FOR IMMEDIATE RELEASE
February 21, 2011
Salient Pharmaceuticals Passes Milestone in Patient Enrollment of Phase II Trial
HOUSTON, Texas -- Salient Pharmaceuticals Incorporated, today announced the enrollment of the 40th patient in its Phase II cancer therapy-induced diarrhea (CTID) trial and the conclusion of the second in-study interim analysis studying the toxicity of its proprietary product, CASAD™. CASAD is being studied for use in treating CTID in patients with metastatic colorectal cancer.
The trial is a randomized, double blind, placebo-controlled study with an objective of enrolling a minimum of 100 patients at MD Anderson Cancer Center in Houston and fifteen other cancer centers across the United States. The protocol was designed with an interim toxicity analysis after enrollment of every 20th patient.
The second interim analysis was performed in December 2010 and according to the biostatistician, there is no reason to stop the study for either toxicity or futility.
"Enrolling the fortieth patient as well as conducting the second toxicity analysis are both significant milestones for the Company and the development of CASAD," said Richard Scruggs, President and CEO of Salient Pharmaceuticals. "The results of the interim analysis provide continued encouragement. We continue to be reassured that at this dose level, CASAD appears to be well tolerated by patients."
Scruggs adds, "The pace of enrollment in the study has increased during the last six months and we hope these interim results further encourage doctors to introduce the study to their patients. We are looking forward to continued enrollment and the study's successful completion."
H. Andrew Hansen II, MD, Salient's Medical Director further stated, "Diarrhea is a debilitating problem for many cancer patients and is often the dose limiting side effect. Controlling this issue can contribute to therapy success and patient health. We are pleased with the results to date and CASAD's potential to address this important medical need."
Formed in 2007, Salient Pharmaceuticals is a Houston, Texas-based life sciences Company whose mission is to improve health and quality of life while strengthening the odds of therapy success for patients suffering from the debilitating effects of chronic and/or acute diarrhea. Launched in February 2009, the Phase II trial is studying the ability of Salient's product to prevent and/or treat diarrhea in metastatic colorectal cancer patients receiving irinotecan®. It is being supported by the National Cancer Institute's Community Clinical Oncology Program.
Salient's proprietary compound is planned for use in treating severe diarrhea associated with chemotherapy, chronic conditions, infectious diseases and other drug therapies.
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