IRISH SCIENTISTS AT SIGMOID PHARMA LTD. DISCOVER NEW POTENTIAL THERAPEUTIC APPROACH FOR GRAFT VERSUS HOST DISEASE
NEW YORK, New York, June 2, 2009 The Irish pharmaceutical product development company, Sigmoid Pharma Limited, has discovered a new potential therapeutic approach to Graft Versus Host Disease (GVHD). GVHD is the principal side effect of allogeneic haematopoietic stem cell transplantation (HSCT), restricting the wider adoption of this often curative procedure for leukaemia. With limited prophylaxes available, GVHD remains a significant cause of morbidity and mortality in the 15,000 patients undergoing the procedure each year.
Sigmoid Pharma, one of the companies attending the 2009 Digestive Disease Week (DDW) Conference in Chicago, Illinois on May 30 to June 4 as part of an official Enterprise Ireland delegation, is now developing a product to prevent and treat GVHD, in general, and Gastrointestinal GVHD (GI-GVHD), in particular.
GVHD occurs in various tissues, primarily manifesting in the gastrointestinal tract (GI), liver, lungs and skin. GI-GVHD carries greatest risk with severe GVHD often occurring in the colon. Owing to its potential to amplify the cytokine storm characteristic of the condition, the colon may propagate the disease to other tissues.
People suffering from severe GVHD usually have a poor prognosis, said Dr. Ivan Coulter, CEO, Sigmoid Pharma Limited. If the GVHD is severe and requires intense immunosuppression involving steroids and additional agents to get under control, the patient may develop serious infections as a result of the immunosuppression and may die of infection. Current therapeutic options in GVHD are very limited and a clear need for improved therapies to prevent or treat GVHD exists,
Elaine Brennan, Senior Vice President Life Science Markets, Enterprise Ireland, added, In the future, thanks to product development innovations at Sigmoid, there is the potential to bring significant benefit to patients diagnosed with leukemia and other diseases which require allogeneic haematopoietic stem cell transplantation.
GVHD is referred to as an Orphan Disease because there are fewer than 200,000 patients in the US. To promote the development of treatments for Orphan Diseases, the US FDA and other regulatory agencies provide regulatory and marketing incentives to companies that develop Orphan Drugs.
Recently, Sigmoid received Orphan Drug designation for its proposed GVHD product. This represents a very exciting development opportunity for Sigmoid and the company is being advised by a number of leading oncologists in Ireland and throughout the EU, said Dr. Coulter. The Orphan designation is timely given the FDAs current interest in supporting the development of new products for this indication.
On May 19, 2009, the FDA and NIH held a workshop seeking to clarify the path to approval of new drugs to prevent or treat acute GVHD. The workshop was cosponsored by the Center for International Blood and Marrow Transplantation Research (CIBMTR) and the American Society for Blood and Marrow Transplantation (ASBMT). With FDA orphan designations for both prevention and treatment, Sigmoids participation in the workshop was important.
Sigmoids proprietary LEDDS and SmPill technologies permit not only controlled release throughout the entire GI tract, but also enable targeted release of poorly soluble drugs directly into the colon.
We developed both LEDDS and SmPill technologies to interact with the changing intestinal environment so enabling drugs, singly or in combination, to be released throughout or to specific regions of the intestine, said Dr. Coulter. Other technologies may be unable to integrate the sometimes incompatible range of formulation approaches required to achieve this. We, however, can bring together disparate technical elements in a single format and so turn intestinal diversity to our advantage. The unique capabilities of Sigmoids SmPill technology have enabled novel approaches to how drugs with potential for GVHD prophylaxis or treatment are delivered to the tissues most affected by, or critical to the further progression of, this often fatal disease.
The development of such innovations requires not only the meeting of scientific and clinical minds, but also the regulatory and funding frameworks that facilitate the development of novel products. On this basis, Dr. Coulter said, The complementary funding provided by Enterprise Ireland to Sigmoid and the positive attitude of regulatory agencies towards innovations in orphan disease product development encouraged the company to explore research into developing products for GVHD.
Dr. Coulter is confident that increased funding of industry-academic collaborations will lead to the development of exciting opportunities for Sigmoid and other indigenous Irish companies. Dr. Coulter added, Technology convergence and translational research has the potential to enable a paradigm shift in the development of novel approaches to both prophylaxis and treatment of GVHD, including GI-GVHD.
The companies attending the 2009 DDW Conference as part of the Enterprise Ireland delegation include Alimentary Health (www.alimentaryhealth.ie), AGI Therapeutics Plc (www.agitherapeutics.com), BioAtlantis (www.bioatlantis.com), Creganna Medical Devices Ltd. (www.creganna.com), Crospon Ltd. (www.endoflip.com), Intuition (www.intuition.com), Opsona Therapeutics Ltd. (www.opsona.com), Pharmatrin Ltd. (www.pharmatrin.com), Socrates (www.Socrates.ie) and Vysera Biomedical Ltd. (www.vysera.com).
Enterprise Ireland is the government agency responsible for the development and promotion of the indigenous business sector. Enterprise Irelands mission is to accelerate the development of world-class Irish companies to achieve strong positions in global markets resulting in increased national and regional prosperity.
Contact: Daniel OConnell
Griffin Integrated Communications
Doconnell@griffinpr.com
(212) 481-3456 Ext. 12