PRINCETON, N.J., March 19, 2013 /PRNewswire/ -- Soligenix,
Inc. (OTCQB: SNGX) (Soligenix or the Company), a clinical stage
biopharmaceutical company, announced today key progress in the
development of ThermoVax™, its proprietary vaccine
thermostabilization technology. Several complementary preclinical
studies have indicated the potential for high temperature stability
for a minimum of six months and increased potency of subunit
vaccines formulated with ThermoVax™. These studies have been
conducted with the Company's proprietary ricin toxin vaccine
(RiVax™) and anthrax vaccine (VeloThrax™) as part of a continuing
program to evaluate the effectiveness of protein subunit vaccines
to withstand extremes of temperature and other environmental stress
conditions. The research and development of ThermoVax™ is
being supported by a $9.4 million
National Institute of Allergy and Infectious Disease (NIAID) grant
to Soligenix for biodefense vaccines to prevent ricin toxin and
anthrax exposure.
ThermoVax™ is a technology that is designed to eliminate the
standard cold chain production, distribution and storage logistics
required for most vaccines. By employing ThermoVax™ during
final formulation of RiVax™ and VeloThrax™, results have shown that
it is possible to produce stable and potent vaccines that are
capable of withstanding temperatures at least as high as 40 degrees
Celsius (104 degrees Fahrenheit) for a minimum of six months.
Recent results also indicate that VeloThrax™ formulated with
ThermoVax™ and subsequently exposed to temperatures as high as 70
degrees Celsius (158 degrees Fahrenheit) for at least one month,
retained full potency in animals as well as other characteristics,
such as receptor binding, indicative of full structural integrity.
The combination of ThermoVax™ and VeloThrax™ along with a potent
secondary adjuvant resulted in rapid onset of antibodies correlated
to protection against anthrax in animal models. These results
corroborate earlier findings demonstrated with ThermoVax™
formulated RiVax™ and further demonstrate proof of principle.
Cold chain requirements add considerable cost to the production
and storage of current conventional vaccines. According to the
Biopharma Cold Chain Sourcebook of 2010, 98% of all vaccines (with
a value of $20.6 billion) require
shipment through cold chain. Elimination of the cold chain would
also enhance the utility of these vaccines for emerging markets and
for other applications requiring but lacking reliable cold chain
capabilities. Further, the World Health Organization reports
that 50% of all global vaccine doses are wasted because vaccines
are not kept within required temperature ranges. NIAID has
also highlighted the priority of technologies for biodefense
vaccines that focus on broad spectrum approaches including vaccine
adjuvants and temperature stabilization for long shelf life, rapid
onset of immunity, and surge capacity for production. For
vaccines that are intended for long-term stockpiling, such as for
use in biodefense or in pandemic situations, the utilization of
ThermoVax™ has the potential to facilitate easier storage and
distribution of strategic national stockpile vaccines in emergency
situations.
"We are pleased with the progress demonstrated thus far with our
vaccines that employ ThermoVax™," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "The ability to engineer
vaccines that are able to withstand extreme temperatures and
thereby eliminate the cold chain while simultaneously reducing the
frequency of vaccinations has the potential to be a significant
step forward in vaccine technology. Beyond its biodefense
applications, ThermoVax™ has the potential to lead to major cost
savings in the production, distribution and storage of currently
marketed vaccines and could further facilitate their use in the
developing world. We are excited about the potential utility
of the ThermoVax™ technology and recently have initiated
discussions with a number of vaccine companies and non-profit
organizations regarding the potential for collaboration on heat
stable versions of their vaccine candidates."
About ThermoVax™
ThermoVax™ is a technology that is designed to eliminate the
standard cold chain production, distribution and storage logistics
required for most vaccines. The technology utilizes precise
lyophilization of protein immunogens with conventional aluminum
adjuvants in combination with secondary adjuvants for rapid onset
of protective immunity where protective immunity is desired with
the fewest number of vaccinations. RiVax™ and VeloThrax™ are
extremely labile in their liquid form requiring careful management
under refrigerated conditions at 4 degrees Celsius (39 degrees
Fahrenheit). By employing ThermoVax™ during their final
formulation, it is possible to produce stable and potent vaccines
that are capable of withstanding temperatures at least as high as
40 degrees Celsius (104 degrees Fahrenheit) for up to six months,
with evidence of protein stability at temperatures at least as high
as 55 degrees Celsius (131 degrees Fahrenheit) for at least several
weeks.
The underlying technology has been developed by Drs.
John Carpenter and Theodore Randolph at the University of
Colorado. The vaccine technology is being developed in
collaboration with Nanotherapeutics, Inc., SRI International, the
University of Kansas, the Wadsworth
Center of the New York State
Department of Health, and the Tulane National Primate Research
Center under the aegis of the cooperative grant form NIAID.
About Soligenix, Inc.
Soligenix is a clinical stage biopharmaceutical company
developing products to treat serious inflammatory diseases where
there remains an unmet medical need, as well as developing several
biodefense vaccines and therapeutics. Soligenix is developing
proprietary formulations of oral BDP (beclomethasone
17,21-dipropionate) for the prevention/treatment of
gastrointestinal disorders characterized by severe inflammation,
including pediatric Crohn's disease (SGX203), acute radiation
enteritis (SGX201) and chronic Graft-versus-Host disease
(orBec®), as well as developing its novel innate defense
regulator (IDR) technology SGX942 for the treatment of oral
Mucositis.
Through its BioDefense Division, Soligenix is developing
countermeasures pursuant to the Biomedical Advanced Research and
Development Authority (BARDA) Strategic Plan of 2011-2016 for
inclusion in the US government's Strategic National Stockpile.
Soligenix's lead biodefense products in development are a
recombinant subunit vaccine called RiVax™, which is designed to
protect against the lethal effects of exposure to ricin toxin and
VeloThrax™, a vaccine against anthrax exposure. RiVax™ has been
shown to be well tolerated and immunogenic in two Phase 1 clinical
trials in healthy volunteers. Both RiVax™ and VeloThrax™ are
currently the subject of a $9.4
million National Institute of Allergy and Infectious
Diseases (NIAID) grant supporting development of Soligenix's new
vaccine heat stabilization technology known as ThermoVax™.
Soligenix is also developing OrbeShield™ for the treatment of
gastrointestinal acute radiation syndrome (GI ARS) under a
$600,000 NIAID Small Business
Innovation Research (SBIR) grant. OrbeShieldTM has
previously demonstrated statistically significant preclinical
survival results in two separate canine GI ARS studies funded by
the NIH.
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
This press release contains forward-looking statements that reflect
Soligenix, Inc.'s current expectations about its future results,
performance, prospects and opportunities. Statements that are not
historical facts, such as "anticipates," "believes," "intends,"
"potential," or similar expressions, are forward-looking
statements. 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. Soligenix 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
vaccines against bioterror threats, manufacturing and conducting
preclinical and clinical trials of vaccines, and obtaining
regulatory approvals, 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 US Government or other countries, or that the US Congress may
not pass any legislation that would provide additional funding for
the Project BioShield program. These and other risk factors are
described from time to time in filings with the Securities and
Exchange Commission, including, but not limited to, Soligenix's
reports on Forms 10-Q and 10-K. Unless required by law, Soligenix
assumes no obligation to update or revise any forward-looking
statements as a result of new information or future events.
SOURCE Soligenix, Inc.