ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that the first patient has been dosed in a Phase I, single arm, dose escalation study at the Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the treatment of small cell lung cancer (SCLC) and other cancers.
“Small cell lung cancer in particular is a disease in urgent need of more effective and better tolerated treatment options.”
The Phase I study is expected to enroll 12 to 15 patients and will assess the safety of the palifosfamide/etoposide/platinum regimen for the planned randomized Phase II study in SCLC patients with extensive disease where the etoposide/platinum combination is standard of care.
Palifosfamide is a novel, bi-functional DNA alkylator and cross-linker, currently in a Phase III trial for soft tissue sarcoma, and comprises the functional active metabolite of ifosfamide (IFOS). IFOS is a pro-drug and must be metabolized in order to be active. The clinical utility of IFOS is often limited by toxicities associated with IFOS metabolites unrelated to DNA-alkylation and by development of resistance conferred by decreased pro-drug activation. IFOS was formally studied in SCLC by the Indiana group where it was added to etoposide and platinum with evidence of significantly enhanced efficacy as measured by the endpoints of progression free survival and survival but with the added toxicity of IFOS negating benefit (Journal of Clinical Oncology, Vol 13, 2594-2599).
"The efficacy data and low toxicities observed with palifosfamide in clinical and preclinical studies together with the known activity of ifosfamide in SCLC provide strong rationale for studying palifosfamide in combination with the standard of care for this extraordinarily difficult to treat cancer," said Lawrence Einhorn, MD, Distinguished Professor at the Simon Cancer Center of Indiana University Medical Center, Lance Armstrong Foundation Chair in Oncology, former President of ASCO and a member of ZIOPHARM's Medical Advisory Board. "Small cell lung cancer in particular is a disease in urgent need of more effective and better tolerated treatment options."
According to the American Cancer society approximately 15 percent of lung cancers are SCLC, or approximately 33,400 patients yearly in the U.S. SCLC is almost exclusively associated with cigarette smoking and the majority of patients with extensive disease are treated front-line but relapse with a very high mortality within one year.
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