ZIO-101 phase I/II myeloma trial
Ziopharm Oncology, Inc. has received approval from the FDA to initiate a Phase I/II trial with ZIO-101, a novel organic arsenic, in patients with advanced myeloma.
Patient treatment is expected to start in early 2006 at leading cancer centres in the US, Canada, and UK. Completion of enrolment is expected by the end of 2006, followed by pivotal trials beginning mid-2007.
The company believes ZIO-101 has the potential to treat patients with myeloma at significantly higher doses compared to arsenic trioxide, an inorganic arsenic currently used to treat APL, which has also shown activity in myeloma. Currently in Phase I clinical trials, interim results on ZIO-101 were reported during a press conference at the AACR-NCI-EORTC International Conference in November 2005.
As announced, dosing of ZIO-101 was approximately 25 times higher (presently 35 times higher) than the approved dose of arsenic trioxide. The interim data reported evidence of meaningful benefit in one patient, and no significant toxicity. The Company believes a higher dose coupled with less toxicity will provide a wider therapeutic window and an incremental benefit, or treatment alternative, for myeloma patients, as newly approved agents continue to be associated with significant toxicities and/or drug resistance at therapeutic doses.
Patient treatment is expected to start in early 2006 at leading cancer centres in the US, Canada, and UK. Completion of enrolment is expected by the end of 2006, followed by pivotal trials beginning mid-2007.
The company believes ZIO-101 has the potential to treat patients with myeloma at significantly higher doses compared to arsenic trioxide, an inorganic arsenic currently used to treat APL, which has also shown activity in myeloma. Currently in Phase I clinical trials, interim results on ZIO-101 were reported during a press conference at the AACR-NCI-EORTC International Conference in November 2005.
As announced, dosing of ZIO-101 was approximately 25 times higher (presently 35 times higher) than the approved dose of arsenic trioxide. The interim data reported evidence of meaningful benefit in one patient, and no significant toxicity. The Company believes a higher dose coupled with less toxicity will provide a wider therapeutic window and an incremental benefit, or treatment alternative, for myeloma patients, as newly approved agents continue to be associated with significant toxicities and/or drug resistance at therapeutic doses.
posted by gwg at 5:34 PM
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