Richard Davies wrote: The UK has a good crop of technology pioneers in cloud computing - for example ElasticHosts, FlexiScale, Flexiant, OnApp - and also some strong government initiatives such as G-Cloud.
We will have to see whether this kind of technical leadership converts into swift mass-market adoption or not.
MIAMI, FL -- (MARKET WIRE) -- 10/31/06 -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR," or the
"Company") announced today that it has formed an alliance with the
Wadsworth Center of the New York State Department of Health in Albany, New
York and Lovelace Respiratory Research Institute (LRRI) in Albuquerque, NM,
to build upon expertise in testing RiVax(TM), DOR's recombinant vaccine
against ricin toxin, to protect against inhalation and oral toxin exposure.
The Company has been developing RiVax(TM), a subunit vaccine against ricin
toxin, by leading a consortium of academic and industry vaccine
investigators under funding from National Allergy and Infectious Diseases
(NIAID). DOR's consortium effort began in 2004 with an initial $6.4
million grant award. Recent grant funding of an additional $4.8 million
has broadened the development capabilities of the program.
The additional capability in the development of animal models is essential
to validate vaccine safety and efficacy under the FDA "two animal" rule,
which dictates that products that cannot be ethically tested in humans must
be tested for efficacy in animals where the correlates of human protection
are well understood. These additional models will be co-developed in
conjunction with LRRI, who have established facilities for handling
aerosolized toxins. In addition, animal testing for examining the effects
of aerosolized ricin toxin and vaccine-induced protection on mucosal
surfaces in the stomach and intestine will be performed using models
developed by Dr. Nicholas Mantis at the Wadsworth Center of the New York
State Department of Health in Albany.
In the development of RiVax(TM), DOR has been working closely with the
University of Texas Southwestern Medical Center (UTSW) where new research
facilities have been constructed for the testing of animals using aerosols
of ricin toxin. The company has also collaborated with UTSW in the
transition of the product to advanced development. UTSW has also
separately been awarded a complementary grant for $2.2 million over 5 years
to conduct research in fundamental areas to characterize immune responses
in small animals and to develop novel ricin vaccine formulations. The
successful outcome of that research will be factored into further options
for alternate routes of delivery of RiVax(TM).
The Company has collaborated closely with academic and industrial partners
during the initial stages of development of RiVax(TM). Under NIAID grant
arrangements the Company in turn funds the activities of its development
partners, since the unique facilities for animal testing and handling of
select agents, such as ricin toxin, are only in place in a few universities
and laboratories in the country. The new consortium continues with the
contributions of Stanford Research International, in Menlo Park, CA, who
has been working also on small animal models and evaluation for vaccine
potency. The vaccine that is being developed contains an adjuvant system
which is necessary to increase the level of ricin neutralizing antibodies
and also to lengthen the period of immunity to ricin exposure. The
development of an adjuvant formulation has centered on the need for protein
stabilization, which is being pursued with the Pharmaceutical Chemistry
Department at the University of Kansas. The Company in conjunction with
Cambrex Biosciences has already developed large scale purification
processes and has manufactured product under cGMP conditions. This process
will be used in the final adjuvant product for continued late-stage
clinical development.
"The consortium approach to developing medical countermeasures is critical
to the success of this type of project, since the facilities and expertise
needed is distributed among a number of premier institutions, both academic
and industrial," said Robert N. Brey, Ph.D. "The development work we are
performing forms a good working example of how academic institutions and
biotech companies can work together with government for the development of
countermeasures. The early clinical success in demonstrating
seroconversion and induction of ricin neutralizing antibodies underlies the
further development of this vaccine."
Newly Formed Alliance for Biosecurity
As part of the effort to enhance the consortium approach to development of
vaccine and countermeasures for emerging pathogens and bioweapons, DOR is
working closely with the newly formed Alliance for Biosecurity, an industry
group of biotechnology and pharmaceutical companies working in
collaboration with the non-profit Center for Biosecurity of the University
of Pittsburgh Medical Center to promote changes in the way the government
approaches the procurement of such products. The Alliance for Biosecurity
is actively engaging with key officials in Congress, Department of Health
and Human Services (HHS), and FDA to advance effective ways to
significantly accelerate research, development, and procurement of
countermeasures.
Both the House of Representatives and the Senate are now considering
important, bi-partisan bills that will provide for additional advanced
development funding that will structurally improve the BioShield program.
Outside of the direct countermeasure procurements of the BioShield program,
the NIH has funded basic research and development, an effort that has grown
from $53 million in 2001 to $1.8 billion in 2006, and broadly includes
research in a wide area of emerging diseases, including pandemic influenza.
The fundamental work has not yet generated the array of new products that
are needed for procurement.
To accelerate development through BioShield and NIH, the HHS has just
unveiled a new strategy for the development of medical countermeasures to
complement the prioritization of the strategic plan initiated in 2004 under
Project BioShield. This new plan calls for the HHS to define specific
countermeasure requirements in light of the stage of development and to
develop a new integrated research and development portfolio. As a result,
HHS has just published an RFI (request for information) to gather input to
the HHS implementation plan for its strategy document, with the ultimate
goal of acquiring the most appropriate medical countermeasures for
mitigating the health effects from the CBRN threats facing the nation.
About Ricin Toxin
Ricin is a potent plant toxin derived from castor beans. It is easily
manufactured and purified, heat stable, and is classified by the CDC as a
Category B biothreat. Ricin is a potent inhibitor of protein synthesis in
mammalian cells. Exposure to ricin leads to irreversible tissue damage,
especially if it is inhaled, shock-like symptoms and multi organ failure
that can result in death in several days.
About Lovelace Respiratory Research Institute
Lovelace Respiratory Research Institute is a not-for-profit research
institution founded in 1947 by Dr. William Randolph Lovelace II. It is one
of the nation's largest independent research institutions and the only one
focused solely on respiratory health. Scientists at LRRI are committed to
eradicating respiratory diseases through research aimed at understanding
their causes and biological mechanisms, eliminating exposures to causal
agents, and developing more effective treatments.
About the Wadsworth Center of the NYS Department of Health
The Wadsworth Center is the reaserch arm of the New York State Department
of Health. As a public health laboratory, Wadsworth conducts programs in
comprehensive biomedical and environmental research based on the tenet that
in order to fulfill its regulatory and analytical missions most
effectively, innovative approaches to investigating diseases and
environmental hazards of public health concern must be pursued.
About the Alliance for Biosecurity
The Alliance for Biosecurity was formed in June of 2005 by pharmaceutical
companies, biotechnology companies and the Center for Biosecurity of the
University of Pittsburgh Medical Center. Alliance members are committed to
partnering with government and promoting a new era in the prevention and
treatment of severe infectious diseases -- particularly those that present
global security challenges -- through innovative and accelerated research,
development and production of countermeasures. Company members of the
Alliance include: Acambis, Inc., Caprion Pharmaceuticals, Inc., DOR
BioPharma, Inc., Dynport Vaccine Company, Elusys Corporation. Emergent
BioSolutions, GlaxoSmithKline, Human Genome Sciences, Inc., Novartis
Vaccines and Diagnostics, Inc., Pfizer, Inc., PharmAthene, and VaxGen, Inc.
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company developing products for
life-threatening side effects of cancer treatments, serious
gastrointestinal diseases, and bioterrorism. Our lead product, orBec®
(oral beclomethasone dipropionate), is a potent, locally acting
corticosteroid being developed for the treatment of gastrointestinal
Graft-versus-Host disease (GI GVHD), a common and potentially
life-threatening complication of bone marrow transplantation. DOR
BioPharma has recently filed a New Drug Application (NDA) with the FDA for
orBec® for the treatment of GI GVHD. orBec® may also have applications
in treating other gastrointestinal disorders characterized by severe
inflammation.
Through our BioDefense Division, we are developing biomedical
countermeasures pursuant to the recently enacted Project BioShield Act of
2004. Our biodefense products in development are recombinant subunit
vaccines designed to protect against the lethal effects of exposure to
ricin toxin and botulinum toxin. Our ricin toxin vaccine, RiVax(TM), has
successfully completed a Phase I clinical trial in normal volunteers.
For further information regarding DOR BioPharma, please visit the Company's
website located at http://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, Inc.'s current expectations about its future results,
performance, prospects and opportunities, including statements regarding
the potential use of orBec® for the treatment of gastrointestinal GVHD
and the prospects for regulatory filings for orBec®. Where possible, DOR
has tried to identify these forward-looking statements by using words such
as "anticipates," "believes," "intends," 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 cannot assure you that it will be able to successfully
develop or commercialize products based on its technology, including
orBec®, particularly in light of the significant uncertainty inherent in
developing 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 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 obtain any further grants and awards,
maintain its existing grants which are subject to performance, enter into
any biodefense procurement contracts with the U.S. Government or other
countries, that the U.S. Congress may not pass any legislation that would
provide additional funding for the Project BioShield program, that it will
be able to 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.
Important factors which may affect the future use of orBec® for
gastrointestinal GVHD include the risks that: because orBec® did not
achieve statistical significance in its primary endpoint in the pivotal
Phase III clinical study (i.e. a p-value of less than or equal to 0.05),
the FDA may not consider orBec® approvable based upon existing studies,
orBec® may not show therapeutic effect or an acceptable safety profile in
future clinical trials, if required, or could take a significantly longer
time to gain regulatory approval than DOR expects or may never gain
approval; DOR is dependent on the expertise, effort, priorities and
contractual obligations of third parties in the clinical trials,
manufacturing, marketing, sales and distribution of its products; or
orBec® may not gain market acceptance; and others may develop
technologies or products superior to orBec®. These and other factors are
described from time to time in filings with the Securities and Exchange
Commission, including, but not limited to, DOR's most recent reports on
Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise
any forward-looking statements as a result of new information, future
events, and changes in circumstances or for any other reason.
Company Contact:
Evan Myrianthopoulos
Chief Financial Officer
(786) 425-3848 www.dorbiopharma.com