The most active Flex-Het, was submitted to the National Cancer Institute’s (NCI’s) Rapid Access to Intervention Development (RAID) program for funding of the Preclinical Testing needed to submit an Investigational New Drug (IND) application to the Food and Drug Administration (FDA). The IND is required prior to initiation of clinical trials. The RAID program awarded over $2 million dollars to fund this testing as outlined below.

Current and Completed Activity in the NCI RAID Program:

• Synthesis of medium scale quantities (completed).

– Formulation (oral and perenteral)

– Radioactive label for research

• Development of HPLC-UV analytical method (completed).

• Pharmacology (partially completed).

• Stability (completed in plasma, but not formulation)

• Extent of protein binding in plasma (completed).

• Metabolism (partially completed)

• Toxicology – dose-range finding study (In progress)

• Efficacy (In progress)

– Ovary

– Melanoma

– Renal Cancer

Current Non-RAID Activity:

• Clinical Trial Design (OUHSC, GOG, Huntsman Cancer Institute)

• Pending grants to fund development of a pipeline of drugs to follow SHetA2 and to better understand the mechanisms of SHetA2.

Next Phase of Activity Needed for IND Submission:

§ Scale up synthesis and quality control for amounts of SHetA2 needed for clinical trials.

o The IND requires a description of the manufacturing and packaging procedure, and identification of the analytical methods and acceptable limitis used to assure the identify, purity, and strength of the components and finished product. Stability data sufficient to support the duration of the proposed clinical studies is also required. This information must be submitted for a placebo, when applicable.

§ Funding for clinical trials.