FDA 510(k) Clinical Trial Progress For AppyScore, World's First Blood-Based Diagnostic Test For Human Appendicitis

AspenBio Pharma,
Inc. (NASDAQ: APPY), an emerging bio-pharmaceutical company dedicated
to the development of novel drugs and diagnostics for humans and
animals, reported the enrollment level in the ongoing FDA 510(k)
clinical trial for AppyScore(TM), the world's first blood-based
diagnostic test for human appendicitis exceeds 700 patients.



As of November 17, 2008, there were 701 patients enrolled in the
ongoing clinical trial in which 800 patient enrollments will complete
the study. Based upon current ongoing weekly enrollment rates, the
company anticipates achieving the goal of 800 patient enrollments
within weeks.



The study enrollment is focused on patients arriving at hospital
emergency rooms with a primary complaint of abdominal pain. Qualified
patients are further narrowed with criteria related to medical
history and duration and location of abdominal pain.



Patient test results from the independent multicenter study are
completely blind. Therefore, until the trial is completed and data is
unlocked, information concerning trial results will remain unknown to
all parties, including AspenBio, its independent Contract Research
Organization ("CRO") and the participating hospitals.



Based upon the current progress, the company expects to complete the
trial later in 2008, to be followed by reporting the data and then
anticipates submitting its FDA 510(k) application early in 2009.



Following achievement of the final study enrollment target of 800,
the company estimates an additional four to six weeks will be required
for its independent medical data contractor to review and QC (quality
control) all final patient and study data, un-blind the study patient
codes, and provide final data metrics for statistical analysis. This
data will be forwarded to an independent medical statistician who
will conduct statistical analysis and study results, which will then
be reported to the company for inclusion in its FDA submission.



The company anticipates completing its FDA 510(k) application in
early 2009. Although the company has confidence in its product,
results of any blind trial can be unpredictable and inconsistent.
Unforeseen events can occur, and there are many factors which are
beyond the control of the company. Therefore, there can be no
assurance AspenBio will be able to achieve its anticipated timelines
or meet expectations.



Upon completion of 800 patient enrollments in this clinical trial,
the company plans to provide an update to shareholders that enrollment
targets have been achieved. Approximately four to six weeks following
achievement of full enrollment, the company plans to issue an
additional summary update to shareholders on the final key study
results as it prepares and completes its submission of the FDA 510(k)
application.
















As discussed in our press release on October 22, 2008, advancing
AppyScore and the current FDA application for our 45 minute ELISA lab
test is the company's number one priority. In addition, the company
continues to make progress on two additional formats of the
appendicitis test in its product pipeline. The two additional
versions of the test, now in formal GMP development, are designed to
be approximately three times faster, providing results in
approximately 15 minutes and are less labor intensive.



AspenBio Pharma president and CEO, Richard Donnelly, stated,
"Completing this 800 patient trial and achieving FDA 510(k) clearance
of our AppyScore appendicitis blood test is the primary focus in the
company. While the actual date of completion of the trial is too
close to call, at current rates, we are now down to just a few more
weeks of enrollment, which is exciting."



As reported earlier, results of recent unpublished pilot data
suggests that the assay performs with consistently high sensitivity
and has shown a trend of improved specificity. Further analysis of
this pilot data suggests that AppyScore in combination with other
existing standard of care tests, including white blood count ("WBC")
and computed tomography ("CT"), may provide a significant improvement
in the quality of diagnostic information available to the physician.
While results in any large blind trial cannot be assured, the company
believes the current 800 patient trial will demonstrate this improved
clinical utility.



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 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. AspenBio Pharma continues to advance the development
and testing of its three first-generation blood-based human
diagnostic tests designed as an aid in the diagnosis of human
appendicitis.




Forward-Looking Statements



This news release includes "forward-looking statements" of AspenBio
Pharma, Inc. ("APPY") 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 APPY 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 APPY 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 APPY. 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
statements regarding the ability to successfully complete the
clinical trials and pivotal studies required for FDA submission,
obtain FDA approval for, cost effectively manufacture and generate
revenues from the appendicitis test as well as the animal products
under this agreement and other new products, execute agreements
required to successfully advance the company's objectives, retain the
scientific management team to advance the products, overcome adverse
changes in market conditions and the regulatory environment,
fluctuations in sales volumes, obtain and enforce intellectual
property rights, and realization of intangible assets. Furthermore,
APPY 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 APPY's recent filings with the SEC.

AspenBio Pharma, Inc.