Initiation of a phase 2 trial of RP101 in latestage pancreatic cancer patients
RESprotect´s US development partner, SciClone Pharmaceuticals, Inc. 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.
RESprotect, the inventor of the RP101 oncology technology, has granted in 2007 the exclusive rights in the United States and Canada to develop and commercialize RP101, a clinicalstage compound for the treatment of cancer, to SciClone Pharmaceuticals, Inc. SciClone acquired the rights from Resistys, Inc., which acquired it 2004 from RESprotect. SciClone performs clinical studies with RP101. The results are freely available to RESprotect.
The randomized, placebocontrolled, doubleblind 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 latestage pancreatic cancer patients, randomized with two patients assigned to the treatment arm for each patient assigned to the control arm. Patients will receive gemcitabine plus RP101 - in the treatment arm or gemcitabine alone - in the control arm 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 progressionfree survival. It is expected to complete enrollment of the 153 patients in the first half of 2009 and report data in the first half of 2010.
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 latestage pancreatic cancer patients, RP101 was used in combination with gemcitabine, the current standard of care, or gemcitabine + cisplatin.
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