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DT-EGF TOXIC FUSION PROTEIN FOR TREATMENT OF BLADDER CANCER

Award Number: R43CA174011
ORGANIZATION: NATIONAL CANCER INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 09/26/2012
PERIOD OF PERFORMANCE END DATE: 08/31/2013

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DT-EGF TOXIC FUSION PROTEIN FOR TREATMENT OF BLADDER CANCER - DESCRIPTION (provided by applicant): Bladder cancer is the 4th most common cancer in the U.S. Accounting For ~70,000 new cases annually and ~15,000 deaths. Treatment of superficial bladder cancer by resection and BCG administration is unsuccessful in about 40% of cases with recurrences that eventually require cystectomy or other aggressive therapy. Bladder cancers overexpress the epidermal growth factor (EGF) receptor in comparison to normal uroepithelium, providing a target for treatment with EGF-directed toxins. DAB389EGF is a fusion toxin that combines modified diphtheria toxin containing the A-chain and partial B-chain with carboxy terminus replaced with EGF. This protein has proven activity in killing EGF receptor expressing cells, and can be produced in our collaborators' GMP facility. The present grant application will demonstrate 1) that DT--EGF is as effective as BCG in an immunocompetent mouse model in treating orthotopic syngenic tumors, and 2) that DT-EGF can kill orthotopic human bladder cancer implants in an immunocompromised animal. These experiments will provide us the necessary proof-of-principle data to justify pursuit of an IND with the FDA to perform a phase II trial in humans following appropriate toxicology studies. PUBLIC HEALTH RELEVANCE: Bladder cancer is a major public health challenge in the U.S. Accounting for 70,000new cases and 15,000 deaths annually. This project will develop a novel therapy that targets bladder cancer cells for killing by use of a bacterial toxin fused to the EGF receptor which is overexpressed in bladder tumors. By instillation of this agent into the bladders of mice bearing tumors, we will demonstrate that this novel approach can delay or prevent bladder cancer from progressing to its lethal invasive state.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2012 ( Subtotal = $149,040 )
2012	2012	AURORA ONCOLOGY INC	2124 PINEDROP LANE	GOLDEN	CO	80401	JEFFERSON	USA	Cancer Treatment Research	000	1	9/26/2012	NEW	$149,040
														Subtotal = $149,040

Grand Total All Awards = $149,040

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DT-EGF TOXIC FUSION PROTEIN FOR TREATMENT OF BLADDER CANCER

Award Number: R43CA174011

ORGANIZATION: NATIONAL CANCER INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 09/26/2012

PERIOD OF PERFORMANCE END DATE: 08/31/2013

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