Multicellular living organisms and unmodified parts thereof and – Method of using a transgenic nonhuman animal in an in vivo...
Reexamination Certificate
1999-12-27
2001-11-13
Priebe, Scott D. (Department: 1632)
Multicellular living organisms and unmodified parts thereof and
Method of using a transgenic nonhuman animal in an in vivo...
C800S008000, C800S009000, C800S010000, C800S013000
Reexamination Certificate
active
06316690
ABSTRACT:
INTRODUCTION
1. Field of the Invention
The field of this invention is animal models of cellular proliferative diseases.
2. Background of the Invention
Cancer remains one of the leading causes of death in the United States. Clinically, a broad variety of medical approaches, including surgery, radiation therapy and chemotherapeutic drug therapy are currently being used in the treatment of human cancer (see the textbook CANCER: Principles & Practice of Oncology, 2d Edition, De Vita et al., eds., J. B. Lippincott Company, Philadelphia, Pa., 1985). With respect to chemotherapeutic drug therapy approaches, a broad variety of different types of active agents have been identified that exhibit anti-cellular proliferative activity, and some of these agents currently find use in the treatment of cancer and related cellular proliferative diseases. Agents which have been found to exhibit anti-cellular proliferative activity include: cytostatics, plant alkaloids, antibiotics, etc. However, despite the large number of compounds that have been identified to date, no ideal drug therapeutic has yet been discovered.
Critical steps in the identification and development of new therapeutic agents are: (a) generation of candidate agents; and (b) screening of the candidate agents for efficacy and safety. With the advent of combinatorial chemistry protocols, large numbers of potential compounds, known as libraries, can be rapidly generated. Such libraries serve as collections of potential therapeutic agents. Following generation of a library of potential therapeutic agents, the library must be screened to identity the promising candidates.
For screening purposes, a number of in vitro high throughput screening protocols have been developed. However, these in vitro screening assays must be followed by in vivo screening assays. Since it is undesirable to immediately screen compounds that show promise from in vitro assays in humans, an important step in the identification of therapeutic agents for such cellular proliferative diseases is the screening of potential therapeutic compounds in non-human animal models. As such, non-human animal models of cancer and other cellular proliferative diseases play an important role in the discovery of therapeutic agents for such diseases.
One type of non-human animal model that can be used for screening purposes to identify therapeutic agents for use in treating cancer and other cellular proliferative diseases is a non-human mammalian model, e.g. mice, etc. However, mice are expensive, have a slow reproduction time, and generate small numbers of offspring. As such, they are less than ideal for many high throughput screening assays.
Accordingly, there is a need for additional animal models of cellular proliferative, e.g. neoplastic, diseases. Of particular interest would be the development of an animal model having a relatively short life span and a rapid reproduction cycle characterized by the production of large numbers of offspring. Preferably, such an animal model should also be relatively simple and economic to maintain.
Relevant Literature
Of interest is: Woodhouse et al., Dev. Genes. Evol. (1998) 207:542-550. Methods of preparing transgenic Drosophila melanogaster are disclosed in: Spradling, A. C., and Rubin, G. M. (1982). Science 218, 341-347; Brand & Perrimon, Development (1993) 118: 401-415; and Phelps & Brand, Methods (April 1998) 14:367-379. See also, Spradling A C, P Element Mediated Transformation in Drosophila: A Practical Approach (ed. D. D. Roberts, IRL Press, Oxford)(1986) pp 175-179.
SUMMARY OF THE INVENTION
Transgenic non-mammalian animals, e.g. flies, that have a neoplastic phenotype, i.e. that spontaneously develop metastatic tumors, are provided. The subject transgenic animals are characterized in that they have a v-myb transgene stably integrated into their genome that is expressed in a manner that gives rise to the neoplastic phenotype. Also provided are methods of screening compounds for activity with respect to cellular proliferative disease conditions, particularly compounds having therapeutic activity with respect to neoplastic disease conditions.
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Bozicevic, Field & Francis
Field Bret E.
Priebe Scott D.
Shukla Ram R.
Tosk, Inc.
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