We have deep experience in successfully conducting clinical trials for oncology compounds in today's marketplace. We will maintain tight schedules while working closely with regulatory authorities, physicians and our leadership team to create a dynamic portfolio of compounds.

Product Development and Clinical Trials



Palifosfamide (Zymafos™) is a novel molecule that is the functional active metabolite of ifosfamide, a standard of care for treating sarcoma, testicular and other cancers including breast and prostate. Palifosfamide delivers only the cancer fighting component of ifosfamide. It is expected to overcome the resistance of ifosfamide and cyclophosphamide in certain cancers. It does not have the toxic metabolites of ifosfamide that cause the debilitating side effects of encephalopathy and severe bladder inflammation. It is easily administered as an outpatient drug. Intravenous (IV) palifosfamide is currently in a randomized Phase II trial in soft tissue sarcoma. An oral form (capsule) of palifosfamide has also been developed.

Darinaparsin (Zinapar™) is a novel, organic arsenic being developed for the treatment of various hematologic and solid cancers. Preclinical and Phase I and II results to date demonstrate that darinaparsin is much less toxic than other forms of arsenic. Intravenous darinaparsin has completed a Phase II lymphoma trial. It is active in refractory lymphoma. It has also shown early activity in Phase I study with oral administration (capsules). Darinaparsin has been very well tolerated in all trials to date. It is expected to progress to a pivotal trial in the 1st half of 2010.

Indibulin (Zybulin™) is a novel, oral tubulin binding agent that targets both mitosis and cancer cell migration. Indibulin is expected to have several potential benefits, including oral dosing, application in multi-drug resistant tumors, no neuropathy and minimal overall toxicity. Indibulin has shown early activity in Phase I study as a single agent in many types of solid tumors. Indibulin is also currently nearing completion in Phase I trials in combination with Tarceva® and Xeloda®. Oral indibulin preclinical "Norton dose density scheduling" dose administration studies with our preclinical partner Dr. Larry Norton have progressed to the point of translation with the intention of further pursuit in clinical study in breast cancer at Sloan-Kettering.