PulmoBioTech Announces Details of Its Regulatory Approval Experiments
25 4월 2008 - 6:16AM
PR Newswire (US)
NEW YORK, April 24 /PRNewswire-FirstCall/ -- PulmoBioTech Inc.
(OTC:PLMO) (BULLETIN BOARD: PLMO) announced today that its
PulmoScience subsidiary has released details of the areas that it
will be investigating as part of the Regulatory Approval
Experiments for Human Trials. The areas are: 1. Efficacy Binding
Studies 2. Characterization of Drug Product Impurities 3. Sterility
Studies 4. Pyrogenicity 5. Immunological Testing 6. Dosimetry 7.
Toxicity PulmoScience will be completing all the relevant tests in
each area and seeking Regulatory sign-off before starting the
detailed Human Trials. This is currently expected to be achieved in
the first half of 2008. About PulmoBioTech Inc. PulmoBioTech Inc.
specializes in the development and marketing of medical technology
and research. Our proven strengths combine extensive commercial
experience and academic credentials. The principal staff members
are acknowledged experts in their specialized field, and work with
a broad range of investment institutions. PulmoBioTech's mission is
to utilize scientific imagination and drive, together with
managerial and financial acumen, to bring innovative and profitable
products to the marketplace to the benefit of all stock holders.
About PulmoScience Inc. PulmoScience Inc. was established in 2006,
and is currently developing a non-invasive Molecular Imaging
technique for the diagnosis of Pulmonary Embolism, Pulmonary
Hypertension and Lung Inflammatory diseases under the trade name
PulmoBind. The company was conceived within the Montreal Heart
Institute "MHI" (a world renowned hospital and educational
facility). Jointly owned by MHI subsidiary Innovacor as the
technical and operational partner, Dr. Jocelyn Dupuis (the
scientific director and originator of the PulmoBind Molecular
Imaging technology), and by PulmoBioTech Inc. as the funding
partner, PulmoScience Inc. aims to develop this unique and exciting
technology, to fund necessary trials, and to bring the products to
market. PulmoScience believes that the market for its product
candidates is worth in excess of $500 million per annum and that,
provided Regulatory Approval is achieved, the safety and efficacy
of its products could allow it to dominate that market. About
PulmoBind PulmoBind uses an intravenously delivered radionuclide
tagged molecule which specifically bonds to the inner walls of the
circulatory system in the lungs, and by the use of an external
Gamma Camera allows an image of the integrity of the blood vessels
throughout the lungs to be seen by a diagnostic clinician.
PulmoScience is currently undertaking Regulatory Approval for Phase
I Human Trials, and while subsequent results from additional tests
might not corroborate the current results, PulmoScience believes
that PulmoBind has the potential to dominate the market for the
diagnosis of Pulmonary Embolism. In particular, this belief is
driven by PulmoScience's expectations of the improved safety and
efficacy that PulmoBind will offer when compared to the current
incumbent nuclear medicine based technology for the diagnosis of
Pulmonary Embolism. In addition, early indications are that
PulmoBind could be highly effective in the early stage diagnosis of
Pulmonary Hypertension, a condition for which there is no current
front line diagnostic test. The addressable market for the product
candidates being developed by PulmoScience is believed by the
company to be worth in excess of $500 million per annum.
Forward-Looking Statements: Forward-looking statements contained in
this and other written and oral reports are made based on known
events and circumstances at the time of release, and as such, are
subject in the future to unforeseen uncertainties and risks. All
statements regarding future performance, earnings projections,
regulatory approval, events or developments are forward-looking
statements. It is possible that the future performance and of the
company may differ materially from current expectations, depending
on economic conditions and the uncertainty of regulatory approval.
A change in economic conditions may have a particularly volatile
effect on results. Among the other factors which may affect future
performance are: competitive market conditions and resulting
effects on sales and pricing; increases in raw-material costs that
cannot be recovered in product pricing; and global economic
factors, including difficulties entering new markets and general
economic conditions such as inflation, interest rates and credit
availability. The company makes these statements as of the date of
this disclosure, and undertakes no obligation to update them.
DATASOURCE: PulmoBioTech Inc. CONTACT: Garry McCann, President of
PulmoBioTech Inc., +011-447-900357945
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