Tom Burke died of colon cancer only a few years ago, but not before he helped create a new drug to fight cancer. That drug, currently called DB-67, recently received approval from the FDA for its use to be studied in cancer patients. The Markey Cancer Center at the University of Kentucky Chandler Hospital now has obtained Investigational New Drug status for DB-67 and will conduct the first clinical trials of this drug in cancer patients, which is set to begin later this summer.
Burke, who was a professor at the UK College of Pharmacy, developed the drug with Dennis Curran, a chemistry professor at the University of Pittsburgh. Burke and Curran had worked together to develop the next generation of a class of anticancer drugs that include the currently used drugs topotecan (ovarian and lung cancer) and irinotecan (colon cancer). At the time of DB-67's initial development and testing, pharmaceutical company Novartis licensed the drug. But after Burke died, the company released its licensing of DB-67, leaving the drug with a dismal future.
However, as a pediatric oncologist and director of the Experimental Therapeutics Program at UK HealthCare's Markey Cancer Center, Dr. Jeffrey Moscow believed the drug had a future. With the enthusiastic support of Markey Cancer Center's director Dr. Alfred Cohen, Moscow put together a team of experts to complete all the necessary pre-clinical studies and to assemble the IND application package for the FDA so the drug could be used in a human clinical trial.
"Not many universities or cancer centers develop a new drug to the point of being able to test it in patients," Moscow said. "The UK Markey Cancer Center now has its own new and promising cancer drug."
Moscow said that while DB-67 is in the same class of other cancer-fighting drugs currently used, its structure is a bit different, making it unique and hopefully more potent. Pre-clinical testing of DB-67 showed that more of the drug's anti-cancer properties could be delivered to the body compared to other drugs currently used.
DB-67 will soon be given to patients for the first time during the first of three phases of the clinical development of the drug. The first phase will determine the correct dosage of the drug. It will be open to all adults with any cancer who do not have any other treatment options available. After the appropriate dosage is determined, phase two will be directed toward fighting individual types of cancers, but specifically brain tumors. If DB-67 is found to be as good as or better at fighting a specific type of cancer than currently approved drugs, it will move on to phase three where a much larger number of patients will be randomized to receive the drug so its effectiveness can be further tested.
If this phase is successfully completed, the drug could be granted a license to be prescribed in the treatment of cancer.
Support from the Kentucky Economic Development Commission of the Markey Cancer Center's Experimental Therapeutics Program also helped make possible DB-67's FDA approval and life thus far.
Several other key people involved in the drug's life to date include:
- Brad Anderson, a professor of pharmaceutical sciences and researcher at the UK College of Pharmacy, who volunteered to pick up the pieces of Burke's research when he became ill. Anderson helped complete the pre-clinical evaluation of the drug.
- Dr. Susanne Arnold, an oncologist at the UK Chandler Hospital, who was Burke's treating physician when he had colon cancer. Now as the drugs' phase I study principal investigator, she will be able to lead the research for a drug one of her former patients helped develop.
- Mark Leggas, a researcher at the UK College of Pharmacy, has applied for a federal grant to help pay for the clinical study of DB-67.
- Lori Latus, Burke's wife, also has been an integral part of the approval process. She is a senior staff associate at the UK Markey Center, and uses her background in biology and molecular genetics to help researchers prepare grant and contract applications. Latus used these skills to help put together the FDA application for DB-67 to be used in clinical studies.
The first phase of clinical trials for DB-67 are set to begin in August at the UK Markey Cancer Center.
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