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GENETICS INSTITUTE AND SCIGENICS RECEIVE FDA GO AHEAD ON M-CSF CHOLESTEROL STUDY

 CAMBRIDGE, Mass., Jan. 19 /PRNewswire/ -- Genetics Institute, Inc. (NASDAQ: GENIZ) and SciGenics, Inc. announced today that the FDA has given regulatory clearance to enroll institutions and patients to test M-CSF (macrophage colony stimulating factor) in a cholesterol lowering study. Genetics Institute plans to commence this study pending final site selections and institutional review board approval. Approximately 500,000 individuals in the United States have a genetic predisposition to severely high blood serum cholesterol levels called familial hypercholesterolemia (FH). A small subset of these patients have the most severe form of this disease, which is characterized by cholesterol levels that are so high as to be life threatening. Current therapy involves removal of cholesterol from such affected individuals by complex blood processing techniques. The initial focus of the study will be to evaluate the safety of M-CSF as an agent to lower cholesterol levels in patients with the most severe form of the disease.
 "We are excited about the opportunity to evaluate the safety of M- CSF as a cholesterol-lowering agent in patients requiring treatment for this rare, debilitating condition, " said Dr. Patrick Gage, Executive Vice President of Genetics Institute. "Our studies of M-CSF in a relevant model of FH in rabbits suggests that this pharmacologic approach may be beneficial," he continued.
 In phase I clinical trial evaluations of M-CSF in normal volunteers and in the treatment of cancer patients with normal cholesterol levels, laboratory tests showed reductions in total cholesterol levels. Cholesterol levels returned to normal when M-CSF administration was discontinued. Additional phase II trials, designed specifically to evaluate the ability of M-CSF to lower cholesterol in patients requiring treatment for elevated levels of cholesterol, will be necessary to determine whether significant cholesterol lowering can be sustained in this patient population.
 The initiation of the phase I study had been on hold due to questions raised by the FDA in 1992 about Genetics Institute's IND submission for this study. An amended protocol was filed last fall and was recently accepted by the FDA. Genetics Institute licensed certain M-CSF patent and technology rights for North America to SciGenics, Inc. in May 1991. Schering-Plough holds the exclusive license from Genetics Institute for M-CSF in Europe, Africa and South America. Morinaga Milk Industry Company, Ltd. holds an exclusive license from Genetics Institute for M-CSF in Japan.
 Genetics Institute is a leading biopharmaceutical firm engaged in the discovery and development of human pharmaceuticals through recombinant DNA and other technologies. The Company has a diversified portfolio of licensed and proprietary pharmaceutical products at various stages of development, including treatments for anemia, hemophilia, cancer, infectious disease, bone damage, heart disease, inflammatory conditions and immune system disorders.
 -0- 1/19/93
 /CONTACT: Dennis Harp or Gina Price of Genetics Institute Corporate Communications, 617-876-1170/
 (GENIZ)


CO: Genetics Institute ST: Massachusetts IN: MTC SU:

TM -- NE001 -- 6181 01/19/93 09:41 EST
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Date:Jan 19, 1993
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