FOSTER CITY, CA--(Marketwire - January 11, 2011) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of the first patient in the company’s phase 2b clinical trial of SCV-07 for the prevention of oral mucositis (OM) -- a painful, debilitating, and costly toxicity caused by chemoradiotherapy regimens used to treat head and neck cancer. The study will examine three doses of SCV-07, including two higher doses than those used in the company’s recent phase 2a study, to assess the drug’s impact on modifying the course of OM in patients with head and neck cancer. In addition, the trial will further evaluate SCV-07’s safety and tolerability in this patient population, as well as the role played by specific genetic profiles on patient response to the treatment.
“We are very pleased with how quickly we have been able to advance the SCV-07 OM program from completion of our phase 2a trial to the initiation of this important phase 2b study. This is particularly impressive considering the fact that our scientific team uniquely designed this study protocol to leverage those findings which emerged from our phase 2a trial, including important information related to dosing and efficacy endpoints,” stated Friedhelm Blobel, Ph.D., SciClone’s President and Chief Executive Officer. “We expect that this upcoming study will provide additional information regarding the potential therapeutic role of SCV-07 in the treatment of OM and, in turn, inform SciClone on the best path for designing a possible pivotal phase 3 trial.”
The multicenter, randomized, double-blind, placebo-controlled study will enroll approximately 160 subjects who are receiving standard chemoradiation therapy for treatment of cancers of the head and neck. Subjects will be randomly assigned to one of the trial’s four treatment arms: placebo and SCV-07 at doses or 0.1 mg/kg, 0.3 mg/kg and 1 mg/kg. The study’s primary efficacy endpoint is the reduction in proportion of subjects with clinically assessed ulcerative OM (WHO Grade greater than or equal to 2) at the time that they have received a cumulative radiation dose of 45 Gy.
The study’s secondary endpoints include, among others, incidence and duration of ulcerative and severe (WHO Grade greater than or equal to 3) OM; analgesic use and pain assessments, breaks in radiation or chemotherapy treatment, and unscheduled office or hospital visits.
About Oral Mucositis
OM is a common, painful, debilitating complication of cancer treatment, and SciClone estimates that total medical costs may reach around $4.2 billion in the U.S. and $10 billion worldwide in 2010. OM is a condition in which the sensitive cells lining the mouth and throat are damaged by cancer treatments such as chemotherapy (with or without radiation) and become painful mouth sores. Severe OM has been reported to occur in about 50% of patients who receive chemoradiation for the prevention of cancers of head and neck (Sonis, Core Evidence, 2009). Importantly, radiation to the head and neck, especially when it includes the tissues of the mouth, pharynx and hypopharynx, results in significant ulcerative OM in greater than 90% of patients (Manas et al, Clinical Translational Oncology, 2009) and can compromise the patient’s ability or willingness to accept a complete course of therapy. Symptoms can include painful ulcers in the mouth and throat, redness and swelling of the gums, dryness and overall soreness in the mouth, and difficulty eating, swallowing, talking and drinking. In addition to the symptoms of OM and its impact on quality of life and continued therapy, mucositis can cause adverse effects on a variety of other health and economic outcomes, such as a risk of serious infection, the need for parenteral nutrition and narcotic analgesia, and increased hospitalization and feeding-tube placement. The National Cancer Institute estimates that 450,000 patients per year in the U.S. suffer from OM during cancer therapy.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including prevention of oral mucositis, treatment of cancer and viral infections, and enhancement of response to vaccines.
SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has been approved for stimulation of depressed immune systems.
About SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a revenue-generating, China-centric, specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. The Company is focused on continuing sales growth and executing a clinical development strategy with prudently managed costs. ZADAXIN® (thymalfasin) is approved in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers, and as a vaccine adjuvant. SciClone is evaluating SCV-07 in a phase 2b trial to modify the course of oral mucositis in patients with head and neck cancer. The Company also has exclusive commercialization and distribution rights in China to a novel treatment for advanced liver cancer, DC Bead®, currently under review by regulatory agencies in that country. Additionally, SciClone owns exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm® in China, including Hong Kong and Macau, and Vietnam. The Company intends to seek regulatory approval for the product, commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery, in these markets. For additional information, please visit www.sciclone.com.
Forward-Looking Statements
The information in this press release contains forward-looking statements, including our expectations and beliefs regarding the timing and results of our clinical trials. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “forecast,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These risks and uncertainties include our forward-looking statements regarding our commercial and development objectives because of uncertainties, including future sales, product pricing, the timing of clinical trial events such as patient enrollment, requirements of, and future actions of, the U.S. Food and Drug Administration, the fact that experimental data, and clinical results derived from studies with animals or a limited group of patients, as well as comparisons with other clinical trials, may not be predictive of the results of larger studies and, therefore, such experimental or clinical data are not necessarily predictive or indicative of the efficacy or safety or the results of larger studies and clinical trials. Please also refer to the other risks and uncertainties described in SciClone’s filings with the Securities and Exchange Commission. All forward-looking statements are based on information currently available to SciClone, and SciClone assumes no obligation to update any such forward-looking statements.
DC Bead is a registered trademark of Biocompatibles UK Limited.
RapidFilm is a registered trademark of Labtec Gesellschaft für technologische Forschung und Entwicklung mbH.
