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Non-invasive Testing for Safety Efficacy

Michael E. Egan, Ph.D. invivome at ONRAMP.NET
Thu Jan 4 14:09:51 EST 1996

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 ----

						Michael E. Egan, Ph.D.
						Vice President, Sales &
						InVivoMetrics, Inc.
						e-mail:  invivome at onramp.net



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 
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:" 

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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