SciClone Announces Additional Topline Results for SCV-07
Company Establishes Scientific Advisory Board for SCV-07 in Oral Mucositis
FOSTER CITY, CA – May 17, 2010 – SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced further topline results from the company’s phase 2 proof of concept study of SCV-07 for the prevention of severe oral mucositis (OM; WHO grades 3-4) in patients with advanced head and neck cancer -- a painful and debilitating condition caused by chemoradiotherapy regimens.
High dose SCV-07 The incidence of severe OM after 5 weeks of chemoradiation was 30% lower in the patients in the high dose treatment arm (0.1 mg/kg; 17 patients) compared to the 20 patients who received placebo (29% vs. 42%). A post hoc data analysis of ulcerative mucositis (WHO grades 2- 4), a major cause of morbidity associated with OM, was also conducted. The high dose of SCV-07 prevented the onset of any ulcerative mucositis in 24% of patients at doses of radiation up to 50Gy (after approximately 5 weeks of treatment) while 100% of patients in the placebo group suffered from ulcerative mucositis at 35Gy (after approximately 3.5 weeks of treatment).
Supportive of these findings, the high dose SCV-07 group also showed improvement over placebo for exploratory endpoints, including the use of gastric tube feedings, unplanned office or emergency room visits, and breaks in planned course of radiation therapy of one week or longer.
Low dose SCV-07 The incidence of severe OM after 5 weeks of chemoradiation was 50% higher in the patients in the low-dose treatment arm (0.02 mg/kg; 20 patients) compared to the 20 patients who received placebo (63% vs. 42%). However, the post hoc data analysis of ulcerative mucositis showed that the low dose of SCV-07 prevented the onset of any ulcerative mucositis in 5% of patients at doses of radiation up to 50Gy compared to 100% of patients in the placebo group who suffered from ulcerative mucositis at 35Gy.
Regarding exploratory endpoints, the low dose group showed similar results to the placebo group.
These results suggest that SCV-07 may be acting on different biological pathways at different doses.
Safety Importantly, both doses of SCV-07 were shown to be safe and well tolerated, with no SCV-07-related serious adverse events reported in either dose arm. The distribution and incidence of adverse events was similar between SCV-07- and placebo-treated patients. The most frequent adverse events in all patients were gastrointestinal disorders (such as nausea and dry mouth), general disorders (such as fatigue and fever), and local injection site reactions. This safety profile supports the potential to administer higher doses of SCV-07 in future clinical studies evaluating oral mucositis.
The initial findings were previously reported by SciClone on March 30, 2010.
Scientific Advisory Board SciClone recently formed a scientific advisory board (SAB) to provide guidance and oversight for the company’s ongoing clinical development of SCV-07 for this indication. The newly established SAB, which includes medical and radiation oncology thought leaders, is working with SciClone to design the clinical development strategy for the OM program based on findings from this study.
“SAB members were encouraged by the findings from SciClone’s phase 2 proof of concept study which suggested a consistent trend favoring patients in the trial’s high dose group,” said Dr. Stephen T. Sonis, Chief of the Division of Oral Medicine at the Dana-Farber Cancer Institute; Senior Surgeon at Brigham and Women’s Hospital; Clinical Professor of Oral Medicine at Harvard. “Furthermore, the data from the study offered insight into study design for the next phase 2 trial.”
SciClone’s newly established SAB includes the following thought leaders from the oncology community:
Stephen T. Sonis, DMD, DMSc – SAB Chair Chief of the Division of Oral Medicine at the Dana-Farber Cancer Institute; Senior Surgeon at Brigham and Women’s Hospital; Clinical Professor of Oral Medicine at Harvard
Roy B. Tishler, M.D., Ph.D. Director of Head and Neck Radiation Oncology, Dana Farber Cancer Institute/Brigham and Women's Hospital; Associate Professor of Radiation Oncology, Harvard Medical School
Ezra Cohen, M.D. Associate Professor of Medicine, University of Chicago Medical Center
Barbara Murphy, M.D. Associate Professor of Medicine, Division of Hematology/Oncology at Vanderbilt University; Director of the Cancer Supportive Care Program and Head and Neck Research Program
Curtis T. Miyamoto, MD Medical Director, Cancer Service Line, Professor and Chairperson, Department of Radiation Oncology, Temple University Hospital, Philadelphia, PA
Joel, Epstein, DMD Professor and Department Head, Oral Medicine and Diagnostic Services University of Illinois at Chicago
“Through this newly formed SAB, we believe that we have assembled a team of key opinion leaders in the area of oral mucositis. We are grateful that these experts have agreed to provide their guidance to this important program - a program that we hope will ultimately offer patients and physicians a solution to a significant unmet medical need,” commented Friedhelm Blobel, Ph.D., SciClone’s President and Chief Executive Officer. “We appreciate the efforts already put forth by this Board in assisting the ongoing clinical development of SCV-07 for OM and look forward to the important contributions that they will make as we continue to advance the program.”
Topline details of the SCV-07 OM clinical development strategy include:
· Plans to conduct another trial to confirm the efficacy of the 0.10 mg/kg SCV-07 dose and to explore two additional, higher dose levels, as a result of the clinically meaningful signal in delaying the onset of OM seen in patients treated with the 0.10 mg/kg SCV-07 dose;
· Meeting with the United States Food and Drug Administration (FDA) in the second quarter of 2010 to discuss the results of this phase 2 proof of concept study and plans for the new phase 2 study;
· If a positive FDA response is received including FDA agreement on the overall design of the study, SciClone would initiate the new phase 2 study promptly.
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 affects 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 400,000 patients in the U.S. suffer from OM during cancer therapy.
SciClone Pharmaceuticals (NASDAQ: SCLN) is a profit-focused, 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 clinical studies as an enhancer of vaccines; SCV-07 in a phase 2 trial for the delay to 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 BeadTM in China, where the product is under regulatory review. The Company also has exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilmTM in China, including Hong Kong and Macau, and Vietnam, for which it will seek regulatory approval. For additional information, please visit Hwww.sciclone.comwww.sciclone.com>H.
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 the outcome of our discussions with the FDA and whether we are able to initiate the Phase 2 trial., and if commenced, complete clinical trials of SCV-07 and for such trials to demonstrate SCV-07 having a significant therapeutic effect for treatment of OM 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.
Posted: May 2010