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AspenBio Pharma, Inc.: AspenBio Completes Clinical Study Patient Enrollment for AppyScore, World's First Blood-Based Diagnostic

^{Published on 2008-12-10 11:33:16 - Market Wire}
 

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As reported earlier, continued analysis of results of unpublished pilot data from earlier in 2008 suggests the assay performs with consistently high sensitivity and has shown a trend of improved specificity.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.