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276 Development of Novel Medicinal Food Products for the Mitigation of the Side-Effects of Cancer Chemotherapy

Number of anticipated awards: 2

(Fast-Track proposals will NOT be accepted. Phase II information is provided only for informational purposes to assist Phase I proposers with their long-term strategic planning.)

Budget (total costs): Phase I: $150,000;
Phase II: $1,500,000

(Note: It is strongly suggested that Proposals adhere to the above budget amounts. Proposals with budgets exceeding the above amounts may not be funded. Phase I project periods may last a maximum of 9 months.)

The deadline for receipt of all contract proposals submitted in response to this solicitation is: November 9, 2009.

About 1,479,350 new cancer cases are expected to be diagnosed in 2009. Many of these patients will be treated with one form or another of chemotherapy; however, side effects are common, as chemotherapeutic agents also affect healthy cells, including those of the digestive tract, hair, and bone marrow leading to nausea, vomiting, hair loss, and fatigue. Indeed, it is the cumulative damage to multiple systems caused by chemotherapy that can limit the dose, frequency, and in many cases the efficacy of the therapy. Although serotonin receptor antagonists are currently being used as antiemetics, the more severe side-effects of chemotherapy such as neutropenia, thrombocytopenia, and neurotoxicity remain problematic. Thus, there remains a need to develop new modalities for the mitigation of chemotherapy side-effects. Recent studies have demonstrated that short-term caloric restriction and down regulation of insulin-like growth factor signaling can differentially protect normal cells, but not cancer cells, against oxidative stress and high doses of chemotherapeutic agents. These observations suggest that novel modalities that mimic short-term caloric restriction, including substitution of glucose with other carbon sources, can be used to protect cancer patients against the side-effects of chemotherapy. As such, the overall goal of this SBIR contract topic is to support small businesses to develop novel modalities for the treatment of the side effects of cancer chemotherapy.

Project Goals:
The aim of this project is to stimulate the development of novel modalities, including medical foods containing specific combinations of carbon sources, vitamins and minerals as well as sugar and amino acid substitutes that mimic the short-term caloric restriction, and thus differentially protect normal cells against chemotherapeutic agents while providing the necessary nourishment to patients.

Phase I activities and expected deliverables:
  • Develop of one or more medical food products with the potential to protect patients against multiple side effects caused by widely used chemotherapeutic drugs.
  • Offerors should provide compelling clinical or pre-clinical data supporting the development of the proposed products, as well as proof that the products do not enhance the survival of cancer cells.
  • Phase I efforts should include animal studies aimed at demonstrating a statistically significant increase in the therapeutic index of a commonly used chemotherapeutic drug (e.g. 5-fluorouracil, cisplatin, etc) as a result of the administration of the medical food product.
  • The plan for the development of the product should be formulated in consultation with NCI.

Phase II activities and expected deliverables:
  • Complete the development of the medical food product for the differential protection of normal cells in cancer patients receiving chemotherapy.
  • Perform animal studies demonstrating utility of the medical food product for protection against the toxicity of several other commonly used chemotherapeutic regimens.
  • Appropriate preclinical data should be accumulated that support a Phase I clinical trial.
  • Perform human studies to determine safety.
  • Provide NCI with updates on a comprehensive IP and development plan, outlining how the small business will develop and commercialize the product.

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