DOR BioPharma Presents Positive New Survival Findings from Phase II and III Clinical Trials of orBec at Annual Bone Marrow Transplant Conference; Abstract Selected for Best Abstracts Award.
The survival data, collected by DOR in response to a specific FDA request as part of its process to submit a New Drug Application ("NDA"), included a comparison of the statistically significant survival benefit demonstrated in favor of orBec(R) in its pivotal Phase III clinical trial to survival among 60 patients previously studied in a randomized, double-blinded, placebo-controlled, Phase II clinical trial of oral beclomethasone dipropionate for iGVHD. The Phase II clinical trial was conducted at the Fred Hutchinson Cancer Research Center in Seattle, as described in a publication in the journal Gastroenterology. 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, patients with iGVHD were randomized to receive an induction course of conventional prednisone therapy plus either oral beclomethasone dipropionate or placebo. 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.
The new survival analysis of patients enrolled in this earlier Phase II trial suggests that results were similar to those from the pivotal Phase III multi-center study. In the Phase II trial, there were reductions in the risk of mortality of 55% and 43% at transplant day-200 and one year post-randomization among patients randomized to oral beclomethasone dipropionate, respectively. The comparable survival data from the 129-patient Phase III pivotal trial were 66% and 51% reductions in the risk of mortality at transplant day-200 and one-year post-randomization among patients randomized to orBec(R), respectively. In the Phase III pivotal trial, a subgroup analysis revealed that among patients who had received stem cells from unrelated donors, the reduction in the risk of day-200 mortality among patients randomized to orBec(R) was 94%.
"We believe that these Phase II results significantly strengthen our case that the robust mortality result that we saw in the Phase III pivotal trial was due to the positive effect of orBec(R)," said Michael T. Sember, President and Chief Executive Officer of DOR. "We have estimated that there is a 1 in 5,000 chance of observing similar odds ratios in the Phase II and Phase III studies if there was no effect of orBec(R) on day-200 survival. Consequently, we believe that since the mortality results from both clinical trials are so similar, this strongly suggests the hazard of mortality for patients randomized to orBec(R) was lower than placebo."
George B. McDonald, MD, Head of the Gastroenterology/Hepatology Section at the Fred Hutchinson Cancer Research Center, inventor of orBec(R) and a consultant to DOR, stated, "Based on all the data we have collected, I believe that orBec(R) represents the first new therapy for iGVHD that significantly improves survival with no discernable side effects. iGVHD is the most significant and life threatening toxicity associated with allogeneic hematopoietic cell transplants. The fact that two randomized trials show similar reductions in the hazard of mortality at one year post-randomization suggests that use of orBec(R) will impact outcomes in the majority of patients undergoing allogeneic transplant--particularly in recipients of unrelated donor stem cells, in whom reductions in mortality were highly significant. Over the past 30 years, there has not been a new drug approved that reduces mortality in any form of Graft-versus-Host Disease. orBec(R)'s topical activity in the gastrointestinal tract results in better survival in patients with intestinal GVHD, probably due to preservation of the intestinal mucosal barrier and the avoidance of prolonged immune suppression with prednisone, resulting in fewer fatal infections."
About Intestinal Graft-versus-Host Disease (iGVHD)
iGVHD is a life threatening condition that is one of the most common causes for the failure of bone marrow transplant procedures. These procedures are being increasingly utilized to treat leukemia and other cancer patients with the prospect of eliminating residual disease and reducing the likelihood of relapse. orBec(R) 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. orBec(R) is intended to reduce the need for systemic immunosuppressives to treat iGVHD. Currently approved systemic immunosuppressives utilized to control iGVHD substantially inhibit the highly desirable graft-versus-leukemia (GVL) effect of bone marrow transplants, leading to high rates of aggressive forms of relapse, as well as substantial rates of mortality due to opportunistic infection.
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, orBec(R) (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(R) for the treatment of iGVHD in the first quarter of 2006.
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 orBec(R) for the treatment of iGVHD and the prospects for regulatory filings for orBec(R). 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 orBec(R), 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 orBec(R) for iGVHD include the risks that: because orBec(R) 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 orBec(R) approvable based upon existing studies, orBec(R) 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 orBec(R) may not gain market acceptance; and others may develop technologies or products superior to orBec(R). DOR BioPharma presently is involved in financing 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.
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|Date:||Feb 21, 2006|
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