Soligenix Announces Grant of US Patent for the Treatment of Irritable Bowel Syndrome with Oral Beclomethasone Dipropionate
PRINCETON, N.J., May 19 Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company, announced today that the United States Patent Office (USPTO) has issued a patent (US 7,704,985) entitled "Treatment of Irritable Bowel Syndrome and Related Bowel Diseases." The patent claims the use of beclomethasone dipropionate (BDP) to treat irritable bowel syndrome (IBS), a painful gastrointestinal condition that affects approximately 15% of the population in the industrialized world.
"There is an increasing awareness that IBS results in part from an inflammatory cascade in the GI tract, which makes it amenable to treatment with topically active steroids such as oral BDP," said Christopher J. Schaber, Ph.D., President and Chief Executive Officer of Soligenix. "This potentially expands the available treatment options for IBS. The granting of the US patent for BDP in IBS further demonstrates its potential novelty and utility in treating inflammatory GI diseases."
Dr. Schaber continued, "This is part of our strategy of broadening our intellectual property platform in inflammatory gastrointestinal diseases with oral BDP and other topically active steroids. We believe that our oral BDP formulations will have utility in other inflammatory GI diseases as well such as Graft-versus-Host disease (GVHD), radiation enteritis, and Crohn's disease."
In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, the Company also benefits from orphan drug designations in the US and in Europe on orBec(®) for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively. Soligenix is also continuing to actively build intellectual property around oral BDP in other inflammatory conditions and has obtained orphan drug designation for the treatment of pediatric Crohn's Disease.
About Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a chronic gastrointestinal disorder that affects the large intestine (colon). IBS commonly causes cramping, abdominal pain, bloating gas, diarrhea and constipation and is generally very disruptive to daily living activities. It is usually treated with anti-diarrheal agents such as loperamide, anticholinergic agents, and prokinetic agents. IBS has been called spastic colon, functional bowel disease, and mucous colitis. IBS affects up to 55 million Americans, mostly women, and its causes are unknown.
IBS represents a therapeutic challenge to both clinicians and developers of pharmaceuticals. The uncertainty and variety of causes, as well as the variable nature of symptomatic expression greatly complicates the task of treating this disorder. In IBS, the movement of the digestive tract does not work as it should, but there is no sign of changes in the intestines, such as inflammation or tumors. It is thought that IBS symptoms are related to problems with the signals sent between the brain and the intestines which in turn cause problems with the way the muscles of the intestines move.
About oral BDP
Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. BDP is the active ingredient in orBec(®), currently in Phase 3 and Phase 2 development by Soligenix for the treatment and prevention of acute GVHD, respectively. BDP is also the active ingredient in SGX201, a time-release formulation in a Phase 1/2 trial for acute radiation enteritis.
orBec(®) represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. orBec(®) is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD. orBec(®) is formulated for oral administration in GI GVHD patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.
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. Soligenix's lead product, orBec(®) (oral beclomethasone dipropionate or BDP), 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 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. Soligenix has also recently initiated an NIH-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis. 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) is also 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 orBec(®), SGX201, RiVax(TM), 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.
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