FOR IMMEDIATE RELEASE
July 01, 2010
Salient Pharmaceuticals Passes Milestone In Patient Enrollment of Phase II Trial
HOUSTON, Texas -- Salient Pharmaceuticals Incorporated, today announced the enrollment of the 20th patient in its Phase II cancer therapy-induced diarrhea (CTID) trial and the conclusion of the first in-study interim analysis studying the toxicity of its proprietary product, CASAD(TM). 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 at least 100 patients at MD Anderson Cancer Center in Houston and fourteen other cancer centers across the United States. The protocol was designed with an interim toxicity analysis after enrollment of the 20th patient. The interim analysis was performed in April 2010 and according to the biostatistician, there is no reason to stop the study for either toxicity or futility.
"Enrolling the twentieth patient as well as concluding the first toxicity analysis are both significant milestones for the Company and the development of CASAD," said Richard Scruggs, President and CEO of Salient Pharmaceuticals. "We are encouraged by the biostatistician's report and are looking forward to the study's completion."
Scruggs adds, "The study is now active at fifteen sites across the US and we are looking forward to continued enrollment and the study's successful completion."
H. Andrew Hansen II, MD, Salient's Medical Director further stated, "For many chemotherapy regimens, diarrhea is the dose limiting side effect and can jeopardize treatment success. We are pleased that the study has reached this milestone and hopeful that CASAD will prove capable of addressing 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(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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