www.soligenix.com
Soligenix, Inc. is a late-stage research and development biopharmaceutical company focused on developing products to treat the life-threatening side effects of cancer treatment and serious gastrointestinal diseases where there remains an unmet medical need, as well as developing biodefense vaccines and therapeutics.
Soligenix establishes proof-of-concept from RiVax thermostabilization study
Soligenix (OTCBB:SNGXD) unveiled Monday positive results from preclinical studies of its proprietary vaccine thermo-stabilization technology, establishing proof-of-concept.
The company's technology allows vaccines that usually need to be refrigerated to maintain their efficacy at higher temperatures.
Soligenix used its aluminum-adjuvant ricin toxin vaccine, RiVax, in the study. RiVax was developed under lyophilization conditions, and uses an active carrier to help maintain the protein structure of the ricin A chain, which provides the immunogenic component of the drug.
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.
For this reason, many vaccines need to be refrigerated or frozen, and as a result, the World Health Organization (WHO) estimates that about half of all global vaccine doses are wasted.
Therefore, Soligenix's technology, which achieves this lyophilization effect but maintains the sensitive material in the vaccine, is especially valuable in biodefense or pandemic situations, where drugs need to be stockpiled for a long period of time.
Like other aluminum-adjuvanted vaccines, RiVax usually requires temperatures at or below eight degrees Celsius for storage and efficacy. However, using Soligenix's tehcnology and the lyophilization process, the company found that the vaccine provided strong, neutralizing antibodies, even in temperatures as high as 40 degrees Celsius.
The study's investigator, Dr. Theodore W. Randolph, said: "Early indications from the ongoing stability evaluation of the ricin vaccine stored at elevated temperatures are very encouraging for a protein immunogen that is otherwise so inherently unstable."
The company's research is being funded by a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID).
Soligenix CSO, Dr. Robert N. Brey, said: "We are very excited about these results as the achievement of extended stability under elevated temperature represents a significant step forward in vaccine technology.
"These studies successfully establish the proof of concept that our vaccine thermostabilization technology works and now allows for the potential to apply this technology to other conventional vaccines that require refrigeration.
"Cold chain requirements add considerable cost to the production and storage of current conventional vaccines. Further, lack of long-term stability is a significant problem in vaccines for use in emergency situations and especially for vaccines used in the developing world where the cold storage chain is difficult to maintain.
"We believe that this technology has the potential to add value to many existing and developing vaccines."
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.
Through its biodefense division, Soligenix is developing its SGX204 vaccine, which is designed to protect against the lethal effects of exposure to anthrax, in addition to RiVax.
On the OTC Bulletin Board, shares of the Princeton, New Jersey-based company rose 1.41 percent to $0.80 per share on Monday.
