AspenBio Pharma Reports Second Quarter 2007 Results
Richard Donnelly, AspenBio's president and CEO, said, "Recent productdevelopment activities demonstrate substantial progress in the second quarter.We remain confident that 2007 will be a major inflection point for AspenBio,as we proceed towards achieving key milestones and delivering on important newproducts, like our breakthrough appendicitis triage blood tests, AppyScore(TM)and AppyScreen(TM)."
Mr. Donnelly further stated, "Following the 2007 second quarter completionof the conversion of warrants that increased our cash position to more than$11 million, we have accelerated development of our key products. Thisincludes making important additions to our scientific staff, engaging wellknown FDA consultants, and signing high quality contract manufacturers toadvance both the appendicitis blood tests and BoviPure FSH(TM) products. Wecontinued to see positive field trial results for all of our top products."
Second Quarter 2007 Key Highlights
AppyScore & AppyScreen: Substantial progress was made in the developmentof AspenBio's breakthrough products; AppyScore Appendicitis Triage Blood Testfor emergency rooms, and its sister product, AppyScreen (being designed as apoint-of-care test for physician offices). Results from the ongoing 400-patient pre-United States Food and Drug Administration ("FDA") trials of theAppyScore blood test continue to demonstrate high sensitivity levels of 94% to97% in the ability to identify patients with appendicitis. While this pre-FDAtrial has taken longer than originally anticipated to complete, this hasallowed us to fine tune specific aspects of blood collection as well as thepractical use of the test in a hospital clinical setting. The company iscurrently engaged with multiple hospital sites for the collection ofadditional trial samples.
AspenBio has also commenced initial steps for the U.S. FDA approvalprocess for AppyScore with the engagement of three widely recognized FDAdevice registration consultants to assist with the process. The companyexpects an initial meeting with the FDA on the AppyScore Appendicitis TriageBlood Test to occur within the next thirty to forty-five days. AspenBio hasalso executed contracts with FDA-approved diagnostic test manufacturersrelated to assay development, GMP manufacturing, and validation of differentversions of the first generation AppyScore and AppyScreen test formats. Theon-going 400 patient pre-FDA trial is anticipated to be completed by the endof September, with an announcement of the data planned shortly aftercompletion. These activities, if successfully completed, put the firstgeneration of AppyScore on a timeline for introduction in the United States in2008.
BoviPure FSH: AspenBio Pharma announced in July it had filed and receivedan INADA file number for BoviPure FSH (bovine follicle stimulating hormone) toofficially start the FDA approval process. Additionally, in order tofacilitate the product advancement, AspenBio also executed a contract withAppTec Laboratory Services, Inc. ("AppTec") for the required GMP manufacturingand validation of this product. This advancement follows a similar path thatcommenced in January for StayBred(TM) (a/k/a BoviPure LH(TM), an LH analog forcows), AspenBio's largest market potential, single-chain, reproduction-enhancing drug.
BoviPure FSH, the company's second largest market potential livestock drug,is currently advancing ahead of schedule with the initiation of the FDAapproval process. This drug is designed to aid in super-ovulation for embryotransfer in dairy and beef cows throughout the world. It will compete in aniche market comprised of a "small eas
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