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Vaccines for head-neck cancers get 'orphan' designation

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SUNCOAST NEWS STAFF REPORT

The Tampa Tribune

Published: April 15, 2009

Two therapeutic vaccines researchers at the University of Maryland developed to target hard-to-cure head and neck cancers have received "orphan drug" approval from the U.S. Food and Drug Administration.

The designation will give the firm that licensed the rights to the investigational drugs certain tax advantages and marketing incentives under the federal government's Orphan Drug Act of 1983.

The act was passed to encourage development of medicines that fight conditions known as "orphan diseases," which often attracted little attention from researchers and pharmaceutical companies because of their relatively low rate of occurrence.

The two vaccines now carrying the orphan designation were developed by a team led by Dr. Scott Strome, a professor at the University of Maryland School of Medicine. The team was following up on work Strome did when he was at the Mayo Clinic.

The vaccines were designed to boost the immune systems of head and neck cancer patients by targeting molecular substances known as antigens that are particular to certain forms of head and neck cancers.

Overall, more than 200,000 people in the country are affected by head and neck cancers, which would make drugs targeting them ineligible for the orphan designation. The two vaccines Strome and his colleagues developed, however, target antigens that are found in the head and neck cancer cells of a much smaller group of patients.

Drugs that attack diseases with such specificity have been designated "personalized" medicines. The antigens they target are known as MAGE-A3 or HPV-16.

Both Strome and Dr. David Block, co-founder, president and CEO of Gliknik Inc., the firm that has licensed the two vaccines, say they hope the medicines will accelerate the long-stalled progress in treating head and neck cancers.

"The survival of head and neck cancer patients has not really improved in 30 years," says Strome.

Head and neck cancers are different from malignant brain tumors. They include cancers of the tongue, tonsils, nasal cavity, sinuses, lips, mouth, salivary glands, throat, and larynx.

"Advanced head and neck cancer is a challenging disease with limited treatment options," Block says. "Even with chemotherapy, radiation, and surgery, people with advanced head and neck cancer may have a limited life expectancy of six to eight months."

Block believes the new vaccines have a reasonable chance to help some patients where others have failed. The FDA based its orphan drug determination on the vaccines in part based on the encouraging signs of possible success they showed on pilot studies conducted in 2006 and 2007.

A clinical trail to determine the most effective dose of the vaccines in fighting head and neck cancers has been under way since July of last year at the University of Maryland's Marlene and Stewart Greenebaum Cancer Center.

The trial is being funded with a grant from the National Institute of Dental and Craniofacial Research, a part of the National Institutes of Health.

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