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TVAX gets OK for human trial of brain-cancer therapy


Al Musella's Comments: (This is his personal views and are not necessarily the views of the Musella Foundation!)



Website: http://kansascity.bizjournals.com/kansascity/stories/2007/02/26/daily4.html

Posted on: 03/04/2007

TVAX gets OK for human trial of brain-cancer therapy

Kansas City Business Journal - 10:44 AM CST Monday, February 26, 2007

TVAX Biomedical has received authorization from the Food and Drug Administration to begin a large-scale human trial to test a new immunotherapy for brain cancer.

A Lenexa-based biotechnology company, TVAX will enroll patients after it has obtained financing for the clinical trial, the company said in a release Monday.

The company's immunotherapy technique was developed by Gary Wood, a former cancer researcher at the University of Kansas Medical Center, where he developed the treatment and performed initial patient trials.

Wood said in an e-mail that the company seeks $10 million to finance the clinical trial. He left academics to start TVAX and commercialize the therapy.

Brain cancer was chosen as the first target for the therapy because studies in experimental animals and initial human clinical trials, which tested the treatment on very advanced brain cancers, "demonstrated that our approach was both safe and effective," Wood said in the release.

The American Cancer Society estimates that there were about 18,000 new cases and roughly 12,000 deaths from primary brain cancer in the United States in 2006.

TVAX immunotherapy combines the resources of the patient's immune system with proprietary manufacturing processes to produce large numbers of what immunologists call "cytotoxic T cells" for reinfusion into the patient. Also called "killer" T cells, they target the patient's cancer cells for destruction, the company said in the release.

Using the circulation system, the cells are able to travel to sites of cancer growth, kill cancer cells and leave normal tissue unharmed.

"There is an overwhelming need for safer and more effective cancer treatments," Wood said in the release. "Immunologists have been trying without success to manipulate the immune system to treat cancer since the immune system was discovered at the end of the 19th century."

Large-scale human, or Phase III, clinical trials represent the final stage of testing to determine how safe and effective a new drug or biological product could be against a specific type of cancer. The FDA uses the data from phase III trials to decide whether a new treatment is sufficiently safe and effective to be made available for widespread public use.

"Our next round of funding is aimed at allowing us to enroll patients with newly diagnosed grade III and grade IV astrocytoma, both deadly forms of brain cancer," Wood said in the release.

TVAX also has filed an application with the FDA to perform a phase III trial to test the TVAX treatment in kidney cancer. The American Cancer Society estimates that there were about 40,000 new cases and about 13,000 deaths from kidney cancer in the United States in 2006.




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