Biopharmaceutical company Soligenix (OTCBB:SNGX) Monday released its first quarter results, and provided highlights of the company’s recent achievements in its vaccine/biodefense business.
is a development stage biopharmaceutical company, developing products
to treat life-threatening side effects of cancer treatments and serious
gastrointestinal diseases, as well as vaccines for certain bioterrorism
In late April, the company announced further progress in the
development of ThermoVax, its vaccine thermostabilization technology
that allows vaccines that usually need to be refrigerated to maintain
their efficacy at higher temperatures.
said that progress had been made based on the stability of prototype
vaccines that had been kept at elevated temperatures for longer than
The development of ThermoVax is being supported by a $9.4 million
National Institute of Allergy and Infectious Disease (NIAID) grant, for
biodefense indications against ricin toxin and anthrax exposure.
said previous test results had indicated that the company's
aluminum-adjuvanted ricin toxin vaccine, known as RiVax, retained
effectiveness and potency, while stored at 40 degrees Celsius for one
month, when combined with the ThermoVax technology.
Confirmatory results extended these initial observations to more than
three months when the vaccine was kept at 40 degrees Celsius, said the
ThermoVax is able to produce “stable and potent” vaccine formulations, said Soligenix, by combining precise lyophilization technology with conventional aluminum adjuvants.
The lyophilization process is often employed to extend the shelf life
of drugs, by removing the water from the pharmaceutical preparation.
Vaccines that undergo this process often lose their potency,
especially if the vaccine is made with aluminum salt adjuvants, as most
technology, however, achieves this lyophilization effect but maintains
the sensitive material in the vaccine, making the technology especially
valuable for biodefense or pandemic situations, where drugs need to be
stockpiled for a long period of time.
The underlying technology was developed by Drs. John Carpenter and
Theodore Randolph at the University of Colorado, whose team performed
the studies along with Dr. Nicholas Mantis of The New York State
Department of Health in Albany.
Through its biodefense division, Soligenix
is also developing its SGX204 vaccine, which is designed to protect
against the lethal effects of exposure to anthrax, in addition to RiVax.
is also developing OrbeShield for the treatment of gastrointestinal
acute radiation syndrome (GI ARS) and said it has demonstrated
"statistically significant" preclinical survival results in a canine
Revenues for the quarter that ended March 31 were $647,418 as compared to $808,005 for the first quarter of 2011.
said the decrease was related to a reduction in reimbursable costs from
its orphan drug grant covering a portion of its phase 3 clinical trial
of orBec, in the treatment of acute gastrointestinal graft-versus-host
The company reported a net loss of $1.44 million or 13 cents per
share, compared to a wider $1.72 million loss, or 16 cents per share,
for the year earlier quarter.
The narrowed loss was due to reduced spending after the stoppage of the orBec trial, Soligenix
said. The study was stopped in September 2011, and the company said it
has continued to incur minor costs associated with the close out of the
clinical sites, as well as data collection and analysis.
Soligenix's research and development expenses for the quarter were $876,794, down from $1.37 million a year earlier.
General and administrative expenses for the quarter were $655,043, versus $604,010 a year earlier. At the end of the quarter, Soligenix’s cash position was approximately $5.32 million, with working capital of around $4.44 million.
"In the first quarter of 2012 we saw meaningful progress in our
vaccine/biodefense business segment particularly with our novel vaccine
thermostabilization technology, ThermoVax,” said president and CEO
Christopher J. Schaber, PhD.
"We also continue to progress with development efforts of our oral
BDP program for pediatric Crohn's disease and plan to initiate a phase
2A clinical trial this year. We remain committed to enhancing our
product development pipeline through internal efforts and external
"We look forward to reporting on further progress this year regarding our Vaccine/biodefense programs."
The company has announced a number of notable operational
achievements of late, including promising results from its preclinical
study of SGX202 (oral BDP), testing for the treatment of
gastrointestinal acute radiation syndrome in dogs.
The study results indicated that dogs treated with SGX202 starting 24
hours after exposure to lethal doses of total body irradiation (TBI)
demonstrated "statistically significant" improvement in survival when
compared to control dogs.
said these results show that SGX202 has the potential to reduce the
inflammatory storm induced by the radiation-damaged GI tract.
Also earlier this year, the company unveiled preliminary results from
a phase 1/2 clinical trial of SGX201, a time-release formulation of
oral BDP for the prevention of acute radiation enteritis.
The study showed that oral administration of SGX201 was safe and well tolerated across all four dose groups.
Acute radiation enteritis is caused by the radiation-induced death of cells in the lining of the bowel.
said 16 subjects with rectal cancer scheduled to undergo concurrent
radiation and chemotherapy prior to surgery were enrolled in one of four
dose groups in the study.
The main goal of the study was to evaluate the safety and
tolerability of escalating doses of SGX201, as well as to assess the
preliminary efficacy of SGX201 for the prevention of signs and symptoms
of acute radiation enteritis.