NanoZolid®-formulated Docetaxel is Safe and Tolerable Showing Signs of Clinical Efficacy
LIDDS AB (publ) announced today that no further patients will be enrolled in its dose escalating Phase I study (NZ-DTX-001) with the primary objective to study safety of NanoZolid®-docetaxel in solid tumors. The data collected in the trial demonstrates safety and tolerability, an active and local drug release of docetaxel over an extended period of time and signs of clinical effect in injected tumors. LIDDS plan to communicate the topline results from the study in Q4 2021.
“We have reached an important milestone with the final enrollment of patients in the NZ-DTX-001 study. Preliminary assessments and observations indicate good safety and tolerability in patients treated intratumorally with NanoZolid®-docetaxel. After proper closing of the study, we intend to communicate next step forward for the program” said Nina Herne, CEO of LIDDS.
The clinical Phase I trial NZ-DTX-001 aims 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, is safe and tolerable. A secondary objective is to assess efficacy on tumor response.
About the NZ-DTX-001 Phase I study
NZ-DTX-001 is 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 NZ-DTX-001 study is a multi-center study including Karolinska University Hospital in Sweden, Herlev Hospital in Denmark, Kaunas University Hospital and Vilnius National Cancer Institute in Lithuania.