Exhibit
99.1
AspenBio
Pharma Reports on AppyScore™ Supplemental Clinical Trial Interim Analysis and
Provides Guidance on FDA 510(k) Filing
--Conference
call scheduled for today at 5:00 PM ET--
CASTLE ROCK, CO—February 9,
2010—AspenBio Pharma, Inc. (NASDAQ: APPY) today reported conclusions from
its pre-planned, independent, interim analysis of the Company’s ongoing
supplemental clinical trial of AppyScore™, the first blood-based test designed
to aid in the evaluation of patients suspected of having acute appendicitis, and
outlined next steps for its AppyScore 510(k) filing with the U.S. Food and Drug
Administration (FDA). Based on the interim analysis, the trial, currently with
over 600 patients enrolled, will continue enrollment to approximately 800
patients with completion anticipated in March of 2010. Given the time estimate
to complete the current trial and related data analysis, the Company has
withdrawn its 510(k) on file with the FDA and will submit a new 510(k) with full
results from the ongoing clinical trial. This clinical trial is statistically
sized to stand alone and thereby becomes the pivotal trial to support the new
510(k) submission.
“We
believe AppyScore has the potential to help improve physicians’ evaluation of
appendicitis, eliminating unnecessary CT scans and reducing radiation exposure
risk for patients—while also reducing health care costs,” said Daryl J.
Faulkner, Chief Executive Officer of AspenBio Pharma. “We continue to actively
enroll patients in the ongoing clinical trial and believe that submitting a new
510(k) based on a full analysis of the data from this study will provide the
most effective path to 510(k) clearance. Our new timeline includes finalizing
the trial results and submitting the new 510(k) in the second quarter of
2010.
“In
addition, we continue to make excellent progress advancing our second generation
AppyScore product—a stand-alone, state-of-the-art cassette and reader instrument
platform—and anticipate being in a position to begin clinical trials for this
rapid assay in the second half of 2010,” concluded Faulkner.
Interim
statistical analyses are conducted to advise clinical trial sponsors on the
progress of a study to determine if: 1) a trial should be stopped as the defined
end point(s) will not be reached; 2) a trial should be stopped as the end
point(s) have already been reached; or 3) a trial should continue as planned. A
fourth item was included in AspenBio’s interim analysis to determine if the
clinical trial size should be expanded in order to generate the statistical
power needed to reach defined end point(s).The interim analysis report for
AspenBio’s trial concluded that the trial should continue. Based upon the data
set, the interim analysis determined that the trial is adequately sized for the
primary endpoint goal, the use of AppyScore test alone. However, the data set
gathered for the interim analysis was not sufficient to provide guidance, at
this stage, on if the trial is adequately sized for the secondary
endpoints—using AppyScore in combination with either white blood cell count
(WBC) or neutrophil count. The Company and all participants in the study remain
blinded to the data until the close of the study and there can be no assurance
of the outcome of the study based on the interim analysis.
In
addition to the current ELISA format AppyScore test, AspenBio is developing a
stand-alone, cassette and reader instrument platform that provides AppyScore
results more rapidly and efficiently than the ELISA format and will
significantly improve ease of use by reducing an operator’s processing steps.
Clinical trials of the rapid assay will be designed to support a 510(k)
submission for this platform using the ELISA test as a predicate, assuming the
ELISA test is cleared by the FDA. In addition, these trials will provide
AspenBio and physicians with additional information on the product's potential
utility. AspenBio recently signed a manufacturing agreement with LRE Medical to
complete commercial development and manufacture of the reader instrument to be
used with the AppyScore cassette system and expects to announce the execution of
a supply agreement with an internationally recognized manufacturer for the test
cassettes in the near future.
“Emergency
medicine physicians need better diagnostic tools to help identify patients at
low risk for appendicitis,” said Angela Mills, MD, Assistant Professor,
Department of Emergency Medicine, University of Pennsylvania School of Medicine
and a consultant to AspenBio Pharma. “Additional test information that
supplements the various modalities we currently use to evaluate patients with
abdominal pain which might be due to acute appendicitis will guide more informed
treatment decisions and, ultimately, support more efficient clinical management
of patients.”
Conference
Call
AspenBio
will hold a conference call today at 5:00 p.m. Eastern Time to discuss today’s
news.
Members
of the Company’s executive management team will host the presentation, followed
by a question and answer period.
Date:
Tuesday, February 9, 2010
Time:
5:00 p.m. Eastern Time
Toll-free
dial-in number: 1-800-862-9098
International:
1-785-424-1051
Conference
ID#: 7ASPENBIO
Please
call the conference telephone number 5-10 minutes prior to the start time. An
operator will request the conference ID and register your name and organization.
If you have any difficulty connecting with the call, please contact the Liolios
Group at 949-574-3860.
For those
unable to join the live conference call, a replay will be available after 7:30
p.m. Eastern Time today through February 16, 2010.
Toll-free
replay number: 1-800-677-6124
International
replay number: 1-402-220-0664
(No
passcode required)
About
AspenBio Pharma, Inc.
AspenBio
Pharma, Inc. (NASDAQ: APPY) is a leader in the development and commercialization
of innovative products that address unmet diagnostic and therapeutic needs. The
Company’s lead product candidate, AppyScore, is a novel, blood-based diagnostic
test that evaluates patients suspected of having acute appendicitis and
addresses the difficult challenge of properly diagnosing appendicitis in the
hospital emergency department setting. For more information, please visit
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 ("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 trial data
assessments required for FDA submission, obtain FDA approval for, cost
effectively manufacture and generate revenues from the appendicitis test as well
as the animal products 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.
Company
Contact:
Gregory
Pusey
Vice
Chairman
Tel:
303-722-4008
Investor
Relations:
Liolios
Group, Inc.
Ron Both
or Geoffrey Plank
Tel:
949-574-3860