Major Milestone Reached in Salient Pharmaceuticals' Phase II Trial

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Salient Pharmaceuticals Incorporated has passed a major milestone in its Phase II study of CASAD™, its proprietary product targeting the treatment and prevention of cancer therapy-induced diarrhea (CTID). The Phase II trial has now enrolled 100 patients, completing the enrollment period of the study for CASAD in treating CTID in patients with metastatic colorectal cancer.

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Enrolling 100 patients in Salient’s Phase II trial is an important milestone for the company. We have been encouraged by the interim feedback we have received.

Salient Pharmaceuticals Incorporated has passed a major milestone in its Phase II study of CASAD™, its proprietary product targeting the treatment and prevention of cancer therapy-induced diarrhea (CTID). Salient announced today that the Phase II trial has now enrolled 100 patients, completing the enrollment period of the study for CASAD in treating CTID in patients with metastatic colorectal cancer.

The trial is a randomized, double blind study where over six weeks, patients receive either active or placebo study drug followed by an optional six-week open label active drug period. The study is being conducted at MD Anderson Cancer Center in Houston and 15 other cancer centers across the United States.

The protocol was designed with an interim toxicity analysis after enrollment of every 20 patients. The most recent interim analysis at the 80-patient point was performed in December 2011 and indicated no unexpected toxicities. Salient anticipates that the last patient will complete the study period later this summer and that initial data will be available soon thereafter.

"This is an important milestone for the company,” said Richard Scruggs, President and CEO of Salient Pharmaceuticals. “We have been encouraged by the interim feedback we have received and look forward to the compilation of efficacy results,” he said.

In addition to cancer therapy-induced diarrhea, Salient has also conducted preclinical work assessing the potential of CASAD in the treatment of indications as diverse as oral mucositis, proctitis, colitis and Clostridium difficile.    

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. For more information, please visit http://www.salientpharmaceuticals.com.

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