LIDDS initiated the company’s first-in-human (FiH) study in 2007 where tolerance and safety of an early version of Liproca Depot was investigated. In 2017, the In 2019, the first patient was treated in the phase I study were NanoZolid formulated docetaxel (nanodotax) was studied in patients with solid tumors. In 2019, the first patient was treated in the phase I study were NanoZolid formulated docetaxel (nanodotax) was studied in patients with solid tumors.
LIDDS are in the process of preparing a multicenter phase III study with Liproca Depot and following the phase I study with nanodotax a short clinical study in prostate cancer patients will be initiated in 2022 to understand the immunological effects observed in the previous study. In addition, the nanoimod and nanoxan combination is being prepared for a FiH study.
|Study||Study design||Number of patients||Length of Study||Results|
|LPC-001||Open-label study for evaluation of tolerance and safety.||10||3-10 weeks||No signs of toxicity. The injection was well tolerated. Signs of local reactions in the prostate in some patients.|
|LPC-002||Open-label study for evaluation of effect on PSA and prostate volume and safety.||24||6-12 months||PSA nadir was achieved in 83% of patients. Reduced prostate volume. Duration of effect at least six months. Well tolerated, few side effects.|
|LPC-003||Open-label study for evaluation of antitumor effect and general effect on PSA and prostate volume.||18||6 weeks||More pronounced PSA and prostate volume reduction than in LPC-002. Significant effect already after six weeks. Verified anticancer effect.|
|LPC-003 (part II)||Extension of the study with a higher dose.||5||8 weeks||PSA decreased on average by 23% and positive effect on prostate volume and MRI. No hormonal side effects were reported.|
|LPC-004||The single blind, two-part dose finding study of Liproca Depot and to determine the level of PSA reduction at month 5.||61||6 months||All doses were safe and well tolerated. Hhe PSA reduction was greatest for the group receiving 16ml. Some 78% of patients showed a prostate volume decrease.|
|LPC-004 OLE||Voluntary open-label extension of the LPC-004 study to study the long-term anti-androgen efficacy of Liproca Depot after a repeated injection.||12||10 months||Six patients met the criteria for a second injection and PSA levels were in average reduced by 28% at 2 months and reduced PSA levels remained in 2 patients at the end of the study.|
|NZ-DTX-001||Open label dose-escalation and dose-expansion study of NanoZolid-docetaxel depot formulation.||6||5-9 weeks||The systemic exposure of docetaxel is low and the study demonstrated activity in both injected lesions and in systemic inflammatory markers.|