PRINCETON, N.J., Jan. 27, 2011 /PRNewswire/ -- Soligenix, Inc. (Soligenix or the Company) (OTC Bulletin Board: SNGX), a late-stage biopharmaceutical company, today announced that it has entered into a definitive license agreement with the University of Colorado (CU) for novel technology for use in the development of subunit vaccines with long-term stability, including stability at elevated temperatures. The technology is the subject of several United States and foreign patent applications that address the use of adjuvants in conjunction with vaccines that are formulated to resist thermal inactivation.
Soligenix has been developing this stabilization technology under an option-to-license agreement from CU that was initiated to support the technology development efforts funded by a $9.4 million grant from the National Institute of Allergy and Infectious Diseases (NIAID). The license agreement has an expanded scope for thermostable vaccines for biodefense as well as all potential vaccine indications. The novel technology involves the use of several unique process and formulation steps that fix sensitive vaccine ingredients in native configuration. For biodefense indications, the company is using the stabilization technology to advance RiVax, its subunit vaccine against ricin toxin, as well a subunit vaccine for anthrax prevention. The underlying technology has been developed by Drs. Amber Clausi, John Carpenter and Theodore Randolph at CU-Boulder. The terms of the license were not disclosed.
“Vaccines are a valuable part of our healthcare arsenal, providing great benefit per dollar spent,” says Theodore Randolph, PhD, Professor of Chemical and Biological Engineering at CU-Boulder. “Most current vaccines, however, require carefully controlled cold storage conditions to retain their potency and safety. This adds cost and greatly complicates strategies for their use, especially in public health emergencies or in developing countries. We are pleased that Soligenix has licensed our technology, which offers the potential to create vaccine formulations whose enhanced thermostability allows them to be stockpiled and delivered to patients with much less stringent temperature control requirements.”
“The achievement of extended stability as well as stability under elevated temperature would represent a significant step forward in vaccine technology. These properties are not shared with conventional vaccines that require refrigeration,” stated Robert N. Brey, PhD, Chief Scientific Officer of Soligenix. “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. Further, this novel thermostability technology has the potential to allow us to expand our vaccine business into the development of countermeasures against other more common infectious diseases.”
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.
