Healthcare Industry News: GvHD
News Release - January 20, 2006
DOR BioPharma Reports Positive New Survival Findings from Previously Completed Phase II and III Clinical Trials of orBec(R)Results to be Presented at Upcoming BMT Conference this February 18th
MIAMI--(HSMN NewsFeed)--Jan. 20, 2006--DOR BioPharma, Inc. (AMEX:DOR ; "DOR", or the "Company") announced today that as part of its process to submit a New Drug Application ("NDA") for orBecŪ (oral beclomethasone dipropionate) for the treatment of patients with gastrointestinal Graft-versus-Host disease (iGvHD) and in response to a specific FDA request, it has completed an analysis to compare the statistically significant survival benefit demonstrated in favor of orBecŪ 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.
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. The new follow-up data and analysis from the earlier Phase II trial suggests that the day-200 post transplant survival results from the Phase II study are in concordance with the approximate 70% reduction in mortality at day-200 post-transplant demonstrated in favor of orBecŪ in DOR's 129 patient, pivotal, multi-center, placebo-controlled Phase III clinical trial of orBecŪ for the treatment of 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 orBecŪ in the pivotal Phase III clinical trial. As previously reported, in DOR's pivotal Phase III study, there were 16 (24%) deaths in the placebo arm as compared to only 5 (8%) deaths in the orBecŪ arm at the prospectively defined day-200 post transplant mortality endpoint, achieving a statistically significant p-value of 0.011. Survival at day-200 was not, however, a prospectively defined endpoint in the Phase II trial and until recently so requested by the FDA, had not been previously analyzed.
The Phase II clinical trial was similar in design to the pivotal Phase III trial which was completed in late 2004. In the Phase II study, 60 patients with iGvHD were randomized to receive an induction course of conventional prednisone therapy plus either oral beclomethasone dipropionate or placebo. Initial responders continued to take oral beclomethasone or placebo for an additional 20 days, during which time the prednisone 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. The treatment response at study day 30 was 22 of 31 (71%) vs. 12 of 29 (41%) in the oral beclomethasone and placebo groups respectively, achieving a statistically significant p-value of 0.02. This data was previously published by Dr. McDonald in the journal Gastroenterology (1998).
DOR is also announcing today that in a recently completed analysis of the day-200 survival endpoint data from the pivotal Phase III clinical trial, it found that there were no previously undetected imbalances between the treatment and placebo groups that could have favored the orBecŪ group over the placebo group. In fact, there was a higher proportion of high risk patients in the orBecŪ group which would be expected to put the orBecŪ arm at a disadvantage. In spite of this, orBecŪ was still the factor with the strongest statistical association with survival.
"These new findings give credence to our belief that orBecŪ has a positive effect on survival in this patient population," said Michael T. Sember, President and Chief Executive Officer of DOR. "Since we missed our primary endpoint in the pivotal trial, the FDA has told us that a very high emphasis would be placed on our survival data. While the new preliminary Phase II survival results were not a prospectively defined endpoint, they are nonetheless supportive and corroborate the results from our pivotal Phase III clinical trial."
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, inventor of orBecŪ and a consultant to DOR stated, "We believe that orBecŪ, a proprietary oral form of the potent site-active corticosteroid, beclomethasone dipropionate, may represent the first new therapy for iGvHD that improves survival. iGvHD is the most significant and life threatening toxicity associated with allogeneic hematopoietic cell transplants. orBecŪ's topical activity in the gastrointestinal tract maintains control of the signs and symptoms of gastrointestinal GvHD, allowing prednisone exposure to be greatly reduced, resulting in fewer infections and better survival."
About DOR BioPharma, Inc.
DOR BioPharma, Inc. is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments, serious gastrointestinal diseases and disorders, and biomedical countermeasures. Our lead product, orBecŪ (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 orBecŪ for the treatment of iGvHD in the first quarter of 2006.
In November we announced that we entered into a binding letter of intent to acquire Gastrotech Pharma A/S, a Danish biotech company developing therapeutics based on peptide hormones to treat cancer and gastrointestinal diseases and conditions.
Through our BioDefense Division, we are developing biomedical countermeasures pursuant to the paradigm established by the recently enacted Project BioShield Act of 2004. Our biodefense products in development are bioengineered vaccines designed to protect against the deadly effects of ricin toxin and botulinum toxin, both of which are considered serious bioterrorism threats. Our ricin toxin vaccine, RiVax(TM), has completed the clinical portion of its Phase I clinical trial in normal volunteers. We have also announced the initiation of a new botulinum toxin therapeutic development program based on rational drug design.
For further information regarding DOR BioPharma, please visit the Company's website located at http://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 statements regarding the potential use of orBecŪ for the treatment of iGvHD and the prospects for regulatory filings for orBecŪ. Where possible, DOR BioPharma 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 BioPharma cannot assure you that it will be able to successfully develop or commercialize products based on its technology, including orBecŪ, 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 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, that it will be able to maintain its listing on the American Stock Exchange ("AMEX") by completing a transaction which will provide it with shareholders' equity of at least $6 million, or that its business strategy will be successful. Important factors which may affect the future use of orBecŪ for iGvHD include the risks that: because orBecŪ did not achieve statistical significance in its primary endpoint in the pivotal Phase III clinical study (i.e. a p-value of less than or equal to 0.05), the FDA may not consider orBecŪ approvable based upon existing studies, orBecŪ 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 BioPharma expects or may never gain approval; DOR BioPharma 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 orBecŪ may not gain market acceptance; and others may develop technologies or products superior to orBecŪ. DOR BioPharma's business strategy has been revised to include the issuance of its securities to acquire companies or assets. DOR BioPharma presently is involved in negotiations which could result in the issuance of a significant number of shares of its equity securities, thereby diluting the equity interests of present stockholders. 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, and changes in circumstances or for any other reason.
Source: DOR BioPharma
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