FluoroPharma Medical, Inc. (OTCBB:FPMI), a company specializing in
the development of breakthrough molecular imaging products that
utilize positron emission tomography (PET) technology for the
detection and assessment of pathology before clinical manifestation
of diseases, announced today the release of a company overview as
presented by FluoroPharma's President, CEO and Chairman of the
Board, Thijs Spoor. This second "State of the Union" address serves
to provide shareholders with a perspective on the company, its
evolution and future potential.
Mr. Spoor began the communication by stating, "Our company
vision is clear, our financial position is sound, our promising
product portfolio is on track and our company is led by a highly
qualified team with significant and directly applicable experience
in the successful development of radiopharmaceuticals. Our
comprehensive technology platform was developed by scientists at
the Massachusetts General Hospital and we are well positioned to
capitalize on its superior technology."
"As we advance our business model, we recognize the importance
of keeping shareholders informed, and it is with this intention
that I present this to you today."
Our Business Outlook
FluoroPharma is looking to capitalize on the growth of PET in
cardiac diagnostics. In development are three novel cardiac
PET radiopharmaceuticals, two of which are in clinical-stage and
have advanced to phase II clinical. The third candidate is in the
pre-clinical, early development stage.
FluoroPharma's products are aimed at improving overall patient
care via improved disease detection and could potentially
provide greater diagnostic accuracy compared to currently
employed nuclear imaging agents and modalities, increase the use of
PET in cardiac imaging, and help reduce the number of unnecessary
diagnostic and therapeutic procedures.
In the U.S., there are estimated to be more than 2 million PET
imaging procedures done per year according to Biotech Systems –
although the vast majority of these scans are for the diagnosis of
cancer. PET is becoming more established in the cardiac setting as
several factors have led to a shift in favor of PET for the
diagnosis of cardiac disease.
Roughly one-third of all Americans are estimated to have some
form of cardiovascular disease, with approximately 13 million
people suffering from coronary artery disease. Cardiovascular
disease is the number one leading cause of death in the U.S.,
claiming almost one million lives per year. People with
cardiovascular disease typically have an accumulation of plaque
within the walls of the coronary arteries (i.e. - atherosclerosis)
that supply the myocardium (heart muscle) with oxygen. Known as
coronary artery disease (CAD), the condition is progressive and can
result in severely reduced supply of blood to the heart (i.e. -
myocardial ischemia or ischemic heart disease). Acute coronary
syndrome (ACS) is a term used to describe symptoms of the disease,
such as chest pain or a heart attack. As these symptoms may not be
present until the disease has progressed to an advanced stage,
barring a reliable diagnosis and appropriate intervention, CAD is
often fatal. Cardiac imaging is used to diagnose CAD and to
determine the presence and severity of ischemic heart disease and
the related risk of suffering a heart attack. It is also used to
help determine the most appropriate course of treatment.
Our Portfolio
FluoroPharma's initial focus is the development of innovative
positron emission tomography (PET) imaging agents for the efficient
detection and assessment of acute and chronic forms of coronary
artery disease (CAD). The FluoroPharma team is advancing two
products in clinical trials for the assessment of cardiac disease.
These first in class novel diagnostic agents have been designed to
rapidly target myocardial cells. Other products in the pipeline
include imaging agents for detection of a bio-marker associated
with Alzheimer's disease and imaging agents that could potentially
be used for imaging specific cancers.
CLINICAL PROGRAMS: FLUOROPHARMA'S DEVELOPMENT
PIPELINE
CardioPET: Cardiac Viability
The Company has advanced CardioPET, a Flourine-18 labeled
tracer, to Phase II. CardioPET, FluoroPharma's first in class
diagnostic agent, is being developed for the detection and
assessment of acute and chronic forms of coronary disease that
affects millions of patients worldwide. CardioPET, a novel
molecular imaging agent is a perfusion and fatty acid uptake
indicator, which is designed to be used as a cardiac imaging agent
that may be a more specific alternative to currently available
diagnostic tests. Its pharmacokinetic characteristics could be
especially valuable in patients who are unable to exercise.
CardioPET is designed to provide metabolic information in
addition to perfusion in the evaluation of the heart. FluoroPharma
believes that CardioPET may be used for cardiovascular assessment
not only through perfusion evaluation but also through its ability
to specifically identify heart tissue that has suffered an acute
episode of ischemia (insufficient blood flow), but is still viable.
Identifying such myocardium, also referred to as hibernating or
stunned myocardium, from non-viable scar tissue is important
because it is well documented that revascularization in patients
with substantial areas of stunned myocardium results in improved
left ventricular function and survival. The company believes that
CardioPET, if approved, may have significant advantages over
currently utilized tests in cardiac evaluation, by including
assessment of cardiac viability.
BFPET: Myocardial Perfusion Imaging
Also advancing to Phase II is FluoroPharma's BFPET, a novel
blood-flow imaging agent for myocardial perfusion imaging with the
potential for measuring cardiovascular blood flow. BFPET, a
Flourine-18 labeled tracer, has been designed to enter the
myocardial cells in direct proportion to blood flow and cell
membrane potential. These are two of the most important
physiological indicators upon which adequate blood supply to the
heart depends. BFPET has been designed to differentiate among those
cells of the myocardium that may be ischemic, infarcted and those
that are healthy.
Ischemic and infarcted cells should take up less BFPET than
healthy myocardial cells. The signal emitted by BFPET should
be inversely proportional to the extent of myocardial injury.
Therefore, FluoroPharma believes that ischemic heart tissue can be
reliably detected by using BFPET.
VasoPET: Vulnerable Plaque
FluoroPharma is developing VasoPET as a novel molecular imaging
agent for the detection of vulnerable coronary artery plaque in
patients with Coronary Artery Disease. The vulnerable (unstable)
atherosclerotic plaque is recognized to be the primary culprit for
the occurrence of myocardial and cerebral infarctions.
Rupture of such an atherosclerotic plaque triggers the formation
of thrombi (blood clots) overlying the plaque, which frequently
detach and occlude (clog) the vessels downstream, resulting in
myocardial ischemia and/or myocardial infarction. In addition a
ruptured plaque can "shed" cholesterol fragments "debris" from the
plaque itself that also cause vessel occlusion as they move
downstream. The risk for rupture and subsequent clinical
consequences (such as a heart attack) is currently thought to
correlate more with the presence of inflammation in the plaque than
plaque size and arterial narrowing.
The detection of vulnerable plaque in atherosclerotic lesions is
a desirable goal and to date remains both a significant unmet
clinical objective and a substantial market opportunity.
VasoPET, if approved, may represent the first PET agent to image
inflamed vascular plaque and could potentially differentiate
between vulnerable and stable coronary artery plaque.
VasoPET has completed preclinical testing and preparation for an
investigational new drug (IND) application is underway.
FluoroPharma's portfolio also includes diagnostics for the early
detection of Alzheimer's disease.
AZPET: Early detection of Alzheimer's
disease
FluoroPharma's early stage AZPET agents include an approach for
directly imaging beta-amyloid plaque and the compensatory receptor
systems in the elderly. Alzheimer's disease patients may
benefit from new treatments that have the potential to slow down
disease progression and impact the healthcare costs associated with
Alzheimer's disease. Imaging and follow up with drugs like AZPET
could allow these patients to receive the proper treatment
earlier.
INTELLECTUAL PROPERTY
FluoroPharma obtained the licenses to the patents (composition
of matter and some method of use patents) of the proprietary
technology and indications related to their products from the
Massachusetts General Hospital (MGH).
There are currently four patents issued and seven patent
applications pending. Any future patent applications are expected
to be initiated by FluoroPharma.
SUMMARY
"I have recently attended the Annual Meeting for the Society of
Nuclear Medicine and Molecular Imaging, and I am encouraged and
confident that FluoroPharma's pipeline of innovative products is in
alignment with the Society's direction of developing novel imaging
strategies, applicable to the era of molecular and personalized
medicine. Scientific presentations and education sessions
provided further support for advances in cardiac PET imaging and as
presented in the meeting highlights lecture, more than 50% of the
cardiology abstracts incorporated PET as a platform," noted Mr.
Spoor.
"The future for diagnostic imaging procedures with higher
sensitivity and specificity is promising as they provide early and
more accurate information to enable more effective treatment and
follow-up of its efficacy. Early treatment means saving the patient
from long and expensive hospital stays, which results in less time
away from family and work."
"Our future is defined by the potential of the market, and that
too is strong. A high growth market provides burgeoning
opportunities and we will be well positioned to seize those
opportunities," notes Mr. Spoor.
"As personalized medicine evolves, patients will see medical
diagnostic products matched closely to therapeutics, such that they
are more likely to be prescribed the exact treatment for their
condition," states Mr. Spoor. "This will improve chances for cure
and reduce unnecessary costs and side effects."
"And as we look forward to advances in science and medicine,
FluoroPharma's goal is to enable personalized medicine by enabling
the physician to prescribe the right medicine, for the right
person, at the right time for the right outcome. This is only
possible with the right diagnostics."
Forward-Looking Statements
Except for historical information contained herein, the
statements in this release are forward-looking. Forward-looking
statements are inherently unreliable and actual results may differ
materially. Examples of forward looking statements in this news
release include statements regarding FluoroPharma's research and
development activities and anticipated operating results. Factors
which could cause actual results to differ materially from these
forward-looking statements include such factors as significant
fluctuations in expenses associated with clinical trials, failure
to secure additional financing, the inability to complete
regulatory filings with the Food and Drug Administration, the
introduction of competing products, or management's ability to
attract and maintain qualified personnel necessary for the
development and commercialization of its planned products, and
other information that may be detailed from time to time in
FluoroPharma's filings with the United States Securities and
Exchange Commission. FluoroPharma undertakes no obligation to
publicly update or revise any forward-looking statements, whether
as a result of new information, future events or otherwise.
About FluoroPharma Medical
FluoroPharma is a biopharmaceutical company engaged in the
discovery and development of proprietary PET imaging products to
evaluate cardiac disease at the cellular and molecular levels. The
Company has licensed technology from the Massachusetts General
Hospital in Boston.
The Company's goal is to enable personalized medicine through
advanced imaging products that will help the medical community
diagnose disease more accurately at the earliest stages, leading to
more effective treatment, management and better patient
outcomes.
The Company's initial focus is the development of breakthrough
positron emission tomography (PET) imaging agents for the efficient
detection and assessment of acute and chronic forms of coronary
artery disease (CAD). FluoroPharma is advancing two products in
clinical trials for assessment of acute and chronic forms of
coronary disease. These first in class agents have been designed to
rapidly target myocardial cells. Other products in development
include agents for detection of inflamed atherosclerotic plaque in
peripheral arteries, agents with the potential to image Alzheimer's
disease and agents that could potentially be used for imaging
specific cancers.
In addition to the United States, Europe and China, patents
related to FluoroPharma's portfolio of imaging compounds have been
issued in Japan, Canada, Australia, Finland, Portugal, Ireland and
Mexico. For more information on the Company, please visit:
www.fluoropharma.com
CONTACT: Carol J. Perlman
cperlman@fluoropharma.com
917-592-9260
FluoroPharma Medical (CE) (USOTC:FPMI)
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부터 11월(11) 2024 으로 12월(12) 2024
FluoroPharma Medical (CE) (USOTC:FPMI)
과거 데이터 주식 차트
부터 12월(12) 2023 으로 12월(12) 2024