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news.Immunomedics, a biopharmaceutical company, has received notice from the FDA granting yttrium-90-labeled hPAM4 fast track designation for the treatment of pancreatic cancer.
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hPAM4 is a humanized monoclonal antibody targeting an epitope in the MUC1 antigen expressed in most pancreatic cancer, but not pancreatitis, normal pancreas or most other normal tissues.
The radiolabeled humanized antibody is currently in a Phase Ib fractionated dose-escalation study in combination with gemcitabine for the treatment of patients with newly diagnosed stage III or stage IV cancer of the pancreas.
Cynthia Sullivan, president and CEO of Immunomedics, said: We are pleased to receive the fast track designation from the FDA which is an acknowledgment of the need for viable treatment options for patients with pancreatic cancer.
The current Phase Ib fractionated dose-escalating study of hPAM4 in combination with gemcitabine is enrolling patients as fast as the protocol permits and we look forward to closely working with the FDA for the development and regulatory review of this important new antibody, a potential first-in-class radioimmunotherapeutic agent for pancreatic cancer.
Immunomedics is a biopharmaceutical company focused on the development of monoclonal, antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases.