AspenBio Pharma,
Inc. (OTC Bulletin Board: APNB) an emerging bio-pharmaceutical company
dedicated to the development of novel drugs and diagnostics for animals and
humans, today reported on the development status of the company’s human
appendicitis blood test and positive results from preliminary clinical
trials. The company also reported that U.S. federal trademark applications
have been filed for AppyScore and AppyScreen for the planned
commercialization of two new human appendicitis blood tests.
AspenBio Pharma continues to make exciting progress in the development
and testing of its two first-generation blood-based human diagnostic tests
designed to rapidly help diagnose or rule out appendicitis in patients
complaining of abdominal pain. AspenBio has created and optimized a
specialized assay test to detect a marker in the blood associated with
appendicitis and has tested this assay in several on-going research trials
involving hundreds of human patients.
Preliminary results indicate that the company’s first-generation triage
test is highly effective in identifying patients with acute appendicitis.
This marker demonstrates a linear (or direct) correlation to the
histopathologic severity of appendicitis. The test is especially accurate
in patients 30 years of age and under, which is also the age group most
commonly afflicted with appendicitis.
As a result of these positive developments, the company’s R&D team is
designing two separate appendicitis triage blood test systems. The primary
test is the AppyScore system which is based on a blood test result scoring
system designed to be used as an initial appendicitis triage test for
patients entering an Emergency Room /urgent care facility complaining of
abdominal pain. The scoring system is designed to quantify the blood marker
level, which guides the physician in determining not only the presence but
also the stage of appendicitis. Determining the stage of appendicitis helps
the physician assess the level of possible danger and the potential for the
appendix to burst causing complications of a life-threatening perforation.
The AppyScreen system is a second appendicitis screening test which is
being developed as a point-of-care test designed specifically for use in a
physician’s office. This rapid-screen qualitative blood test would be used
by a primary care doctor to quickly screen and identify potential
appendicitis patients — especially children and young adults — who should
immediately go to the emergency room for further appropriate care that may
include a more quantitative AppyScore test.
Appendicitis can advance rapidly. Delays in the diagnosis and care of
appendicitis are associated with serious complications. After basic tests
and examination, a CT scan is the most commonly used emergency room
diagnostic method for ruling out appendicitis for patients with abdominal
pain. Costing $1,500 to $3,000 per procedure, an estimated $4.5 to $9.0
billion is spent annually in the US on CT scans for this purpose. The scans
can take more than four hours to complete and expose patients to ionizing
radiation. While CT scans are still the current medical standard, CT
diagnostic error rates are estimated to range between 15% and 40%, and a
high percentage of CT scan results are simply inconclusive. The present
approach contributes to a significantly large number of unnecessary
appendicitis surgeries due to diagnostic errors.
Every year in the United States alone, approximately 6 million patients
enter emergency rooms complaining of abdominal pain. About 700,000 of these
patients are diagnosed with appendicitis and have emergency surgery to
remove the appendix. However, due to diagnostic errors some 100,000 of
these patients (or approximately one out of seven) who undergo this
emergency surgery end up having a normal appendix removed.
In addition to involving other risks, hospital charges for such
unnecessary (negative) appendectomies are estimated to give rise to
hospital charges of approximately $1.5 billion annually in the US alone.
Additionally, about 95,000 patients are not diagnosed correctly in time and
suffer a potentially life-threatening perforation of the appendix requiring
immediate and more complex emergency surgery. This also results in a more
lengthy hospital stay, a longer recovery or treatment period, and
substantially increased cost.
“When we first started our investigations to develop this blood test,
our main goal was to be able to more accurately identify patients with
appendicitis,” said Dr. John Bealer, a pediatric surgeon based in Denver
Colorado and co-inventor of the test. “In initial clinical studies of
patients with appendicitis, AppyScore has been impressively accurate at
detecting appendicitis. False-negative results for AppyScore have been
exceedingly rare and to date seen only in those cases with minimal
histological evidence of appendicitis. This finding opens up the potential
of two different roles for AppyScore in treating patients. For some
patients, AppyScore could potentially be a stand-alone diagnostic test of
appendicitis. For others, it could also be useful as a triage tool by
determining which abdominal-pain patients are the best candidates for CT
scanning. By both adding new diagnostic information and supplementing
standard diagnostic methods, AppyScore could become very important for the
6 million patients annually who enter emergency rooms with abdominal pain.”
Appendicitis most frequently occurs in patients aged 10 to 30, but can
affect all ages usually presenting as abdominal pain. While this
first-generation test can be falsely-positive in some patients with other
specific inflammatory diseases, these diseases are infrequent in people
less than 30 years of age and generally are less of a diagnostic challenge
than appendicitis.
Appendicitis is especially difficult to diagnose in children and young
adults using a CT scan because of their low body fat. This lack of body fat
results in very poor tissue differentiation on the CT scan. AspenBio
Pharma’s new triage/diagnostic tests also have the potential to enhance
overall safety by reducing the amount of radiation exposure in children
from unnecessary CT scans. Adds Bealer, “Given these factors, we are
particularly excited about what this triage test could mean for helping to
diagnose or rule out the disease in the highest-risk appendicitis
population of children and young adults.”
Based upon a potential annual emergency room/urgent care usage of 6
million tests and management’s estimates of a sales price of a few hundred
dollars per test, the annual U.S. market potential for AppyScore and
AppyScreen systems could exceed several hundred million dollars, with the
international market potential at a multiple of that of the U.S.
“We believe that these two first generation triage tests will prove to
be very cost-effective and welcomed innovations for emergency room
physicians who must quickly and correctly diagnose or rule out
appendicitis,” said Richard Donnelly, AspenBio Pharma’s president and CEO.
“Rarely do you find a new healthcare technology that is faster, more
accurate, and much less expensive than current techniques. These
blood-based tests can potentially save the US healthcare system and
insurance providers billions of dollars in reduced numbers of CT scans
alone. Consequently, the AppyScore and AppyScreen tests have legitimate
blockbuster sales potential in the human medical markets worldwide.”
Beginning in 2004, AspenBio commenced the establishment of an
intellectual property portfolio for the appendicitis testing technology and
products. The company has filed for worldwide patent coverage related to
several aspects of the initial discovery and various test applications.
Further enhancement and expansion of the proprietary patent position is
ongoing with respect to the scope of protection for the company’s first
generation and future generation versions of tests. Strong scientific and
technical progress remain the basis for these innovative efforts.
Clinical studies will continue, while activities for securing an
international licensing partner to support FDA approval, distribution, and
marketing will commence in the near future. The company anticipates
submitting an FDA regulatory filing for approval of the tests during the
third quarter of 2007.
About AspenBio Pharma, Inc.
AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to
the discovery, development, manufacture, and marketing of novel proprietary
products, including those that enhance the reproductive efficiency of
animals and that have large worldwide market potential. The company was
originally formed to produce purified proteins for diagnostic applications
and has become a leading supplier of human hormones to many of the nation’s
largest medical diagnostic companies and research institutions. The company
has successfully leveraged this foundational science and technology
expertise to rapidly develop an enviable late-stage pipeline of several
novel reproduction hormone analogs for wide-ranging therapeutic use
initially in bovine and equine species. For more information, please visit:
aspenbiopharma.
Forward Looking Statements
This news release includes “forward looking statements” of AspenBio
Pharma, Inc. (“APNB”) as defined by the Securities and Exchange Commission
(the “SEC”). All statements, other than statements of historical fact,
included in the press release that address activities, events or
developments that APNB believes or anticipates will or may occur in the
future are forward-looking statements. These statements are based on
certain assumptions made based on experience, expected future developments
and other factors APNB believes are appropriate in the circumstances. Such
statements are subject to a number of assumptions, risks and uncertainties,
many of which are beyond the control of APNB. Investors are cautioned that
any such statements are not guarantees of future performance. Actual
results or developments may differ materially from those projected in the
forward-looking statements as a result of many factors, including the
ability to successfully complete the development of new products and
produce them economically, secure intellectual property positions including
valid and enforceable patent and trademark rights, execute agreements
required to successfully advance the company’s objectives, retain the
scientific management team to advance the products, obtain additional
funding as and if needed, adverse changes in market conditions and the
regulatory environment, fluctuations in sales volumes, and realization of
intangible assets. Furthermore, APNB does not intend (and is not obligated)
to update publicly any forward-looking statements. The contents of this
news release should be considered in conjunction with the warnings and
cautionary statements contained in APNB’s recent filings with the SEC.
AspenBio Pharma, Inc.
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