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BioWorld Today Although orBec did not show a statistically significant benefit over placebo in the median time to treatment failure at study day 50, the primary endpoint, it did at study day 80, a secondary endpoint. OrBec, on the other hand, acts locally by treating the gastrointestinal manifestation of the side effect, reducing the need for systemic immunosuppressives. In addition to the Phase III results, the NDA will include data from a Phase II study in which orBec achieved statistical significance, showing that at day 30, iGVHD patients were able to consume at least 70 percent of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administration in the hospital. www.bioworld.com /servlet/com.accumedia.web.Dispatcher?next=bioWorldHeadlines_article&forceid=35204   (2271 words)

BioPortfolio News : Positive new survival findings reported from phase II, III trials of orBec The analysis compares the statistically significant survival benefit demonstrated in favor of orBec in its pivotal phase III clinical trial to the survival results of the earlier successful 60 patient, randomized, double-blinded, placebo-controlled, phase II clinical trial of oral beclomethasone dipropionate for iGVHD. In addition, the long term follow-up data from the phase II clinical trial are also in concordance with the long-term survival benefit seen in favor of orBec in the pivotal phase III clinical trial. In spite of this, orBec was still the factor with the strongest statistical association with survival. www.bioportfolio.com /feb_06/17_02_2006/Positive_new_survival.html   (642 words)

PTCommunity.com - Daily News Briefing OrBec®, if approved by the FDA, would be the first oral formulation of beclomethasone dipropionate (BDP) available in the United States. OrBec® is being developed as a two-pill system with dual release characteristics that initially begins to release BDP in the stomach, and continues to release BDP as it travels down the GI tract for broader coverage in the intestines. The initial indication that orBec® is being developed for is the treatment of intestinal Graft-versus-Host Disease (GvHD), a severe, potentially life-threatening complication of allogeneic bone marrow and stem cell transplants. www.pharmscope.com /Daily/DailyDetail.cfm?chosen=55153   (656 words)

Cancer Resources—Cancer News, Cancer Conferences, Cancer Causes, Cancer Prevention OrBec is an oral formulation of beclomethasone dipropionate. OrBec did not achieve statistical significance in its main endpoint of delaying the need for additional treatment through day 50, but it did achieve statistical significance in its secondary endpoint of delaying treatment failure through day 80, the company said. In addition, the drug was associated with a 70% reduction in mortality, with 5 deaths (or 8%) in the orBec arm during the 200-day-post-transplant period versus 17 deaths (or 26%) in the placebo group. www.oncolink.upenn.edu /resources/article.cfm?c=3&s=8&ss=23&Year=2004&Month=12&id=11419   (369 words)

Biotechnology News and Information Portal, biotech jobs and career resources Resources.   (Site not responding. Last check: 2007-11-01) orBec® is being developed as a twopill system with dual\r\nrelease characteristics that initially begins to release BDP in the\r\nstomach, and continues to release BDP as it travels down the GI tract\r\nfor broader coverage in the intestines. orBec® has previously been\r\ngranted Orphan Drug Designation and has received Fast Track\r\ndesignation from the FDA.\r\nMichael Sember, Chief Executive Officer of DOR stated, This new\r\npivotal trial data, and collectively all the preclinical and clinical\r\ndata before it, are very encouraging and clearly demonstrate to me the\r\npotential of orBec® in treating iGVHD. For purposes of the study, patients that did not begin the rapid taper of high dose prednisone on Day 10 as called for by the regimen were deemed treatment failures for all purposes, including the calculation of statistical significance of time to treatment failure at Day 50. www.bioexchange.com /news/news_page.cfm?id=21079   (2379 words)

orBec® Improves Survival in Patients with Intestinal Graft-Versus-Host Disease orBec is an oral steroid that reduces inflammation of the lining of the gastrointestinal track. Approximately half of the patients were treated with orBec, while the other half received placebo (inactive substitute). The researchers concluded that orBec appears to reduce the risk of death associated with GVHD in patients undergoing bone marrow or stem cell transplants. patient.cancerconsultants.com /other_cancer_news.aspx?id=36316   (524 words)

DORbiopharma, Inc. While orBec® did not achieve statistical significance in its primary endpoint of time to treatment failure through Day 50 (p-value 0.1177), orBec® did achieve statistical significance in its secondary endpoint of time to treatment failure through Day 80 (p-value 0.0226). Perhaps of greatest clinical relevance, orBec® demonstrated a 70% reduction in mortality, registering only 5 (8%) deaths during the prospectively defined Day 200 post-transplant period versus 17 (26%) deaths for the placebo group (p-value 0.006). The treatment response at Day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the orBec® and placebo groups respectively, achieving a statistically significant p-value of 0.02. www.dorbiopharma.com /press/2004/2004DEC30.htm   (1463 words)

FDA Grants Orphan Drug Status To orBec (Beclomethasone Dipropionate) For Prevention Of Graft-Versus-Host-Disease orBec previously received a designation to treat intestinal GVHD; this is the subject of an ongoing, pivotal, multi-center, phase III clinical trial. orBec allows larger doses of BDP to be delivered to the afflicted gastrointestinal area without systemic side effects associated with other steroids used to treat GVHD. As a designated Orphan Drug, orBec is eligible for certain tax benefits based upon clinical development costs, as well as assistance from the FDA in guiding the drug through the regulatory approval process. www.docguide.com /dg.nsf/PrintPrint/65DC55E1D4AF5DD985256AD2005C0703   (527 words)

orBec New Drug Application orBec   (Site not responding. Last check: 2007-11-01) orBec was previously tested in a randomized, double blind, placebo-controlled Phase II study (Gastroenterology, 1998; 115: 28-35). Initial responders continued to take orBec or placebo for an additional 20 days, during which time the conventional therapy was rapidly tapered. The primary endpoint for this study was the clinically relevant determination of whether iGVHD patients at Day 30 were or were not able to consume at least 70% of their daily caloric intake by mouth, as compared to intravenous parenteral nutrition administered in the hospital. bontril.easyentire.info /nda/orbec_050420.html   (1064 words)

DOR BIOPHARMA ANNOUNCES TOP-LINE RESULTS OF PHASE III TRIAL OF ORBEC FOR INTESTINAL GRAFT-VERSUS-HOST DISEASE   (Site not responding. Last check: 2007-11-01) One hundred and twenty-nine post-bone-marrow transplant patients presenting with Grade II iGVHD were enrolled in the randomized, double-blind, placebo-controlled, multicenter clinical trial, which was conducted at 16 bone marrow transplant centers in the U.S. and France. All patients in the Phase III clinical trial were initially treated with constant daily high-dose (1-2 mg/kg) prednisone, which is the current standard therapy, in combination with an oral dose of either orBec (8 mg/day) or placebo for the first 10 days. orBec represents a first-of-its-kind oral, locally acting therapy tailored to treat the gastrointestinal manifestation of GVHD, the organ system where GVHD is most frequently encountered and highly problematic. www.fdanews.com /dailies/dpa/3_2/news/33964-1.html   (300 words)

BioPortfolio News : Company to file NDA for orBec In addition to the strong positive trends on our primary endpoint of median-time-to-treatment failure at study day 50 in our pivotal trial, we saw a statistically significant result in median time-to-treatment failure at study day 80. This result, combined with a highly statistically significant outcome and approximately 70% reduction in the prospectively defined secondary endpoint of mortality at 200 days post transplant, has given us confidence in the consistency and clinical durability of activity of orBec. Our immediate priorities are to assemble a high-quality data package to support the filing of an NDA as soon as possible but by the fourth quarter of 2005, and to submit the results of the pivotal trial for publication in a prominent peer-reviewed publication. www.bioportfolio.com /may_05/24_05_2005/Company_to_file_NDA_for_orBec.html   (364 words)

DOR BIOPHARMA COMPLETES ENROLLMENT IN PHASE III TRIAL OF ORBEC FOR ACUTE INTESTINAL GRAFT-VERSUS-HOST DISEASE DOR BioPharma has announced the completion of patient enrollment in the company's multicenter, pivotal Phase III clinical trial of orBec (oral beclomethasone dipropionate) for the treatment of acute intestinal Graft-versus-Host Disease (GvHD), a severe, potentially life-threatening complication of bone marrow and stem cell transplant. OrBec, if approved by the FDA, would be the first oral formulation of beclomethasone dipropionate (BDP) available in the U.S. BDP is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. OrBec is being developed as a two-pill system with dual release characteristics, which initially begins to release BDP in the stomach and continues to release BDP as it travels down the GI tract for broader coverage in the intestines. www.fdanews.com /dailies/dpa/2_141/news/27877-1.html   (202 words)

Houses / homes for sale or for rent in Orbec - Vacation Rental   (Site not responding. Last check: 2007-11-01) If you are considering buying real estate in Orbec, or anywhere else for that matter, the most widely used method of borrowing the funds to make the purchase is a mortgage. When renting a home in Orbec you are usually limited to the changes/improvements you can make. In many cases vacation rentals in Orbec are offered by the owners of the property but in some instances real estate agents offer vacation rentals in Orbec. www.propertyworld.com /_France_Alsace_Orbec   (831 words)

ORBEC, Orbec Tourist Information and Travel Guide at InfoHub.com ORBEC, Orbec Tourist Information and Travel Guide at InfoHub.com The larger town of ORBEC, 19km southeast of Lisieux, also epitomizes the simple pleasures of the region. Along the rue Grande, you'll see several houses in which the gaps between the timbers are filled with intricate patterns of coloured tiles and bricks. www.infohub.com /destinations/Europe-&-Russia/France/Orbec/80779.htm   (158 words)

DOR BioPharma licenses irritable bowel syndrome patents. | Technology from AllBusiness.com   (Site not responding. Last check: 2007-11-01) Treatment with orBec, at least in some patients, may be curative and therefore much more desirable. While our pivotal Phase III clinical trial of orBec for the Fast-Track indication of intestinal graft-vs.-host disease continues with accelerating enrollment, we are eager to explore the potential of orBec in follow-on indications such as the billion dollar irritable bowel syndrome market. DOR BioPharma is a specialty pharmaceutical company specializing in the oral delivery of approved chemical entities for gastrointestinal disease and oral non-live vaccines for the treatment of a variety of disorders and biological defense. www.allbusiness.com /periodicals/article/293418-1.html   (693 words)

orBec New Drug Application   (Site not responding. Last check: 2007-11-01) DOR's target for submission of the NDA for orBec is now in the July - August timeframe of 2006. We remain highly enthusiastic about orBec and its prospects and we are working diligently to file both the NDA and the MAA as soon as possible. When approved, we expect that orBec will be indicated for the treatment of GI GVHD associated with allogeneic bone marrow or stem cell transplant (BMT/SCT) procedures. didrex.easyentire.info /nda/orbec_060630.html   (737 words)

MacReport.Net MIAMI--April 15, 2005--DOR BioPharma, Inc. (AMEX: DOR) ("DOR" or the "Company"), announced today that data from the recently completed orBec® pivotal Phase III clinical trial in intestinal Graft-versus-Host Disease (iGVHD) has been accepted for presentation at the 2005 Annual Meeting of the American Association of Cancer Research (AACR) in Anaheim California from April 16-20. DOR's lead therapeutic product, orBec® (an oral formulation of beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host Disease (iGVHD), a severe, life-threatening form of gastrointestinal inflammation. DOR recently announced top line results of its pivotal Phase III clinical trial of orBec® in iGVHD in which orBec® demonstrated a highly statistically significant reduction in mortality during the prospectively defined Day 200 post-transplant period and positive trends on its primary endpoint. www.macreport.net /tools/todaysMarkets/041805/prDOR.asp   (701 words)

Healthcare Sales & Marketing Network News: DOR BioPharma Reports Positive New Survival Findings from Previously ... Our lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other GI disorders characterized by severe inflammation. We plan to file a new drug application (NDA) with the FDA for orBec® for the treatment of iGVHD in the first quarter of 2006. Important factors which may affect the future use of orBec® for iGVHD include the risks that: because orBec® did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. salesandmarketingnetwork.com /news_release.php?ID=2009577   (1203 words)

Pharmacy Choice - Pharmaceutical News - Positive new survival findings reported from phase II and III clinical trials ... The randomized, double-blinded, placebo-controlled, phase II clinical trial of oral beclomethasone dipropionate in 60 patients with iGVHD was conducted and completed at the Fred Hutchinson Cancer Research Center in Seattle, Washington. McDonald, head of the gastroenterology/hepatology section at the Fred Hutchinson Cancer Research Center, inventor of orBec, and a consultant to DOR, stated, "We believe that orBec, a proprietary oral form of the potent site-active corticosteroid, beclomethasone dipropionate, may represent the first new therapy for iGVHD that improves survival. This article was prepared by Medical Letter on the CDC and FDA editors from staff and other reports. www.pharmacychoice.com /news/article.cfm?Article_ID=22062   (729 words)

Healthcare Sales & Marketing Network News: DOR BioPharma Provides Update on Programs and Corporate Matters In its initial correspondence with DOR about the orBec® program, the FDA's Oncology Division had questions and comments about orBec® and the transplantation field in general to which DOR has submitted a response. In other orBec® news, DOR has recently received a notice of grant from the FDA's Orphan Products Division for its grant application dated April 6, 2004 entitled "Oral BDP for the Treatment of GI GVHD". Our lead product, orBec® (oral beclomethasone dipropionate), is a potent, locally-acting corticosteroid being developed for the treatment of intestinal Graft-versus-Host disease (iGVHD), a common serious complication of bone marrow transplantation for cancer, as well as other gastrointestinal disorders characterized by severe inflammation. salesandmarketingnetwork.com /news_release.php?ID=2007813   (972 words)

Car Hire Orbec, Book Now! We specialise in car rental in Orbec and other destinations in France. Book your car hire in Orbec, France from Argus Car Hire - with no cancellation fee and price guarantee. Argus Car Hire offers low cost car hire at Orbec in France with the best fully inclusive car hire rates from the world's top 100 car rental companies. www.argusrentals.com /Europe-Car-Rental/France/car-rental-car-hire-Orbec.html   (278 words)

DOR BioPharma reports orBec improves mortality rates in leukemia patients following bone marrow transplant. | Health ...   (Site not responding. Last check: 2007-11-01) Patients taking orBec had an 8% mortality rate at 200 days following BMT compared to a 26% rate in the placebo group. If approved by FDA, OrBec would be the first oral formulation of beclomethasone dipropionate (BDP) available in the US. DOR says BDP has been marketed in the US and worldwide since the early 1970s as a nasal spray and in a metered dose inhaler for treatment of patients with allergic rhinitis and asthma. www.allbusiness.com /periodicals/article/345742-1.html   (450 words)

ORBEC - tourist office Petite ville du Haut Pays d'Auge, Orbec s'est implantée au bord d'un cours d'eau dont elle prit le nom scandinave de ``rivière des truites'' après la colonisation Viking. Find information about ORBEC on I-mode, Smartphone, PDA at http://imode.tourisme.fr MAP : France - NORMANDY - Calvados (ORBEC en B3) - Offices de tourisme duCalvados www.tourisme.fr /tourist-office/orbec.htm   (146 words)

ORBEC   (Site not responding. Last check: 2007-11-01) Orbec : Set in one of the green valleys of the Auge Country, on the river Orbiquet, Orbec offers the visitor all the charm of an ancient town with streets lined with timber-framed dwellings and private mansions. The powerful flow of the Orbiquet encouraged the building of watermills in the Middle Ages, follwed by textile mills in the XIXth century. These activities were replaced by cider and cheese-making, traditional sectors which continue to flourish today. www.normandy-tourism.org /gb/02ville/O/Orbec.html   (75 words)

Globeinvestor.com: DOR's Abstract Describing orBec Phase III Clinical Trial Results Selected for Presentation at the ... Globeinvestor.com: DOR's Abstract Describing orBec Phase III Clinical Trial Results Selected for Presentation at the Annual Meeting of the American Association of Cancer Research DOR's Abstract Describing orBec Phase III Clinical Trial Results Selected for Presentation at the Annual Meeting of the American Association of Cancer Research The poster presentation: "A Phase 3 Randomized, Placebo-Controlled Study of Oral Beclomethasone 17, 21-Dipropionate (BDP) in Conjunction with Ten Days of High-Dose Prednisone Therapy for Patients with Gastrointestinal Graft vs. Host Disease" will be presented by the study's lead investigator, Dr. David Hockenbery, Member of the Fred Hutchinson Cancer Research Center. www.globeinvestor.com /servlet/ArticleNews/print/BWIRE/20050415/20050415005086   (671 words)

La Vespiere Orbec car hire / La Vespiere Orbec car rental from 27 EUR per day all inclusive La Vespiere Orbec car hire / La Vespiere Orbec car rental from 27 EUR per day all inclusive La Vespiere Orbec car hire and La Vespiere Orbec car rental offers cheap and discounted car hire in France. Compare car rental rates in La Vespiere Orbec of the most important car hire providers in La Vespiere Orbec and save on you car rental. france.rentalcargroup.co.uk /Orbec.htm   (263 words)

[No title] DOR BioPharma Inc. said Friday that certain data from a late-stage trial was found to be similar to an earlier mid-stage trial, and its analysis will be submitted to the Food and Drug Administration to support an approval application for its orBec treatment. OrBec is a steroid that treats gastrointestinal graft-versus-host disease that occurs following bone marrow transplants due to cancer. The analysis suggests a concordance at 200 days between the survival benefit of patients given orBec in the mid-stage study and the 70 percent reduction in mortality seen in orBec patients in the late-stage clinical study. www.kiplingerforecasts.com /apnews/XmlStoryResult.php?storyid=150823   (362 words)

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