SciClone Announces First Patient Enrolled In Phase 2 Clinical Trial Using SCV-07 To Prevent Oral Mucositis

Main Category: Cancer / Oncology
Also Included In: Ear, Nose and Throat;  Neurology / Neuroscience;  Clinical Trials / Drug Trials
Article Date: 02 Jan 2009 - 0:00 PDT

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SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced the enrollment of its first patient in its phase 2, multi-center, randomized, double-blind, placebo-controlled study to assess the safety and efficacy of SCV-07 for prevention of oral mucositis (OM) in patients receiving radio-chemotherapy for the treatment of head and neck cancer.

"Despite its frequency, pain, adverse impact on health, and healthcare cost, there are very few treatment options available for oral mucositis," said Stephen T. Sonis, DMD, DMSc, Brigham and Women's Hospital, Boston, MA. "Data from the preclinical studies of SCV-07 were very promising, showing a compelling prevention of oral mucositis. Intriguingly, the preclinical models also showed a decrease in tumor growth in addition to preventing oral mucositis. And, SCV-07 was well-tolerated. Based on these significant findings, we believe that further studies of SCV-07 for the prevention of oral mucositis in head and neck cancer patients are warranted."

Currently, there is no approved intervention for oral mucositis induced by radiation or radio-chemotherapy, and there is only a single approved therapy for oral mucositis associated with the administration of conditioning regimens prior to stem cell transplant for the treatment of cancer.

The first patient was enrolled in the phase 2 trial at the University of Alabama at Birmingham. The study will be conducted at approximately 15 to 20 centers in the United States, and will include three treatment cohorts of 20 patients each. Each cohort will receive either placebo, SCV-07 at a dose of 0.02 mg/kg, or SCV-07 at a dose of 0.10 mg/kg. The treatment period will be approximately seven weeks depending on the patient's prescribed radiation plan, with a follow-up visit approximately 30 days following the last day of radiation therapy. The primary efficacy endpoint is delay of onset of severe OM

"In preclinical studies, SCV-07 has demonstrated its effectiveness in inhibiting the expression of STAT3, a signaling molecule closely connected with macrophage activation and other immune system parameters," said Cynthia W. Tuthill, Ph.D., Chief Scientific Officer of SciClone. "Additionally, STAT transcription factors play significant roles in a series of biological processes that are particularly relevant to oral mucositis. We are therefore excited to continue exploring SCV-07's potential in preventing oral mucositis in addition to carrying out our ongoing clinical investigation of SCV-07 in the treatment of patients with chronic hepatitis C infection."

SciClone filed an investigational new drug application for oral mucositis with the FDA in July 2008. For more information on SciClone's phase 2 trial of SCV-07 in the prevention of oral mucositis, please visit http://www.clinicaltrials.gov.

About SCV-07

SciClone's proprietary drug candidate SCV-07 (gamma-D-glutamyl-L-tryptophan) is a synthetic peptide with proven immune stimulating effects, including stimulation of T-helper 1 cells (Th1) and inhibition of IL-6-dependent STAT3 signaling. T-cells and STAT transcription factors play significant functional roles in a range of biological processes that are particularly relevant to oral mucositis as a clinical indication for SCV-07. Radiation- and chemotherapy-associated toxicities have been associated with a shift in Th1 to Th2 helper cell ratios to highly favor Th2 cells and increases in STAT3; SCV-07 has been shown to shift the Th1 to Th2 ratio back to favor the Th1 state and to inhibit STAT3-dependant responses.

Additional preclinical studies with SCV-07 are ongoing in other indications that could also benefit from this change in Th1/Th2 ratio, including various immune-sensitive cancers, asthma, and viral infections such as those from papilloma and herpes viruses. The decrease in growth of tumors and increase in survival rates seen in these preclinical cancer models suggest that the use of SCV-07 in this new clinical study, i.e., the prevention of radio-chemotherapy induced oral mucositis, could also have the added benefit of positive effects against the primary tumor.

About Oral Mucositis

Oral mucositis is a painful and debilitating side effect of many of the drug or radiation regimens used to treat cancer. Oral mucositis 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. Oral mucositis has been reported to occur in about 40% of patients who receive chemotherapy (Sonis et al., Nature, 2004). Radiation to the head and neck, especially when it includes the tissues of the mouth, pharynx and hypopharynx, almost always results in significant oral mucositis. 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. Decision Resources, a market research firm, estimates that there were 242,000 oral mucositis patients in the US in 2006.

About SciClone

SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) is a global biopharmaceutical company dedicated to developing and commercializing promising therapies for life-threatening diseases. SciClone's corporate infrastructure leverages diverse global resources to finance growth in multiple markets and fund development of its advanced pipeline of mid- to late-stage product candidates. SciClone's lead product, ZADAXIN(R), is approved for sale in over 30 countries for the treatment of hepatitis B, hepatitis C, and certain immune-sensitive cancers. According to SciClone's most recent publicly-issued guidance, sales of ZADAXIN are expected to grow for the full year 2008 by more than 40% compared to 2007, and are expected to reach about $49 to $51 million in China alone. SciClone has several products in clinical development, consisting of thymalfasin for stage IV melanoma, RP101 for the treatment of pancreatic cancer, and SCV-07 for the treatment of HCV and oral mucositis; and, awaiting approval in China, DC Bead(TM) for the treatment of liver cancer. For additional information, please visit http://www.sciclone.com

SciClone Pharmaceuticals, Inc.