Preclinical Studies of Natural Product Derivatives as Antimalarial Agents

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$998,181.00
Award Year:
2011
Program:
SBIR
Phase:
Phase II
Contract:
2R44AI077109-03
Award Id:
n/a
Agency Tracking Number:
R44AI077109
Solicitation Year:
2011
Solicitation Topic Code:
NIAID
Solicitation Number:
PA10-123
Small Business Information
13303 Sunny Brooke Place, Room 101, Potomac, MD, -
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
142006910
Principal Investigator:
SHUREN ZHU
(301) 675-3714
shuren.zhu@gmail.com
Business Contact:
SHUREN XHU
(301) 675-3714
shuren.zhu@gmail.com
Research Institute:
Stub




Abstract
DESCRIPTION (provided by applicant): This project focuses on the development of a novel therapeutic agent for preventing and treating P. falciparum malaria. A two-year Phase I research has discovered novel molecules with potent antimalarial activity against both sensitive and resistant malaria strains in rodent models. Lead compounds are low in toxicity and possess high oral bioavailability and other ideal ADMET properties. The potential for development of resistance was confirmed to be small and a scalablechemical synthesis was also established. After pre-IND meeting with FDA, the proposed SBIR Phase II research was designed. Under Phase II support, we will perform: (I) Scale up synthesis of two lead compounds and cGMP manufacturing of one compound for GLPtoxicity studies; (II) Range-finding toxicity and pharmacokinetics in monkeys; (III) Repeat dose toxicity in monkeys; (IV) Antimalarial activity in Aotus monkeys infected with P. falciparum; (V) GLP toxicology studies: definitive 28-day toxicity study with toxicokinetic, functional observations battery and micronucleus evaluations. An investigational new drug (IND) application will be filed with FDA at the end of Phase II research. The novelty of the project is the discovery of new molecular entities. Theproject involves standard approaches to drug development, but the multidisciplinary team and multi-institution collaboration that has been assembled will accelerate the generation of clinical candidates. PUBLIC HEALTH RELEVANCE: Malaria is one of the most common infectious diseases in the world. It affects approximately 250 million people and leads to 1-3 million death a year. The increasing prevalence of multiple drug resistant strains in most malaria endemic areas has significantly reduced the efficacy of current antimalarial drugs for prophylaxis and treatment of this disease. This project focuses on the development of a novel therapeutic agent for preventing and treating P. falciparum malaria. The novelty of the research is the discovery of new molecular entities. The multidisciplinary team and multi-institution collaboration that has been assembled will accelerate the generation of clinical candidates.

* information listed above is at the time of submission.

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