Friday, 19 April 2013

Soligenix shares rise sharply in light of recent ricin threats

After two letters containing ricin were intercepted, one addressed to U.S. President Barack Obama and the other intended for Republican Senator Roger Wicker, shares ofSoligenix (OTC:SNGX) surged as traders showed support for its RiVax™ vaccine being developed to protect against disease and death caused by exposure to the deadly toxin. 
According to media supports, the FBI confirmed on Wednesday that the letter addressed to President Obama tested positive for ricin, just a day after a separate letter intended for Senator Wicker also tested positive for the poisonous substance. Both letters were intercepted at off-site facilities.
The Center for Disease Control (CDC) has classified ricin toxin as a Category B biological agent and there are currently no FDA approved therapeutics or vaccines that can be used to protect against ricin exposure or to reverse its effects once exposed. Once exposed to lethal doses of ricin, death is irreversible after four hours and takes three to five days to kill an individual. 
Soligenix has said the RiVax™ vaccine, which recently completed its second human clinical trial, in a Phase 1B clinical study in healthy volunteers was shown to be safe and well tolerated and induce neutralizing antibodies anticipated to protect humans from ricin exposure. These positive results provide a route forward for further development of the vaccine in larger and more definitive trials in humans and provide the additional correlates of protective immunity for pivotal animal studies.
The development of RiVax™ has been funded through a series of grants from the National Institutes of Health (NIH), granted toSoligenix and to the University of Texas Southwestern Medical Center (UTSW), where the vaccine originated. 
Soligenix says it has positioned thermostable RiVax™ for large scale manufacturing and is further establishing correlates of the human immune response in non-human primates. 
The company notes that its process for product development of biodefense products such as RiVax™ is highly dependent on government funding, since the government itself will be the final supplier of the products. 
Currently, Soligenix is operating under a $9.4 million grant award from the National Institute of Allergy and Infectious Diseases (NIAID), which will fund, over a five-year period, the development of formulation and manufacturing processes for vaccines like RiVax™ that are stable at elevated temperatures. 
The thermostabilization technology, called ThermoVax™, is being developed to eliminate the standard cold chain production, distribution and storage logistics required for most aluminum-adjuvanted vaccines.
Last month, Soligenix reported that several preclinical studies have demonstrated that vaccines formulated with ThermoVax™ have the potential for high temperature stability seen for a minimum of six months, and potency stabilization. 
The studies were conducted in a program designed to see if the vaccines could withstand extreme temperatures and other environmental stress conditions. For vaccines that are intended for long-term stockpiling, such as for use in biodefense or in pandemic situations, Soligenix indicated the use of ThermoVax™ can lead to easier storage and the distribution of strategic national stockpile vaccines in emergency situations.
The company’s shares have rallied as of late, as investors cheer its progress in developing RiVax™ and the ThermoVax™ technology, and more recently ahead of this week’s World Vaccine Congress & Expo, where chief scientific officer, Robert N. Brey, PhD, will discuss the stockpiling of biodefense vaccines.
The clinical stage biopharmaceutical company says Dr. Brey will make his presentation at the Expo today, at the Gaylord National Resort & Convention Center in National Harbor, Maryland.
Soligenix is focused on developing products for serious inflammatory diseases as well as developing several biodefense vaccines and therapeutics.
The New Jersey-based company’s lead compound, SGX942, is projected to enter phase 2 for oral mucositis in head and neck cancer in the second half of this year, with results anticipated in the second half of 2014. 
Meanwhile, its SGX203 drug for pediatric Crohn’s disease should enter phase 1/2 trials in the first half of 2013.
Soligenix is also developing OrbeShield, a drug for the treatment of gastrointestinal acute radiation syndrome (GI ARS), which occurs after toxic radiation exposure and involves several organ systems, notably the bone marrow, the gastrointestinal tract and later, the lungs.
Shares of the company closed up 18.57 per cent, or 26 cents, Wednesday, at $1.66. Shares have risen about 177 per cent since December 31, 2012.

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