Full antigen detection

 
Through our Biotherapeutics Division, we are developing novel orally administered drugs based on chemical entities that have been approved for use in other indications. The modified drugs can then be used to treat diseases for which the unmodified drugs cannot effectively be used. The Company's lead product, orBec™ (oral beclomethasone dipropionate), is currently in a pivotal phase III clinical trial for the treatment of intestinal graft-vs.-host disease, and holds promise for treatment of symptoms of other gastrointestinal inflammatory conditions such as Crohn’s Disease and Ulcerative Colitis. We are also testing orBec™'s usefulness in treating a large percentage of persons diagnosed with irritable bowel syndrome (IBS), a disease that affects approximately 35 million persons in the U.S. alone.



orBec™ (beclomethasone) . . . . . . .
IGVHD (intestinal Graft-Versus-Host Disease) . .
Crohn’s Disease . . .
Oraprine™ (azathioprine) . . . . . . .
Oral Autoimmune Disorders . . .
Rheumatoid Arthritis / Transplantation . . . .
LPM™/ LPE™/ PLP™ Delivery Systems

 
Oral LPM™ Leuprolide  
Oral LPE™, PLP™ Paclitaxel  
Others  



DOR BioPharma’s lead product, orBecTM, is an oral form of beclomethasone dipropionate (BDP). A highly potent, orally-active corticosteroid, has shown benefit in the management of the following intestinal diseases: intestinal Graft-Versus-Host Disease, inflammatory bowel disease (IBD) and idiopathic lymphocytic enterocolitis (a form of inflammatory bowel disease). 

Currently, orBec™ is being evaluated in a multicenter pivotal phase III clinical trial for the treatment of moderate to severe intestinal Graft-Versus-Host-Disease (IGVHD). orBecTM has completed phase I/II clinical trials as well as a 60 patient randomized-controlled phase II/III clinical trial for the treatment of IGVHD. The data generated in the phase III trial will be used to file a New Drug Application or NDA.




DOR BioPharma’s second clinical-stage compound is OraprineTM, an oral suspension of azathioprine, which the Company believes is bioequivalent to the oral azathioprine tablet currently marketed in the United States as Imuran®. Azathioprine (AZA) is one of the most widely used immunosuppressive medications in clinical medicine. AZA is commonly prescribed to organ transplant patients to decrease their natural defense mechanisms to foreign bodies (such as the transplanted organ). The decrease in the patient’s immune system increases the chances of preventing rejection of the transplanted organ in the patient. This same reduction in the body's own defenses makes AZA useful in the treatment of rheumatoid arthritis. AZA is prescribed as a “second-line” treatment of severe, active rheumatoid arthritis inpatients that do not respond to initial arthritis medications. Currently, AZA is marketed under the brand name Imuran® by Faro Pharmaceuticals in North America and by Glaxo Wellcome abroad. It is sold in solid dosage form, powder, and intravenous forms.

The Company has completed a pilot phase I bioequivalency trial using OraprineTM comparing it to the marketed Imuran® tablet. The Company plans to position this product as a specialty generic product to be used by patients having autoimmune disorders that cannot tolerate tablet formulations. Post-approval, the Company plans to conduct clinical studies in pediatric patients who are afflicted with Crohn’s Disease, Ulcerative Colitis, Inflammatory Bowel Disease (IBD), chronic oral GVHD and autoimmune diseases of the mouth and upper esophagus. The Company has already completed a pilot phase I/II clinical efficacy trial using this formulation for the treatment of oral GVHD. The Company has filed patent applications for the use of oral AZA solution to treat oral autoimmune disorders. Oraprine™ has been granted Orphan Drug designation by the FDA for the treatment of oral GVHD.


 


DOR BioPharma's fundamental platform drug delivery technologies reside in its ability to formulate "problem" drugs for oral delivery using proprietary patented technology. Entire classes of therapeutic compounds cannot be delivered by the gastrointestinal route because they are exceptionally fragile or cannot permeate the mucosal tract. By employing DOR BioPharma's system, a specially engineered lipid-based technology for entrapment of drugs, many of these problem drugs can be made orally available at therapeutic levels. Other applications of this technology include the development of oral forms of cancer drugs, many of which are water insoluble. The following three new proprietary lipid-based drug delivery systems have been validated in key animal models.

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