LOS ANGELES--(BUSINESS WIRE)--NeOnc Technologies, Inc., a privately held biotechnology company today announced the initiation of its multi-center Phase 1/2a clinical trial of NEO100 with the first patient being treated at the Cleveland Clinic. Additional clinical sites in Wisconsin, Washington, California, Utah, Florida, and Brazil are being qualified. Details of the study are posted on the National Institutes of Health clinical trials website and at the company website www.neonctech.com.
Dr. Thomas Chen, founder, Chairman and CEO of NeOnc, said, “We are very excited about initiating our first clinical trial in the US with NEO100. NEO100 is the first GMP quality perillyl alcohol (POH) that is FDA approved for human clinical trials. An ongoing clinical trial in Brazil using chemical grade POH has given encouraging results in patients with recurrent GBM, with a number of patients with recurrent GBM achieving extended survival (more than four years) using intranasal POH alone.
It is anticipated that a total of approximately 40 patients will be enrolled in the trial over the next 18 months. NEO100 is a novel chemotherapeutic agent which was initially investigated by the National Cancer Institute. In those studies, the drug was given orally, and did not appear to be effective. In the NeOnc sponsored trial, like the study being conducted in Brazil, the drug is delivered intranasally. This is the first human clinical trial using this novel delivery method for brain tumors.
“Intranasal brain delivery results in the drug going first into the brain, maximizing the exposure of the drug to the tumor, and minimizing side effects in the body,” Dr. Chen noted.
Recurrent GBM is poorly treated by currently available therapies and thus is a serious unmet medical condition. Only 3-5% of patients with GBM survive for more than 5 years.
“This clinical trial offers a non-invasive, minimal toxicity trial for patients with recurrent GBM, with previous human validation,” Dr. Chen said.
The clinical study consists of two phases; first a dose escalation phase, followed by 25 patients being treated at the highest dose that is well tolerated. NEO100 is administered four times a day, with each treatment lasting about 15 minutes, and therapy is continued for up to 6 months. Minimal side-effects were experienced by the patients in Brazil.
About NeOnc Technologies
NEO100 is the first therapeutic being tested in a clinical trial by NeOnc. In addition NeOnc is developing several proprietary chemotherapy agents which have demonstrated positive effects in laboratory tests on various types of cancers and has assembled a portfolio of intellectual property around these proprietary chemotherapy agents. Privately held NeOnc is based in Los Angeles. For additional information see its website (www.neonctech.com) or contact Pat Walters at pwalters@neonctech.com.
