BOSTON, Sept. 22 /PRNewswire/ -- FluoroPharma Inc. announced commencement of Phase I clinical trials for CardioPET, following institutional review board (IRB) approval of the proposed studies. The Phase I trial is a single center, open label study, designed to evaluate safety, distribution and dosimetry of CardioPET as a PET tracer for myocardial imaging in healthy subjects. The study will be led by Dr. Alan Fischman, Director of the Nuclear Medicine Division at Massachusetts General Hospital. In May, FluoroPharma filed an Investigational New Drug (IND) application for CardioPET, which is the company’s first IND.
CardioPET is a novel cardiac viability imaging agent in development that allows acute and chronic coronary artery disease to be assessed while patients are at rest. Approximately 20% of patients with suspected coronary artery disease cannot undergo sufficient physical exertion on a treadmill, which is a standard test to assess the disease. FluoroPharma projects that CardioPET may be an accurate alternative to standard treadmill stress-testing in these patients.
“The commencement of the CardioPET clinical program as well as filing of the CardioPET IND with the FDA is an important step for FluoroPharma,” said Dr. David Elmaleh, FluoroPharma’s founder and Chairman of the Board. “We look forward to further advancing both CardioPET and our other PET imaging agents.”
“We are delighted to see FluoroPharma receive IRB approval to start its first clinical trial,” added Walter Witoshkin, a FluoroPharma board member and CEO of QuantRx Biomedical Corporation. QuantRx recently agreed to provide up to $9 million dollars in financing to FluoroPharma to advance the company’s products into clinical trials. Other investors in FluoroPharma include PureTech Ventures.
About FluoroPharma
FluoroPharma is a molecular imaging company engaged in the discovery and development of proprietary products for the PET market. FluoroPharma is advancing three proprietary products for assessment of acute and chronic forms of coronary disease. These agents have been designed to rapidly target either the myocardial cells within the heart or vulnerable plaques within the coronary arteries. http://www.fluoropharma.com
David Elmaleh, FluoroPharma’s scientific founder, is a leader in imaging. In addition to being the director of Contrast Media Chemistry at Massachusetts General Hospital, he created several important imaging agents that are in human use and he was the scientific founder of Molecular Insight Pharmaceuticals.
About QuantRX
QuantRX Biomedical Corporation is a leading biomedical research, development and manufacturing company with corporate offices in Ambler, Pennsylvania. The firm specializes in creating innovative medical technology platforms and products for diagnosis and treatment of a wide range of medical needs.
About PureTech Ventures
PureTech is a life science venture firm specializing in translation of academic innovation. http://www.puretechventures.com
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.
FluoroPharma Inc.
CONTACT: David Elmaleh, of FluoroPharma +1-617-784-0490
Web site: http://www.fluoropharma.com//
