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press release

Margaret Maughan margaret at phylonix.com
Fri Jun 4 09:46:00 EST 2004


CONTACT:          Chaoyong Ma, Ph.D.

                        Bus Devel Manager

                                Phylonix, Inc.

100 Inman Street, Cambridge, MA 02139

617-441-6700 ext. 326



Cambridge, MA (June 2, 2004) - Phylonix today announced that it had
recently received a Phase II Small Business Innovation Grant (SBIR) from
the National Cancer Institute to develop zebrafish apoptosis assays for
drug screening. The amount of the award is $993,463.

Apoptosis is the genetically programmed process of precise, predictable
cell suicide. It occurs as a normal physiological process for removing
unnecessary cells throughout the life of an organism. Inappropriate
apoptosis has been shown to be the cause of many diseases. Development of
agents that modulate apoptosis is a major focus of biopharmaceutical
research.  The ability to manipulate apoptosis could permit therapeutic
intervention in: cancer, heart disease, stroke, AIDS, autoimmunity, and
degenerative diseases.

"Apoptotic cells in live, transparent zebrafish can be visualized by
acridine orange staining without complicated processing.  At Phylonix, we
are also developing a quantitative, vital dye assay for high throughput
screening using an automated liquid handling workstation and a microplate
reader", Chuenlei Parng, Ph.D, the Principal Investigator for this
research, said.

Conventional cell-based assays evaluate the potential effects of drugs in
culture, but cannot assess the complex metabolism that affects actual drug
efficacy or causes toxicity in animals and humans.  Therefore, many drugs
that appear effective in cell-based assays fail in subsequent, costly
animal testing.  To streamline the drug development time-line, prioritize
drug candidates for animal testing, and reduce unnecessary costs for
mammalian studies, we are developing a family of drug screening assays
using the small vertebrate zebrafish.  This convenient animal model will
serve as an intermediate step between cell-based evaluation and animal
testing for drug evaluation.

Zebrafish Background

Laboratory animals are critical for defining the mechanisms of drug
activity and for testing therapeutic regimens, however, only a few useful
models have been developed. Zebrafish has several important advantages for
drug screening: they are small, inexpensive to maintain and easily bred in
large numbers.  Eggs are externally fertilized and a single mating
produces 100-200 eggs.  Single embryos can be maintained in fluid volumes
as small as 100 microliters for the first six days of development and
cultured in microtiter wells.  Chemicals can then be added directly to the
fish water, permeating the intact embryo.  Standard microtiter plate
readers can be used for quantitation, making this format particularly
attractive for high throughput drug screening.

The Company is developing a family of zebrafish microplate assays with
compelling advantages: 1) short assay time, 2) single dosing, 3) small
amount of drug required for each test, 4) statistically significant
numbers of animals can be assayed for each condition, 5) embryos
maintenance during drug delivery is easy, and 6) low cost: the estimated
cost of each zebrafish assay is <$100.

Whole embryo testing has previously been performed on invertebrates,
including fruitfly and nematode, however, these organisms are not closely
related to humans and they lack many of the same organs and enzymes.
Therefore, their use as comparative models for toxicity effects in humans
is limited.  All essential components of vertebrate form and organ
development are mimicked in the transparent zebrafish and their molecular
basis is either identical or similar, underscoring the potential for use
in research on human diseases.

Company Background

Phylonix Pharmaceuticals, Inc. is a Contract Research Organization focused
on developing and marketing novel in vivo zebrafish based assays for
therapeutic and industrial screening for cancers, central nervous system
and cardiovascular diseases, apoptosis, and organ toxicity.  The Company
is assembling embryo and chemical sample handling instrumentation to
automate analysis.  The Company has established a state of the art
aquaculture facility. Initially, the Company offers drug screening
services, primarily to the pharmaceutical industry.  Long term, the
Company expects to contribute to the study and treatment of human diseases
by genetic screening, gene cloning, and target identification using
zebrafish as a model organism.

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