Human Clinical Trials

We have evaluated DTI-015 in 71 patients with recurrent, inoperable brain cancer in two Phase I/II trials conducted at leading medical centers throughout the United States. In our company-sponsored, multi-center Phase I/II trial #99-01, 28 patients with recurrent inoperable glioblastoma multiforme were treated with DTI-015. An earlier physician-sponsored trial conducted at the University of Texas M.D. Anderson Cancer Center treated 43 patients with high-grade gliomas (a broader category of highly malignant brain tumor types), including 26 patients with recurrent inoperable glioblastoma multiforme.

In March 2002, we met with the U.S. Food & Drug Administration (FDA) to review the company’s clinical and preclinical data and to discuss the steps remaining to obtain marketing approval for DTI-015 in the US. Based upon the information presented at this meeting and in subsequent written reports, in November 2002, the FDA concluded that: "Phase I and Phase II studies have identified doses and schedules of the proposed formulation that have a safety profile that supports Phase III testing" of DTI-015 in patients with glioblastoma multiforme.