Soligenix Receives FDA Orphan Drug Designation for RiVax™ for the Prevention of Ricin Intoxication

News provided by

Jan 20, 2011, 07:00 ET

PRINCETON, N.J., Jan. 20, 2011 /PRNewswire/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax™ for the prevention of ricin intoxication. RiVax™ is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.

The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders that affect fewer than 200,000 individuals within the United States. In addition to providing a seven-year term of market exclusivity for RiVax™ upon FDA approval, Orphan Drug Designation also positions Soligenix to be able to take advantage of certain financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a Biologics License Application for RiVax™, and certain tax credits.

RiVax™ induces a protective immune response in animal models of ricin exposure and is currently being evaluated in humans. A human Phase 1A clinical trial of RiVax™ has been completed and a Phase 1B clinical trial remains ongoing. Results of the Phase 1A clinical trial of RiVax™ indicated that the immunogen was safe and induced antibodies anticipated to protect humans from ricin exposure. The outcome of the study was published in the Proceedings of the National Academy of Sciences (Vitetta et al., 2006, PNAS, 105:2268-2273). The Phase 1B trial, sponsored by University of Texas Southwestern Medical Center in Dallas (UT Southwestern), is currently evaluating a more potent formulation of RiVax™. Soligenix has developed processes for large-scale manufacturing of the vaccine product and is developing the product using animal models for efficacy under the FDA animal rule. RiVax™ was invented by Ellen Vitetta, PhD, Director of the Cancer Immunobiology Center and colleagues at UT Southwestern.

"The FDA's decision to grant RiVax™ Orphan Drug Designation for the prevention of ricin intoxication marks another important step forward in our biodefense pipeline," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "Marketing exclusivity through Orphan Drug Designation adds significantly to the existing patent estate surrounding RiVax™. We are enthusiastic about the prospects of developing a ricin vaccine to anticipate civilian and military biodefense requirements and for potential government stockpiling."

About RiVax™

RiVax™ is Soligenix's proprietary vaccine developed to protect against exposure to ricin toxin and is the most advanced vaccine in the company's portfolio. RiVax™ has been shown to induce a protective immune response in animal models of ricin exposure and in human clinical trials. The current Phase 1B clinical trial is being supported by a grant to UT Southwestern from the FDA's Office of Orphan Products. The development of RiVax™ to date has been sponsored through a series of overlapping challenge grants (UC1) and cooperative grants (U01) from the National Institutes of Allergy and Infectious Diseases (NIAID) which were granted to Soligenix and to UT Southwestern where the vaccine originated. Soligenix and UT Southwestern have collectively received approximately $25 million in grant funding from the NIH for development of RiVax™ and related vaccine technologies.

About Ricin Toxin

Ricin toxin is a toxin thought to be a potential bioterror threat because of its stability and high potency as well as the large worldwide reservoir created as a by-product of castor oil production. Ricin toxin is relatively easy to produce and exposure to small amounts, especially by inhalation, can lead to lung damage, nausea, fever, abdominal pain, and death within several days. Exposure to ricin results in local tissue necrosis, and general organ failure leading to death within several days of exposure. The potential use of ricin toxin as a biological weapon has been highlighted in an FBI terrorism report, which states that "Ricin and the bacterial agent anthrax are emerging as the most prevalent agents involved in WMD investigations" (http://www.fbi.gov/stats-services/publications/terrorism-2002-2005).

There are currently no effective means to prevent the effects of ricin intoxication. The successful development of an effective vaccine against ricin toxin may act as a deterrent against the actual use of ricin as a biological weapon and could be used in rapid deployment scenarios in the event of a biological attack. RiVax™ would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.

About Soligenix, Inc.

Soligenix, Inc. (Soligenix) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. Through its Biodefense Division, Soligenix is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004. Soligenix's lead biodefense product in development is a recombinant subunit vaccine called RiVax™, which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax™ has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax™ is also the subject of a $9.4 million NIAID grant received by the Company supporting development of new heat stable vaccines.

Soligenix's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally acting corticosteroid being developed for the treatment of acute gastrointestinal Graft-versus-Host disease (GI GVHD), a common and potentially life-threatening complication of hematopoietic cell transplantation. orBec® is currently the subject of a $1.2 million FDA Orphan Products Grant-supported confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD. Soligenix is also conducting a National Cancer Institute (NCI)-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. Additionally, Soligenix has a Lipid Polymer Micelle (LPM™) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

For further information regarding Soligenix, Inc., please visit the Company's website at www.soligenix.com.

This press release contains forward-looking statements that reflect Soligenix, Inc.'s current expectations about its future results, performance, prospects and opportunities. Statements that are not historical facts, such as "anticipates," "believes," "intends," 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 or commercialize products based on its technology, including orBec®, SGX201, RiVax™, and LPM™, particularly in light of the significant uncertainty inherent in developing vaccines against bioterror threats, manufacturing and conducting preclinical and clinical trials of vaccines, and obtaining regulatory approvals, that its cash expenditures will not exceed projected levels, 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 grants and awards, maintain its existing grants which are subject to performance, enter into any biodefense procurement contracts with the US Government or other countries, that the US Congress may not pass any legislation that would provide additional funding for the Project BioShield program, that it will be able to patent, register or protect its technology from challenge and products from competition or maintain or expand its license agreements with its current licensors, or that its business strategy will be successful. Important factors which may affect the future use of orBec® for gastrointestinal GVHD include the risks that: the FDA's requirement that Soligenix conduct additional clinical trials to demonstrate the safety and efficacy of orBec® will take a significant amount of time and money to complete and positive results leading to regulatory approval cannot be assumed; Soligenix is dependent on the expertise, effort, priorities and contractual obligations of third parties in the clinical trials, manufacturing, marketing, sales and distribution of its products; orBec® may not gain market acceptance if it is eventually approved by the FDA; and others may develop technologies or products superior to orBec®. Factors affecting the development and use of SGX201 and LPM™ are similar to those affecting orBec®. These and other 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.

SOURCE Soligenix, Inc.