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COMPLEMENT INHIBITORS AS DMOADS

Award Number: R44AG041564
ORGANIZATION: NATIONAL INSTITUTE ON AGING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 08/15/2013
PERIOD OF PERFORMANCE END DATE: 07/31/2014

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COMPLEMENT INHIBITORS AS DMOADS - DESCRIPTION (provided by applicant): Complement system play a role in preventing inflammation and joint immobility. Osteoarthritis (OA), an inflammatory disease of the joints, is quite prevalent among the elderly and causes disability in nearly 10% of the population over 55 years. Current medications only manage the disease and do not cure or halt the disease. The prevalence of OA coupled with the absence of Disease Modifying Osteoarthritis Drugs (DMOADs) heightens the negative impact of this disease on humanity. Recent studies have shown that cytokines are important in the development and progression of OA. It has been hypothesized that neutralizing IL-12 or TNF-1 may provide benefit to OA patients, hence, biologics or drugs that neutralize these cytokines are being investigated. Clinical trials with an anti-TNF-1 antibody are currently ongoing. The alternative pathway (AP) of complement has recently been implicated in the etiology of OA. We have developed a proprietary group of antibodies that selectively target the AP without affecting the host defense mediated via the classical pathway (CP). Our preliminary results suggest that the AP plays an important role in the development and progression of OA and that our target antibody is highly effective in resolving OA as indicated by rabbit models of OA. The current application proposes development of a humanized IgG1 as a potent treatment for halting and arresting the progression of OA in humans. In the Phase I segment, we further test a specific neutralizing anti-complement monoclonal antibody in the young rabbit OA model. In the Phase II segment, we will study the efficacy of the targeted humanized antibody to aged rabbits, evaluate the efficacy of the biologic in multiple modes of administration, and establish protocol for scaled up preparation of the humanized antibody. Our studies will provide new insight into the development of novel therapies for the treatment of OA. Overall, the proposed work is a critical step in the direction of developing a cost-effective, efficacious and safe therapeutic agent for preventing joint damage caused by OA.


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: 2013 ( Subtotal = $386,620 )
2013	2013	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Aging Research	001	2	9/10/2013	SUPPLEMENT FOR EXPANSION	$78,750
2013	2013	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Aging Research	000	2	8/6/2013	EXTENSION WITH OR WITHOUT FUNDS	$307,870
														Subtotal = $386,620

Issue Date FY: 2012 ( Subtotal = $294,766 )
2012	2012	NOVELMED THERAPEUTICS INC	11000 Cedar Ave Ste 135	Cleveland	OH	44106	CUYAHOGA	USA	Aging Research	000	1	7/17/2012	NEW	$294,766
														Subtotal = $294,766

Grand Total All Awards = $681,386

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COMPLEMENT INHIBITORS AS DMOADS

Award Number: R44AG041564

ORGANIZATION: NATIONAL INSTITUTE ON AGING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

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

PERIOD OF PERFORMANCE START DATE: 08/15/2013

PERIOD OF PERFORMANCE END DATE: 07/31/2014

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