When well-loved theater and television performer Jack Klugman died in December of 2012 at age 90, few people remembered an important role that the actor played in the country's drug development process. Klugman, who had gained television fame as Oscar Madison in The Odd Couple, and later as a medical examiner in the long running series Quincy, was one of the earliest stars to use his celebrity to effectively drive social causes.
In 1982, Klugman went to Washington and testified before Congress on behalf of the Orphan Drug Act. The idea was to provide various governmental supports to encourage pharmaceutical companies to invest in developing drugs for relatively small medical markets. Few people were aware of the need for such support until an episode of Quincy was broadcast in 1981, showing how many people suffered from diseases that went unresearched because they were considered unprofitable. Klugman was called to testify in support of the Act in 1982, and was instrumental in finally getting it passed in 1983.
Since the Act became law some 30 years ago, it has helped support the development of hundreds of drugs, drugs that have gone on to help countless people, and it continues to serve today. Most recently, Advaxis, a developer of immunotherapies for cancer and infectious diseases, applied for Orphan Drug Designation with the FDA Office of Orphan Products Development for the company's ADXS-HPV drug.
ADXS-HPV is being developed for the treatment of human papillomavirus (HPV)-associated head and neck cancer. Although such cancers do not get the publicity or funding associated with more common diseases, it is still estimated that there are 50,000 new cases of head and neck cancer in the U.S. annually, with about 15,000 deaths. Situations such as this are exactly what the law was meant to address. Orphan Drug Designation entitles the sponsor to clinical protocol assistance with the FDA, as well as federal grants, tax credits, and a seven-year market exclusivity period. The new Advaxis drug is good news for sufferers, with the company's Chief Scientific Officer, Robert Petit, saying: "We believe ADXS-HPV could become an important new non-cytotoxic treatment for patients with HPV-associated head and neck cancer."
For additional information, visit Advaxis.com
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