SBIR/STTR Research Award

Preclinical and Clinical Evaluation of Humanized NM9405

Award identifier 3617f42d8aac8af63c91e11dfd505b90b1ed18789b5e1750a19174f7c8bb77c9Awarding agency Department of Health and Human Services · National Institutes of Health

Award amount

$467,832

Program and phase

SBIR · Phase I

Award year

2014

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Award details

Awarding agency
Department of Health and Human Services
Branch
National Institutes of Health
Recipient company
Novelmed Therapeutics Inc
Proposal award date
Not reported
Contract end date
Not reported
UEI
D5B7ANZ8LE45
Solicitation number
PA13-088
Topic code
NHLBI

Research abstract

ABSTRACT NovelMed has developed an anti-properdin antibody (hNM9405) for the treatment of intra and extravascular lysis in paroxysmal nocturnal hemoglobinuria (PNH). The selection of this antibody was based on positive results obtained from in vitro, ex vivo, in vivo, and PK/PD studies in rabbits and primates. These strong positive results have provided a firm foundation for initiation of our Phase I clinical trial. Our lead drug candidate is indicated for PNH, an orphan disease, and aims to fill an urgent need for this devastating condition. With this application, NovelMed is proposing to conduct Investigational New Drug (IND) enabling studies for its lead drug candidate. In PNH, red blood cells (RBCs) are attacked by the body's own complement activationproducts causing significant cell lysis. RBC lysis increases the levels of hemolglobin and lactate dehydrogenase (LDH) in the circulating blood. Elevated levels of these compounds cause further damage to multiple organs, ultimately risking total organ failu

Technology keywords

Not reported

Other awards by this recipient

Verified by the same UEI. These are other public SBIR/STTR award pages, not a merged company record.

Awards with the same topic code

Verified by an exact topic code match. This is not a text-similarity match.

Research funding history

29 SBIR/STTR records share this UEI (2003–2021). Reported award amounts total $19,981,617. Reported amounts are not federal obligations.

Phases: Phase I, Phase II

Agencies: Department of Health and Human Services

Agency intelligence

Department of Health and Human Services

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