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MERIAL RECIEVES APPROVAL FOR CANINE CANCER VACCINE, MAY BE STEP TOWARDS HUMAN VACCINE
Merial news release
Duluth, GA - Merial, a world-leading animal health company, has gained full-licensure from the U.S. Department of Agriculture for ONCEPT™ Canine Melanoma Vaccine, DNA. ONCEPT is a breakthrough vaccine indicated for aiding in extending survival of dogs with stage II or stage III oral canine melanoma, a common yet deadly form of cancer in dogs.

ONCEPT is the first and only USDA-approved, therapeutic vaccine for the treatment of cancer - in either animals or humans.

Traditionally, dogs with stage II or stage III malignant melanoma survive less than five to six months when treated with surgery alone.1 Clinical studies of ONCEPT demonstrated significantly longer life spans even in dogs with stage II or stage III of oral melanoma. In fact, median survival time of dogs treated with ONCEPT could not be determined because more than 50 percent of the treated dogs were still living melanoma-free at the conclusion of the study or died of unrelated illness.2

Canine oral melanoma is a common type of cancer in dogs and is the most common malignant tumor of the dog's mouth. It can also be seen in the nail and footpad.3 Canine melanoma may be seen in any breed and is a highly aggressive cancer that frequently spreads throughout the body, including the lymph nodes, liver, lungs and kidneys.4 To date, the most common treatments for this form of cancer have been radiation and surgery to establish local tumor control. Canine oral melanoma, however, has a high propensity to metastasize to other parts of the body and is often resistant to chemotherapy.2,3

"Canine melanoma spreads readily, and, unfortunately, existing treatments have not succeeded in controlling the disease," said Dr. Bob Menardi, a veterinarian and spokesperson for Merial. "ONCEPT is a new adjunct treatment option for dogs that have been diagnosed with this often fatal disease."

The vaccine was developed through a partnership between Merial and Memorial Sloan-Kettering Cancer Center. While Memorial Sloan-Kettering was testing a human melanoma vaccine, they received an inquiry from Dr. Philip Bergman - who at the time was with Animal Medical Center, and currently with Brightheart Veterinary Center - seeking novel treatments for canine melanoma. The discussions resulted in clinical trials of the Memorial Sloan-Kettering melanoma vaccine, and subsequent parallel trials by Dr. Bergman and Memorial Sloan-Kettering refined the dosage and protocol to the current therapeutic regimen for dogs. Dr. Bergman completed the initial clinical work on ONCEPT at Animal Medical Center in New York.

"We're very excited about continuing research into this vaccine to explore the potential implications it has for humans. We hope this will result in improved cancer treatment for all," explained Jedd D. Wolchok, MD, PhD, a medical oncologist who specializes in immunotherapy on the Melanoma and Sarcoma Service at Memorial Sloan-Kettering and also Associate Director of the Ludwig Center for Cancer Immunotherapy.

The USDA issued a conditional U.S. Veterinary Biological Product License for ONCEPT in 2007. During the period of conditional licensure, ONCEPT was available to veterinary oncologists as Merial conducted additional research to further support the safety and efficacy of the vaccine.

The results of that research led to the full licensure of ONCEPT. Merial obtained licensing rights from Memorial Sloan-Kettering and Dr. Philip Bergman, and, using their access to and experience with DNA vaccine technology licensed from Vical Incorporated (Nasdaq: VICL), completed the industrialization and regulatory requirements for full licensure. The vaccine will be administered via a Canine Transdermal Device, which delivers the vaccine without the use of a needle.5 The device was developed in conjunction with Bioject, Inc., a Portland-based drug delivery company (OTCBB: BJCT).

"The Canine Transdermal Device makes administration of the vaccine easy and quick for oncologists and their patients, leaving one less worry for dog owners dealing with their pet's cancer treatment" said Dr. Richard Stout, executive vice president and chief medical officer of Bioject. "We are proud to work with Merial in bringing this breakthrough product to market."

"The approval of ONCEPT is a milestone in the cancer vaccine field and a significant advancement for our DNA delivery technology platform," said Vijay B. Samant, Vical's President and Chief Executive Officer. "Therapeutic vaccines - the holy grail of vaccinology - are delivered after disease onset to impede disease progress for the patient's benefit. We believe this achievement is a major step toward the initial approvals of therapeutic vaccines for humans."