A Phase I/II Study of HE3235 in Patients With Prostate Cancer

Hollis-Eden Pharmaceuticals, Inc. has commenced a Phase I/II clinical trial with its oral drug candidate APOPTONE(TM) (HE3235) in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment.

The Phase I/II open-label dose ranging study, being conducted with the Prostate Cancer Clinical Trial Consortium (PCCTC), will evaluate the safety, tolerance, pharmacokinetics and potential activity of APOPTONE when administered twice daily for 28 days in up to 44 late-stage prostate cancer patients. Potential activity of the compound will be measured by standard prostate-specific antigen (PSA) tests and effect on well-established markers of progression free survival (PFS). In addition, in conjunction with Memorial Sloan-Kettering Cancer Center, the clinical trial will evaluate circulating tumor cell (CTC) enumeration as a marker for effectiveness for tumor treatment. Previous studies have shown that metastatic prostate cancer patients with less than 5 CTCs per 7.5 ml of blood have statistically better survival than patients with greater than 5 CTCs.