FOSTER CITY, CA--(Marketwire - November 23, 2009) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that patient enrollment is complete ahead of schedule for its phase 2 trial of SCV-07 -- a small molecule synthetic peptide with immunomodulating properties -- for the treatment of severe oral mucositis (OM) in patients with head and neck cancer. Topline results of the oral mucositis trial are expected to be announced in the first half of 2010.
“Oral mucositis is a painful, debilitating side effect of radiation therapy used for the treatment of head and neck cancers,” said Stephen T. Sonis, DMD, DMSc, Brigham and Women’s Hospital, Boston, MA. “Despite the fact that oral mucositis occurs in the vast majority of patients in this population, there are currently no effective treatment options available. We are encouraged by previous preclinical data which suggest that SCV-07 may be safe and effective in delaying the onset and reducing the severity of oral mucositis and we look forward to the results of the current trial.”
SciClone’s multicenter, randomized, double-blind, placebo-controlled, dose ranging study is designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of oral mucositis in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. SciClone is encouraged by the rate of enrollment, which began 11 months ago.
“SCV-07 appears to work through inhibition of the STAT3 signaling pathway. Studies have shown that over-expression of STAT3 can dampen natural immune responses, and increases in STAT3 have been correlated with epithelial cell damage after radiation,” said Cynthia W. Tuthill, Ph.D., Chief Scientific Officer of SciClone. “SCV-07’s safety profile and its ability to stimulate the immune system make it a promising treatment, particularly for patients undergoing complicated chemotherapy or radiation treatments due to their malignancies.”
The study is being conducted at 21 centers in the United States, and includes 20 patients in each of the three treatment cohorts. Each cohort receives 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 is 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. All the patients have been treated with a standard cisplatin regimen in addition to radiation therapy. The primary efficacy endpoint is delay of onset and severity of severe OM.
For more information on SciClone’s phase 2 trial of SCV-07 in the delay to onset and severity of oral mucositis, please visit www.clinicaltrials.gov.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which stimulates 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 viral infections and cancers, and in the enhancement of response to vaccines.
Additionally, SciClone is currently running a multicenter, multidose, open label phase 2 clinical trial of SCV-07 as a monotherapy and in combination with ribavirin to treat patients infected with hepatitis C virus, who have relapsed after the last treatment. SCV-07 has shown a good safety profile in several early stage clinical trials in healthy volunteers and subjects with HCV infection at various doses. SciClone expects to complete enrollment in this study in the first half of 2010 and provide initial results in the second half of 2010.
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 recently been approved for stimulation of depressed immune systems.
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 chemoradiation (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. The National Cancer Institute estimates that 400,000 patients in the U.S. suffer from oral mucositis during cancer therapy.
About SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-driven, global specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. SciClone is focused on continuing international sales growth, a cost-containing clinical development strategy, and overall expense management. ZADAXIN® (thymalfasin or thymosin alpha 1) is sold in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers and as a vaccine adjuvant. SciClone’s pipeline of drug candidates includes thymalfasin, in preclinical studies as an enhancer of H1N1 flu vaccines; thymalfasin for stage IV melanoma, for which SciClone has reached agreement with the FDA on the design of a phase 3 trial; SCV-07 in a phase 2 trial for the delay of onset of severe oral mucositis in patients receiving chemoradiation therapy for the treatment of cancers of the head and neck; and SCV-07 in a phase 2 trial for the treatment of HCV. SciClone has exclusive commercialization and distribution rights to DC Bead™ in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm™ in China and Vietnam, for which it will seeking regulatory approval. For additional information, please visit www.sciclone.com.
Forward-Looking Statements
This press release contains forward-looking statements regarding development objectives and timing expectations. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “might,” “believes,” “estimates,” “projects,” “potential,” “expects,” “potential,” “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 ability to complete clinical trials of SCV-07 and for such trials to demonstrate SCV-07 having a significant therapeutic effect for treatment of oral mucositis without adverse side effects. Please also refer to other risks and uncertainties described in SciClone’s filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements.
