NanOlogy has concluded the dose escalation portion of a Phase II, open-label clinical trial of NanoPac (submicron particle paclitaxel sterile suspension) for the treatment of prostate cancer.
The dose escalation phase was performed to determine highest concentration of NanoPac that can be safely administered.
In this phase, 6mg/ml, 10mg/ml, 15mg/ml concentrations of NanoPac were injected into three patient cohorts followed by a safety review for each cohort.
No drug related serious adverse events were observed in any of the cohorts and preliminary data show evidence of tumour reduction and tumour cell death.
Completion of the dose escalation phase has also enabled NanOlogy to identify the highest concentration of NanoPac to begin the dose confirmation phase of the trial, which will continue to provide data on safety and tumour response.
NanOlogy has already started the dose confirmation phase, which will enrol nine additional patients for a total of 18 patients who received direct injection of NanoPac 28 days prior to their scheduled prostatectomy.
This phase will investigate the safety and tolerability as well as tumour size and histologic evidence of tumour response. It will also analyse the local lymph nodes to investigate potential lymphatic transport of NanoPac.
NanOlogy expects to complete and provide the final report of the trial by the third quarter of this year.
University of Southern California Institute of Urology Image-Guided Surgery and Focal Therapy of Prostate and Kidney Cancerco-director Andre Abreu said: “NanoPac is injected directly into the cancerous lobe of the prostate under MRI/TRUS fusion guidance.
“The drug injected locally has been well tolerated to date and we have progressed into the dose confirmation phase of the trial to further assess safety and tumour response.
“If we are successful, we may offer a treatment option for moderate or high-risk patients with localized or non-metastatic disease potentially providing better oncologic outcomes while minimising side-effects of chemotherapy, and therefore maintaining quality of life.”
Prostate cancer is estimated to affect around three million men in the US, with about 160,000 new cases and 27,000 deaths reported annually.