Soligenix, Inc., a late-stage biotechnology company, announced that the European Patent Office granted patent EP 1830857 "Method of Treatment of Graft-versus-Host Disease and Leukaemia with Beclomethasone Diproprionate and Prednisone." The patent claims beclomethasone dipropionate (BDP) in conjunction with a short duration of high-dose prednisone with a rapid taper for the reduction of mortality associated with Graft-versus-Host disease (GVHD) and leukaemia. Oral BDP has the potential to provide a safer and more efficacious method to treat GVHD than prolonged treatment with high-dose systemic glucocorticoids. This is the second European patent granted to Soligenix this year concerning its BDP technology. BDP is the active ingredient in orBec, a proprietary oral formulation for treatment of acute gastrointestinal (GI) GVHD.

Resulting from hematopoietic cell transplantation (HCT), acute GI GVHD often leads to fatal necrosis of the intestinal mucosa. The standard treatment for acute GI GVHD typically entails high-dose prednisone, a glucocorticoid, along with other systemic immunosuppressive agents. Prolonged high-dose prednisone therapy causes glucocorticoid side effects such as increased risk of fatal infection, hypothalamic-pituitary adrenal axis suppression, myopathy, neuropsychiatric disease, and bone demineralization. BDP is a topically active glucocorticoid with low systemic bioavailability that preferentially blocks necrotic inflammation in the intestinal mucosa. The use of BDP diminishes profound immunosuppression and maintains the Graft-versus-Leukaemia (GVL) effect of donor T cells.

"This patent is based on evidence that we have generated in a previous phase 3 GVHD clinical trial that orBec significantly reduces mortality," said Christopher J Schaber, PhD, president and CEO of Soligenix. "This patent further solidifies our proprietary position in the field of topically active steroids and is yet another building block in our growing intellectual property estate for oral BDP. We are pleased that our work in the field of topically active steroids and GVHD is now materializing into a robust portfolio of issued patents."

In addition to issued patents and pending worldwide patent applications held by or exclusively licensed to Soligenix, orBec also benefits from orphan drug designations in the US and in Europe for the treatment of GI GVHD, which provide for seven and 10 years of post-approval market exclusivity, respectively.

Beclomethasone dipropionate (BDP) is a highly potent, topically active corticosteroid that has a local effect on inflamed tissue. BDP has been marketed in the US and worldwide since the early 1970s as the active pharmaceutical ingredient in a nasal spray and in a metered-dose inhaler for the treatment of patients with allergic rhinitis and asthma. BDP is the active ingredient in orBec, currently in phase 3 and phase 2 development by Soligenix for the treatment and prevention of acute GVHD, respectively. BDP is also the active ingredient in SGX201, a time-release formulation in a Phase 1/2 trial for acute radiation enteritis.

orBec 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 GI 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.

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.