Orathecin (rubitecan) is an anti-cancercompound developed by Stehlin Foundation researchers and patented as 9-NitroCamptothecin. This oral chemotherapy agent has been co-investigated by the Stehlin Foundation and SuperGen Incorporation as a treatment for patients with pancreatic cancer who have failed at least one prior chemotherapy. It is a great achievement for any cancer research laboratory to take a drug all the way from initial development, through their search, clinical trials, patenting process and then into the public marketplace.

Orathecin capsules, an orally active camptothecin, is a topoisomerase I inhibitor that was developed for the treatment of pancreatic cancer. Orathecin has Orphan Drug status in both EU and US. The Orathecin European filing or Marketing Authorization Application contains data from a Phase III clinical program believed to be the largest program in pancreatic cancer ever initiated globally, with more than 1,000 patients. Orathecin is also in clinical trials for many other cancers and blood disorders.

The first-line Phase III pancreatic cancer study enrolled 996 patients who were randomized to receive Orathecin or gemcitabine. While the trial failed to reach its endpoint of improving endurance over gemcitabine, the chemo-naive pancreatic cancer patients that were the subjects of this study fall outside of the proposed use of Orathecin as a second and/or third line therapy in the current NDA SuperGen. The treatment of chemo-naive pancreatic cancer patients with Orathecin will be more explored in a proposed, post-marketing, confirmatory study of gemcitabine with or without Orathecin. The completed single agent, chemo- naive study, along with other completed Orathecin trial data, will be open in a future scientific forum.