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news.Hollis-Eden Pharmaceuticals has filed an investigational new drug or IND application with the FDA to begin clinical trials with its oral drug candidate Apoptone for the treatment of hormone receptor sensitive cancers.
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After IND clearance by the FDA, Hollis-Eden plans to initiate a Phase I/II dose ranging clinical trial of Apoptone in prostate cancer patients during the second quarter of 2008. The patient population for this initial clinical trial will be considered ‘late stage’, which is defined as patients failing at least one round of chemotherapy.
Dwight Stickney, chief medical officer of Hollis-Eden, said: “This initial dose ranging clinical study in prostate cancer is designed to understand the safety, pharmacokinetics, activity and maximum tolerated dose of Apoptone in this patient population.”