Award Information
Agency: Department of Health and Human Services
Branch: N/A
Contract: N/A
Agency Tracking Number: 2R44CA083443-02
Amount: $386,951.00
Phase: Phase II
Program: SBIR
Awards Year: 2001
Solicitation Year: N/A
Solicitation Topic Code: N/A
Solicitation Number: N/A
Small Business Information
2625 N LOOP DR, STE 2150, AMES, IA, 50010
HUBZone Owned: N
Woman Owned: N
Socially and Economically Disadvantaged: N
Principal Investigator
 () -
Business Contact
Phone: (515) 296-9916
Research Institution
DESCRIPTION: (Scanned from the applicants description) The American Cancer Society estimates 564,800 Americans will die of cancer this year. Evidence suggests that up to one-third of those deaths are related to malnutrition and cachexia for which there are currently no effective nutritional interventions. Weight loss is a predictor of survival in patients receiving cancer therapy and supplemental nutrition is often indicated in patients undergoing surgery, chemotherapy, or radiation therapy. Phase I research has clearly shown that daily supplementation with HMB/Arg/Gln was effective in preventing and reversing the weight and muscle mass losses in stage IV cancer patients who were undergoing various regimens of chemotherapy. In this Phase II multicenter trial, it is proposed to include a more homogenous group of cancer patients, with diagnoses limited to lung and proximal GI-tract cancers which are notoriously known to result in significant wasting. The proposal will determine if early therapeutic interventions with HMB/Arg/Gln will result in (a) decreasing weight loss, (b) reversing muscle wasting, (c) decreasing protein turnover, (d) decreasing toxicity to chemotherapeutic agents and better adherence to chemotherapeutic regimens, and (e) improving overall feeling of well being. If as expected Phase II results confirm the effectiveness of the nutrient mixture in cancer patients, a product would be marketed for this purpose. PROPOSED COMMERCIAL APPLICATION: Since over 1.2 million cases of cancer are expected to be diagnosed this year alone (American Cancer Society), the market potential for the proposed nutritional product is very large. It is expected that Phase II will continue to support the positive findings of Phase I and that a product containing the nutrient combination in a ready-to-drink formulation would be marketed upon this confirmation. A balanced nutritional product containing high quality protein and other nutrients would likely be developed. It is envisioned that these products will be highly effective over-the-counter and/or prescription nutritional supplements for cancer patients with cachexia to improve quality of life of cancer patients.

* information listed above is at the time of submission.

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