FOR IMMEDIATE RELEASE
June 03, 2011
Third Milestone in Patient Enrollment Passed in Salient Pharmaceuticals Phase II Trial
HOUSTON, Texas -- Salient Pharmaceuticals Incorporated, today announced the enrollment of the 60th patient in its Phase II cancer therapy-induced diarrhea (CTID) trial and the conclusion of the third 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 third interim analysis was performed in April 2011 and according to the biostatistician, "the trial should continue to accrue in both treatment arms since the grade 3/4 diarrhea rate and toxicity rate in either arm did not exceed the protocol-defined cut-off for stopping."
"The enrollment rate of our study has increased in recent months and meeting the 60-patient milestone was significant for us," said Richard Scruggs, President and CEO of Salient Pharmaceuticals. "The results of the interim analysis continue to be encouraging. We look forward to completing the study within the next few months," he said.
H. Andrew Hansen II, MD, Salient's Medical Director further stated, "Diarrhea continues to be a debilitating problem for many cancer patients and is often the dose limiting side effect. While this is a blind study, we continue to be pleased with the results to date."
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(R). 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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