Protexin has announced that preliminary data from a clinical trial supports the use of Denamarin® to protect against lomustine (CCNU)-induced hepatotoxicity in dogs.
The study is being performed at the University of California-Davis, Veterinary Medical Teaching Hospital, and the initial results were recently presented at the American College of Veterinary Internal Medicine (ACVIM) Annual Forum. Marketed in the UK by Protexin, Denamarin is the combination of S-adenosylmethionine (SAMe) and silybin.
According to the company, most dogs treated with the chemotherapeutic agent CCNU experience liver enzyme elevation. Elevation of certain liver enzymes such as alanine transferase (ALT) is a key indicator of liver trauma; significant enzyme elevation may lead to a discontinuation, delay, or reduction in chemotherapy. The ongoing clinical trial was designed to evaluate Denamarin as a hepatoprotectant in dogs diagnosed with neoplasia that are undergoing CCNU therapy.
The trial consists of two groups of randomly assigned dogs. Dogs in Group 1 receive Denamarin beginning at the start of CCNU therapy. Group 2 dogs do not receive Denamarin unless they develop a Grade IV hepatotoxicity.
Results of a planned interim analysis completed on the first 30 dogs enrolled revealed that starting Denamarin when CCNU therapy was instituted (Group 1 dogs) appeared to provide hepatoprotection. While the mean post-therapy ALT elevation for Group 1 was 119 IU/L (p=0.1), for Group 2 dogs, the post-therapy ALT level was 815 IU/L (p=0.046). Chemotherapy was altered due to elevated liver enzymes in three Group 2 dogs but only one dog in Group 1.
Janine Barlow, Technical Manager at Protexin said: "We are extremely pleased by the initial findings of this research. The use of Denamarin with chemotherapy looks to help protect liver function allowing for successful completion of therapy and hopefully a longer, happier life for the pet. We look forward to the results of the full study."
Protexin says the SAMe and silybin in Denamarin support and maintain hepatic function by mechanisms including increasing levels of glutathione, the liver's main detoxifying agent; promoting protein synthesis; and stimulating bile flow. Denamarin is useful as part of a polymodal approach to the management of liver health.
Denamarin is available for both dogs and cats in an enteric-coated tablet.
Protexin has launched what is billed as the first therapeutic veterinary GI diet to contain an added probiotic: Pro-Balance, with Enterococcus faecium.
For more information, see: http://www.protexin.com/