PRINCETON, N.J., Nov. 20 Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), formerly known as DOR BioPharma, Inc., a late-stage biotechnology company, announced today that it has formed a consortium to develop thermostable technology to advance RiVax(TM) and other rapidly acting vaccines. Soligenix received a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), to support this work.
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A key component of this initiative is the formation of collaborative partnerships between industry and academic researchers from different disciplines. Soligenix will partner with academic institutions, including the University of Colorado, the University of Kansas, and the Tulane National Primate Research Center. Industry partners include SRI International, Health Research Inc, Battelle Memorial Institute, Nanotherapeutics, and BioCon Inc.
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As part of the initiative, Soligenix has executed an option agreement with the University of Colorado. The agreement covers novel technology to develop vaccines that can maintain stability at elevated temperatures. This new technology will form the cornerstone of the R&D effort. Work will involve the development of formulation and manufacturing processes for vaccines, including RiVax(TM), that are stable at elevated temperatures. An additional goal will be the development of improved thermostable adjuvants expected to result in rapidly acting vaccines that can be given with fewer injections over shorter intervals.
"Each of our academic and industry consortium members brings impressive expertise to our vaccine stabilization program," said Dr. Robert N. Brey, PhD, Chief Scientific Officer of Soligenix. "This association has the potential to address the practical issue of long-term stability in stockpiled biodefense vaccines, using a technology basis that can ultimately be applied to other commercial vaccine products."
"Our progress with RiVax(TM) has been notable, and this grant award further validates the previous work and merits of our biodefense program," stated Christopher J. Schaber, PhD, President and CEO of Soligenix. "We look forward to working with our outstanding partners in this consortium to develop thermally stable biodefense vaccines to address two high-priority biothreats."
About RiVax(TM)
RiVax(TM) 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(TM) induces a protective immune response in animal models of ricin exposure and is currently being evaluated in humans. One human Phase 1 clinical trial has been completed and a second trial is currently being conducted.
Results of the first Phase 1 clinical trial of RiVax(TM) established 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 second trial, sponsored by UTSW, is currently evaluating a more potent formulation of RiVax(TM). Soligenix has developed processes for large-scale manufacturing and is further establishing correlates of the human immune response in non-human primates.
The development of RiVax(TM) has been sponsored through a series of overlapping challenge grants (UC1) and cooperative grants (U01) from the NIH, granted to Soligenix and to the University of Texas Southwestern Medical Center (UTSW) where the vaccine originated. The second clinical trial is being supported by a grant to UTSW from the US Food and Drug Administration's Office of Orphan Products Development. Soligenix and UTSW have collectively received approximately $25 million in grant funding from the NIH for RiVax(TM).
About Ricin Toxin
Ricin toxin is thought to be a 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. Exposure to ricin results in general organ failure leading to death within several days of exposure. The potential use of ricin toxin as a biological weapon of mass destruction (WMD) 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/publications/terror/terrorism2002_2005.pdf).
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(TM) would potentially be added to the Strategic National Stockpile and dispensed in the event of a terrorist attack.
About Soligenix, Inc.
Soligenix, Inc. (Soligenix), formerly known as DOR BioPharma, Inc., 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. Soligenix's lead product, orBec® (oral beclomethasone dipropionate or BDP), is a potent, locally acting corticosteroid being developed for the treatment of GI GVHD, a common and potentially life-threatening complication of hematopoietic cell transplantation. orBec® is currently the subject of a confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD and an NIH-supported, Phase 2, randomized, double-blind, placebo-controlled trial in the prevention of acute GVHD. Both of these trials are actively enrolling. Soligenix also expects to begin an NIH-supported Phase 1/2 clinical trial of SGX201 in radiation enteritis in the second half of 2009. Additionally, Soligenix has a Lipid Polymer Micelle (LPM(TM)) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.
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(TM) which is designed to protect against the lethal effects of exposure to ricin toxin. RiVax(TM) has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax(TM) will also be the subject of a recent $9.4 million NIH grant received by the Company supporting development of new heat stable vaccines.
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 SGX201, orBec® and LPM(TM), 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(TM) 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.
