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SciClone Initiates Phase 2 Trial of RP101 in Late-Stage Pancreatic Cancer Patients
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that the first patient has been dosed in its phase 2 clinical trial using RP101, a nucleoside analog which may act to enhance the beneficial effect of chemotherapy, for the treatment of pancreatic cancer. In a previous phase 1 clinical study in 22 late-stage pancreatic cancer patients, patients receiving RP101 in combination with gemcitabine, the current standard of care, had a median survival of 9.3 months, compared to a historical control of approximately 6 months for patients treated with gemcitabine alone. In addition, SciClone announced that RP101 has been granted Orphan Drug Designation for the adjunct treatment of pancreatic cancer by the U.S. Food and Drug Administration (FDA).
"We are eager to evaluate RP101's potential new mechanism of treating pancreatic cancer, by increasing sensitivity to chemotherapy while at the same time reducing chemoresistance," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc. "We are working with the Pancreatic Cancer Research Team and other experts in the field to ensure that this international trial is completed with the highest quality standards."
"There is an urgent, unmet medical need to develop new therapies to treat patients with pancreatic cancer, a difficult to diagnose and treat disease which is expected to claim approximately 33,000 lives in the United States this year," said Manuel Hidalgo, M.D., Ph.D., Director of Gastrointestinal Oncology at Johns Hopkins University and Chairman of the Pancreatic Cancer Research Team, an organization of international researchers focused on accelerating the development of new treatments for pancreatic cancer. "RP101 has demonstrated promising phase 1 results and we are eager to analyze further its potential in this phase 2 trial."
About the Phase 2 Trial
The randomized, placebo-controlled, double-blind phase 2 clinical trial will be conducted at 55 sites throughout the United States, Europe and South America. SciClone plans to enroll a total of 153 late-stage pancreatic cancer patients, randomized with two patients assigned to the treatment arm for each patient assigned to the control arm. Patients will receive either gemcitabine plus RP101 or gemcitabine alone for three weeks, followed by one week of rest, for each of six cycles. The primary endpoint is overall survival, with a secondary endpoint of progression-free survival. SciClone expects to complete enrollment of the 153 patients in the first half of 2009 and report data in the first half of 2010.
In addition to the increase in median survival to 9.3 months in the prior phase 1 clinical study as noted above, six and 12-month survival rates for treated patients were 68% and 39%, respectively, compared to historical controls of 47% and 13% for patients treated with gemcitabine alone. In this trial, the most common adverse events were nausea, fatigue, vomiting, neutropenia, anorexia and fever, all toxicities expected for gemcitabine alone.