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SciClone Initiates Phase 2 Trial of RP101 in Late-Stage Pancreatic Cancer Patients

Posted on: Monday, 4 February 2008, 06:00 CST

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.

About RP101

RP101, also known as BVdU, is a nucleoside analog which has shown the potential to prevent the induction of resistance to chemotherapy, suppressing genes involved in development of that resistance, and enhancing sensitivity to chemotherapy. Additionally, RP101 has been shown to induce cell death, or apoptosis, in cancer cells. In several preclinical and clinical studies, RP101 has shown biological activity in various cancer indications and has shown the potential to extend survival for pancreatic cancer patients.

RP101 is approved in several European countries for antiviral indications. SciClone believes that the compound's potential efficacy to combat chemoresistance and improve chemosensitivity constitutes a new clinical use which is protected by use patents. In April 2007, SciClone acquired the exclusive rights in the United States and Canada to develop and commercialize RP101 for the treatment of cancer from Resistys, Inc., a wholly owned subsidiary of Avantogen Oncology, Inc.

About Pancreatic Cancer

Pancreatic cancer is one of the most deadly forms of cancer. The American Cancer Society estimates that in 2007 approximately 37,170 new cases and 33,370 deaths will result from pancreatic cancer in the United States, making it the fourth leading cause of overall cancer death. This disease is difficult to diagnose in its early stages, and most patients have incurable disease by the time they are diagnosed with pancreatic cancer. The overall median survival of patients with pancreatic cancer is only four to six months. Patients with advanced stages of pancreatic cancer are typically treated with chemotherapeutic agents such as gemcitabine, alone or with other additive therapeutics, with minimal increases in overall survival.

About FDA Orphan Drug Designation

In November 2007, RP101 was granted Orphan Drug designation for the adjunct treatment of pancreatic cancer by the U.S. FDA. This designation will allow SciClone a seven-year period of market exclusivity once RP101 is approved. The Orphan Drug designation is intended to provide incentives to drug and biologics suppliers to develop and supply drugs for the treatment of rare diseases, currently defined as diseases that affect fewer than 200,000 individuals in the United States.

About SciClone

SciClone Pharmaceuticals is a biopharmaceutical company engaged in the development of therapeutics to treat life-threatening diseases. SciClone's lead product ZADAXIN(R) (thymalfasin) is currently being evaluated in late-stage clinical trials for the treatment of malignant melanoma and hepatitis C virus. ZADAXIN is approved for sale in select markets internationally, most notably in China where SciClone has an established sales and marketing operation. A key part of SciClone's strategy is to leverage its advantage and broaden its portfolio in the rapidly growing Chinese market by in-licensing or acquiring the marketing rights to other products, such as DC BeadTM. For the U.S. market, SciClone's clinical-stage drug development candidates are RP101 for the treatment of pancreatic cancer and SCV-07 for the treatment of hepatitis C virus. For more information about SciClone, visit www.sciclone.com.

The information in this press release contains forward-looking statements including our expectations and beliefs regarding progress and results of our clinical trials. Words such as "expects,""plans,""believe,""may,""will,""anticipated,""intended" and variations of these words or similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict. Therefore, our actual results could differ materially and adversely from those expressed in any forward-looking statements as a result of various factors, including the progress of ongoing and proposed trials and studies for RP101, unexpected adverse results to patients, future actions by the U.S. Food and Drug Administration or equivalent regulatory authorities in China and Europe and the fact that experimental data and clinical results derived from pre-clinical studies or from studies with a limited group of patients may not be predictive of the results of larger studies, as well as other risks and uncertainties described in SciClone's filings with the Securities and Exchange Commission.

 Corporate Contact Richard Waldron Executive Vice President and Chief Financial Officer SciClone Pharmaceuticals, Inc. 650-358-3437  

SOURCE: SciClone Pharmaceuticals, Inc.

Source: MARKET WIRE

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