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news.Ziopharm Oncology has received clearance from the FDA to initiate a phase I trial with an oral capsule form of the company's proprietary small molecule organic arsenic.
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The injectable form of the drug, ZIO-101, is currently in three phase II studies including advanced myeloma, liver cancer, and hematological malignancies. The phase I study of oral ZIO-101 will include patients with advanced solid tumors and will evaluate safety and pharmacokinetics. Starting dose will be 300 mg two days per week for three weeks followed by a one week break.
“This IND approval is an important achievement as part of the company’s plan to explore the clinical utility of all its drugs in the oral format,” said Jonathan Lewis, CEO of Ziopharm.
Separately the company announced that the US Adopted Names Council (USAN) and World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee have approved darinaparsin as the non-proprietary name for ZIO-101 (for all forms of the drug).