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Thu, November 12, 2009 SciClone Pharmaceuticals Announces Presentations of SCV-07 Data at Upcoming Medical Meetings
FOSTER CITY, CA--(Marketwire - November 12, 2009) - SciClone Pharmaceuticals, Inc. (
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
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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.
