EU grants orphan status for pancreatic and gastric drug

The European Union has granted Orphan Drug status for Miami-based Aphton Corporation's anti-gastric immunogen G17DT, also known as G17(9)DT, for the treatment of both pancreatic cancer and gastric (stomach) cancer indications.

Orphan Drug status in the European Union confers numerous benefits, including up to ten years of marketing exclusivity, and substantial reduction of fees. This includes a fee reduction of 100% for pre-authorisation activities such as protocol assistance (scientific advice)and a reduction of 50% for all other fees, including the application for marketing authorisation, inspections and post-authorization activities, annual fees etc.

The US FDA granted orphan drug status for its immunogen G17DT for both pancreatic cancer and gastric cancer indications, in July 2002.

It is estimated that approximately 88,000 new cases of pancreatic cancer will be diagnosed in the US and Europe this year. The prognosis for most of these patients is very poor. The great majority of patients have advanced disease at the time of diagnosis and are considered incurable, with a very short survival time. Surgery, when possible, and chemotherapy are the primary treatment options currently available, but have shown only very limited benefit.

It is estimated that there are approximately 570,000 patients with gastric cancer in the US, Europe and Japan, alone. The prognosis for the overwhelming majority of these patients is also very poor. Patients diagnosed with metastatic disease have five-year survival rates of only about 3%. Surgery and chemotherapy are the primary treatment options currently, but have shown only very limited benefit.

Aphton believes that its anti-gastrin targeted immunotherapy approach has the potential to extend patient survival with both cancers without adding toxicity.