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news.Ziopharm Oncology has filed an investigational new drug (IND) application to commence a clinical study of DNA-based therapeutic candidate, Ad-RTS-IL-12 (INXN 2001/1001) with the US Food and Drug Administration (FDA).
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The Phase I study will investigate the safety, immunological and the biological effect of the drug in patients who are suffering from melanoma.
Through intratumoral injection, Ad-RTS-IL-12 employs an adenoviral vector (Ad) to deliver directly into the patient’s own cells a gene which expresses Interleukin-12 (IL-12), an anticancer cytokine.
Ziopharm executive vice president and chief development officer Mark Thornton said L-12, for example, naturally elicits an immune response to cancer, but is too toxic to be given as a recombinant protein.
"We expect to achieve therapeutic levels of IL-12 without being limited by the toxicities typically associated with recombinant therapy," Thornton said.