USDA Grants Conditional Approval for First Therapeutic Vaccine to Treat Cancer

Merial's New Vaccine Treats Deadly Cancer in Dogs



Mar 26, 2007, 01:00 ET from Merial US

    DULUTH, Ga., March 26 /PRNewswire/ -- Merial, the world's leading
 animal health company, gained conditional approval from the U.S. Department
 of Agriculture for a breakthrough vaccine to treat canine melanoma, a
 common yet deadly form of cancer in dogs. This is the first time that the
 U.S. government has approved a therapeutic vaccine for the treatment of
 cancer -- in either animals or humans.
     The vaccine will initially be available for use by specialists
 practicing veterinary oncology, so pet owners will want to ask their
 veterinarians about how to access this treatment option.
     The vaccine was developed through a partnership between Merial,
 Memorial Sloan-Kettering Cancer Center (MSKCC) and The Animal Medical
 Center (AMC) of New York. Drs. Alan Houghton and Jedd Wolchok of MSKCC were
 doing laboratory testing of a melanoma vaccine they developed. An inquiry
 by Dr. Philip Bergman of The AMC, seeking novel treatments for canine
 melanoma, resulted in the clinical trial of the Memorial Sloan-Kettering
 melanoma vaccine at The Animal Medical Center. Subsequent parallel trials
 at AMC and MSKCC refined the dosage and protocol to the current therapeutic
 regimen for dogs.
     "Both humans and dogs develop this cancer in exactly the same way. The
 disease occurs spontaneously through an interaction of genes with the
 environment," explained Jedd D. Wolchok, MD, PhD, an oncologist on the
 Clinical Immunology Service at Memorial Sloan-Kettering. "By conducting
 trials in humans and in animals that live in the same surroundings as
 humans, there can be a synergy that we hope will result in improved cancer
 treatment for all."
     Canine melanoma is an aggressive form of cancer that typically appears
 in a dog's mouth, but also may appear in the nail bed, foot pad or other
 areas. Dogs with melanomas that have gone beyond initial stages typically
 have a lifespan of one to five months with conventional therapies. To date,
 the most common treatments for this form of cancer have been radiation and
 surgery. "Melanoma spreads readily, and, unfortunately, is often resistant
 to chemotherapy," said Bob Menardi, DVM, a veterinarian and spokesperson
 for Merial.
     Clinical studies of the vaccine in dogs led by Philip Bergman, DVM, MS,
 PhD, Dipl. ACVIM-Onc. at The Animal Medical Center's Donaldson-Atwood
 Cancer Center and Flaherty Comparative Oncology Laboratory, demonstrated
 significantly longer life spans even in dogs with advanced stages of
 melanoma. In fact, many dogs have survived beyond the 389-day median
 survival of the initial study.
     "Historically speaking, treatment of oral melanoma with surgery,
 radiation or chemotherapy has not been very effective," said Dr. Bergman.
 "This therapeutic vaccine is an adjunct therapy for dogs that have been
 diagnosed with this often fatal disease."
     Merial obtained licensing rights from MSKCC and AMC, and, using their
 access to and experience with DNA vaccine technology licensed from Vical
 Incorporated (Nasdaq:   VICL), completed the industrialization and regulatory
 requirements for conditional licensure. The vaccine will be administered
 via a new Canine Transdermal Device, which delivers the vaccine without the
 use of a needle. The device was developed in conjunction with Bioject, a
 Portland- based research pharmaceutical device company (Nasdaq:   BJCT).
     "We're all very proud of what we've accomplished here," said Tim Leard,
 DVM, PhD, Director of Biologics Research and Development at Merial. "We've
 brought together a number of partners, all committed to innovation and
 discovery. This product will improve the health and well-being of dogs, and
 we're very excited about continuing this work, leveraging technology, and
 developing more treatments."
     The USDA has issued a conditional U.S. Veterinary Biological Product
 License for this therapeutic vaccine. This conditional license is a
 response to an application and assurance of safety and purity, and a
 reasonable expectation of efficacy based on initial trials performed at
 MSKCC and AMC.
     During the period of conditional licensure, Merial will conduct
 additional research to further support the safety and efficacy of the
 vaccine. Production under this license is in compliance with all
 regulations and standards applicable to such products.
     Merial is a world-leading, innovation-driven animal health company,
 providing a comprehensive range of products to enhance the health,
 well-being and performance of a wide range of animals. Merial employs
 approximately 5,000 people and operates in more than 150 countries
 worldwide. Its 2006 sales were nearly $2.2 billion. Merial Limited is a
 joint venture between Merck & Co. and sanofi-aventis. For more information,
 please see http://www.merial.com.
     The not-for-profit Animal Medical Center is New York City's largest
 facility for animal care, research and education. Eighty-seven
 veterinarians (32 of them board-certified) practice specialty or critical
 care for companion animals and exotics. With over 50,000 patient visits
 annually, The AMC is open 24 hours a day, 365 days a year.
 (http://www.amcny.org)
     Memorial Sloan-Kettering Cancer Center is the world's oldest and
 largest institution devoted to prevention, patient care, research and
 education in cancer. Our scientists and clinicians generate innovative
 approaches to better understand, diagnose and treat cancer. Our specialists
 are leaders in biomedical research and in translating the latest research
 to advance the standard of cancer care worldwide. For more information, go
 to http://www.mskcc.org
 
 

SOURCE Merial US
    DULUTH, Ga., March 26 /PRNewswire/ -- Merial, the world's leading
 animal health company, gained conditional approval from the U.S. Department
 of Agriculture for a breakthrough vaccine to treat canine melanoma, a
 common yet deadly form of cancer in dogs. This is the first time that the
 U.S. government has approved a therapeutic vaccine for the treatment of
 cancer -- in either animals or humans.
     The vaccine will initially be available for use by specialists
 practicing veterinary oncology, so pet owners will want to ask their
 veterinarians about how to access this treatment option.
     The vaccine was developed through a partnership between Merial,
 Memorial Sloan-Kettering Cancer Center (MSKCC) and The Animal Medical
 Center (AMC) of New York. Drs. Alan Houghton and Jedd Wolchok of MSKCC were
 doing laboratory testing of a melanoma vaccine they developed. An inquiry
 by Dr. Philip Bergman of The AMC, seeking novel treatments for canine
 melanoma, resulted in the clinical trial of the Memorial Sloan-Kettering
 melanoma vaccine at The Animal Medical Center. Subsequent parallel trials
 at AMC and MSKCC refined the dosage and protocol to the current therapeutic
 regimen for dogs.
     "Both humans and dogs develop this cancer in exactly the same way. The
 disease occurs spontaneously through an interaction of genes with the
 environment," explained Jedd D. Wolchok, MD, PhD, an oncologist on the
 Clinical Immunology Service at Memorial Sloan-Kettering. "By conducting
 trials in humans and in animals that live in the same surroundings as
 humans, there can be a synergy that we hope will result in improved cancer
 treatment for all."
     Canine melanoma is an aggressive form of cancer that typically appears
 in a dog's mouth, but also may appear in the nail bed, foot pad or other
 areas. Dogs with melanomas that have gone beyond initial stages typically
 have a lifespan of one to five months with conventional therapies. To date,
 the most common treatments for this form of cancer have been radiation and
 surgery. "Melanoma spreads readily, and, unfortunately, is often resistant
 to chemotherapy," said Bob Menardi, DVM, a veterinarian and spokesperson
 for Merial.
     Clinical studies of the vaccine in dogs led by Philip Bergman, DVM, MS,
 PhD, Dipl. ACVIM-Onc. at The Animal Medical Center's Donaldson-Atwood
 Cancer Center and Flaherty Comparative Oncology Laboratory, demonstrated
 significantly longer life spans even in dogs with advanced stages of
 melanoma. In fact, many dogs have survived beyond the 389-day median
 survival of the initial study.
     "Historically speaking, treatment of oral melanoma with surgery,
 radiation or chemotherapy has not been very effective," said Dr. Bergman.
 "This therapeutic vaccine is an adjunct therapy for dogs that have been
 diagnosed with this often fatal disease."
     Merial obtained licensing rights from MSKCC and AMC, and, using their
 access to and experience with DNA vaccine technology licensed from Vical
 Incorporated (Nasdaq:   VICL), completed the industrialization and regulatory
 requirements for conditional licensure. The vaccine will be administered
 via a new Canine Transdermal Device, which delivers the vaccine without the
 use of a needle. The device was developed in conjunction with Bioject, a
 Portland- based research pharmaceutical device company (Nasdaq:   BJCT).
     "We're all very proud of what we've accomplished here," said Tim Leard,
 DVM, PhD, Director of Biologics Research and Development at Merial. "We've
 brought together a number of partners, all committed to innovation and
 discovery. This product will improve the health and well-being of dogs, and
 we're very excited about continuing this work, leveraging technology, and
 developing more treatments."
     The USDA has issued a conditional U.S. Veterinary Biological Product
 License for this therapeutic vaccine. This conditional license is a
 response to an application and assurance of safety and purity, and a
 reasonable expectation of efficacy based on initial trials performed at
 MSKCC and AMC.
     During the period of conditional licensure, Merial will conduct
 additional research to further support the safety and efficacy of the
 vaccine. Production under this license is in compliance with all
 regulations and standards applicable to such products.
     Merial is a world-leading, innovation-driven animal health company,
 providing a comprehensive range of products to enhance the health,
 well-being and performance of a wide range of animals. Merial employs
 approximately 5,000 people and operates in more than 150 countries
 worldwide. Its 2006 sales were nearly $2.2 billion. Merial Limited is a
 joint venture between Merck & Co. and sanofi-aventis. For more information,
 please see http://www.merial.com.
     The not-for-profit Animal Medical Center is New York City's largest
 facility for animal care, research and education. Eighty-seven
 veterinarians (32 of them board-certified) practice specialty or critical
 care for companion animals and exotics. With over 50,000 patient visits
 annually, The AMC is open 24 hours a day, 365 days a year.
 (http://www.amcny.org)
     Memorial Sloan-Kettering Cancer Center is the world's oldest and
 largest institution devoted to prevention, patient care, research and
 education in cancer. Our scientists and clinicians generate innovative
 approaches to better understand, diagnose and treat cancer. Our specialists
 are leaders in biomedical research and in translating the latest research
 to advance the standard of cancer care worldwide. For more information, go
 to http://www.mskcc.org
 
 SOURCE Merial US