Ilex Oncology Incand Symphar S.A. of Geneva, Switzerland, announced that they have opened a phase II clinical study of Apomine for patient accrual in Lyon, France.

Apomine is a potent, orally active bisphosphonate tetra-ester derivative being co-developed by Ilex and Symphar. The phase II study will be conducted at Lyon's center Leon Berard by a group of physicians under the direction of Dr. Jean-Pierre Droz.

The clinical trial will begin evaluating the effectiveness of Apomine in the treatment of prostate cancer and will further study the drug's safety in this patient category. According to the National Cancer Institute, prostate cancer is the most common tumor in men in the United States, diagnosed in almost one-fifth of American males during their lifetimes.

Apomine induces apoptosis, the normal biological process involving a genetically programmed series of events leading to the death of a cell. "Apomine activates the Farnesoid X Receptor (FXR), an orphan receptor in the nucleus, and a cascade of biological signals within the cells that rapidly induce apoptosis without affecting normal, healthy cells," said Symphar director of R&D Craig Bentzen.

"The prior phase I studies have confirmed the lack of cytotoxicity to normal tissues as demonstrated by the absence of any myelosuppresion along with an excellent safety profile thus making Apomine one of the more encouraging cancer drugs on the research horizon," he added.

"With this study, we continue examining Apomine's potential for broad use in several types of cancers," Ilex president and CEO Richard L. Love said. "Currently, there are no compelling data that show any one prostate cancer therapy has a clinically better chance of success over any other. The possibility of giving patients more treatment options with a new drug such as Apomine holds significant therapeutic and commercial promise."

This is the first study of Apomine in the treatment of prostate cancer. In the current study, men previously diagnosed with prostate cancer who have rising prostate-specific antigen (PSA) levels in three consecutive PSA screenings will be given a continuous daily dose of Apomine for about three months. These patients also must have shown no response to hormonal therapy.