AspenBio Pharma, Inc. (Nasdaq: APPY), an in vitro diagnostic company, today provided a clinical and business update for the third quarter 2012. The Company reported it has started the hospital training phase of its pivotal U.S. clinical study and remains on track to initiate patient enrollment before the end of the year. AspenBio also reiterated its anticipated timeline for obtaining CE Mark for its lead blood-based diagnostic test by year end, and provided an update on market development activities in Europe, including its discussions with potential commercial distributors.
Steve Lundy, Chief Executive Officer of AspenBio Pharma, commented, "We're happy with the progress made since our last update. We updated our clinical trial protocol for the pivotal study, incorporating the FDA's feedback from our September meeting, and have begun training our hospital sites, preparing them to begin enrolling patients. This is a key development for AspenBio, because it sets the foundation for a clinically successful trial and brings us closer to potential FDA clearance and commercialization of our in vitro diagnostic test in the United States. In parallel, we've advanced our negotiations significantly with European distributors in key commercial territories, engaged an experienced Europe-based sales and marketing consultant, and continued to scale up our product manufacturing activities in order to maximize our potential for a timely and successful European product launch after obtaining CE Mark."
AspenBio expects to continue training the remaining hospital sites on the trial protocol over the coming weeks in order to advance to patient enrollment before the end of the year. Once enrollment commences, the study is expected to enroll a total of ~2,000 net evaluable patients at approximately 25 hospital emergency departments across the United States. AspenBio plans to complete this study, file for marketing clearance, and upon receipt of such clearance from the FDA, launch the product in the U.S. in late 2013.
In Europe, the Company is currently pursuing agreements with top distributors in what AspenBio believes will be major sales territories, including Germany, UK, France, Italy and Benelux. The Company expects to file for and obtain CE Mark for its diagnostic test before the end of the year and hopes to be positioned to commence sales and distribution efforts as soon as possible thereafter.
At September 30, 2012, the Company had $10.2 million in cash, cash equivalents and short-term investments. AspenBio believes it has sufficient cash to complete the planned pivotal trial, as well as launch the product in Europe.
Mr. Lundy concluded, "This is a critical time in the Company's history, with many exciting regulatory, development and commercial initiatives ongoing. We remain deeply focused on execution of these important milestones, and we look forward to providing additional near-term updates as we advance toward commercialization of our first diagnostic product."