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news.NanOlogy has commenced the Phase 2 clinical study of intraperitoneally (IP) administered NanoPac (nanoparticle paclitaxel) to treat ovarian cancer.
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The company has recruited first patient in the trial of NanoPac sterile suspension in patients with ovarian cancer.
The trial will assess NanoPac’s safety and efficacy after IP instillation of the drug at the end of cytoreductive (debulking) surgery.
The company currently has an extensive clinical development program for NanoPac sterile suspension, including clinical trials in ovarian cancer, prostate cancer, pancreatic cancer, and pancreatic mucinous cysts.
NanOlogy, along with its affiliate, is also carrying out clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis.
Based on IND approval, clinical studies for NanoDoce (nanoparticle docetaxel) are planned in 2018.
An inhaled version of NanoPac is in a preclinical efficacy trial for lung cancer after pharmacokinetic studies showed retention of drug in lung tissues for more than 14 days following nebulized delivery and no abnormalities within the trachea or lung upon gross and histologic exam.
NanOlogy nanoparticle technology platform is based on a patented production process, which decreases the size of paclitaxel and docetaxel API crystals by up to 400 times into patented, stable and naked nanoparticles with increased surface area and unique geometry.
NanOlogy medical affairs vice president Dr Gere diZerega said: “Systemically administered paclitaxel has been shown to be effective in ovarian cancer but is limited by its adverse effects.
“We are attempting to show that a single, IP-instilled dose of NanoPac will effectively treat the cancer with high locally sustained concentrations of the drug and no contribution to systemic adverse effects.”