Resumed the clinical study of clivatuzumab tetraxetan in patients with advanced pancreatic cancer.
MORRIS PLAINS, NJ, USA I November 2, 2011 I Immunomedics, Inc. (Nasdaq:IMMU – News), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that it has resumed the clinical study of clivatuzumab tetraxetan in patients with advanced pancreatic cancer. The U.S. Food and Drug Administration (FDA) notified the Company that the partial clinical hold on the Phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer has been lifted.
The partial clinical hold resulted from a single inadvertent administration of an yttrium-90 dose higher than prescribed to a patient undergoing retreatment, following a prior successful therapy cycle at one of the trial sites. The Company has committed to retraining all participating clinical sites and third-party radiopharmacies on the ordering, delivering, administering, and cancellation of each dose using a revised dose order form.
"We are pleased that the FDA has agreed to remove the partial clinical hold of this clinical trial. Although the current study is now fully enrolled, it is important for patients who are eligible for retreatment to receive additional cycles of therapy," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We continue to work with FDA and our Key Opinion Leaders to complete the protocol designs for the pivotal Phase III trials of this promising agent, which we plan to begin in 2012," Ms. Sullivan added.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 182 patents issued in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
SOURCE: Immunomedics
Post Views: 78
Resumed the clinical study of clivatuzumab tetraxetan in patients with advanced pancreatic cancer.
MORRIS PLAINS, NJ, USA I November 2, 2011 I Immunomedics, Inc. (Nasdaq:IMMU – News), a biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases, today announced that it has resumed the clinical study of clivatuzumab tetraxetan in patients with advanced pancreatic cancer. The U.S. Food and Drug Administration (FDA) notified the Company that the partial clinical hold on the Phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer has been lifted.
The partial clinical hold resulted from a single inadvertent administration of an yttrium-90 dose higher than prescribed to a patient undergoing retreatment, following a prior successful therapy cycle at one of the trial sites. The Company has committed to retraining all participating clinical sites and third-party radiopharmacies on the ordering, delivering, administering, and cancellation of each dose using a revised dose order form.
"We are pleased that the FDA has agreed to remove the partial clinical hold of this clinical trial. Although the current study is now fully enrolled, it is important for patients who are eligible for retreatment to receive additional cycles of therapy," commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. "We continue to work with FDA and our Key Opinion Leaders to complete the protocol designs for the pivotal Phase III trials of this promising agent, which we plan to begin in 2012," Ms. Sullivan added.
About Immunomedics
Immunomedics is a New Jersey-based biopharmaceutical company primarily focused on the development of monoclonal antibody-based products for the targeted treatment of cancer, autoimmune and other serious diseases. We have developed a number of advanced proprietary technologies that allow us to create humanized antibodies that can be used either alone in unlabeled or "naked" form, or conjugated with radioactive isotopes, chemotherapeutics, cytokines or toxins, in each case to create highly targeted agents. Using these technologies, we have built a pipeline of therapeutic product candidates that utilize several different mechanisms of action. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology with us for making fusion proteins and multifunctional antibodies, and a new method of delivering imaging and therapeutic agents selectively to disease, especially different solid cancers (colorectal, lung, pancreas, etc.), by proprietary, antibody-based, pretargeting methods. We believe that our portfolio of intellectual property, which includes approximately 182 patents issued in the United States and more than 400 foreign patents, protects our product candidates and technologies. For additional information on us, please visit our website at www.immunomedics.com. The information on our website does not, however, form a part of this press release.
SOURCE: Immunomedics
Post Views: 78
