Nanology has concluded subject enrolment in a Phase IIa clinical trial of large surface area microparticle paclitaxel (LSAM-PTX) plus standard of care (SOC) therapy in non-operable lung cancer patients.
The single-arm trial enrolled 18 participants with primary or recurrent, non-operable, locally advanced stages II and III with nodal disease, or stage IV advanced disease, at four study sites.
Participants who were enrolled into the study had received, or are simultaneously receiving, chemotherapy, radiotherapy, and/or immune checkpoint inhibitor (ICI) therapy as part of SOC.
These subjects were given up to three monthly doses of intratumoral (IT) LSAM-PTX.
Safety, as evaluated by treatment-emergent adverse events, is the trial’s primary outcome measure.
The concentration of paclitaxel in plasma, survival, tumour response, and immune response by flow cytometry analysis comprise the secondary measures of the trial.
Before open enrolment, the company carried out a safety evaluation for each of the initial three participants.
According to the early trial findings obtained so far, IT LSAM-PTX was found to be well tolerated, with favourable signs of tumour and immune responses.
NanOlogy plans to report the final trial data by the third quarter of next year.
The company intends to carry out additional clinical research in lung cancer to assess its LSAM investigational therapies along with ICIs, as per a new US patent permitting the usage of LSAM taxanes offered locally in combination with systemic ICIs.
The clinical programmes of the company analysing LSAM investigational drugs are progressing in multiple solid tumours including lung, pancreas, peritoneal, prostate, bladder, ovarian, and dermal cancers.
In November 2020, NanOlogy enrolled the first subject in a Phase II trial of NANOPAC, sterile nanoparticulate paclitaxel, to treat local prostate cancer.