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Mammastatin is a naturally occurring protein that functions as a tissue-specific growth inhibitor for breast cells. Discovered in 1986 by Dr. Paul Ervin, Jr. at the University of Michigan Cancer Center, the protein exists in several polypeptide forms, most notably an active 53 kDa phosphorylated form expressed in normal human mammary cells and an inactive 44 kDa non-phosphorylated form often found in breast cancer cells. As a biologic therapeutic, mammastatin specifically inhibits the growth of transformed human mammary cell lines without affecting non-mammary tissues. The drug was developed by Biotherapies Incorporated (later Abviva, Inc.) under an exclusive license from the University of Michigan. In a 1996 preliminary clinical study involving 34 late-stage breast cancer patients, regular injections of mammastatin were reported to arrest breast cancer cell growth in 60% of patients, with 15% experiencing significant tumor reduction or complete remission, and no negative side effects observed. The company also developed the Mammastatin Serum Assay (MSA) as a companion diagnostic test for breast cancer risk assessment.
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