DOR BioPharma Will Advance orBec To Phase II Trials For Irritable Bowel Syndrome; Decision To Pursue Second Indication Follows Positive Results In Animal Models.Business Editors/Health/Medical Writers LAKE FOREST, Ill.--(BUSINESS WIRE)--June 19, 2003 DOR Dor or Dora, Canaanite seaport, ancient Palestine (modern Israel), N of Caesarea Palestinae. It was never a Jewish city but rather a Phoenician outpost. It was rebuilt by the Romans; still visible are the ruins of a temple and a theater. BioPharma Inc. (AMEX AMEX See: American Stock Exchange :DOR) (the "Company" or "DOR") announced that the Company's lead product orBec(R) has demonstrated positive results in preliminary experiments with animal models of Irritable Bowel Syndrome irritable bowel syndrome (IBS), condition characterized by frequently alternating constipation and diarrhea in the absence of any disease process. It is usually accompanied by abdominal pain, especially in the lower left quadrant, bloating, and flatulence. (IBS IBS Irritable bowel syndrome, see there )-like pain. Based on these positive findings, DOR is planning to conduct a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in patients who suffer from post-infection IBS. Ralph Ellison, MD, Chief Executive Officer and President of DOR stated, "IBS affects approximately 35 million patients per year in the U.S. and represents a significant market opportunity for orBec(R) beyond intestinal GVHD GVHD graft-versus-host-disease. GVHD Graft-versus-host disease, see there , which is currently the subject of a pivotal Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the ". Dr. P. Jay Pasricha, Director of the Gastroenterology and Hepatology Division at University of Texas-Galveston (UTMB UTMB University of Texas Medical Branch ) stated, "In preliminary experiments using animal models of post-inflammatory IBS-like rectal pain, orBec(R) was able to reduce measures of pain in response to rectal distention dis·ten·tion or dis·ten·sion n. The act of distending or the state of being distended. distention, n a state of dilation. . The amount of distention pressure required to produce maximum pain behavior pain behavior, n a joint test during which the patient indicates a particular point in which pain is initially experienced and/or increases while the practitioner moves the joint through the range of motion. nearly doubled after 14 days of orBec(R) treatment. Although clearly preliminary, these results are encouraging and have potentially important implications. A growing body of clinical literature suggests that in a significant number of patients, IBS develops after a bout of infection. It is conceivable that some form of ongoing but subtle (and clinically unrecognized) inflammation may persist in these patients and contribute to their symptoms. Although its mechanism of action in this condition needs further study, it is possible that oral beclomethasone dipropionate bec·lo·meth·a·sone di·pro·pi·o·nate n. A corticosteroid usually used as an inhalant to treat asthma. beclomethasone dipropionate (bek´l given in low doses may ameliorate this inflammation by its local effects without significant systemic absorption. Therefore, orBec(R) could represent a logical and attractive approach for treating what may be a substantial portion of IBS sufferers". As part of its ongoing development program to broaden uses of orBec(R) to other gastrointestinal diseases, DOR has had a sponsored research arrangement with UTMB which led to these preliminary, but encouraging results. UTMB has tested orBec(R) in post-colitis animal models of functional bowel pain developed by Dr. Pasricha's laboratory. This model closely mimics the symptoms of IBS. About Irritable Bowel Syndrome Irritable Bowel Syndrome (IBS) is also known as irritable colon Irritable colon An intestinal disorder often accompanied by abdominal pain and diarrhea. Mentioned in: Antigas Agents and spastic colon spastic colon n. See irritable bowel syndrome. spastic colon Irritable bowel syndrome, see there . IBS causes lower abdominal pain and discomfort, urgency and irregular bowel habits, such as diarrhea or constipation. In some people IBS causes mostly constipation; in others, mostly diarrhea; some people have alternating periods of diarrhea and constipation. According to the International Foundation for Bowel Dysfunction (IFBD IFBD Institute for Business Development (Belgium) IFBD International Foundation for Bowel Dysfunction (now IFFGD: International Foundation for Functional Gastrointestinal Disorders) ), IBS affects at least 10-15% of adults, and is second only to the common cold as a cause of absenteeism from work. IBS costs the U.S. healthcare system approximately $30 billion annually in direct and indirect costs. IBS results in 2.5 to 3.5 million yearly visits to physicians and approximately 20 to 40 percent of all visits to gastroenterologists are due to IBS symptoms. DOR BioPharma, Inc. DOR BioPharma, Inc. is a specialty pharmaceutical company specializing in the oral and nasal delivery of drugs and vaccines. Dor is currently developing vaccines against Ricin Toxin and Botulinum Toxin. DOR's lead product, orBec(R) (oral beclomethasone dipropionate), is currently in a pivotal phase III clinical trial for the treatment of intestinal graft-vs.-host disease. 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's current expectations about its future results, performance, prospects and opportunities, including its product development and product pipeline. Where possible, DOR BioPharma has tried to identify these forward-looking statements by using words such as "anticipates," "believes" 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 BioPharma cannot assure you that it will be able to successfully develop or commercialize orBec(R) for the lead indication of intestinal graft-vs.-host disease or that orBec(R) will prove either safe or effective for indication of irritable bowel syndrome, especially in light of the uncertainty surrounding the diagnosis and understanding of irritable bowel syndrome, the novelty of utilizing anti-inflammatory drugs to treat irritable bowel syndrome and the clinical trials that would be required in order to prove orBec(R)'s safety and efficacy sufficient to support a Supplemental New Drug Application with the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. for necessary regulatory approval to commercialize orBec(R) for irritable bowel syndrome, 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 patents and negotiate and execute a definitive license agreement with respect to the patent applications that are the subject of this press release, or maintain any such license agreement if so executed, or that its business strategy will be successful. These and other factors are described from time to time in filings with the Securities and Exchange Commission, including, but not limited to, DOR BioPharma's most recent reports on Form 10-QSB and Form 10-KSB. DOR BioPharma assumes no obligation to update or revise any forward-looking statements as a result of new information, future events, changed circumstances or for any other reason. |
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