Clinical-stage pharmaceutical development company NanOlogy announced April 30 that it has completed the dose escalation phase of an open-label clinical trial of NanoPac – a submicron particle paclitaxel sterile suspension – injected directly into the tumor area for treatment of prostate cancer.
The company said that the test – to determine the permissible dosage of the cancer-fighting treatment, involved three doses injected directly into the tumor in nine patients with no drug-related local or systemic side effects observed. The news release said that examination of the prostate tissue showed tumor regression.
Phase 2a is enrolling patients with local prostate cancer who are scheduled for surgery to remove all or part of the prostate gland.
The patients will be treated with NanoPac 28 days before surgery and researchers will compare the size of the tumor and the prostate tissue biopsy prior to NanoPac treatment to tumor volume and tissue after surgery.
“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 tumor response,” said Andre Abreu, MD, assistant professor of Clinical Urology, co-director of Image-Guided Surgery and Focal Therapy of Prostate and Kidney Cancer at the University of Southern California’s Institute of Urology.
NanOlogy said in the release that the dose confirmation phase will enroll nine additional patients for a total of 18 patients who received direct injection of NanoPac 28 days prior to their scheduled prostatectomy. The trial phase will assess safety and tolerability, tumor size and evidence of tumor response and local lymph nodes will be analyzed to investigate potential lymphatic transport of NanoPac.
Completion of the clinical trial and final report are expected in the third quarter of 2018, the company said.
Prostate cancer affects an estimated 3 million men in the U.S. with about 160,000 new cases and 27,000 deaths annually.
“Patients at higher risk for disease progression or those in whom the cancer has spread may face surgical removal of the prostate or radiation therapy. Unfortunately, these patients often suffer incontinence or impotence, which significantly decrease quality of life,” the news release said.
“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 minimizing side-effects of chemotherapy, and therefore maintaining quality of life,” Abreu said.
NanOlogy LLC is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals of Fort Worth, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California.
The company also announced that it will present an abstract detailing results of a preclinical trial of an inhalable form of NanoPac at the American Society of Clinical Oncology 2018 Annual Meeting in Chicago in June. That trial has demonstrated prolonged lung tissue residence time and tumor regression in preclinical studies, the company said.
The NanOlogy submicron particle technology platform is based on a patented production process
that reduces the size of paclitaxel and docetaxel crystals by up to 400 times into submicron particles that can be used in treatment without the serious adverse side effects associated with traditional chemotherapy.
Paclitaxel and docetaxel are the primary drugs used in chemotherapy and both they and the medium used to make them infusible are toxic. Injectable and inhalable versions in a neutral sterile solution not only concentrates the drugs longer in treatment but also reduces the side effects of treatment.
Other treatments under testing by NanOlogy include treatment for ovarian cancer, pancreatic cancer and pancreatic mucinous cysts. NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed
SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis.
Clinical trials for NanoDoce – submicron particle docetaxel – are planned in 2018 pending U.S. Food and Drug Administration approval.
– Paul K. Harral