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news.Hollis-Eden Pharmaceuticals has started a Phase I/II clinical trial with its oral drug candidate Apoptone in late-stage prostate cancer patients who have failed hormone therapy and at least one round of chemotherapy treatment.
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The Phase I/II open-label dose ranging study, being conducted with the Prostate Cancer Clinical Trial Consortium, 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 tests and effect on well-established markers of progression free survival.
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 of the tumor treatment.
Richard Hollis, chairman and CEO of Hollis-Eden, said: “Based on our previously reported positive data from testing Apoptone in preclinical models of late stage prostate cancer, we are excited to study the compound’s unique therapeutic approach in a patient population with limited treatment options.”