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news.Ziopharm Oncology has reported that dosing of the first patient took place in two separate new studies, including a Phase I/II combination study evaluating oral indibulin combined with oral Tarceva in the treatment of patients with solid tumors, and a Phase I/II study of palifosfamide used in combination with Adriamycin in the treatment of patients with sarcoma.
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The Phase I/II study evaluating indibulin combined with erlotinib is supported by preclinical studies that have demonstrated potent synergistic activity between indibulin and erlotinib. Indibulin is a novel synthetic anti-mitotic agent that binds to tubulin, destabilizes microtubule polymerization, arrests tumor cell growth at the G2/M phase and inhibits cell mobility and metastasis. Erlotinib is approved in lung cancer and blocks EGF signal transduction T-kinase activation.
The Phase I/II study of palifosfamide used in combination with doxorubicin in the treatment of patients with sarcoma is supported by preclinical studies that have demonstrated potent synergistic activity when combining the two agents. Both palifosfamide and doxorubicin interfere with the repair and replication of DNA in cancer cells. This Phase I/II combination study will serve as lead in to the randomized Phase III pivotal trial of palifosfamide expected to begin in the second half of 2008.
The company also announced that the US Adopted Names Council (USAN) and World Health Organization (WHO) International Nonproprietary Names (INN) Expert Committee have approved palifosfamide as the non-proprietary name for isofosforamide mustard (IPM), the active pharmaceutical ingredient in ZIO-201.