Hollis-Eden Pharmaceuticals, Inc. (NASDAQ:HEPH) has announced a new phase I/II clinical trial of Apoptone (HE3235) for late stage prostate cancer. Howard Scher, M.D., Chief of the Genitourinary Oncology Service at Memorial Sloan-Kettering Cancer Center said “The preclinical data generated to date suggest that Apoptone may offer a unique therapeutic approach to late-stage prostate cancer where traditional therapies have failed.”
To qualify for this trial with the oral drug candidate Apoptone™ (HE3235) one must have late-stage prostate cancer, failed hormone therapy and at least one round of chemotherapy treatment.
The trial is a dose ranging study that will evaluate the safety, tolerance, pharmacokinetics and potential activity of Aoptone when administered twice daily for 28 days in up to 44 late-stage prostate cancer patients. The primary endpoints will be measured by prostate-specific antigen (PSA) tests and effect on well-established markers of progression free survival (PFS).
The trial will also 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.
To date, Apoptone has been tested in a number of preclinical cancer models and has demonstrated that it is active in controlling the incidence, growth and development of new tumors. The manufacturer, Hollis-Eden believes that Apoptone may also induce apoptosis, or cell death.
Trial sites are located in New York, Seattle and San Francisco.
To learn more about Apoptone and this clinical trial go to the government’s clinical trial web page. In the upper right corner search for apoptone. Then click on “A Phase I/II Study of HE3235 in Patients With Prostate Cancer. “
Joel T Nowak MA, MSW