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Public Companies : Healthcare/BioTech


AspenBio Pharma Commences FDA Clinical Trial for AppyScore(TM) Appendicitis Blood Test

Jun 26, 2008 - 8:36:01 AM

News Source MARKET WIRE

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CASTLE ROCK, CO -- (MARKET WIRE) -- 06/26/08 -- AspenBio Pharma, Inc. (NASDAQ: APPY) anemerging bio-pharmaceutical company dedicated to the development of noveldrugs and diagnostics for humans and animals, has officially initiated aclinical trial to support the FDA 510(k) application for the AppyScore(TM)Human Appendicitis blood-based diagnostic test.

Enrollment of the first patients in the independent, blind, multicenterstudy began this week, which will include patients from a large children'shospital. The study is focused on patients arriving at hospital emergencyrooms with a primary complaint of abdominal pain. This is further narrowedwith criteria related to medical history and duration and location ofabdominal pain.

To help insure a successful trial, AspenBio engaged a highly qualified andexperienced Contract Research Organization ("CRO") to plan and direct thetrials. Clinical teams have been assembled and include principalinvestigators, co-investigators, monitors, technicians, statisticians andcoordinators.

Clinical studies provide data regarding clinical accuracy and usefulness.Key study endpoints in the trial will be AppyScore's sensitivity,specificity, negative predictive value, positive predictive value andappendicitis prevalence. The company must prove the clinical performancecharacteristics of the final device to support the proposed intended usestatement as an aid in the diagnosis of appendicitis.

Following consultations between AspenBio management, the CRO and theindependent statisticians, a determination was made to increase enrollmentof the clinical trial to approximately 800 patients. This is expected toprovide higher statistical power allowing for more definitive support ofthe AppyScore's test performance and medical value.

In addition to performance results in the clinical trial, AppyScore's510(k) clearance process also requires the submission of a non-clinicaldata package. Non-clinical studies are required to demonstrate assayperformance characteristics, like accuracy and precision. The company is inthe final stages of completing this non-clinical section for the 510(k)submission package.

Based upon the rate of recent pilot patient enrollments, AspenBio expectsthe FDA clinical trial to be completed in approximately four to six monthsand thereupon, the company plans to submit the results to the FDA as partof a final data package. After the data has been successfully reviewed bythe FDA, final steps will include determining the product label claims,which are also subject to FDA approval. The company looks to complete thisprocess and anticipates FDA 510(k) clearance in early 2009.

AspenBio Pharma president and CEO, Richard Donnelly, stated: "Theinitiation of this clinical trial is a major milestone for AspenBio in ourefforts to commercialize the first and only known blood test for humanappendicitis and what has been heralded by analysts as a medicalbreakthrough. We are encouraged by the pilot results we have achieved todate, and we have great confidence in the highly experienced andprofessional team overseeing this trial process and FDA submission."

While the company remains optimistic that the AppyScore test will besuccessful in achieving FDA clearance, since the trial is a totally blindindependent clinical study, the final data and successful clinicalperformance cannot be assured or known until the study is completed.

Meanwhile, AspenBio continues to advance AppyScreen(TM), a secondgeneration, revised format point-of-care version of the appendicitis test.AppyScreen is a rapid appendicitis blood screen test designed for use inphysician offices and urgent care facilities throughout the world. Manychildren and young adults complaining of abdominal pain are taken to theirfamily physician's office or an urgent care facility for medical attentionrather than to a traditional hospital emergency room. The AppyScreen bloodtest system is designed as a valuable new screening tool to help physiciansmake better decisions on ruling out appendicitis conditions or recommendingpatients have further work-up at the hospital emergency room.

Before year-end, the company looks to complete the development of thissimplified point-of-care test version AppyScreen, which preliminarily hasbeen able provide results significantly more rapidly than thefirst-generation AppyScore. The company has executed agreements to have afinal prototype of this device developed in 2008.

AspenBio continues to seek a potential worldwide licensing partnership ortransaction for AppyScore in the upcoming months, and would accelerate thatprocess upon the successful completion of the clinical trial and submissionof the final package for FDA 510(k) clearance. While the exact timing ofthese events cannot be determined, the company looks to achieve a worldwidelicensing partnership or transaction prior to the FDA 510(k) clearance forAppyScore.

About AspenBio Pharma, Inc.

AspenBio Pharma is an emerging bio-pharmaceutical company dedicated to thediscovery; development, manufacture, and marketing of novel proprietaryproducts, including those that enhance the reproductive efficiency ofanimals and that have large worldwide market potential. The company wasoriginally formed to produce purified proteins for diagnostic applicationsand has become a leading supplier of human hormones to many of the nation'slargest medical diagnostic companies and research institutions. The companyhas successfully leveraged this foundational science and technologyexpertise to rapidly develop an enviable late-stage pipeline of severalnovel reproduction hormone analogs for wide-ranging therapeutic useinitially in bovine and equine species. AspenBio Pharma continues toadvance the development and testing of its two first-generation blood-basedhuman diagnostic tests designed to rapidly help diagnose or rule outappendicitis in patients complaining of abdominal pain. For moreinformation, 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, includedin the press release that address activities, events or developments thatAPPY believes or anticipates will or may occur in the future areforward-looking statements. These statements are based on certainassumptions made based on experience, expected future developments andother factors APPY believes are appropriate in the circumstances. Suchstatements are subject to a number of assumptions, risks and uncertainties,many of which are beyond the control of APPY. Investors are cautioned thatany such statements are not guarantees of future performance. Actualresults or developments may differ materially from those projected in theforward-looking statements as a result of many factors, includingstatements regarding the ability to successfully complete the clinicaltrials and pivotal studies required for FDA submission, obtain FDA approvalfor, cost effectively manufacture and generate revenues from theappendicitis test as well as the animal products under this agreement andother new products, execute agreements required to successfully advance thecompany's objectives, retain the scientific management team to advance theproducts, overcome adverse changes in market conditions and the regulatoryenvironment, fluctuations in sales volumes, obtain and enforce intellectualproperty rights, and realization of intangible assets. Furthermore, APPYdoes not intend (and is not obligated) to update publicly anyforward-looking statements. The contents of this news release should beconsidered in conjunction with the warnings and cautionary statementscontained in APPY's recent filings with the SEC.

For more information contact:

AspenBio Pharma, Inc.
Gregory Pusey
Chairman
Tel 303-722-4008

Investor Relations:
Liolios Group, Inc.
Geoffrey Plank or Ron Both
Tel 949-574-3860



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