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Posted: June 2, 2010
National Cancer Institute seeks to evaluate nanotechnology cancer drugs in large animal studies
(Nanowerk News) The National Cancer Institute (NCI), part of the National Institutes of Health, has established the NCI Alliance for Nanotechnology in Cancer to harness the power of nanotechnology to reduce the burden of cancer. Several, recent developments have demonstrated that improved approaches to therapy can be realized using nanotechnology. The development of new therapies based on localized nanoparticle delivery is of particular interest to oncology due to the potential for delivery of lower doses of the drug or drug candidates with equal or improved efficacy and lowered side effects.
There is a pressing need to enable the testing of nanoscale devices, delivery systems and drug payloads using appropriate animal models for preclinical safety and efficacy testing in GLP certified contract research organizations (CROs), academic institutions or pharmaceutical facilities.
Prior to initial entry of a new drug or biologic agent into humans, the basis for the determination of in vivo safety is the preclinical testing performed in animals. Traditional drug development programs evaluating the safety of small molecule or protein therapeutics, typically conduct toxicology testing in normal animals using a well-defined paradigm to establish the acute, subchronic, and cumulative toxicities of an agent prior to its first exposure in large animals and eventually in humans. The advantages of this approach include:
testing a wide range of doses
investigating multiples of the expected human exposure;
Evaluating the mechanism of action and efficiency of binding of the device/therapeutic payload with the desired target
understanding the metabolism and disposition profiles in a different species
establish a basis for comparison for clinical dosing and the background incidence of any specific, adverse finding
provide well-documented efficacy data in the particular strain of animals being tested (deployed as the first of two animal species that need to be used for the initial demonstration of safety)
Note: for the purposes of filing IND (Investigational New Drug) application with FDA, typically testing in both rodents (i.e. mice, rats, or hamsters), and one non-rodent species (e.g. dog, pig, or non-human primate) is required. The use of more than one species in traditional drug evaluation programs is generally encouraged, to increase the chance of detecting any toxicity to be monitored during Phase 1 and 2 human clinical trials.
The purpose of this subcontract is to identify and evaluate the clinical potential of candidate targeted nanotherapeutics which has shown promise in small animal models for subsequent efficacy and toxicity testing in large animal models. It is expected that data gathered under this subcontract will enable filing of Investigational New Drug (IND) applications with the US-FDA.
Solicitation Number: S10-155
Response Date: Jun 29, 2010 3:00 pm Eastern
ALL INTERESTED OFFERORS ARE TO CONTACT MATT DESANTIS AT DESANTISMA@MAIL.NIH.GOV AND REQUEST THE APPROPRIATE RFP TYPE FOR THEIR ORGANIZATION: TIME & MATERIALS OR COST REIMBURSEMENT.