Patient Enrollment for AspenBio Pharma's FDA 510(k) Clinical Trial for AppyScore(TM), World's First Appendicitis Blood Test, Nearing Halfway Point
343 Patients Enrolled in Ongoing 800 Patient Trial
CASTLE ROCK, CO--(Marketwire - September 4, 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 enrollment levels
are approaching fifty percent in the ongoing FDA 510(k) clinical trial for
AppyScore™, the world's first blood-based diagnostic tool for human
appendicitis.
Since the trial commenced in late June 2008, enrollment rates have
accelerated, as the number of participating institutions have expanded and
all are active, including a large children's hospital. As of the end of
August 2008, 343 patients were enrolled in the 800 patient clinical trial.
The study is focused on patients arriving at hospital emergency rooms with
a primary complaint of abdominal pain. This is 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 the
participating parties, including AspenBio, its independent Contract
Research Organization ("CRO"), and the participating hospitals.
Based upon recent enrollment rates, AspenBio expects patient enrollment
will continue to accelerate over the coming weeks. Accordingly, the company
expects to complete the trial later in the fall of 2008 and be in a
position to submit its FDA 510(k) application before the end of the year.
Upon completion of the final study enrollment of 800 patients, the company
estimates an additional five to six weeks will be required for an
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.
The final data will be forwarded to an independent medical statistician who
will conduct final statistical analysis and study results, which will then
be reported to the company for inclusion in the FDA submission. Once the
data has been submitted, successfully reviewed and accepted by the FDA,
final clearance steps will include determining the final product label
claims, which are also subject to FDA approval.
The company anticipates completing this process and FDA 510(k) clearance 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 eight 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 completes its submission
of the FDA 510(k) application.
AspenBio Pharma president and CEO, Richard Donnelly, stated: "As we near
the halfway point of our 800 patient study, this marks another important
milestone in our efforts to commercialize the first and only blood test for
human appendicitis and what has been heralded by analysts as a medical
breakthrough. We remain confident that our professional team and CRO
overseeing this trial process will help us achieve our goal of completing
our on-going AppyScore study and filing our FDA 510(k) submission before
the end of this year."
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. AspenBio Pharma continues to
advance the development and testing of its two 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.