SCIENCES, INC. TO HUMANIZE ITS UNIQUE MONOCLONAL ANTIBODY
Has Multiple Therapeutic Applications In The Management
Of Thrombosis And As A Potential Cancer Therapeutic
New York - March 22, 2000 - American Biogenetic Sciences,
Inc. (ABS)(OTCBB:MABA), announced today that it is
seeking a partner to humanize the company's patented
anti-fibrin monoclonal antibody MH-1. This antibody
has proved to be a safe, rapid and effective diagnostic
imaging agent for detection of thrombi (blood clots)
such as deep vein thrombosis (DVT) and pulmonary embolism
(PE). The product has several other clinical applications.
ABS has obtained a license for the patented technology
for humanizing monoclonal antibodies from the Medical
Research Council of Great Britain.
MH-1 imaging agent is an antibody that is highly specific
for polymeric fibrin, a major component of a blood
clot", explained Professor G. V. R. Born, MB.CHB.
D. Phil., Director of the William Harvey Research
Institute, St. Bartholomew's Hospital, London, England,
and a Director of ABS. "I strongly support the decision
to humanize this monoclonal antibody given its properties
and its clinical imaging ability. In phase I/II human
clinical trials, MH-1 imaging agent clearly detected
pulmonary embolism and deep vein thrombosis, two serious
thrombotic conditions with high associated morbidity.
The properties of this antibody are likely to make
it suitable, if humanized, for use in the treatment
of clinical indications including thrombolysis (the
break up of a blood clot)."
The U.S. Food & Drug Administration (FDA) has accepted
the completion of Phase I studies of MH-1 for imaging
DVT and PE. The agent was used successfully in fifty
patients. Furthermore, the FDA has allowed the company
to proceed with Phase I/II clinical studies.
- In pre-clinical
studies MH-1 has demonstrated antithrombotic effects
for both fibrin and platelet deposition. Humanization
of MH-1 will have potential for multiple and/or
continuous dosing for prevention of clot formation.
- In pre-clinical studies
MH-1 has demonstrated utility as a site-specific
delivery vehicle for thrombolytics (clot dissolving
drugs). The extremely high specificity of MH-1 for
cross-linked fibrin permits site directed thrombolysis.
This should translate as a subsequent and significant
reduction in the dose of thrombolytic administered,
which confers a major reduction in risk of bleeding.
- Recent in vitro
studies have demonstrated the utility of MH-1 for
imaging fibrin deposition on live A375 (human myeloma)
cells via confocal laser scanning microscopy. This
agent may therefore have potential in imaging fibrin
deposition during tumor build up in vivo, thereby
allowing anti-cancer agents to be attached to MH-1
for site directed anti-tumor genesis.
recent study entitled "Therapeutic and Diagnostic
Monoclonal Antibodies", published by Decision Resources,
predicted that revenues from therapeutic monoclonal
antibodies in seven major pharmaceutical markets (U.S.,
Japan and five European countries) will grow from
about $500 million in 1998 to a total of $4.4 billion
in 2008. Currently there are at least eight therapeutic
antibodies sold in the US for a range of disorders
including cardiovascular disease, cancer, and organ
rejection. The Pharmaceutical Research and Manufacturers
of America have reported that monoclonal antibodies
comprised 20% of all biopharmaceuticals in clinical
development in 1998.
Biogenetic Sciences, Inc. based in Copiague, N.Y.,
researches and develops diagnostic tests for cardio-pulmonary
conditions and infectious diseases, as well as new
treatments for neurological disorders including epilepsy,
migraine, mania, Parkinson's disease and Alzheimer's
disease. ABS also seeks out new technologies and conducts
research and development through its Global Scientific
Network in the United States, Europe, Israel, Russia
in this release that are not strictly historical are
"forward looking" statements within the meaning of
the Private Securities Litigation Reform Act of 1995,
and should be considered as subject to various risks
and uncertainties that could cause actual results
to differ materially from those anticipated. For further
details and a discussion of these risks and uncertainties,
see the Companys' Securities and Exchange Commission
filings including their annual report of Form 10-K.