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Pancreas Cancer News and Archives | |
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For educational purposes only; not to be relied upon. Please read Pancreatica Disclaimer | |
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Aphton Presented Phase III
Data for Monotherapy with G17DT for Advanced Pancreatic Cancer
Patients to Overseas Regulatory Agency
Aphton Corporation announced
today that the company has met with and presented results of
its randomized, double blind, controlled, monotherapy, Phase
III clinical trial conducted in Europe with G17DT for patients
with advanced pancreatic cancer to an appropriate foreign regulatory
authority. Aphton believes that the results of the trial are already sufficient for filing for marketing approval in the European Union, Canada and Australia. Therefore, Aphton has begun the process of gathering and compiling the data and the preparation of the extensive regulatory documentation required for submission for marketing approval. This process can be expected to take approximately five months, but cannot be stated with certainty. Aphton expects it will receive priority review of the filings. The time for review and the granting of marketing approval in each jurisdiction cannot, however, be predicted by Aphton with certainty. Aphton believes that with these clinical trial and regulatory developments, it has reached the decisive turning point in its corporate development and in the pursuit of its corporate objectives. Aphton has drastically reduced its burn rate going forward at this time and is currently pursuing a number of strategic funding opportunities. Aphton believes a number of these can, if successful, carry it forward and achieve its strategic objectives. 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 has advanced disease at the time of diagnosis which is 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 time significantly, without adding 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.
Press Release |
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