HOUSTON, Texas -- Salient Pharmaceuticals Incorporated, today announced the enrollment of the 80th patient in its Phase II cancer therapy-induced diarrhea (CTID) trial and the conclusion of the fourth 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 fourth interim analysis was performed in December 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."
"As of the end of 2011, over 90 patients have been enrolled in the study," said Richard Scruggs, President and CEO of Salient Pharmaceuticals. "Completing the last interim toxicity analysis was an important accomplishment for us. We believe we are on track for study completion in the first half of 2012. The ongoing analysis continues to reaffirm our confidence in the product's safety. We look forward to efficacy results in the next few months," he said.
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.
# # #