FOSTER CITY, CA--(Marketwire -03/02/12)- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN - News) today announced that results from a pre-planned interim analysis of the phase 2b trial of SCV-07 in patients with oral mucositis (OM) indicate that the trial would not meet the pre-specified efficacy endpoints. After conferring with the study's independent Data Monitoring Committee (DMC), the Company has decided to discontinue development of SCV-07 in this indication. SciClone is notifying the FDA and study investigators of the trial's discontinuation. No additional patients will be enrolled in the trial. Dosing of subjects currently enrolled in the trial will be discontinued, but subjects will be followed per protocol for a full year.
"Oral mucositis remains a debilitating condition for cancer patients who are in need of effective therapeutic options. We express our sincere appreciation to the investigators and patients who have participated in the phase 2b trial," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone. "While we certainly would have preferred to see a positive outcome from the SCV-07 phase 2b trial interim analysis, as a practical matter, we now have the opportunity to complete our transition to a China-focused specialty pharmaceutical company. This will enable us to further curtail our US development expenses and focus resources on continuing to grow our commercial business in China, expand sales of our broad portfolio of marketed products and build our track record of impressive growth in revenue, profitability and earnings per share."
Following the originally planned completion of the phase 2b trial in mid-2012, SciClone had anticipated a significant decrease in development expenses beginning later this year. SciClone now anticipates that decreases in clinical activities and expenses related to the trial will begin earlier this year, and will have a positive impact on the company's full-year 2012 profitability and earnings.
About SCV-07 and the Phase 2b Trial
The interim analysis included data on 85 subjects. The DMC had no safety concerns, but recommended discontinuing enrolling subjects into the trial as all three dosage arms indicated no efficacy of the drug relative to the primary or secondary OM endpoints.
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule that appears to stimulate 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 prevention of oral mucositis, treatment of cancer and viral infections, and enhancement of response to vaccines.
Initiated in January 2011, the Phase 2b trial of SCV-07 is a multicenter, randomized, double blind placebo-controlled study examining three doses of SCV-07, including two higher doses than those used in the Phase 2a study, to assess the drug's impact on modifying the course of oral mucositis in patients with head and neck cancer. The primary endpoint is the reduction in the proportion of patients with clinically assessed ulcerative OM, defined as WHO grade greater than or equal to 2 at the time they have received a cumulative radiation dose of 45 Gy.
SciClone Pharmaceuticals is a revenue-generating, profitable, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders. SciClone's ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), as a vaccine adjuvant, and certain cancers according to the local regulatory approvals. Besides ZADAXIN, SciClone markets nearly 20 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a fast-acting hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also developing SCV-07 in a phase 2b trial for the delay to onset of oral mucositis in patients with head and neck cancer. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.
This press release contains forward-looking statements regarding financial results for fiscal 2012 and expected future financial results and expectations. Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," "unaudited," "approximately" 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 include risk and uncertainties relating to the course, cost and outcome of regulatory matters, including pricing decisions by authorities in China; the on-going regulatory investigations and SciClone's independent investigation; the Company's ability to execute on its goals in China and on its objectives for revenue in fiscal 2012; the challenges presented by integrating an acquired business into existing operations; the dependence on third party license, promotion or distribution agreements including the need to renew such agreements; operating an international business; the clinical trial process, including the regulatory approval and the process of initiating trials at, and enrolling patients at, clinical sites; the Company's ability to remediate its identified material weaknesses over internal control; and changes in its practices and policies which could adversely affect its ability to generate revenue. SciClone cannot predict the timing or outcome of the SEC and DOJ investigations, of the various litigations that may be filed relating to any of those matters, or of its efforts to cooperate with those investigations, however the Company expects to incur substantial expenses in connection with the investigations and the results of the investigations could include fines and further changes in its internal control or other remediation measures that could adversely affect its business. 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.
Ambien, Depakine, Stilnox and Tritace are registered trademarks of Sanofi.
Aggrastat is a registered trademark of Merck & Co., Inc.