PRINCETON, N.J., Feb. 17 /PRNewswire-FirstCall/ -- Soligenix, Inc. (OTC Bulletin Board: SNGX) (Soligenix or the Company), a late-stage biotechnology company, announced today that it has received a Hong Kong patent which addresses its Lipid Polymer Micelle (LPM™) technology for the improved oral delivery of drugs. The issued Hong Kong patent, HK 1071054, entitled "Stabilized Reverse Micelle Compositions and Uses Thereof" covers lipid structures (reverse micelles) that promote the intestinal absorption of peptides and other sensitive drugs that cannot otherwise be given orally.
"The issuance of the Hong Kong patent for LPM™ further demonstrates the novelty of this drug delivery system and the preclinical results clearly show that it is a competitive system for oral delivery of drugs, especially those biotechnology products derived from synthetic peptide chemistry or recombinant DNA," said Christopher J. Schaber, PhD, Soligenix President and CEO. "We also believe that the LPM™ system will be applicable to a large number of water-soluble drugs including peptides that are poorly permeable, resulting in increased patient compliance and safety."
The issuance of this patent in Hong Kong follows the issuance of the same patent in Europe in 2009.
About the LPM™ Technology
The LPM™ technology is a platform technology that uses reverse micelles stabilized by polymers. Reverse micelles are generally described as a lipid system and are similar to water-in-oil emulsions in that the hydrophilic lipid head groups are directed towards the micelle core, with the hydrophobic tails imbedded in the oil phase. This results in a drug-delivery system that is a thermodynamically stable clear dispersion of the water-soluble drug in the lipid phase. But unlike water-in-oil systems, stabilized reverse micelles do not depend on the presence of other surfactants and are thermodynamically stable. In the LPM™ system, water-soluble drugs are contained in the water space in the core of the micelles and are protected against degradation.
Soligenix anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM™ technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, Soligenix has demonstrated that the LPM™ technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to less than 5 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under trade names such as Lupron® and Eligard® had worldwide sales of approximately $1.7 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.
LPM™ is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only molecules of a certain dimension to pass through, excluding extremely large molecules, bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract. Other sensitive drugs that can be delivered orally with the LPM™ system include various classes of drugs such as peptides, nucleic acids and proteins which are degraded in the stomach and small intestine. Corresponding patents in the United States and elsewhere are currently pending.
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. Both of these trials are actively enrolling patients. 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™) 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™, 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 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™, 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.
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"The issuance of the Hong Kong patent for LPM™ further demonstrates the novelty of this drug delivery system and the preclinical results clearly show that it is a competitive system for oral delivery of drugs, especially those biotechnology products derived from synthetic peptide chemistry or recombinant DNA," said Christopher J. Schaber, PhD, Soligenix President and CEO. "We also believe that the LPM™ system will be applicable to a large number of water-soluble drugs including peptides that are poorly permeable, resulting in increased patient compliance and safety."
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The issuance of this patent in Hong Kong follows the issuance of the same patent in Europe in 2009.
About the LPM™ Technology
The LPM™ technology is a platform technology that uses reverse micelles stabilized by polymers. Reverse micelles are generally described as a lipid system and are similar to water-in-oil emulsions in that the hydrophilic lipid head groups are directed towards the micelle core, with the hydrophobic tails imbedded in the oil phase. This results in a drug-delivery system that is a thermodynamically stable clear dispersion of the water-soluble drug in the lipid phase. But unlike water-in-oil systems, stabilized reverse micelles do not depend on the presence of other surfactants and are thermodynamically stable. In the LPM™ system, water-soluble drugs are contained in the water space in the core of the micelles and are protected against degradation.
Soligenix anticipates proceeding towards clinical development of an oral form of the peptide hormone drug leuprolide using the LPM™ technology. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone (GnRh) that is used in treatment of endometriosis in women and prostate cancer in men. In preclinical studies in rats and dogs, Soligenix has demonstrated that the LPM™ technology results in high systemic bioavailability of intestinally absorbed leuprolide. In both animal models, the bioavailability of leuprolide ranged from 20 to 40 percent, compared to less than 5 percent for the control oral solution. Leuprolide is one of the most widely used anti-cancer agents for advanced prostate cancer in men. Injectable forms of leuprolide marketed under trade names such as Lupron® and Eligard® had worldwide sales of approximately $1.7 billion in 2006. Injectable leuprolide is also widely used in non-cancer indications, such as endometriosis in women (a common condition in which cells normally found in the uterus become implanted in other areas of the body), uterine fibroids in women (noncancerous growths in the uterus) and central precocious puberty in children (a condition causing children to enter puberty too soon). Leuprolide is currently available only in injectable, injectable depot and subcutaneous implant routes of delivery.
LPM™ is thought to promote intestinal absorption through the action of the micelles to open up small channels that allow only molecules of a certain dimension to pass through, excluding extremely large molecules, bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract. Other sensitive drugs that can be delivered orally with the LPM™ system include various classes of drugs such as peptides, nucleic acids and proteins which are degraded in the stomach and small intestine. Corresponding patents in the United States and elsewhere are currently pending.
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. Both of these trials are actively enrolling patients. 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™) 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™, 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 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™, 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.
