FOSTER CITY, CA--(Marketwire - November 12, 2009) - SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced presentations of multiple abstracts demonstrating SCV-07’s anti-tumor immunomodulating properties at two upcoming events: Cold Spring Harbor Laboratory’s Harnessing Immunity to Prevent and Treat Disease meeting; and the American Association for Cancer Research (AACR), National Cancer Institute (NCI), and European Organization for Research and Treatment of Cancer (EORTC)'s Molecular Targets and Cancer Therapeutics International Conference. The presentations include data on SCV-07’s role as a breast cancer adjuvant, its efficacy in treating B16 melanoma, and its effect on STAT3-related immune responses.
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. The compound has demonstrated an ability, for example, to reduce progression of renal and lung carcinoma as well as melanoma in mouse models.
Additionally, SciClone is conducting a phase 2 multicenter, randomized, double-blind, placebo-controlled, dose ranging study, designed to assess the safety and efficacy of SCV-07 for the delay to onset and severity of severe oral mucositis in patients receiving standard chemoradiation therapy for treatment of cancers of the head and neck. SciClone expects to complete enrollment in this study in the second half of 2009 and provide initial results in the first half of 2010.
SciClone is also currently running a multicenter, multidose, open label phase 2 clinical trial of SCV-07 as a monotherapy and in combination with ribavirin to treat hepatitis C virus. 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.
The Novel Immunomodulator SCV-07 Provides Enhancement to a Breast Cancer Vaccine
In a study conducted by colleagues at the University of Washington in Seattle, Cynthia Tuthill, Ph.D., SciClone’s Senior Vice President of Scientific Affairs and Chief Scientific Officer, obtained data on SCV-07’s role as a breast cancer vaccine adjuvant in a mouse model of HER-2 positive breast cancer. It was shown that SCV-07 helped stimulate a shift of T helper cells to the Th1 profile of cytokines and was able to enhance the host’s response to a breast cancer vaccine as determined by an inhibition of tumor growth. These findings will be shared during an oral presentation at the Cold Spring Harbor Laboratory’s Harnessing Immunity to Prevent and Treat Disease meeting on November 12, 2009 at 2 pm ET in Cold Spring Harbor, NY.
Extended Survival of Mice Bearing B16 Melanoma after Treatment with SCV-07
During a poster session at the Cold Spring Harbor meeting, Dr. Tuthill will present data on SCV-07’s efficacy -- both alone and in combination with chemotherapy -- in treating mice with B16 melanoma. Combination treatment with chemotherapy and SCV-07 in a melanoma mouse model demonstrated beneficial effects as reflected by increased survival and decreased treatment toxicity. The poster will be presented at the Harnessing Immunity to Prevent and Treat Disease meeting, during the evening session on November 12, 2009 in Cold Spring Harbor, NY.
The Anti-tumor Activity of SCV-07 Is Attributable in Part to an Inhibitory Effect on STAT3 Driven Responses
Additional data on SCV-07 will be presented in a poster session at the annual AACR-NCI-EORTC meeting at which Dr. Tuthill and colleagues will discuss SCV-07’s effect on STAT3. Because STAT3 is known to be up-regulated in tumor microenvironments, and STAT3-driven gene expression triggers global immune suppression of anti-tumor responses, SCV-07 was tested to determine whether or not it modulates STAT3-induced responses as part of its mechanism in stimulating anti-tumor immune response. The results provide support that SCV-07 does in fact reduce STAT3-driven gene expression and leads to anti-tumor natural killer cell responses in the host. This poster (C107) will be presented at AACR-NCI-EORTC’s Molecular Targets and Cancer Therapeutics International Conference on November 18, 2009 at 12:30 pm ET in Boston, MA.
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 SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profitable, 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 seek 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 identify and consummate our previously-announced goals of acquiring additional products to sell, either through licensing or the acquisition of businesses. 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.
