SciClone Pharmaceuticals (SCLN) Reports Results for Interim Analysis of Phase 2 SCV-07 Oral Mucositis Trial
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SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) 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.
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.
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