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DOR BioPharma Announces Issuance of Patents for Oral Graft Versus Host Disease
Tuesday, September 25, 2007
Miami, FL -- DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or the "Company") announced today that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance of patent claims based on U.S. Patent Application #09/433,418 entitled "Topical Azathioprine for the Treatment of Oral Autoimmune Diseases." Concurrently, the patent has also been issued by the European Patent Office with the serial number EP 1 212 063 B1. This patent family specifically includes claims for treatment and prevention of oral graft versus host disease (GVHD) with locally or topically applied azathioprine, a potent immunosuppressive drug. Oral GVHD can occur in up to 70% of patients who have undergone bone marrow/stem cell transplantation despite treatment with other immunosuppressive drugs such as prednisone, methotrexate, tacrolimus, and cyclosporine.
Azathioprine is a drug that has been widely used in transplant medicine over the past three decades, and is currently clinically indicated for the treatment of kidney transplant rejection, as well as used as a third line therapy for rheumatoid arthritis. Experimentally, it has been used by a number of clinical investigators to treat inflammatory conditions of the intestine, including Crohn's disease, and other inflammatory diseases. Azathioprine is a drug that belongs to the class of purine analogues that interfere with DNA metabolism and suppress gene transcription, especially in lymphocytes. The drug is believed to act through the suppression of autoreactive T cells that can result in local inflammatory lesions.
Oral GVHD results in painful ulcerative mucosal lesions in the oral cavity and esophagus, often resulting in dental demineralization and infections. The concept behind the issued patent claims is that potent anti-inflammatory drugs, such as azathioprine, can be applied locally in the oral cavity, and suppress or reverse the ulcerative lesions caused in the host by transplanted donor T cells. Specifically, the basis for the claims stems from human studies in which a marked improvement in oral ulcerations was observed in patients with oral GVHD given periodic mouth rinses with a formulation containing azathioprine. Since systemic exposure to azathioprine is associated with significant toxicity including among others bone marrow depression, the local application of the drug to the site of lesions is expected to result in minimal side effects and increase the ability to use the treatment in addition to other systemic immunosuppressive drugs ordinarily used in transplant medicine.
Both the US and the European patents contain claims that address the methods and the use of the azathioprine in oral lesions of GVHD whether used alone or in combination with other immunosuppressive drugs. Additionally, DOR has previously received Orphan Drug Designation for azathioprine covering the treatment of oral lesions associated with GVHD.
"The issuance of these patents in both the United States and Europe continues to reinforce and broaden our development pipeline in the area of GVHD," said Christopher J. Schaber, PhD, President and CEO of DOR. "Our azathioprine program is clearly synergistic on a number of levels with our orBec® programs as we are committed to developing therapies that can benefit patients in controlling the painful and many times life-threatening side effects of allogeneic hematopoeitic cell transplantation. While shareholders have not heard much about azathioprine, we plan on advancing this program into the clinic while assessing the optimal regulatory strategy for accelerating its development."
About DOR BioPharma, Inc.
DOR BioPharma, Inc. (DOR) 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 for orBec® with the FDA for the treatment of GI GVHD, and subsequent to supplemental information recently submitted, the FDA has extended the PDUFA (Prescription Drug User Fee Act) date to October 21, 2007. An MAA (Marketing Authorization Application) with the EMEA (European Medicines Evaluation Agency) has also been filed and validated. orBec® may also have application in treating other gastrointestinal disorders characterized by severe inflammation. DOR has recently initiated a development program with its Lipid Polymer Micelle (LPM™) oral drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis, as well as a development program with its oral azathioprine technology for the treatment of oral GVHD.
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, RiVax™, has been shown to be well 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 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 3 clinical study (i.e. a p-value of less than or equal to 0.05), the Oncologic Drug Advisory Committee ("ODAC") appointed by the FDA voted that the data supporting orBec® did not show substantial evidence of efficacy by a margin of 7 to 2 for the treatment of GI GVHD, although the FDA is not bound by ODAC's decision, 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.
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