Salirasib: a New Orally Available Targeted Cancer Treatment

In extensive preclinical studies in established laboratory and animal models, Salirasib inhibited the growth of Ras-dependent tumor cells including those driven by upstream stimulators of Ras such as growth factors and by oncogenic Ras. Additionally, Salirasib treatment of the Ras-transformed cells changed their abnormal cancer morphology to one with an appearance of normal cells. Salirasib prolonged survival of animals bearing human cancers.

In September 2005, Concordia filed an IND with the FDA, and initiated Phase I clinical trials. Results from the single and multi-dose healthy volunteer safety studies indicate that the oral dose is well tolerated with no significant side effects and the predicted levels of absorption.

Salirasib Clinical Trials

We have completed the Phase I Maximum Tolerated Dose ("MTD") studies in cancer patients with solid tumors and hematologic malignancies at MD Anderson Cancer Center. A Phase I/II clinical study is ongoing at Johns Hopkins Kimmel Cancer Center in patients recently diagnosed with pancreatic cancer. A Phase II clinical trial is ongoing at Memorial Sloan Kettering Cancer Center in patients with lung cancer. A second Phase II clinical trial in lung cancer is planned to start in 2008 at M.D. Anderson.

Chemical Entities Under Development

Concordia has initiated development of a second compound from the FTS-family of Ras-inhibitors designed to penetrate the blood brain barrier for treatment of glioma.