Fast-Track proposals will be accepted.
Number of anticipated awards: 2-4
Budget (total costs, per award):
Phase I: $225,000 for 9 months;
Phase II: $1,500,000 for 2 years
It is strongly suggested that proposals adhere to the above budget amounts and project periods. Proposals with budgets exceeding the above amounts and project periods may not be funded.
The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 25, 2013 by 4:30 p.m. ET.
Many promising chemotherapeutic candidates have failed to gain FDA approval due to adverse properties discovered in pre-clinical development or in human clinical trials. Such failures often occur due to unacceptable toxicity, although other limitations may also derail the development of promising anti-cancer agents. Novel drug delivery systems for cancer treatment that carry and deliver therapeutic payloads within close proximity of the tumor in vivo play a significant role in increasing the effectiveness of the treatment while decreasing the severity of toxicities. The successful delivery of well-established chemotherapeutics has been demonstrated previously using a number of platforms; however, such systems provide only incremental improvements in the overall therapeutic index of previously-approved drugs. An even greater opportunity is associated with reformulating once promising chemotherapeutic drugs that either failed to reach clinical trials or failed in clinical development. Among the limitations that reformulation strategies can address are poor oral bioavailability, poor solubility in biological fluids, inappropriate pharmacokinetics, and/or lack of efficacy within a tolerable dose range. To accelerate such efforts, the National Cancer Institute (NCI) requests proposals for the development of commercially-viable platforms for the reformulation of chemotherapeutic drugs that have failed previously in pre-clinical development or in human clinical trials.
The goal of this project is to add new agents to the current arsenal of chemotherapeutic drugs by identifying and evaluating candidate delivery systems to enable the therapeutic potential of drugs that could not otherwise be delivered to humans in free form. The focus of this topic is on the reformulation of small-molecule chemotherapeutic agents. The proposed drug-delivery platform must yield a significant improvement in properties with respect to the free drug in order to enable the re-evaluation of the chemotherapeutic drug as a potential therapy for cancer treatment.
Proposals submitted under this topic must:
The proposed drug-delivery platform/reformulation approach may utilize any technology capable of meeting the stated goals of this contract topic. Examples include the use of multi-functional targeted drug delivery platforms or multi-chamber chips carrying encapsulated drugs, although other approaches will be favorably considered. The final drug formulation may utilize an imaging agent(s) for a combination of therapeutic and diagnostic modalities, in order to provide real-time feedback and monitoring of therapy; however, such “theranostic” approaches are NOT required. Acceptable technologies/approaches under this contract may include, but are not necessarily limited to:
Please note that the following approaches are NOT acceptable under this contract topic: