Marking an important milestone in the development of new cancer treatments, officials from the KU Cancer Center announced the opening of a Phase I clinical trial using a new ovarian cancer drug developed by KU researchers.

The drug, Nanotax, is the reformulation of a commonly used chemotherapy drug, Paclitaxel. Negative side effects associated with Paclitaxel are attributed to the solvent that it is mixed with in order to be administered to patients.

Bala Subramaniam, distinguished professor of chemical and petroleum engineering, Valentino Stella, distinguished professor of pharmaceutical chemistry and co-leader of the KU Cancer Center’s Drug Discovery and Experimental Therapeutics Research Program, and Roger Rajewski, director of the Biotechnology, Innovation and Optimization Center at KU developed technology that broke Paclitaxel down into a nanoparticle form. This reformulation allows it to be mixed with water and then administered to patients in the abdomen, an innovative approach for delivery that KU researchers believe dramatically boosts survival rates, compared to the drug being delivered intravenously.

“Though Paclitaxel is an effective drug, its side effects are incredibly difficult for patients,” said Roy Jensen, director of the KU Cancer Center. “By removing the source of the negative side effects, we believe Nanotax will be a less toxic treatment.”

The technology developed by researchers at KU was licensed to CritiTech, Inc., a Lawrence-based biotechnology firm, who filed the new drug application with the Food and Drug Administration (FDA). Collaborating with CritiTech, researchers at KU formulated the drug and developed the clinical trial that will take place at the KU Hospital’s Cancer Center and Medical Pavilion. Kathy Roby, associate professor of anatomy and cell biology at the KU Medical Center and member of the KU Cancer Center, tested Nanotax in mice. The mouse studies indicated the new delivery method allows the drug to stay in the abdomen where the cancer has spread, rather than be absorbed throughout the body.

Nanotax represents the first KU “bench to bedside” drug, meaning it was discovered and tested by KU scientists and is now being taken into a clinical trial with patients at the KU Cancer Center. This marks an important achievement toward meeting key criteria for obtaining National Cancer Institute (NCI) designation.

“With the discovery, development and clinical trial of Nanotax, we move closer to our goal of being the No. 1 academic producer of anti-cancer drugs and in our effort to obtain NCI designation for this region,” said Dr. Jensen. “Ultimately, we want to offer more cancer treatment options for patients closer to home.”

The American Cancer Society estimates that 15,520 deaths will occur in 2008 from ovarian cancer, which causes more deaths than any other cancer of the reproductive system. Only 19 percent of ovarian cancer cases are detected early.

The Nanotax clinical trial offers an additional option for ovarian cancer patients who have limited choices for treatment. The trial will enroll a very small number of patients.