The enclosed Press Release may interest professional
toxicologist working to optimize their efforts in
pre-clinaical demonstration of safety and efficacy. Our test
methods use high field MRI and MRS and can add considerable
insight into issues such as the disease-status of a model
system. MRS and MRI are non-invasive and do not interfere
with the normal physiology of the animal.
For additional information, contact us at
invivome at onramp.net.
----------------------------- more ----
PRESS RELEASE...
CONTACT
Michael E. Egan, Ph.D.
Vice President, Sales &
Marketing
InVivoMetrics, Inc.
1/800/670-2854
e-mail: invivome at onramp.net
FOR IMMEDIATE RELEASE
InVivoMetrics, Inc INTRODUCES TECHNOLOGY TO REDUCE THE COST
OF DEVELOPING NEW PHARMACEUTICALS
Albuquerque, NM December 6, 1995 : InVivoMetrics, Inc.
becomes the first contract research company to offer non-invasive
techniques to establish the safety and efficacy of new drugs
or medical devices. InVivoMetrics will offer its services to
manufacturers in the pre-clinical phase of development and will
assist them in satisfying the Food and Drug Administration's
requirements to demonstrate safety and efficacy before authorizing
human clinical testing.
The company's name means "in life testing" and emphasizes the
use of technology that collects information without harming or
interfering with the physiology of test animals. Because this
technology enables repeated observations of the same animal,
InVivoMetrics' methods use far fewer animals (as much as 90%).
Fewer animals also reduce the amount of drug required for the
test, saving the pharmaceutical company the cost of synthesis,
thereby shortening the development time-- another potential
savings. Test results are immediately available, and offer
the added benefit of potentially demonstrating safety and
efficacy at the same time.
m o r e
InVivoMetrics' methods use Magnetic Resonance Imaging (MRI) and
Magnetic Resonance Spectroscopy (MRS). MRI is widely used today
in medicine as a diagnostic tool. It provides detailed information
about the bones, eyes, blood vessels and internal organs, and is
indispensable in modern health care. Using MRI, InVivoMetrics
can track changes in the internal structure and function of
organs, and evaluate their response to drugs, visualizing structures
as small as 0.1 mm. MRS is based on another widely used technique,
nuclear magnetic resonance spectroscopy, which scientists use to
study the properties of chemicals. MRS provides similar information,
but evaluates the chemical properties inside a living animal without
harming or disturbing the animal. For example, MRS can determine
properties like intracellular pH, metabolism, and blood oxygen
levels without touching the animal.
Dr. Ray Nunnally, President said, "The convergence of several factors
has encouraged us to launch the business at this time: The success
of several IND submissions supported by MRI/MRS results and the
acceptance of such data by the FDA clearly establishes the
appropriateness of non-invasive testing methods for demonstration
of safety and efficacy. This combined with a large and expanding
scientific literature that validates results from MRI/MRS with
traditional methods, plus the capabilities of the current
generation of laboratory MRI instruments tells us that the timing
is right. Our focus on the use of non-invasive test methods has
one overriding objective -- to get new drugs and devices to
clinical trials sooner than is feasible with traditional invasive
testing."
Dr. Michael Egan, Vice President, noted, "To demonstrate how our
non-invasive approach saves time and money, compare a typical
study using traditional methods with ours. In a common
pre-clinical test for drug effectiveness, ten animals per time
interval are evaluated at 15 different intervals. That's 150
animals and 150 'doses' of the candidate drug. Test results
are established by a battery of tests on each animal's organs
requiring weeks of laboratory work With our non-invasive methods,
we re-test each animal at every time interval, so fewer are used
and less drug is required. In addition, the results are available
at the conclusion of the test, and can either be evaluated from
computer images, graphs or printed. Here's a summary:"
Table
Testing, Traditional Methods InVivoMetrics' Methods
==============================================================================
8-10 animals for each test point. The same animals are re-tested
at each time point, plus the
"disease" status may be vali-
dated prior to drug adinistration.
------------------------------------------------------------------------------
Est 150 animals. Cost: $15,000. 15-20 animals.Cost,$1,500-2,000.
-------------------------------------------------------------------------------
Need 150 drug doses. Cost: $15,000. Need 15-20 doses.Cost,$1,500-$2,000
-------------------------------------------------------------------------------
Concerns for humane animal treatment. Markedly fewer animals used, tests
harmless, and non-invasive to animal.
--------------------------------------------------------------------------------
Cannot test progress or effects over All animals provide progressive
time in the same animal. results over the full test time.
--------------------------------------------------------------------------------
Test results frequently take weeks Test Results are immediately
to produce and become available. available - within minutes or
hours of measurement. This
can provide quicker decision
points, shorter development
times and lower costs.
================================================================================
InVivoMetrics, Inc. is a Delaware Corporation operating in Albuquerque,
NM. It has a sales office in Dallas, Texas. The company was founded
by Ray Nunnally, Ph.D., an internationally known MRI/MRS scientist and
businessman, who serves as President and CEO. Key management includes
Vice President of Operations Mary Nunnally, Ph.D., whose 15 years
experience in the pharmaceutical industry will be applied to
establishing a fully GLP compliant facility (Good Laboratory Practice is
an FDA-mandated standard for pre-clinical safety testing), and Vice
President of Sales & Marketing Michael E. Egan, Ph.D., who bring 15
years experience in technical sales and marketing plus a background in
physiology to the business launch. The company intends to add
additional non-invasive technologies to its services as they emerge.
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