DOR BIOPHARMA Inc. (OTC:DORB)
Industry: Healthcare
DOR Biopharma, Inc. (DOR), incorporated in 1987, is a biopharmaceutical company focused on the development of biodefense vaccines and biotherapeutic products intended for areas of unmet medical need. The Company operates in two business segments: biodefense and biotherapeutic. Its biodefense business segment consists of converting biodefense vaccine programs from early stage development to advanced development and manufacturing. DOR's biotherapeutic business segment consists of development of orBec and other biotherapeutics products, such as Oraprine, LPM-Leuprolide, and LPE and PLP Systems for Delivery of Water-Insoluble Drugs. BioTherapeutics Segment The Company's therapeutic product orBec is an orally administered corticosteroid that exerts a potent, local anti-inflammatory effect within the mucosal tissue of the gastrointestinal tract. orBec has completed a multicenter, placebo-controlled pivotal Phase III clinical trial in intestinal graft-versus-host disease (iGVHD). The active ingredient in orBec, beclomethasone 17, 21-dipropionate (BDP), is a mucosally active anti-inflammatory agent, with a potent local effect, that is the active ingredient in a variety of marketed products, including Beconase Aqua (nasal spray for rhinitis), Becloforte (inhalant for asthma) and Propaderm (a topical cream for eczema and psoriasis). orBec is manufactured as a two-pill formulation (one milligram BDP per pill) administered four times daily (total of eight milligram) for the indication of acute iGVHD. The two-pill combination consists of an immediate-release pill designed to primarily dissolve in the stomach and proximal intestine and an enterically coated pill designed to dissolve in the more alkaline phosphates (pH) portion of the small intestine. The Company designed a Phase III clinical protocol that was subject to a Special Protocol Assessment (SPA) by the United States Food and Drug Administration (FDA). The primary efficacy endpoint of this trial is the time to treatment failure at Study Day 50. Treatment failure was defined as use of prednisone or equivalent IV corticosteroids at doses higher than stated in protocol, or use of any additional other steroid, in response to uncontrolled signs or symptoms of iGVHD. The target enrollment was 130 patients. The pivotal trial was conducted at 16 bone marrow transplant centers 14 in the United States and two in France, and the product has been assigned orphan drug designation and fast track status by the FDA. The trial was a randomized, double blind, placebo controlled safety, efficacy and pharmacokinetic trial that was to serve as the basis for a new drug application to be filed with the FDA. Oraprine is an oral suspension of azathioprine, which is bioequivalent to the oral azathioprine tablet marketed in the United States as Imuran. DOR acquired the azathioprine formulation (Oraprine) as a result of the merger of Endorex Newco and Corporate Technology Development, Inc. in November 2001. LPM-Leuprolide is an oral dosage formulation of the peptide drug leuprolide, a hormone-based drug that is among the drugs used to treat endometriosis and prostate cancer, which utilizes a novel drug delivery system. The Company was developing two lipid-based systems, LPE and PLP, to support the oral delivery of small molecules of water insoluble drugs. Such drugs include most kinds of cancer chemotherapeutics delivered intravenously. The LPE system is in the form of an emulsion or an emulsion pre-concentrate incorporating lipids, polymers and co-solvents. BioDefense Segment In collaboration with two United States academic research institutions, the Company is developing vaccine products to combat the threat posed by two potent biological toxins: ricin toxin and botulinum toxin. Both vaccines under development are recombinant products produced in bacterial hosts and both consist of non-toxic subunits of the native toxins. These subunits retain the ability to induce antibodies that neutralize the toxins, from which they are derived. In collaboration with University of Texas Sou
As Of: 10/07 00:00 ET
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