QuantRx(R) Biomedical's FluoroPharma Unit to Begin Phase I Clinical Trials for CardioPET(TM) Imaging Agent for Coronary Disease
DOYLESTOWN, PA -- (MARKET WIRE) -- October 03, 2006 -- QuantRx® Biomedical Corporation (OTCBB: QTXB), an emerging leader in the research and development of medical diagnostic platforms and products, is pleased to announce that its affiliate company FluoroPharma, Inc. has begun Phase I clinical trials for CardioPET™, a novel cardiac viability imaging agent. The product has been developed to allow acute and chronic coronary artery disease to be assessed while patients are at rest.
"Initiating the CardioPET clinical program represents a significant stride for QuantRx and our affiliated FluoroPharma unit. Our approach to proprietary diagnostic imaging products such as CardioPET, as well as our other products for both consumer and professional use, is driven not just by innovation but also by a clear understanding of market requirements," Walter Witoshkin, QuantRx Biomedical president and chief executive officer, said.
"Importantly, the CardioPET process makes possible this important diagnostic cardiac examination for those patients who cannot undergo the exertion of standard treadmill stress tests. As such, CardioPET brings this diagnostic process to a greater number of patients, and has the potential to trim healthcare costs," Mr. Witoshkin said, adding that FluoroPharma estimates that approximately 20 percent of patients with suspected coronary artery disease cannot undergo the exertion of a treadmill test and would be ideal candidates for the non-invasive nature of the CardioPET technique.
The recently announced move to Phase I trials follows Boston-based FluoroPharma's filing with the Food and Drug Administration of an investigational new drug (IND) application for CardioPET, the company's first such application.
The Phase I trial, which has received institutional review board approval, is a single-center, open-label study designed to evaluate safety, distribution and dosimetry of CardioPET as a positron emission tomography (PET) tracer for myocardial imaging in healthy subjects. The study is to be led by Dr. Alan J. Fischman, Director of the Nuclear Medicine Division of Massachusetts General Hospital and a highly respected leader in PET uses and techniques.
"The commencement of the CardioPET clinical program as well as filing of the CardioPET IND with the FDA is an important step for FluoroPharma. We look forward to further advancing both CardioPET and our other PET imaging agents," said Dr. David Elmaleh, founder and chairman of FluoroPharma, an affiliated unit of QuantRx that is engaged in the discovery, development and commercialization of proprietary diagnostic imaging products from the PET market. Its PET imaging agents, which allow detection and assessment of acute and chronic forms of coronary disease, have been designed to rapidly target either the myocardial cells within the heart or vulnerable plaques within coronary arteries.
About QuantRx Biomedical
QuantRx Biomedical Corporation (OTCBB: QTXB) is an emerging leader in the research and development of medical diagnostics, specializing in creating, acquiring and commercializing diagnostic platforms and developing products, based on its core intellectual property, for both professional and consumer use. The company's technology portfolio includes rapid point-of-care testing products that bring medical information directly to the healthcare provider or the patient; genome-based diagnostics chips for medical professionals and institutions; PAD technology for diagnosis and treatment of women's health concerns and other medical needs; and diagnostic imaging products for the positron emission tomography (PET) market.
QuantRx has corporate offices in Doylestown, Pennsylvania, and its research and development and pre-manufacturing facility in Portland, Oregon. The Company holds significant positions in FluoroPharma, Inc., a Boston-based molecular imaging company, and Genomics USA, Inc., a Chicago-based developer of microarray technology for DNA testing.
This release may contain forward-looking statements within the meaning of the federal securities laws. Such forward-looking statements reflect, among other things, management's current expectations, plans and strategies, and anticipated financial results, all of which are subject to known and unknown risks, uncertainties and factors that may cause our actual results to differ materially from those expressed or implied by these forward-looking statements. Many of these risks are beyond our ability to control or predict including the company's need for additional funds, the company's dependence on a limited number of imaging compounds, the early state of the products the company is developing, uncertainties relating to clinical trials and regulatory reviews, competition and dependence on collaborative partners, the company's ability to avoid infringement of the patent rights of others, and the company's ability to obtain adequate patent protection and to enforce these rights. Because of these risks, uncertainties and assumptions, you should not place undue reliance on these forward-looking statements. Furthermore, forward-looking statements speak only as of the date they are made. FluoroPharma does not undertake any obligation to update or review any such forward-looking information, whether as a result of new information, future events or otherwise.