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DOR BioPharma and U.K. Ministry of Defence Execute Letter of Intent for Intranasal Vaccine Technology Demonstrates Broad Application of DOR's Microvax(TM) Technology for a Wide Variety of Biodefense Threats
LAKE FOREST, Ill., Jan 14, 2003 (BUSINESS WIRE) -- DOR BioPharma Inc.
(AMEX: DOR) ("DOR" or the "Company") announced today that it has executed a
letter of intent to exclusively license international patent applications
covering intranasal microencapsuled vaccine technology, including anthrax and
plague invented and tested by the U.K.'s Ministry of Defence (Porton Down),
including PCT patent application numbers WO 00/56282; 00/56362; 00/56361 and
01/70200.
The only FDA approved anthrax vaccine, BioThrax(TM), requires six injections
given over 18 months, with annual booster injections recommended thereafter.
This novel intranasal anthrax vaccine has been developed in the laboratory of
Dr. Diane Williamson and Dr. Helene Flick-Smith at Porton Down, the United
Kingdom's leading military research laboratory, in collaboration with Dr. Oya
Alpar at the University of London School of Pharmacy The research was recently
reported in the journal Infection and Immunity (Flick-Smith, et. al, Apr. 2002,
vol. 70, no.4, p. 2022-2028),
www.ncbi.nlm.nih.gov/entrez/...st_uids=11895967&dopt=Abstract.
This work showed that an experimental microencapsulated intranasally delivered
anthrax vaccine was capable of protecting 100% of animals against lethal
challenge to anthrax spores with only two intranasal administrations of the
vaccine.
The microencapsulated anthrax vaccine technology and data already generated by
the MOD should allow DOR to quickly develop an intranasal anthrax vaccines for
human use which could potentially provide for rapid systemic and mucosal
immunity without needles. The U.S. Government has indicated that it is seeking
to procure an initial 25 million doses of a "Next Generation Anthrax Vaccine."
DOR is aggressively pursuing this and other anthrax vaccine contract
opportunities as well as application of its patented Microvax(TM) synthetic
(non-live) mucosally administered vaccine technology to a number of other
biodefense threats.
DOR's President & CEO, David Kent stated, "We believe the development of a
recombinant intranasal anthrax vaccine may confer greater patient immunity with
a less invasive route of administration." David Kent went onto say, "This
anthrax initiative is an excellent follow-on to our previously announced ricin
vaccine program. We look forward to collaborating with the
United Kingdom's Ministry of Defense and the U.S. Department of Defense on this
important development program."
DOR BioPharma, Inc.
DOR BioPharma, Inc. is a specialty pharmaceutical company specializing in the
oral delivery of approved chemical entities and synthetic (non-live) mucosally
administered vaccines that may conveniently and rapidly confer mucosal immunity
(such as in the lungs) against potentially the entire spectrum of identified
bioterror threats, while completely avoiding the risks associated with vaccines
that contain live replication competent pathogens or genetic material. The
Company's lead product, orBec(R) (oral beclomethasone dipropionate), is
currently in a pivotal phase III clinical trial for the treatment of intestinal
graft-vs.-host disease and the Company is currently testing orBec's(R)
usefulness in treating a large percentage of persons diagnosed with irritable
bowel syndrome (IBS), a disease that affects approximately 35 million persons in
the U.S. alone. The Company's synthetic (non-live) mucosally administered
vaccine Microvax(TM) technology is protected by worldwide issued patents under
license to the Company for various fields of use, including U.S. patents,
6,024,983; 5,942,252; 5,853,763; 5,820,883; 5,814,344; and 5,811,128 as well as
European patents EP 0 266 119 and EP 0 333 523 and other additional
corresponding international patents. For further information regarding DOR
BioPharma, please visit the company's website located at www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of
Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma's
current expectations about its future results, performance, prospects and
opportunities, including its product development and product pipeline. Where
possible, DOR BioPharma has tried to identify these forward-looking statements
by using words such as "anticipates," "believes" or similar expressions. These
statements are subject to a number of risks, uncertainties and other factors
that could cause actual events or results in future periods to differ materially
from what is expressed in, or implied by, these statements. DOR BioPharma cannot
assure you that it will be able to successfully develop or commercialize
products based on its technology, particularly in light of the significant
uncertainty inherent in developing mucosally administered vaccines against
bioterror threats, manufacturing and conducting preclinical and clinical trials
of vaccines, and obtaining regulatory approvals, that its technologies will
prove to be safe and effective, that its cash expenditures will not exceed
projected levels, that it will be able to obtain future financing or funds when
needed, that, that product development and commercialization efforts will not be
reduced or discontinued due to difficulties or delays in clinical trials or due
to lack of progress or positive results from research and development efforts,
that it will be able to successfully enter into profitable biodefense contracts
with the U.S. Department of Defense and other countries, patent, register or
protect its technology from challenge and products from competition or maintain
or expand its license agreements with its current licensors, or that its
business strategy will be successful. These and other factors are described from
time to time in filings with the Securities and Exchange Commission, including,
but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form
10-KSB. DOR BioPharma assumes no obligation to update or revise any
forward-looking statements as a result of new information, future events,
changed circumstances or for any other reason.
CONTACT: DOR BioPharma Inc.
David M. Kent, 847/573-8990
dkent@dorbiopharma.com
www.dorbiopharma.com
or
Redington, Inc.
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