FOR IMMEDIATE RELEASE
November 10, 2010
Salient Enrolls First Patients in New Cancer Therapy-Induced Study in Canines
HOUSTON, Texas -- In support of the ongoing development of its proprietary CASADTM compound planned for use in treating severe diarrhea associated with chemotherapy, chronic conditions, infectious diseases and other drug therapies, Salient Pharmaceuticals Incorporated today announced the launch of a second cancer therapy-induced diarrhea study in dogs.
The study being conducted in cooperation with the Clinical Animal Registration and Education (CARE) Foundation follows successful research first conducted in 2007 at Gulf Coast Veterinary Specialists in Houston.
"Cancer is likely in almost fifty per cent of all dogs, ten years or older," said Robert Hunt Carpenter, DVM, Salient's Chief Science Officer. "This study is important for it may lead to the control of a very debilitating side-effect and potentially enable veterinarians to change the way they treat cancer in companion animals," he added.
The study was initiated in early August and will eventually include 60-animals in a blind, placebo controlled study of dogs receiving Adriamycin on an every two-week schedule. As of the date of this release, over 10 dogs have been enrolled in the study. A consortium of four veterinary oncology clinics in Texas has stepped forward to administer the study with coordination by the CARE Foundation. The four participating clinics include Gulf Coast Veterinary Specialists (Houston), South Texas Veterinary Specialists (San Antonio), Sugarland Veterinary Specialists (Sugarland) and Texas Veterinary Oncology (Austin).
CASADTM is being administered prior to and during chemotherapy with the goal of preventing cancer therapy-induced diarrhea. Each dog will be followed for a minimum of four courses of chemotherapy treatment.
The results of the Company's initial study of cancer therapy-induced diarrhea in dogs were published by Kevin A. Hahn, DVM, PhD, ACVIM and Robert H. Carpenter, DVM, MS in 2008 in The International Journal of Applied Research in Veterinary Medicine. The study included 23 cancer-bearing dogs with intractable diarrhea that had not responded to the standard of care for diarrhea. All dogs in the study benefited from the use of CASAD and in 65% of the cases, the diarrhea completely resolved within 48-72 hours.
Dr. Theresa W. Fossum, founder, President and CEO of CARE, noted that Salient's work is a great example of a CARE's mission in action. "We are excited about this trial," Fossum said. "It focuses on a critical need and can have a tremendous impact on drug development in our state by bringing together the resources of our network - in this case, leading Texas veterinarians to manage critical drug studies."
CASAD is also being studied for use in treating cancer therapy-induced diarrhea (CTID) in humans with metastatic colorectal cancer. Salient is several months into a Phase II CTID trial and has completed the first in-study interim analysis studying the toxicity of the product.
Richard Scruggs, President and CEO of Salient Pharmaceuticals, understands the devastating impact that severe diarrhea can cause as a result of many chemotherapy regimens. "The type of diarrhea that we are fighting can jeopardize treatment successes in cancer patients," he said. "We are pleased with the results we have seen and the milestones achieved by CASAD."
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.
The Clinical Animal Registration and Education Foundation (CARE) was established in 2004 to promote the use of animals with spontaneous (naturally occurring) disease in clinical studies. CARE has developed the necessary infrastructure to capture reliable information about animal disease and treatment.
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