SITIS Archives - Topic Details
Program:  SBIR
Topic Num:  A11-122 (Army)
Title:  Therapy for Secondary Lymphedema
Research & Technical Areas:  Biomedical

Acquisition Program:  Office of the Principal Assistant for Acquisition
  Objective:  Develop an innovative, curative treatment for secondary lymphedema that will restore the function of the lymphatic vessel system.
  Description:  Secondary lymphedema is a condition in which blockage or damage to the lymphatic drainage system leads to the retention and build-up of lymphatic fluid in the surrounding tissue. The most common cause of lymphedema in the United States is the surgical removal of part of the lymphatic system in cancer patients, most significantly in breast cancer patients. Chemotherapy and radiation therapy in breast cancer patients can also damage the function of lymph nodes, leading to lymphedema. There are approximately 2.4 million breast cancer survivors in the United States, and each year, about 240,000 women are diagnosed with breast cancer. A recent prospective study found that 42% of breast cancer survivors developed secondary lymphedema within 5 years of their treatment. Other causes of secondary lymphedema include trauma from burns, surgery, and physical injuries, as well as parasitic infection. Filariasis, a parasitic insect-transmitted infection that is prevalent in tropical regions, is the most common cause of secondary lymphedema internationally. Lymphedema in filariasis infection can progress to a debilitating condition known as elephantiasis. There is no cure for lymphedema. Quality of life for individuals with lymphedema is diminished. Although lymphedema may be temporary in some cases, chronic lymphedema is an irreversible, debilitating, and lifelong condition that can cause pain and discomfort, disfigurement, skin damage, limb impairments, fibrosis, and recurring risk of infection in the affected tissue. Current treatment options are limited to palliative approaches, including compression sleeves, massage, skin care, bandage wrapping, and exercise. This topic is seeking to develop a curative therapy for lymphedema that will restore lymph drainage in the affected tissue using a minimally invasive approach. The therapeutic strategy should include a delivery system that will be localized only to the affected tissue and will minimize adverse effects on distal lymphatic function.

  PHASE I: Phase I work will conceptualize the strategy, develop the prototype therapy, and design a plan for preliminary testing in an in vitro or phantom system. This phase will result in proof-of-feasibility of a therapy for lymphedema.
  PHASE II: Based on Phase I results, Phase II work will demonstrate, optimize and validate the therapeutic strategy in in vitro or phantom models. Parameters including optimal concentrations, biological activity, and toxicity will be defined. Appropriate controls will be used. The therapy will then be tested in animal models of secondary lymphedema. Validation of curative success will include demonstration of the regression or resolution of lymphedema symptoms in the animal models.

  PHASE III: A successful Phase III project will result in a minimally invasive therapeutic modality that restores lymphatic function in secondary lymphedema. During Phase III, additional experiments will be performed in animal models as necessary to prepare for FDA review of an IND application. A plan for protection of intellectual property should be created and executed. A detailed market analysis will be conducted, an initial application for the therapeutic selected, and a Phase I clinical trial initiated. Military application: The therapeutic will be available to service women and men who suffer from lymphedema caused by: treatments for breast or other cancers; burn or other combat- or service-related traumas; and/or infection with filariasis as a result of their deployment in tropical regions. Commercial application: Health professionals worldwide could utilize this therapeutic to treat cancer, trauma, and filariasis patients who suffer from secondary lymphedema.

  References:  ) Fu MR, Ridner SH, and Armer J. 2009. Lymphedema: Post-breast cancer, Part 1. Amer J Nursing. 109(7): 48-54. 2) Norman SA, Localio AR, Potashnik SL, Simoes Torpey HA, Kallan MJ, Weber AL, Miller LT, DeMichele A, and Solin LJ. 2008. Lymphedema in breast cancer survivors: incidence, degree, time course, treatment, and symptoms. J Clin Oncol. 27:390-397. 3) Tammela T and Alitalo K. 2010. Lymphangiogenesis: molecular mechanisms and future promise. Cell. 140:460-476. 4) Leggat PA and Melrose W. 2005. Lymphatic filariasis: disease outbreaks in military deployments from World War II. Mil Med. 170:585-589.

Keywords:  secondary lymphedema, lymphangiogenesis, therapeutic, breast cancer, filariasis, elephantiasis, trauma

Questions and Answers:
Q: Additional information from TPOC to clarify requirements for topic A11-122:
As long as the overall goals/results of the topic are met, applicants can propose a technical approach that is different than the approach suggested in the topic solicitation. It is recommended that the applicant explain how the proposed technical approach would yield the appropriate outcomes and conclusions for Phase I.
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Q: How many meetings will be required (kickoff, final report presentation, any others) for this proposal and in what city+state will the meetings be for this project?
A: There are no required meetings that must take place face to face. There is usually a kick-off meeting that is held between the Contracting Officer's Representative and the small business to introduce yourselves and talk about the direction of the project, but that can be done over the phone.

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