BOSTON, July 23 /PRNewswire/ -- FluoroPharma Inc., a company developing
breakthrough molecular imaging agents for the Positron Emission Tomography
(PET) market, announced positive Phase I results for BFPET, its novel
Fluorine-18 labeled tracer for myocardial perfusion imaging. BFPET is
FluoroPharma's second cardiovascular product to complete Phase I clinical
development.
BFPET is a PET imaging agent, designed to assess the blood flow in the
heart (myocardial perfusion). Myocardial perfusion imaging is a standard
test to assess coronary artery disease (CAD), with more than 9 million
Americans undergoing the test annually. The Phase I trial, led by Principal
Investigator Alan J. Fischman, MD, PhD at the Massachusetts General
Hospital, was designed to evaluate safety, distribution and dosimetry of
BFPET in 12 healthy subjects following a single dose injection at rest.
"BFPET Phase I data demonstrates that the agent has a favorable
dosimetry and pharmacokinetics profile and is well tolerated. All safety
endpoints were achieved with no adverse events and no clinically
significant changes noted in follow-up clinical and laboratory testing,"
said Dr. Fischman, Professor of Radiology at Harvard Medical School.
"Biodistribution results indicate fast blood clearance, rapid and stable
myocardial uptake and high heart to background ratios."
"We are encouraged by the positive initial clinical safety results and
look forward to validating BFPET's performance in the next stage of
development," said Dr. David Elmaleh, FluoroPharma's founder, Chief
Scientific Advisor, and Associate Professor of Radiology at Harvard Medical
School. "The high quality cardiac images obtained in this study indicate
that new cardiac PET imaging agents can expand the applications of PET
beyond the use of FDG (2-18Fluoro-2-deoxy-D-Glucose) in oncology and
neurology. With two cardiac agents in clinical development and a third in
our pipeline, FluoroPharma hopes to pave the way for cardiovascular PET."
"We are delighted to have reached this important clinical milestone as
it addresses the need for innovative agents that draw on the inherently
superior resolution of PET imaging compared to SPECT," said Dr. Kundakovic,
President of FluoroPharma. "There is tremendous opportunity for BFPET, as a
PET alternative in the SPECT dominated myocardial perfusion imaging market.
The use of BFPET in conjunction with PET technology holds the promise to
better quality CAD diagnosis."
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 inflamed plaques
within the coronary arteries. http://www.fluoropharma.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.
See Also:
- Brain and Spinal Injuries in Georgia: A Needs Assessment and State Action Plan
- Instrumentation Laboratory Launches New Corporate Websites
- Pioneer(R) Surgical Technology, Inc. Announces the Market Launch of the SlimFuse(TM) Anterior Cervical Plate System
- 'August is Children's Vision and Learning Month' Public Awareness Campaign Launched by The College of Optometrists in Vision Development (COVD)
- CVS/pharmacy Makes Medication Management Easy with the Introduction of the New CVS.com
[Via Healthcare]
0 коментарі:
Post a Comment