Soligenix announces Q1 results, highlights progress of biodefense unit

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.
Soligenix 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 agents.
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.
Soligenix said that progress had been made based on the stability of prototype vaccines that had been kept at elevated temperatures for longer than three months.
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.
Soligenix 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 company.
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 are.
Soligenix's 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.
Soligenix 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 model.
Revenues for the quarter that ended March 31 were $647,418 as compared to $808,005 for the first quarter of 2011.
Soligenix 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 disease.
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 strategic alliances.
"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.
Soligenix 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.
Soligenix 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.