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241 Multifunctional Therapeutics Based on Nanotechnology

Number of anticipated awards: 3-5
(Fast-Track proposals will be accepted.)
Budget (total costs): Phase I: $150,000;
Phase II: $1,000,000

The deadline for receipt of all contract proposals submitted in response to this solicitation was:
5:00 p.m. Eastern Standard Time
Monday, November 6, 2006

The goal of this project is to develop nanodevice-based therapeutic delivery vehicles for high efficacy, low side effects therapies.

Nanoscale devices carrying therapeutic payloads and delivered to a close proximity of tumor in vivo can play a significant role in increasing the effectiveness of the treatment while decreasing severity of side effects. Such techniques would be highly relevant, particularly, for organs that are difficult to access because of a variety of biological barriers, including those developed by tumors. For example, nanoparticles are capable of crossing the blood-brain barrier due to their small size and thus are an excellent candidate for non-invasive treatment of brain tumors. Multifunctional nanoscale devices also offer the opportunity to utilize new approaches to therapy, such as localized heating or reactive oxygen generation, and to combine a diagnostic or imaging agent with a therapeutic and even a reporter of therapeutic efficacy in the same nanodevice package.

In conjunction with the development of these devices, local targeting techniques emerge. This process can utilize epitopes expressed on specific signatures of tumor cells or other cellular markers of biological processes such as angiogenic and apoptotic pathways. In molecular oncology, this is more intriguing and potentially useful as a general approach since it allows for targeting of multiple cancers or even more broadly for targeting of multiple diseases. For instance, there are already examples of multi-functional nanoparticles that target vascular peptides, growth factor receptors, transmembrane proteins such as ion channels, and are utilized for both cancer and cardiovascular disease recognition.

The development of an appropriate nanoparticle platform with specific particle size, its physical property providing for particular optical, magnetic, or electrochemical signature, target-specific surface chemistry, and ability to carry the therapeutic payload would lead to the ultimate multi-functional 'find-detect-kill' platforms with superior efficacy.

The goal of this program is to demonstrate in vivo nanodevice-based delivery platform. These devices can take, for example, the form of multi-functional nanoparticles or multi-chamber chips carrying encapsulated drugs. The devices can be administered orally, intravenously, or can be implanted. Two different tracks of technologies will be considered.

TRACK I would focus on discovery and demonstration of novel delivery platform concepts involving, among others:

  • novel nanodevices
  • novel tumor targeting and concentrations schemes
  • novel drug loading and releasing schemes
  • schemes enabling crossing the blood-brain barrier.

Phase I Activities and expected deliverables:

  • Fabrication technique resulting in the manufacturing of nanodevices with good reproducibility should be developed. The novel use of existing particles acquired from the commercial manufacturer will be also considered under this program.
  • in vitro (cell culture) demonstration of drug efficacy

Phase II Activities and expected deliverables:

  • Demonstration of targeting (multiple biomarkers) and concentration techniques for a specific organ/disease
  • in vivo small animal drug efficacy demonstration (at least 60 day study with statistically relevant number of animals)

TRACK II would involve further development of existing nanodevice platforms that have demonstrated improved therapeutic efficacy in at least one animal model.

Phase I Activities and expected deliverables:

  • Nanodevice manufacturing and scale-up activities
  • Additional small animal studies showing improved therapeutic efficacy over non-targeted nanodevices

Phase II Activities and expected deliverables:

  • Long term toxicity studies (biodistribution and bioelimination for IV administered nanodevices and biocompatibility for implanted devices)
  • IND-enabling studies carried out in a suitable pre-clinical environment
  • Initiation of large animal studies

Fast-Track justification:

While not necessary for all grantees, there are specific situations where fast-track funding would be appropriate. Fast-track combines Phase I and Phase II projects into one submission and allows for a faster transition between the phases. If there is a significant amount of preliminary data, or proof of concept demonstration already exists, this approach may result in a faster rate of technology development. A fast-track application requires inclusion of quantitative and specific deliverables in the Phase I portion of the application.

Before Phase II funding is awarded, a progress report towards meeting of the Phase I milestones must be received. Only upon successful evaluation of this report by the program manager will Phase II funding be approved.

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