Fast-Track proposals will be accepted.
Number of Anticipated Awards: 2-3
Budget (total costs, per award):
Phase I: up to $300,000 for up to 9 months
Phase II: up to $2,000,000 for up to 2 years
PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED.
Cachexia is characterized by a dramatic loss of skeletal muscle and adipose tissue mass, which cannot be reversed by nutritional intervention. More than half of all cancer patients experience cachexia, and it is estimated that nearly one-third of cancer deaths can be attributed to cachexia. Patients suffering from cachexia are often so frail and weak that walking can be extremely difficult. Cachexia occurs in many cancers, usually at the advanced stages of disease. Cancer cachexia is most prevalent in gastric, pancreatic, and esophageal cancer (80%), followed by head and neck cancer (70%), and lung, colorectal, and prostate cancer (60%). Despite cachexia's impact on mortality and data strongly suggesting that it hinders treatment responses and patients' abilities to tolerate treatment, no effective therapies have been developed to prevent or hamper its progression. Even for patients able to eat—appetite suppression or anorexia is a common cachexia symptom—improved nutrition often offers no respite. Overall, cachexia is characterized into three prominent stages, namely pre-cachexia, cachexia, and refractory cachexia. Pre-cachexia is characterized by some metabolic and endocrine changes, but weight loss is minimal. In cachexia, the patient undergoes more prominent weight loss, anorexia, muscle mass depletion, and reduced muscle strength. At this point, weight loss can be somewhat countered by health supplements and corticosteroids, but improved muscle function has not been achieved. In refractory cachexia, there is severe body weight, muscle, and fat loss; the reversal of weight loss is negligible even with the dietary supplements.
Over the last few years, researchers have begun to better understand the underlying biology of cancer- and cancer therapy-related cachexia. Findings from several studies point to potential therapeutic approaches, and a number of clinical trials of investigational drugs and drugs approved for other uses have been conducted or are under way. For recent research on the biological pathways involved in cachexia, please refer to Abstracts from the 3rd Cancer Cachexia Conference published J Cachexia Sarcopenia Muscle. 2017 Feb; 8(1): 145–160. Published online 2017 Feb 27. doi: 10.1002/jcsm.12186.
The goal of this SBIR contract solicitation is to provide support for the development of targeted agents, including small molecules and biologics, to prevent or treat cachexia related to cancer and/or cancer therapy, including chemotherapy and/or radiotherapy. Proposals submitted in response to this topic must focus on cancer indications with the highest prevalence of cancer- and cancer therapy-related cachexia. Any route of administration is acceptable, but it must be kept in mind that once cachexia has developed, absorption in patients may be impaired.
To apply for this Topic, offerors should:
Activities not supported by this Topic:
Proposals involving supplements and food products will not be considered.
Projects proposing to develop anti-tumor agents will not be considered.
Closing date: October 22, 2018, 5:00 PM Eastern Daylight Time
Apply for this topic on the Contract Proposal Submission (eCPS) website.
For full FY19 Contract Solicitation, CLICK HERE.