[ SHOWGSD-L ] cancer vaccine

  • From: MORGAN LEWIS <shadowland22000@xxxxxxxxx>
  • To: germanshepherds4show@xxxxxxxxxxxxxxx, gsdgeneticdefects@xxxxxxxxxxxxxxx, gsd showlist <showgsd-l@xxxxxxxxxxxxx>
  • Date: Mon, 9 Jul 2007 07:05:45 -0700 (PDT)

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"97546168";             DULUTH, GA. ? The U.S. Department of Agriculture 
approved the first 
conditional license for a cancer therapeutic vaccine from Merial Ltd. 
The vaccine ranks as the world's first for animals or humans, 
explains Dr. Bob Menardi, Merial's manager of technical services. 

The therapeutic vaccine will make its way to market this month as a 
treatment for stage II or stage III oral melanoma in dogs. 

Available through boarded oncologists, the conditional license from 
USDA represents a milestone, Menardi says. "This vaccine is an 
example of how human medicine and veterinary medicine can work 
together for the benefit of both species," he adds.The vaccine 
represents a decade-long collaboration with researchers at New York's 
Animal Medical Center (AMC) and Memorial Sloan-Kettering Cancer 
Center. 

Robert Nordgren, Merial's vice president for biological research and 
technology acquisition, explains that the DNA vaccine alerts the 
immune system to the presence of the melanoma tumor protein 
tyrosinase. The gene for human tyrosinase protein is inserted into a 
DNA plasmid, which in turn stimulates an immune response in the 
canine patient suffering from melanoma. 

"The earlier you begin immunotherapy the greater the chances for 
survival," Nordgren adds. 

The vaccine shows promising improvements in survival times when 
compared to surgery and radiation. In fact, in a Phase I clinical 
trial of dogs with advanced malignant melanoma after DNA vaccination 
with xenogeneic human tyrosinase, the median survival time was 389 
days for dogs with stages II, III or IV canine melanoma receiving 
four biweekly vaccinations. In comparison, the historical median 
survival time for dogs with stage II oral melanoma is less than 150 
days; for dogs with stage II or stage IV it is less than two to three 
months. 

Studies demonstrating efficacy and safety were conducted by AMC's 
Philip Bergman, DVM, MS, PhD, Dipl. ACVIM. His studies from 2000 to 
present have shown an increase in survival times. 

Research for a conditional license demonstrates "a reasonable 
expectation of safety," Menardi says. Follow-up studies are ongoing 
to pursue full licensure and further support safety and efficacy of 
the vaccine. 

For oncologists using the treatment, the vaccine is administered 
using a canine transdermal device. The Canine Melanoma Vaccine is 
administered in a 0.4mL dose volume. The injection site for all dogs 
is the muscle of the medial thigh just caudal to the femur. Initial 
treatment requires four doses of vaccine at two-week intervals. A 
booster dose should be administered at six-month intervals, the 
company says. 

For fastest response, call 
(888) MERIAL1 
www.merial.com/ 









       
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