SUPERGEN CANCER DRUG MISSES PHASE II TRIAL ENDPOINT
Ireland-based biotechnology company SuperGen's experimental cancer drug Orathecin has failed to meet the Phase II trial endpoint needed to proceed to a Phase III study, the company announced.
In a multicenter Phase II trial, capsules of Orathecin -- an orally active camptothecin that was developed for the treatment of pancreatic cancer -- were administered to 39 patients with primary advanced pancreatic cancer. Patients received 1000 mg/m2 gemcitabine every week for three out of four weeks with concurrent 1.5 mg/m2 Orathecin given daily for five of the seven days each week. This cycle was repeated every four weeks until progression or patient withdrawal. The study's pre-established goal for median survival time, the company reported, was not reached.
"We are working with our clinical advisors, investigators and potential partners to evaluate the best options for Orathecin that will maximize this product's potential to help patients in need," said James Manuso, president and CEO of SuperGen.
Orathecin has orphan-drug status in both the U.S. and the EU. The drug is currently involved in other clinical trials for different types of cancer.