Soligenix Discusses Ricin Toxin Vaccine

Dr. Oreola Donini, Senior Vice President and Chief Scientific Officer, discusses the Company’s ricin toxin vaccine with ROI-NJ. To read the article please click here .

Two letters sent to the Pentagon tested positive for ricin on Tuesday, according to several reports Wednesday morning.

Investigators are still determining the origins of the letters; meanwhile, the mail delivery area of the Pentagon remains under quarantine.

This could all be avoided if the heat-stable ricin vaccine, RiVax, from Princeton-based Soligenix, was approved, a company official said Tuesday.

The vaccine has been in the works since 2006, and has been awarded up to $24.7 million from the National Institute of Allergy and Infectious Diseases.

But the road to approval is a lot more complicated than the usual clinical trials for therapeutics.

That’s because the trials can’t include humans, according to Soligenix Chief Scientific Officer Oreola Donini.

“From a regulatory perspective, the animal rule has three components,” she said. “You have to know the disease is the same between animals and humans, you have to show safety in humans and you have to be able to show efficacy in animals in a way that you can translate to humans — in other words, you have to have a biomarker you can track in humans and in animals.”

The development of the product has been rapid in the last few years, she said.

“Early progress was inhibited by the fact the vaccine itself was very unstable, which made storage and stockpiling very difficult. Some of our most recent activities have generated a thermo-stabilized version of the product. We’ve got it in the form we would like to take forward,” Domini said.

Just last month, Soligenix published a report that RiVax is showing 100 percent protection in mice, even after the vaccine has been stored for 12 months at 104 degrees Fahrenheit. The vaccine is stored in a solid form and then rehydrates when it’s ready for use.

The new report confirms the longer shelf-life of the vaccine.

“It retains its potency … in mice and nonhuman primates,” Donini said. “The most lethal form of exposure to ricin toxin is inhalation. We’ve shown protection in that model as well in non-human primates.”

In the last one to two years, the company has identified biomarkers in mice and primates that can also be easily used in blood tests for any healthy human volunteers for the Phase I and II clinical study, she said.

“That would of course add a lot of value for a lot of war fighters, but also civilian first responders and people at high risk,” like employees at the Pentagon, Donini said. “These high-risk individuals would have been potentially vaccinated. That being the case, it wouldn’t have mattered if they inhaled a puff of powder out of the envelope or if they got it on their hands or absorbed it through their skin somehow — they would have been protected.”

The company now needs one more clinical study, planned for next year, and concurrently with that will need to do a pivotal animal study.

“That’s, ideally, the sum total of what’s needed.”

There’s one last hurdle. Not many products are approved under the animal rule, Donini said.

But, if RiVax is proven to be effective and subsequently approved, Tuesday’s scare could be avoided in the future.
This interview and the articles referred to herein 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 US 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 US 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. 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.