PRINCETON, N.J., July 29, 2019 /PRNewswire/ -- Soligenix,
Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage
biopharmaceutical company focused on developing and commercializing
products to treat rare diseases where there is an unmet medical
need, announced today that the European Patent Office has issued
two patents, both titled "Topically Active Steroids for use in
Radiation and Chemotherapeutics Injury" with the latest issuing
October 24, 2018, following the
expiration of the objection period as of July 24, 2019. The new patents (#2,373,160
and #2,902,031) claim use of oral beclomethasone 17,21-dipropionate
(BDP) for treatment of damage to the gastrointestinal (GI) tract as
a result of acute radiation injury, including total body
irradiation in an accidental or biodefense context.
SGX201 and OrbeShield® are
proprietary oral formulations of BDP that function as mucosally
delivered steroidal treatments for the GI tract while minimizing
systemic steroid side effects, including risk of severe
infection. SGX201 utilizes an enteric coated tablet to
deliver steroid to the distal GI tract, while
OrbeShield® employs both immediate and
delayed release, enteric-coated formulations to cover both the
proximal and distal GI tract. Due to the low systemic
bioavailability of BDP, these formulations maximize
anti-inflammatory steroid action at the site of injury, while
minimizing common side effects of steroids, including immune
suppression, enabling their use in expanded populations.
SGX201 has been evaluated in the treatment of acute radiation
enteritis in patients with rectal carcinoma. Future studies
may include the evaluation of oral BDP in patients with
gynecological cancers at risk of acute and chronic radiation
enteritis due to radiation therapy.
OrbeShield® is being developed in the
biodefense context, as a potential treatment in the event of
radiation exposure in a mass casualty incident. The
combination of immediate and delayed release oral BDP is also being
developed as a treatment for Pediatric Crohn's Disease in
Soligenix's SGX203 program, for which a pivotal Phase 3 clinical
trial protocol has been agreed with U.S. Food and Drug
Administration (FDA). The conduct of the Phase 3 trial in
Pediatric Crohn's Disease is pending partnership and/or additional
funding.
"Soligenix continues to evaluate opportunities for its
proprietary formulations of oral BDP," stated Christopher J. Schaber, PhD, President and Chief
Executive Officer of Soligenix. "These therapeutic use
patents are generally valid until 2029 and allow us to expand our
intellectual property portfolio across the two business segments of
our rare disease pipeline."
About SGX201 and
OrbeShield®
SGX201 is formulated for oral administration in cancer
patients as a single product consisting of a delayed release
(enteric coated) tablet which releases BDP in the distal portions
of the GI tract. SGX201 has been awarded fast-track designation
from the FDA for the prevention of radiation enteritis.
Previous studies with SGX201 have been supported by a National
Cancer Institute Small Business Innovation Research (SBIR) grant
#R43CA141968.
OrbeShield® is formulated for oral
administration in gastrointestinal acute radiation syndrome (GI
ARS) patients as a single product consisting of two tablets. One
tablet releases BDP in the proximal portions of the GI tract, and
the other tablet releases BDP in the distal portions of the GI
tract. OrbeShield® has also been granted
Orphan Drug and Fast Track designations by the FDA for the
prevention of death following a potentially lethal dose of total
body irradiation during or after a radiation disaster.
OrbeShield® development as a medical countermeasure
for GI ARS has been supported by the Biomedical Advanced Research
and Development Authority (BARDA) (contract #HHSO100201300023C) and
the National Institute of Allergy and Infectious Diseases (NIAID)
(contract #HHSN27220130030C) contracts.
Oral BDP has been marketed in the U.S. and worldwide since the
early 1970s as the active pharmaceutical ingredient in inhalation
products for the treatment of allergic rhinitis and asthma.
To date, immediate and delayed release oral BDP has been
safely administered to more than 380 human subjects in multiple
clinical studies. Oral BDP also is being developed for
use in other GI disorders characterized by severe inflammation such
as in pediatric Crohn's disease, which uses a combination of
immediate and delayed release oral BDP, referred to as
SGX203. SGX203 has received both orphan drug and fast
track designations in the U.S. for the treatment of Crohn's Disease
in the pediatric population.
About Acute Radiation Enteritis
Radiation Enteritis is an inflammatory bowel condition resulting
from radiation damage to the abdominal and pelvic areas. Acute
Radiation Enteritis occurs during or immediately after a radiation
treatment course while the chronic disease represents an inadequate
healing process in the intestines after radiation damage.
Radiation enteritis occurs to some degree in almost all patients
treated with radiation directed at the abdomen or pelvic area. This
includes most patients with cancer of the bladder, uterus, cervix,
rectum, prostate, and vagina. The bowel is very sensitive to
radiation damage. There are over 100,000 patients annually in the
U.S. receiving abdominal or pelvic radiation treatment for cancer
who are at risk of developing acute and chronic radiation
enteritis
Acute radiation enteritis generally occurs around the second
week of radiation treatment and includes symptoms of diarrhea,
nausea, vomiting, stomach cramps, fecal urgency and loss of
appetite.
Chronic radiation enteritis occurs after radiation is complete.
Symptoms vary and may include pain after eating, acute or
intermittent small bowel obstruction, nausea, loss of appetite,
weight loss, bloating, diarrhea, inability to extract nutrients
from food eaten and the excretion of fat in feces. Chronic
radiation enteritis is often associated with a thickening or
scarring of the intestinal lining (called fibrosis) which is
believed to have been caused by the initial radiation damage and
subsequent inflammatory response.
About GI ARS
ARS occurs after toxic radiation exposure and involves several
organ systems, notably the bone marrow, the GI tract and later the
lungs. In the event of a nuclear disaster or terrorist
detonation of a nuclear bomb, people exposed to radiation levels
greater than 2 Gy are at high risk of developing ARS. According to
the U.S. Centers for Disease Control and Prevention (CDC), exposure
to high doses of radiation exceeding 10 to 12 Gy causes acute GI
injury, which can result in death in 5 to 15 days. The GI
tract is highly sensitive to radiation-induced damage due to the
requirement for incessant proliferation of crypt stem cells and
production of mucosal epithelium. The extent of injury to the bone
marrow and the GI tract are the principal determinants of survival
after exposure to total body irradiation. Although
hematopoietic ARS can be rescued by bone marrow transplantation or
growth factor administration, there is no established treatment or
preventive measure for the GI damage that occurs after high-dose
radiation. Therefore, there is an urgent need to develop specific
medical countermeasures against the lethal consequences of
radiation-induced GI injury.
About Soligenix, Inc.
Soligenix is a late-stage biopharmaceutical company focused on
developing and commercializing products to treat rare diseases
where there is an unmet medical need. Our Specialized
BioTherapeutics business segment is developing SGX301 as a novel
photodynamic therapy utilizing safe visible light for the treatment
of cutaneous T-cell lymphoma, our first-in-class innate defense
regulator (IDR) technology, dusquetide (SGX942) for the treatment
of oral mucositis in head and neck cancer, and proprietary
formulations of oral beclomethasone 17,21-dipropionate (BDP) for
the prevention/treatment of gastrointestinal (GI) disorders
characterized by severe inflammation including pediatric Crohn's
disease (SGX203) and acute radiation enteritis (SGX201).
Our Public Health Solutions business segment includes active
development programs for RiVax®, our ricin toxin vaccine
candidate and SGX943, our therapeutic candidate for antibiotic
resistant and emerging infectious disease. The development of our
vaccine programs incorporates the use of our proprietary heat
stabilization platform technology, known as
ThermoVax®. To date, this business segment has
been supported with government grant and contract funding from the
National Institute of Allergy and Infectious Diseases (NIAID) and
the Biomedical Advanced Research and Development Authority
(BARDA).
For further information regarding Soligenix, Inc., please visit
the Company's website at www.soligenix.com.
This press release may contain forward-looking statements that
reflect Soligenix, Inc.'s current expectations about its future
results, performance, prospects and opportunities, including but
not limited to, potential market sizes, patient populations and
clinical trial enrollment. Statements that are not historical
facts, such as "anticipates," "estimates," "believes," "hopes,"
"intends," "plans," "expects," "goal," "may," "suggest," "will,"
"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,
achieve regulatory approval for or commercialize products based on
its technologies, particularly in light of the significant
uncertainty inherent in developing therapeutics and vaccines
against bioterror threats, conducting preclinical and clinical
trials of therapeutics and vaccines, obtaining regulatory approvals
and manufacturing therapeutics and vaccines, 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 funding to support product development and
commercialization efforts, including grants and awards, maintain
its existing grants which are subject to performance requirements,
enter into any biodefense procurement contracts with the U.S.
Government or other countries, that it will be able to compete with
larger and better financed competitors in the biotechnology
industry, that changes in health care practice, third party
reimbursement limitations and Federal and/or state health care
reform initiatives will not negatively affect its business, or that
the U.S. Congress may not pass any legislation that would provide
additional funding for the Project BioShield program. In addition,
there can be no assurance as to timing or success of the Phase 3
clinical trial of SGX942 (dusquetide) as a treatment for oral
mucositis in patients with head and neck cancer receiving
chemoradiation therapy or the Phase 3 clinical trial of SGX301
(synthetic hypericin) for the treatment of cutaneous T-cell
lymphoma. There also can be no assurance as to timing or
success of the preclinical/clinical trials of
RiVax®, that
RiVax® will be approved for the
Priority Review Voucher (PRV) program or the amount for which a PRV
for RiVax® can be sold. 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.
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