Enrollment In Phase 2 Clinical Trial For RP101 In Advanced Pancreatic Cancer Patients Completed
Dresden, Germany – March 31, 2009 – RESprotect´s development partner for North America, SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) announced that enrollment has been completed in the Company’s phase 2 clinical trial for RP101. The study is investigating a new treatment of late-stage pancreatic cancer. In 2007 RESprotect, the inventor of the RP101 technology granted the exclusive rights in the United States and Canada to develop and commercialize RP101, a clinical-stage compound for the treatment of cancer and other indications, to SciClone Pharmaceuticals, Inc. SciClone performs clinical studies with RP101, and the results are freely available to RESprotect.
About the Phase 2 Trial
This study is a randomized, placebo-controlled, double-blind phase 2 clinical trial conducted throughout the United States, Europe, and South America. Patients assigned to the treatment arm are receiving RP101 plus gemcitabine, an approved chemotherapy drug used to treat cancers of the pancreas, while patients in the control arm receive gemcitabine alone. Treatment is delivered in cycles of three weeks followed by one week of rest, for at least six cycles of dosing. The primary endpoint for the trial is overall survival, with progression-free survival as a secondary endpoint. "We have reached our enrollment goal of 153 patients at 50 study sites for this trial more than six weeks ahead of schedule, and we are impressed with RP101's excellent safety profile thus far." said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone Pharmaceuticals, Inc.
About RP101
RP101’s potential efficacy for treating cancer patients was discovered by the founder of RESprotect, Prof. Fahrig. RP101 has been evaluated in combination with cytostatic agents such as gemcitabine which is used to treat pancreatic, lung, ovarian and breast cancer patients. Although approved in several European countries for antiviral indications, RP101’s potential efficacy to combat chemoresistance and improve chemosensitivity constitutes a new clinical use for RP101 which is protected by three use patents by RESprotect. In two separate, unrelated phase 1 clinical trials with late-stage pancreatic cancer patients, RP101 was used in combination with gemcitabine, the current standard of care, or gemcitabine + cisplatin. The results were published in 2006 (Fahrig, et al., Anti-Cancer Drugs 17, 2006, 1045-56). Summarizing both studies, RP101 co-treatment approximately doubled median survival. Moreover, 4 - 5 times more patients with late-stage metastases (stage IV) survived one year or longer in comparison with the gemcitabine-alone group.
About RESprotect
RESprotect GmbH is a privately owned biotechnology company located in Dresden, Germany. RESprotect is focusing on the inhibition of chemoresistance and the enhancement of chemosensitivity. Chemogenomics, the approach of RESprotect, focuses on the application of small synthetic molecules, which elicit favourable phenotypic changes. The combination with genomic tools concentrating on specific biological pathways allows a better understanding of the broader effect of a drug. Thus, it is possible to discover drugs that target the cause of a disease rather than its symptoms. RESprotect's compounds are given in addition to standard chemotherapy. In contrast to the well known efforts to circumvent or decrease existing chemoresistance, RESprotect´s approach is unique.
RESprotect is looking for an appropriate partner(s) to develop RP101 in Europe, South America and Asia and its follow-on compounds worldwide.
