About This ProjectTriple negative breast cancer (TNBC) is a rarer form of breast cancer where patients have few treatments. Two novel biotherapies are proven to inhibit growth of TNBC cancer cells in culture, and need to be tested in animals. To gain FDA approval for patients, we seek funding to purchase the specialized nude mice needed to demonstrate efficacy and lack of toxicity for our novel biotherapies
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What is the context of this research?
Triple negative breast cancer (TNBC) represents 15% of all new breast cancers worldwide. TNBC lacks hormonal receptors for normal therapy, and women with TNBC have few options other than surgery. More than 39000 women in the US die of breast cancer annually. A new regulatory pathway has been discovered [Opioid Growth Factor (OGF) - Opioid Growth Factor Receptor (OGFr)] that inhibits growth of cancer cells in a non-toxic manner. Human TNBC cells have the necessary peptide and receptor to respond to OGF (a neuropeptide in the brain) and LDN (low dosages of naltrexone that stimulates the body's own production of OGF). OGF and LDN are effective in treatment of many other human cancers in mice; OGF has been tested in patients with pancreatic or liver cancer and is nontoxic and effective.
What is the significance of this project?
To gain approval for FDA clinical trials, studies in animals are required to demonstrate lack of toxicity and efficacy at several dosages. The acceptable animal model of human cancer drug therapy is the nude mouse. We plan to inoculate mice with TNBC cells and treat daily with either OGF or LDN. Tumor growth will be monitored; body weight changes of mice will demonstrate toxicity. Tumors will be evaluated for biological markers related to the advancement of cancer, particularly TNBC. These data will support application for a clinical trial of TNBC patients using OGF or LDN.
What are the goals of the project?
1. Determine safety and effiicacy of OGF treatment on growth of hiuman triple negative breast cancer cells in nude mice.
2. Determine safety and efficacy of LDN therapy on gorwth of triple negative breast cancer cells in nude mice.
There is currently no funding for the required animal studies to demonstrate efficacy of LDN and OGF therapy to inhibit triple negative breast cancer. Because OGF and LDN have already been shown effective in pancreatic cancer, NIH is not funding this work, yet the FDA requires preclinical studies to be conducted on each type of human cancer - including human triple negative breast cancer before it will approve clinical trials.
Funding is requested for the purchase of the nude mice required to host the human cancer cells. The research will be performed by a PSU graduate student as part of her thesis. The animal studies are critical to move these biotherapies to the clinic and be able to offer patients with TNBC a nontoxic, but effective, alternative to surgery. Once funding is secured, and animals can be purchased, the experiments can be completed within 60 days; data can be analyzed within another 2 months. Thus within 6 months after receiving funding, applications for funding for clinical trials to treat patients with TNBC can be prepared.
Meet the Team
Team BioI am a cell biologist and basic scientist at Penn State University College of Medicine and work on the OGF-OGFr regulatory pathway. I was part of the team that discovered the OGFr and have moved much of the basic science to the bedside in order to help patients with various diseases including cancer, multiple sclerosis, and complications from type 1 diabetes. I am also the Director of the Anatomy Graduate Program at the College of Medicine.
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