FDA Extends Review Of orBec For Acute GI Graft-Versus-Host Disease
This article was originally published in The Pink Sheet Daily
Executive Summary
DOR BioPharma, meanwhile, has launched a Phase II trial of the oral beclomethasone dipropionate product in the prophylactic GVHD setting.
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FDA extended its review of DOR BioPharma's acute gastrointestinal Graft-versus-Host disease treatment orBec (oral beclomethasone dipropionate) by three months after the company submitted new data that amounted to a major amendment to the NDA, the company announced July 19. The NDA's July 21 action date has now been moved to October 21, DOR CEO Christopher J. Schaber said during a same-day conference call. "We are pleased with this opportunity and believe that we have provided a compelling clinical picture for use of orBec in the treatment of acute GI GVHD," Schaber said. DOR submitted the additional data after meeting with the agency June 13 to discuss its further evaluation of orBec in light of the Oncologic Drugs Advisory Committee's negative vote on the product May 9. At the meeting, ODAC voted 7-2 that there was not substantial evidence of orBec's efficacy to support the product's proposed indication. The committee suggested the firm conduct an additional Phase III trial designed to foster more robust efficacy results, a solution Schaber said at the time was not an option because of lack of funds. Nonetheless, on July 12, the company announced it had launched a Phase II study of orBec in the prophylactic GVHD setting. The double-blind, placebo-controlled clinical trial anticipates enrolling up to 138 patients undergoing allogeneic hematopoietic stem cell transplantation to replace red blood cells destroyed along with cancer cells during chemotherapy and radiation treatments for blood cancers. Enrollment is expected to complete in the second quarter of 2008, the company said. The primary endpoint of the study is the proportion of subjects who develop acute GVHD with sufficient severity to require systemic immunosuppressive treatment on or before day 90 after transplantation. In GVHD, immune cells that are mixed in among transplanted hematopoietic stem cells from an allogeneic (non-self) donor attack the patient's tissues, including, frequently, the gastrointestinal system. The current standard of care is dosing with systemic immunosuppressive agents such as prednisone. One problem ODAC had with the orBec NDA is that Miami-based DOR had supported the application with data from a Phase III clinical study that missed its primary endpoint of time to treatment failure through day 50 (1 (Also see "DOR Biopharma’s orBec For GI Disease Misses Primary Endpoint" - Pink Sheet, 25 Jan, 2007.)). The goal of the trial was to first control the inflammatory process caused by GVHD with an induction course of prednisone, then taper the prednisone and maintain control with beclomethasone for 40 additional days. The study did, however, achieve statistical significance in a secondary endpoint of median time to treatment failure through day 80. During the call, Schaber said that since the ODAC meeting "all the companies that were reviewing orBec and taking a look at the company [are] ... in a wait-and-see mode. We know that there are several companies out there that have an interest in orBec, and we imagine that their interest will be [rekindled] over the coming months," he said. In January, DOR rebuffed a pre-ODAC acquisition offer from Seattle-based Cell Therapeutics (2 (Also see "Cell Therapeutics CEO James Bianco: An Interview With “The Pink Sheet” DAILY" - Pink Sheet, 26 Jan, 2007.)). - Shirley Haley ([email protected]) |