PRINCETON, N.J., Jan. 18, 2012 /PRNewswire/ -- Soligenix, Inc.
(OTCBB: SNGX) (Soligenix or the Company), a development stage
biopharmaceutical company, announced today results from long-term
stability studies of its proprietary DNI (dominant negative
inhibitor) anthrax rPA (recombinant protective antigen) subunit
protein vaccine, known as SGX204. SGX204 is a hyperimmunogenic
derivative of PA and is being developed as a vaccine to protect
against anthrax disease either as a pre-exposure prophylactic
vaccine or post-exposure vaccine.
Positive stability was demonstrated when DNI rPA was subjected
to temperatures as high as 70 degrees Celsius for one
month. In that case, DNI rPA retained native configuration
with no evidence of denaturation that typically occurs in water
buffers under the same thermal conditions. Redundant methods to
determine protein structure each yielded results that indicated
that the thermally stressed DNI protein retained completely native
conformation after exposure to 70C. The water free DNI protein was
formulated with common excipients that allow for preservation of
protein structure in the dried state. Long-term stability of DNI
rPA was also demonstrated after refrigerated storage for more than
7 years. More importantly, when DNI rPA was combined with a potent
adjuvant formulation, animals vaccinated with the combination
developed high titer neutralizing antibodies that confer protection
against anthrax disease.
"We are very excited about these extraordinary stability
results," stated Robert N. Brey,
PhD, Chief Scientific Officer of Soligenix. "We believe that the
combination of long-term stability over several years with
stability at such elevated temperatures has the potential to confer
a distinct advantage over other anthrax vaccine technologies
currently in development. Further, SGX204 is highly immunogenic and
thereby offers the potential for complete immunization with just
one or two doses. As with any biodefense product, our goal is to
have SGX204 stockpiled by the US government."
About
SGX204
Soligenix has entered into to a field-exclusive option
agreement with Harvard University to
negotiate a license under patent rights that cover prophylactic
uses of a modified anthrax toxin protein. Initial development work
will be covered pursuant to a previously issued $9.4 million National Institute of Allergy and
Infectious Disease (NIAID) grant enabling development of
thermo-stable ricin and anthrax vaccines. The option encompasses an
issued U.S. patent that covers engineered variants of protective
antigen developed in the Harvard Medical
School laboratory of Dr. John
Collier. Protective antigen is the principal
determinant of protective immunity to anthrax. Soligenix believes
that it will be able to develop the Collier anthrax vaccine with an
efficacy profile superior to other anthrax vaccines.
About Anthrax
Anthrax is an acute infectious disease that is easily transmitted
to humans by environmentally durable spores that are produced by
Bacillus anthracis. Because the spores are robust and contagious,
anthrax is considered a Category A bioterror threat. Anthrax
infection can occur in three forms: cutaneous (skin), inhalation,
and gastrointestinal. Inhaled spores can cause a rapidly
progressing form of anthrax since the spores are transported to
lymph nodes near the lungs where they germinate, releasing
vegetative bacteria into the bloodstream. Bacteria synthesize a
complex series of toxin components that make up anthrax toxin,
resulting in overwhelming toxemia that causes shock and organ
failure. Treatment of anthrax involves long-term antibiotic
therapy, since ungerminated spores can lie dormant in the lungs for
up to 60 days. Only a few inhaled spores can cause inhalational
anthrax. Once the toxin has entered the bloodstream, antibiotics
are ineffective, and only toxin-specific therapy is effective.
Passively transferred antibodies can neutralize anthrax toxins and
can be used post-exposure in conjunction with antibiotics. Because
of the long residence time of spores in the lung, it is possible to
vaccinate post-exposure, but the onset of neutralizing antibodies
must occur during the period of antibiotic therapy.
About Soligenix, Inc.
Soligenix is a development stage biopharmaceutical company
developing products to treat life-threatening side effects of
cancer treatments and serious gastrointestinal diseases, and
vaccines for certain bioterrorism agents. Soligenix's lead product,
orBec® (oral beclomethasone dipropionate), is a potent, locally
acting corticosteroid that has been initially developed for the
treatment of acute gastrointestinal Graft-versus-Host disease (GI
GVHD), a common and potentially life-threatening complication of
hematopoietic cell transplantation. Soligenix is also conducting a
National Cancer Institute (NCI)-supported Phase 1/2 clinical trial
of SGX201 in the prevention of acute radiation enteritis.
Additionally, Soligenix is developing SGX203 for the treatment of
pediatric Crohn's disease.
Through its Biodefense Division, Soligenix is developing
countermeasures pursuant to the Project BioShield Act of 2004.
Soligenix's 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 SGX204, a vaccine
against anthrax exposure. RiVax™ has been shown to be well
tolerated and immunogenic in a Phase 1 clinical trial in normal
volunteers. Both RiVax™ and SGX204 are currently the subject of a
$9.4 million National Institute of
Allergy and Infectious Disease (NIAID) grant supporting development
of new heat stable vaccines. Soligenix is also developing SGX202
for the treatment of gastrointestinal acute radiation syndrome (GI
ARS) and has recently released positive preliminary preclinical
results in a canine GI ARS model.
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," 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, including orBec®, SGX201, SGX202, SGX203,
SGX204, RiVax™, and LPM™, 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 cash expenditures will not exceed projected levels, 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,
that the US 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 Data
Safety Monitoring Board's recent determination disclosed in our
Form 8-K dated September 15, 2011
recommending that Soligenix stop its confirmatory Phase 3 clinical
trial of orBec® in acute GI GVHD and the likelihood that: the FDA
will require that Soligenix conduct additional clinical
trials to demonstrate the safety and efficacy of orBec® which will
take a significant amount of time and money to complete and
positive results leading to regulatory approval cannot be assumed;
Soligenix 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;
orBec® may not gain market acceptance if it is eventually approved
by the FDA; and others may develop technologies or products
superior to orBec®. Factors affecting the development and use of
SGX201, SGX202, SGX203, SGX204, RiVax™ and LPMTM are similar to
those affecting orBec®. These and other 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.