In another in a rapid series of announcements, Fort Worth-based NanOlogy – formed by Paul Dorman’s DFB Pharmaceuticals and two other companies – has announced that the first patient has been enrolled in a clinical trial of the cancer treatment NanoPac for prostate cancer.
NanoPac is nanoparticle paclitaxel – a chemotherapy drug – suspended in a sterile solution and injected directly into cancerous tissue. It is part of the nanoparticle technology developed by the company that seeks to treat cancer without some of the severe side effects of traditional chemotherapy delivered systemically.
“Systemically administered paclitaxel has been shown to be effective for prostate cancer but is limited to metastatic disease (cancer that has spread to other parts of the body),” Dr. Gere diZerega, MD and vice president of medical affairs for NanOlogy said in a news release.
This clinical trial is the first study in humans to examine whether NanoPac injected directly into the tumor will effectively and safely treat the tumor with a high locally sustained concentration of the drug, diZerega said.
The company said prostate cancer affects an estimated 3 million men in the U.S. and about 27,000 die annually from the disease. In 2017, about 161,000 new cases of prostate cancer will be diagnosed.
In low risk patients, the cancer may be closely monitored but not immediately treated. Treatment for higher risk patients can include the partial or complete removal of the prostate through surgery. Side effects of the surgery can include incontinence or impotence, which significantly decrease the patient’s quality of life.
“If we are successful, we may offer a treatment option for moderate or high-risk patients with localized or non-metastatic disease without a negative impact on quality of life,” Shelagh Verco, the clinical director of NanOlogy, said in the news release.
NanOlogy has an extensive clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer, prostate cancer, pancreatic cancer and pancreatic mucinous cysts.
The Phase 2a trial for prostate cancer will include as many as 30 patients already scheduled for surgery. Four weeks before the surgery, the patients will receive NanoPac injected directly into the lobe of the prostate with the dominant tumor, the company said.
The test will be used to assess the safety and tolerability of NanoPac, and to evaluate tumor size and other changes. The patients’ local lymph nodes also will be analyzed to investigate potential lymphatic transport of NanoPac to other parts of the body.
NanOlogy is a collaboration of DFB Pharmaceuticals of Fort Worth, CritiTech Inc. of Lawrence, Kansas, and US Biotest Inc. of San Luis Obispo, California, to finance and clinically develop a patented nanoparticle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and effectiveness in the treatment of cancer and related conditions.
Other products in or scheduled for clinical trials include SOR007 (nanoparticle paclitaxel) ointment developed by NanOlogy and affiliate DFB Soria for potential skin cancers and an inhaled version of NanoPac for treatment of lung cancer.