Mar 9 2007, 6:18 AM EST
MARKETWIRE
DOR BioPharma, Inc. (OTCBB: DORB) ("DOR" or "the Company") announced that it has formed an experienced consulting team which includes key oncologic and gastrointestinal opinion leaders and ex-FDA personnel to prepare for the upcoming Oncologic Drugs Advisory Committee ("ODAC") meeting, scheduled for May 10, 2007 at 8AM EDT. The ODAC meeting will review the New Drug Application ("NDA") for orBec(R) (oral beclomethasone dipropionate) for the treatment of gastrointestinal Graft-versus-Host disease ("GI GVHD").
DOR has executed an agreement with PharmApprove(SM) to assist with regulatory coordination and strategic preparation for the ODAC meeting. PharmApprove is a communications consulting service that specializes in the navigation of global drug teams through the US and European drug approval and advisory committee process. The firm provides customized training to help create and implement strategic regulatory plans -- from early team discussions through final approval and/or launch. PharmApprove is staffed by internationally experienced communications professionals and is complemented by therapeutic experts and former FDA officials. The firm's client list includes both major global as well as smaller domestic pharmaceutical companies.
Pete Taft, President and Managing General Partner of PharmApprove, stated, "orBec(R) is clearly an important therapy which we believe would clearly address a currently unmet medical need. We're proud to be associated with this project and look forward to assisting the DOR medical and regulatory teams in making a clear and compelling case for the drug's approval before ODAC."
"We view the ODAC panel meeting as a pivotal next step in the regulatory approval process for orBec(R) and believe we now have committed the necessary resource to achieve the best possible outcome," stated Christopher J. Schaber, Ph.D., President and Chief Executive Officer of DOR. "With the team we have assembled we believe we will be prepared to answer any and all questions the panel may ask of us and that this will be a productive experience for all involved.
About the orBec(R) NDA
The data provided in the NDA submission demonstrate that orBec(R) may provide a higher rate of survival when compared with the current standard of care, and a lowered exposure to systemic corticosteroids following allogeneic transplantation. Currently there are no approved products to treat GI GVHD. Thus an approval of orBec(R) would represent the first directed therapy for GI GVHD. DOR currently has a PDUFA goal date of July 21, 2007 and is scheduled to meet to review orBec(R) with the Oncologic Drugs Advisory Committee ("ODAC") on May 10, 2007 at 8AM EDT.
The NDA filing is supported by data from two randomized, double-blinded, placebo-controlled clinical trials. The first trial was a 129-patient pivotal Phase 3 multi-center clinical trial of orBec(R) conducted at 16 leading bone marrow/stem cell transplant centers in the U.S. and France. The second trial was a 60-patient Phase 2 single-center clinical trial conducted at the Fred Hutchinson Cancer Institute. Although orBec(R) did not achieve statistical significance in the primary endpoint of its pivotal trial, namely time to treatment failure through Day 50 (p-value 0.1177), orBec(R) did achieve statistical significance in other key outcomes such as median time to treatment failure through Day 80 (p-value 0.0226) and, most importantly, demonstrated a statistically significant long-term survival advantage compared with placebo.
In the pivotal Phase 3 trial, analysis of patient survival at the pre-specified endpoint of 200 days post-transplant showe
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