Aphton announced that it has begun submission of regulatory documentation to the Australian Therapeutic Goods Administration (ATGA) for the registration of G17DT as monotherapy in patients with advanced pancreatic cancer who are either unable to tolerate or elect not to take chemotherapy.
"This filing, our first such, represents a significant milestone for Aphton and is the culmination of years of hard work by our entire team," stated Philip Gevas, chairman and CEO of Aphton.
"This is an exciting day for patients who suffer from pancreatic cancer, one of the most devastating and aggressive forms of cancer," said Patrick Mooney, MD, Aphton's chief medical officer. "Many of these patients either cannot tolerate or elect not to take chemotherapy for their disease, since it adds only a relatively small clinical benefit at a cost of significant side-effects. We believe that G17DT is a safe, targeted biological with negligible systemic side effects and that it is an effective alternative for the significant number of patients worldwide that have this terrible disease."
Aphton's anti-gastrin targeted immunotherapy induces in patients antibodies that bind to both gastrin 17 and gly-gastrin and remove them from circulation before they can bind to the cancer cell and initiate cell growth. Gastrin 17 and gly-gastrin are believed to be central growth factors, or the initiating signals, for cell growth, cell proliferation and metastasis, or spread, in pancreatic, gastric (i.e. stomach), esophageal, colorectal and other gastrointestinal (GI) system cancers. This signaling cascade is triggered by gastrin binding to the large numbers of gastrin receptors which appear, de novo, in the great majority of cases, on tumor cell surfaces of the gastrointestinal system. Interrupting this process by immunizing the patient with Aphton's anti-gastrin immunogen is specifically targeted immunotherapy. This specificity of targeting only cancer cells occurs because gastrin is not normally secreted and gastrin receptors are not normally found on cells in the GI system, unless they are malignant, or on the path to malignancy
Recent findings have shown that inhibiting gastrin inhibits cell growth, proliferation and metastasis, leading to programmed cell death (apoptosis). This tilts the balance, from cell growth, to cell suicide. Gastrin also stimulates the secretion and expression of other important growth factors and receptors within and on the surfaces of the cancer cells involved in tumor growth. Hence, inhibiting gastrin inhibits all of the foregoing factors that contribute to tumour growth and spread, resulting in tumour cell death. Aphton's anti-gastrin targeted immunotherapy adds a biological dimension to the treatment of gastrointestinal cancers.
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 these 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. Aphton believes that its anti-gastrin targeted immunotherapy approach has the potential to extend patient survival with negligible toxicity.
Aphton Corporation is a biopharmaceutical company developing products using its innovative targeted immunotherapy technology for neutralizing hormones that participate in gastrointestinal system and reproductive system cancer and non-cancer diseases.