Official websites use .gov

A .gov website belongs to an official government organization in the United States.

Secure .gov websites use HTTPS

A lock ( 🔒 ) or https:// means you've safely connected to the .gov website. Share sensitive information only on official, secure websites.

Need Help

A Pilot/Supportive Study of RC-2Beta to be Used in the Treatment of Canine Lympho

Award Number: R01FD005039
ORGANIZATION: FOOD AND DRUG ADMINISTRATION
OPDIV: FDA
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/01/2014
PERIOD OF PERFORMANCE END DATE: 01/31/2018

Group Awards By:

View Award Description

A Pilot/Supportive Study of RC-2Beta to be Used in the Treatment of Canine Lympho - Project Summary/Abstract Study Title: A Pilot/Supportive Study of RC-2¿ to be Used in the Treatment of Canine Lymphoma Experimental Design: This is an exploratory study designed as a prospective, open label, single site, single arm, clinical field study. Objectives/Purpose of study: The purpose of this clinical trial is to determine the safety and efficacy of the drug, RC-2¿, in client-owned canines na¿ve or relapsed Stage II-V lymphoma. Client owned dogs meeting the enrollment/eligibility criteria will be recruited from the cases presented to the Texas A M Veterinary Oncology Service. All dogs must have progressive disease upon entry into the study. The primary efficacy variable will be the time to tumor progression (TTP). Other variables recorded and reported include ORR (overall response rate- partial remission or better), the disease control rate (stable disease or better), and the duration of response (DOR). Variables will be reported separately for na¿ve versus relapsed patients. The secondary objective is to determine the tolerability of the drug over a 3-month period in all dogs by recording and reporting in a real time fashion any adverse events. Study Site: Texas A M University, College of Veterinary Medicine, Small Animal Clinical Sciences Study Dogs: A minimum of 15 client owned dogs with newly diagnosed or first relapse stage II - IV lymphoma will be enrolled in this study. Dogs must meet all eligibility criteria and no exclusion criteria. Justification: Lymphoma is the most common malignancy diagnosed in canines representing up to 24% of all neoplasms seen in dogs. This disease is almost inevitably fatal with the median survival time for dogs receiving aggressive combination chemotherapy at 12 months. New therapeutic approaches, such as RC-2¿, are desperately needed to improve upon current disease outcomes. Study Standards and Ethics: This study protocol will be reviewed by the Institutional Animal Care and Use Committee at TAMU. Absolute compliance with this committee and its suggestions will be met before, during and after the study is performed. Written informed client consent will be obtained from each enrolled dog's owner before the dog can be enrolled. The welfare, treatment and care of the study animals will be ensured by the veterinary staff at the TAMU CVM Small Animal Clinic


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: 2022 ( Subtotal = -$75,000 )
2022	2014	OGENX THERAPEUTICS CORPORATION	1290 GULF BLVD STE 1201	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	7/7/2022	NEW	-$75,000
														Subtotal = -$75,000

Issue Date FY: 2019 ( Subtotal = -$75,000 )
2019	2014	OGENX THERAPEUTICS CORPORATION	1290 GULF BLVD STE 1201	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	3/26/2019	NEW	-$75,000
														Subtotal = -$75,000

Issue Date FY: 2017 ( Subtotal = $0 )
2017	2014	OGENX THERAPEUTICS CORPORATION	1290 GULF BLVD STE 1201	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	2/23/2017	NEW	$0
														Subtotal = $0

Issue Date FY: 2016 ( Subtotal = $0 )
2016	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	2/5/2016	NEW	$0
2016	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	001	1	7/20/2016	NEW	$0
														Subtotal = $0

Issue Date FY: 2015 ( Subtotal = $0 )
2015	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	3/25/2015	NEW	$0
														Subtotal = $0

Issue Date FY: 2014 ( Subtotal = $75,000 )
2014	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	001	1	5/20/2014	NEW	$0
2014	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	002	1	5/22/2014	NEW	$0
2014	2014	Ogenx Therapeutics Corporation	1290 Gulf Blvd.	CLEARWATER	FL	33767	PINELLAS	USA	Food and Drug Administration Research	000	1	1/30/2014	NEW	$75,000
														Subtotal = $75,000

Grand Total All Awards = -$75,000

Top

All Categories

About

Search

Reports

Data Submission

Award Information

A Pilot/Supportive Study of RC-2Beta to be Used in the Treatment of Canine Lympho

Award Number: R01FD005039

ORGANIZATION: FOOD AND DRUG ADMINISTRATION

OPDIV: FDA

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 02/01/2014

PERIOD OF PERFORMANCE END DATE: 01/31/2018

Federal Websites

Department of Health & Human Services

HHS Operating Divisions

HHS Staff Divisions

Download A Document Viewer