AspenBio Completes Clinical Study Patient Enrollment for AppyScore, World's First Blood-Based Diagnostic Test for Human Appendicitis
Enrollment Target of 800 Patients Achieved for FDA 510(k) Clinical Trial
CASTLE ROCK, CO--(Marketwire - December 10, 2008) - AspenBio Pharma, Inc. (NASDAQ: APPY), an
emerging bio-pharmaceutical company dedicated to the development of novel
drugs and diagnostics for humans and animals, reported its FDA 510(k)
clinical trial for AppyScore™, the world's first blood-based diagnostic
test for human appendicitis, has reached the 800 patient (study "subjects")
target and thereby has officially concluded enrollment in the study.
As of December 9, 2008 slightly more than 800 subjects have been enrolled
in the independent, blind, multicenter study. The company estimates that
four to six weeks will be required to allow its independent medical data
management contractor to review and validate all final clinical and assay
data, un-blind the study subject codes, and provide final data metrics for
statistical analysis.
This data will then be forwarded to an independent medical statistician who
will conduct statistical analysis and study results, to then be reported to
the company for inclusion in its FDA 510(k) submission package. The company
plans to issue a summary of the data to shareholders on the final key study
results as it prepares and completes the submission package. The company
anticipates completing its FDA 510(k) submission in early 2009.
AspenBio Pharma president and CEO, Richard Donnelly, stated, "Achieving our
800 subject enrollment target in this trial is a key milestone for AspenBio
Pharma. Analyzing the final data and successfully achieving FDA 510(k)
clearance of our AppyScore appendicitis blood test is now our number one
priority. While the actual final results of this blind trial will not be
known for several more weeks, we are excited that this large AppyScore
clinical trial has been completed. We look forward to sharing the results
in early 2009."
During the final review and evaluation process of each subject enrolled in
this blind trial, it is expected that a number of subjects will not conform
to the study criteria and therefore will be removed from the final
population of evaluable subjects, which is typical with any such clinical
trial.
As reported earlier, continued analysis of results of unpublished pilot
data from earlier in 2008 suggests the assay performs with consistently
high sensitivity and has shown a trend of improved specificity. Additional
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") could 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
this clinical trial will demonstrate this improved clinical utility.
While advancing AppyScore with the current FDA application of the company's
45 minute ELISA lab test is currently the company's primary focus, AspenBio
continues to make progress on two additional formats of the appendicitis
test in its multi-product pipeline. The two additional versions of the
test, now in advanced development and anticipated future GMP manufacturing,
are designed to be approximately three times faster, providing results in
approximately 15 minutes, and are less labor intensive. The company plans
to provide additional updates and information on the progress of the GMP
development of these two new rapid versions of the test in the near future.
Although the company has confidence in its product, results of any blind
trial can be unpredictable and inconsistent with previous data. 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.
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. For more information, go to
http://www.aspenbiopharma.com.
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.