit detailed study data for publication in a relevant journal.
“We are pleased to see that the study meets its primary endpoint of being safe and tolerable and that the reported adverse events are generally mild and local. The latter is most likely due to the observation of a very low systemic exposure of docetaxel which is in line with our intended local treatment regimen. In addition to meeting the primary endpoint, we also see signs of immune activation by an upregulation of key immune regulating molecules. This is indeed encouraging indicating that the NanoZolid®-formulated docetaxel could have the potential to change the immune microenvironment. We are working hard to finalize our plan forward and will very soon communicate how we intend to take the project further in clinical development.” said Nina Herne, CEO of LIDDS.
About the NZ-DTX-001 Phase I study
NZ-DTX-001 was 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) given as an intratumoral injection in patients with advanced solid tumors. The clinical Phase I trial NZ-DTX-001 aimed to examine whether NanoZolid® in combination with docetaxel, one of the most commonly used drugs for cytostatic treatment of breast, prostate, head, neck, stomach and lung cancer, was safe and tolerable.
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LIDDS AB (publ) is a Swedish-based pharmaceutical company focusing on a unique proprietary drug delivery technology: NanoZolid®. NanoZolid® is a clinically validated drug development technology and superior 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 clinical and preclinical phase for cytostatics and immunoactive agents. LIDDS shares are listed on Nasdaq First North Growth Market (ticker LIDDS). Redeye AB is the Certified Adviser to LIDDS (+46 (0) 8 121 576 90, email: email@example.com) For more information, please visit liddspharma.com