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SAFETY OF ADENOSINE A2A AGONIST FOR TREATMENT OF SEPSIS

Award Number: R41AI063671
ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2006
PERIOD OF PERFORMANCE END DATE: 06/30/2010

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SAFETY OF ADENOSINE A2A AGONIST FOR TREATMENT OF SEPSIS - DESCRIPTION (provided by applicant): ATL146e is a synthetic small molecule developed by Adenosine Therapeutics, LLC (ATL) that acts as a selective agonist of the adenosine A2A receptor. ATL146e, sterile solution for intravenous (i.v.) bolus injection, is currently in Phase III of clinical development for use as a coronary vasodilator in pharmacodynamic stress imaging. ATL146e, when administered parenterally (intravenously, i.v.; intraperitoneally, i.p.; or subcutaneously s.c.) at much lower levels of systemic exposure (below those that elicit cardiovascular effects) exerts potent anti-inflammatory/tissue protective effects in sepsis and multiple other models of acute inflammation. Based upon its established nonclinical and clinical safety, ATL is rapidly advancing development of ATL146e for the treatment of sepsis. Accordingly, we are applying for an SBIR advanced technology grant to complete the following specific aims: 1) complete required toxicity testing for ATL146e in a second animal species to demonstrate that ATL146e is equally safe when administered as a continuous i.v. infusion compared to its administration as an i.v. bolus and 2) conduct additional pharmacodynamic testing with both ATL146e and ATL's identified lead backup compound, ATL313, in clinically-relevant mouse and rabbit models of sepsis: cecal ligation-puncture model (CLP) of polymicrobial bacteremia in mice and rabbits; and fungemia model (Candida albicans) in mice. The rationale for conduct of the additionally proposed pharmacological studies include: 1) establishment of benefit of ATL146e and ATL313 in clinically-relevant, polymicrobial models of septicemia 2) demonstrate that protective effects are not species specific (i.e. demonstrable protective effects in second nonrodent species (rabbit CLP moldel); 3) expansion of potential for use in septicemia induced by fungal infections; 4) identification of relevant cytokines that could serve as surrogate markers for monitoring clinical benefit of treatment. Since research shows that mechanisms for protection against sepsis-induced mortality by ATL146e and ATL313 relate to their broad-spectrum anti-inflammatory properties, the research proposed in this grant has direct relevance to the Small Business Bio-defense program of the National Institute for Allergy and Infectious Diseases (NIAID).


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: 2009 ( Subtotal = $0 )
2009	2007	ADENOSINE THERAPEUTICS, LLC	PO BOX 4632	CHARLOTTESVILLE	VA	22905	CHARLOTTESVILLE CITY	USA	Allergy and Infectious Diseases Research	000	2	7/1/2009	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2007 ( Subtotal = $415,035 )
2007	2007	ADENOSINE THERAPEUTICS, LLC	PO BOX 4632	CHARLOTTESVILLE	VA	22905	CHARLOTTESVILLE CITY	USA	Allergy and Infectious Diseases Research	000	2	7/12/2007	NON-COMPETING CONTINUATION	$415,035
														Subtotal = $415,035

Issue Date FY: 2006 ( Subtotal = $861,737 )
2006	2006	ADENOSINE THERAPEUTICS, LLC	PO BOX 4632	CHARLOTTESVILLE	VA	22905	CHARLOTTESVILLE CITY	USA	Allergy and Infectious Diseases Research	000	1	6/16/2006	NEW	$861,737
														Subtotal = $861,737

Grand Total All Awards = $1,276,772

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SAFETY OF ADENOSINE A2A AGONIST FOR TREATMENT OF SEPSIS

Award Number: R41AI063671

ORGANIZATION: NATIONAL INSTITUTE OF ALLERGY & INFECTIOUS DISEASES

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 07/01/2006

PERIOD OF PERFORMANCE END DATE: 06/30/2010

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