Prevention and Treatment of Breast Cancer
Technical Report,15 Jul 2015,14 Jul 2019
Albany Medical College Albany United States
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The purpose of this project was to test the hypothesis that AFPep is safe and effective for prevention and treatment of breast cancer. Aim 1was to document the preventive efficacy and safety of AFPep. The data reported herein allow us to conclude that AFPep prevents estrogen-induced breast cancer in ACI rats, just as it prevented carcinogen-induced breast cancer in Sprague Dawley rats. Data from rats, mice, monkeys and dogs allow us to conclude that AFPep is extraordinarily safe. We have reported a therapeutic index of greater than 1000.Aim 2 was to measure and maintain blood levels of AFPep at effective doses in mice, dogs, and non-human primates. Assessing pharmacokinetic data in mice, dogs, and primates, we conclude that an efficacious blood level of AFPep is approximately 0.1 microgramml, and this blood level can easily be achieved in higher mammals with no evidence of toxicity. Based on a proof-of-concept clinical trial in dogs, we conclude that blood levels of AFPep 10 to 50 times the effective blood level are easily achieved, well tolerated, and effective as monitored by biomarker response to AFPep. We conclude from the data of Years 1 through 3 of this project that AFPep is safe and effective for the prevention and treatment of breast cancer, and should proceed to clinical trials for the prevention and treatment of breast cancer as soon as possible. We outline our efforts to secure funding toward that end.
- Medicine and Medical Research