In laboratory studies with animals, perillyl alcohol showed potent anticancer activity. However, the very first clinical trials with cancer patients were disappointing. In these early trials, patients had to swallow large numbers of perillyl alcohol-containing gelatine capsules several times a day. But patients found it very difficult to tolerate the unrelenting discomfort (vomiting, nausea, fatigue) that emerged as a side effect of oral (by mouth) ingestion of these capsules. As a result, some of the patients were unwilling to participate in these trials any further and simply gave up treatment.
In order to avoid those extremely unpleasant side effects of perillyl alcohol capsules, the clinical trial undertaken by NeOnc Technologies, Inc., will apply a different method of delivery. In this trial, a spray version of perillyl alcohol will administer the compound via inhalation through the nose. This alternative concept is based on the results of successful clinical trials that were performed by Dr. Clovis Da Fonseca at Fluminense Federal University in Rio de Janeiro, Brazil. Dr. Da Fonseca developed the method of intranasal delivery to patients with malignant brain tumors (anaplastic astrocytomas and glioblastomas) that had become unresponsive to standard treatment. He could demonstrate that inhaled perillyl alcohol was very well tolerated by all of his patients and did not cause the hard-to-endure types of discomfort that were observed in those trials where perillyl acohol was ingested by mouth. In addition, in many patients inhaling perillyl alcohol, a therapeutic benefit on their brain tumors could be demonstrated.