DOR BioPharma reports positive results in orBec clinical trials

By Lisa Kerner

Erie, Pa., Jan. 20 - DOR BioPharma, Inc. said follow-up data related to an earlier phase 2 study reaffirms the positive survival benefit found in a phase 3 clinical trial of its drug orBec (oral beclomethasone dipropionate) to treat gastrointestinal Graft-versus-Host disease (iGVHD).

The company said the analysis is part of DOR's process to submit a New Drug Application for orBec for the treatment of patients with iGVHD and in response to a specific Food and Drug Administration request, according to a company news release.

DOR said it plans to file the New Drug Application in the first quarter of this year.

Follow-up data from the earlier phase 2 trial suggests that the day-200 post transplant survival results are in concordance with the approximate 70% reduction in mortality at day 200 post-transplant demonstrated in the phase 3 trial, according to the news release.

The phase 3 trial was a 129 patient, pivotal, multi-center, placebo-controlled clinical trial of orBec for the treatment of iGVHD.

Long-term follow-up data from the phase 2 clinical trial are also in concordance with the long-term survival benefit seen in favor of orBec in the pivotal phase 3 clinical trial. In the phase 3 study, there were 16 deaths, or 24%, in the placebo arm as compared to only five deaths, or 8%, in the orBec arm at the day-200 post transplant mortality endpoint.

Survival at day 200 was not, however, a prospectively defined endpoint in the phase 2 trial. That data has not been analyzed prior to the FDA's request.

In the phase 2 study, 60 patients with iGVHD were randomized to receive an induction course of conventional prednisone therapy plus either oral beclomethasone dipropionate or placebo. 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 71% versus 41% in the oral beclomethasone and placebo groups, respectively.

"These new findings give credence to our belief that orBec has a positive effect on survival in this patient population," Michael T. Sember, DOR president and chief executive officer, said in the release. "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 2 survival results were not a prospectively defined endpoint, they are nonetheless supportive and corroborate the results from our pivotal phase 3 clinical trial."

Miami-based DOR BioPharma is a biopharmaceutical company addressing life-threatening side effects of cancer and cancer treatments and gastrointestinal diseases and disorders.

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