Rich66
03-09-2009, 01:02 AM
Immunomedics wins FDA fast track designation for cancer drug
Published:10-February-2009
By Datamonitor staff writer
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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<!-- Rest of content --> 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.
Published:10-February-2009
By Datamonitor staff writer
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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Immunomedics reports positive preclinical results from colorectal cancer study (http://drugdiscovery.pharmaceutical-business-review.com/news/immunomedics_reports_positive_preclinical_results_ from_colorectal_cancer_study_220109)
Immunomedics reports encouraging initial results from Phase I/II ITP study (http://drugdiscovery.pharmaceutical-business-review.com/news/immunomedics_reports_encouraging_initial_results_f rom_phase_iii_itp_study_111208)
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Biogen Idec, Inc. (http://www.pharmaceutical-business-review.com/companies/biogen_idec_inc)
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<!-- Rest of content --> 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.