Oral corticosteroid beclomethasone orBec to treat gastrointestinal disease enters crucial phase of clinical studies: Soligenix

orBec, oral corticosteroid beclomethasone dipropionate to treat gastrointestinal manifestation of Graft-versus-Host disease (GVHD) has entered into phase 2 clinical study,  Soligenix, Inc announced.

orBec, oral beclomethasone dipropionate (oral BDP), 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 is intended to reduce the need for systemic immunosuppressive drugs to treat GI GVHD.  orBec is formulated for oral administration in GVHD patients as a single product consisting of two tablets; one tablet is intended to release BDP in the proximal portions of the GI tract, and the other tablet is intended to release BDP in the distal portions of the GI tract.

Oral BDP may also have application in treating other gastrointestinal disorders characterized by severe inflammation.

Soligenix has completed patient enrollment in a randomized, double-blind, placebo-controlled Phase 2 clinical trial of orBec for the prevention of acute Graft-versus-Host disease (GVHD) after allogeneic hematopoietic cell transplantation (HCT) with myeloablative conditioning regimens.

The Phase 2 trial enrolled 140 patients who have been randomized to either orBec or placebo at a 2:1 ratio.

The primary endpoint of this trial is the proportion of subjects who develop acute GVHD with severity sufficient to require systemic immunosuppressive treatment on or before day 90 after transplantation.  Subjects in the orBec group began study drug at the start of their conditioning regimen and continued through day 75 following HCT.

Results from the Phase 2 study are expected in the second half of 2010.

What is Graft-versus-Host-Disease (GVHD)?

GVHD is a debilitating and painful disease.  It is a common disorder among immunocompromised cancer patients after receiving allogeneic stem cell or bone marrow transplants.

Unlike organ transplants where the patient’s body may reject the organ, in GVHD it is the donor cells that begin to attack the patient’s body – most frequently the gut, liver and skin.

Patients with mild-to-moderate GI GVHD typically develop symptoms of anorexia, nausea, vomiting and diarrhea.  If left untreated, GI GVHD can progress to ulcerations in the lining of the GI tract, and in its most severe form, can be fatal.

Systemic immunosuppressive agents such as prednisone, which are the current standard treatments for GVHD, are associated with high mortality rates due to infection and debility.

Further, these drugs have not been approved for treating GVHD in the U.S. or European Union, but rather are used off-label for this indication.

Soligenix, Inc is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents.

Soligenix’s lead product, orBec is currently the subject of a confirmatory Phase 3 clinical trial for the treatment of acute GI GVHD and an NIH-supported, Phase 2 trial in the prevention of acute GVHD. Both of these trials are actively enrolling patients.

Soligenix has also recently initiated an NIH-supported Phase 1/2 clinical trial of SGX201 in the prevention of acute radiation enteritis.

Additionally, Soligenix has a Lipid Polymer Micelle (LPM) drug delivery technology for the oral delivery of leuprolide for the treatment of prostate cancer and endometriosis.

Through its Biodefense Division, Soligenix is developing biomedical countermeasures pursuant to the Project BioShield Act of 2004.

Soligenix’s lead biodefense product in development is a recombinant subunit vaccine called RiVax, which is designed to protect against the lethal effects of exposure to ricin toxin.

RiVax has been shown to be well tolerated and immunogenic in a Phase 1 clinical trial in normal volunteers. RiVax is also the subject of a recent $9.4 million NIH grant received by the company supporting development of new heat stable vaccines.