Healthcare Industry News: GvHD
News Release - April 4, 2007
DOR BioPharma Announces Initiation of Clinical Development Program for Oral LeuprolideFirst Potential Oral Version of Injectable Product
MIAMI, FL--(Healthcare Sales & Marketing Network)--Apr 4, 2007 -- DOR BioPharma, Inc. (OTC BB:DORB.OB ) ("DOR" or "The Company") announced that it plans to initiate a clinical development program in humans with its Lipid Polymer Micelle ("LPM(TM)") oral drug delivery technology. The LPM(TM) system is a platform technology designed to allow for the oral administration of drugs such as leuprolide that are water-soluble but poorly permeable through the gastrointestinal tract. DOR has previously demonstrated in preclinical animal models that the LPM(TM) technology is adaptable to oral delivery of peptide drugs and that high systemic levels after intestinal absorption can be achieved with the peptide hormone drug leuprolide.
In preclinical studies, DOR's LPM(TM) delivery technology significantly enhanced the ability of leuprolide, to pass through the intestinal epithelium in comparison to leuprolide alone. Leuprolide is a synthetic peptide agonist of gonadotropin releasing hormone ("GnRh"), which is used in the treatment of prostate cancer in men and endometriosis in women. Leuprolide exhibits poor intestinal absorption from an aqueous solution with the oral bioavailability being less than 5%. Utilizing LPM(TM) in both rats and dogs, the bioavailability of leuprolide averaged 30% compared to 2.2% 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 tradenames such as Lupron® and Eligard® had worldwide sales of approximately $1.8 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 depo and subcutaneous implant routes of delivery which limits its use and utility.
The LPM(TM) system is a proprietary oral delivery platform technology that utilizes a lipid based delivery system that can incorporate the peptide of interest in a thermodynamically stable configuration called a "reverse micelle" that through oral administration, can promote intestinal absorption. Reverse micelles are structures that form when certain classes of lipids come in contact with small amounts of water. This results in a drug delivery system in which a stable clear dispersion of the water soluble drug can be evenly dispersed within the lipid phase. LPM(TM) is thought to promote intestinal absorption due to the ability of the micelles to open up small channels through the epithelial layer of the intestines that allow only molecules of a certain dimension to pass through while excluding extremely large molecules such as bacteria and viruses. The reverse micelles also structurally prevent the rapid inactivation of peptides by enzymes in the upper gastrointestinal tract via a non-specific enzyme inhibition by surfactant(s) in the formulation.
In re-initiating the LPM(TM) technology, DOR has enlisted the assistance of experienced drug delivery, formulation and clinical consultants who have been intimately involved with the development of the LPM(TM) technology.
"One of the major limitations in the development of drugs derived from synthetic peptide chemistry or recombinant DNA technology is that they must be given by injection due to their inability to penetrate the epithelial layer of the intestines," said Christopher J. Schaber, Ph.D., President and CEO of DOR. "Given the high relative bioavailability that the LPM(TM) system delivers, we believe that this technology will be applicable to a large number of water soluble drugs including peptides with poor intestinal permeability, resulting in increased patient compliance and safety. With the preclinical data we have generated to date, we anticipate initiation of a Phase 1 safety, tolerability and pharmacokinetic study with LPM-leuprolide around midyear 2007. Expansion of our pipeline beyond orBec® for the treatment of GI GvHD is an important focus of our company. In addition to the follow-on clinical studies with orBec®, we are encouraged with the potential the LPM(TM) system has to enhance delivery across a number of therapeutic areas."
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents. DOR's lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of GI GvHD, a common and potentially life-threatening complication of bone marrow transplantation. DOR has filed an NDA with the FDA for the treatment of GI GvHD, and has received a PDUFA date of July 21, 2007. In addition, the FDA's Oncology Drug Advisory Committee ("ODAC") will review the NDA for orBec® on May 9, 2007. An MAA with the EMEA for orBec® has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation.
Through its Biodefense Division, DOR is developing biomedical countermeasures pursuant to the recently enacted Project BioShield Act of 2004. DOR's biodefense products in development are recombinant subunit vaccines designed to protect against the lethal effects of exposure to ricin toxin and botulinum toxin. DOR's ricin toxin vaccine, RiVaxTM, has been shown to be safely tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers.
For further information regarding DOR BioPharma, please visit the Company's website located at www.dorbiopharma.com.
This press release contains forward-looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, that reflect DOR BioPharma, Inc.'s current expectations about its future results, performance, prospects and opportunities, including statements regarding the potential use of orBec® for the treatment of gastrointestinal GvHD and the prospects for regulatory filings for orBec®. Where possible, DOR has tried to identify these forward-looking statements by using words such as "anticipates," "believes," "intends," or similar expressions. 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. DOR also cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBec®, 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 technologies will prove to be safe and effective, that its cash expenditures will not exceed projected levels, that it will be able to obtain future financing or funds when needed, 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 U.S. Government or other countries, that the U.S. 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: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBec® approvable based upon existing studies, orBec® may not show therapeutic effect or an acceptable safety profile in future clinical trials, if required, or could take a significantly longer time to gain regulatory approval than DOR expects or may never gain approval; DOR 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; or orBec® may not gain market acceptance; and others may develop technologies or products superior to orBec®. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR's most recent reports on Form 10-QSB and Form 10-KSB. DOR assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, and changes in circumstances or for any other reason. Lupron®, and Eligard® are registered trademarks of Takeda Pharmaceuticals, TAP Pharmaceuticals, Abbott Laboratories and QLT, Inc.
Source: DOR BioPharma
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