Ziopharm receives FDA acceptance to initiate oncology drug trial
Ziopharm Oncology has received the US Food and Drug Administration (FDA) acceptance for its investigational new drug (IND) application to commence ZIN ATI-001 clinical study in oncology.
The Phase I trial is expected to assess safety along with the immunological and biological effects of ZIN ATI-001 in patients with melanoma.
ZIN ATI-001 employs an adenoviral vector to deliver, directly into the patient's own cells, a gene which expresses Interleukin-12 (IL-12,a potent, naturally occurring anticancer cytokine central to the initiation and regulation of cellular immune responses.
Ziopharm board of director RJ Kirk said ZIN ATI-001, which offers an effective, yet simpler approach to introducing IL-12 therapy, is the first of many products they expect to introduce into the clinic as partners over the next two years.
"Ziopharm's understanding of the development spectrum, from preclinical work through large outcome studies, ensures that the great promise of this technology is delivered quickly and intelligently," Kirk said.
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