Immunomedics, Inc., 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 the Company has been notified by the U.S. Food and Drug Administration (FDA) that a partial clinical hold has been placed on the Company's Phase Ib/II clinical trial of clivatuzumab tetraxetan in patients with advanced pancreatic cancer, due to the administration of an incorrect dose to a patient enrolled at one of its trial sites.
This decision by the FDA was not due to safety issues of the product, but was based on a single incident in which a patient undergoing retreatment following a prior successful therapy cycle was inadvertently administered a yttrium-90 (Y-90) dose higher than prescribed. After this error was discovered, no further doses were given to the patient, who remains on study with no critical toxicity. To date, there have been approximately 360 doses of clivatuzumab tetraxetan labeled with Y-90 successfully and correctly administered to almost 100 patients.
In response to this development, Cynthia L. Sullivan, President and CEO of Immunomedics, said, "We are preparing the requested remediation documents for the agency to ensure that this single error by the radiopharmacy will not reoccur in our trial, so that the partial clinical hold can be lifted as soon as possible. We are also working closely with the FDA to ensure patients who are eligible for retreatment can go on to receive additional cycles of therapy, once the partial hold is lifted. The Phase Ib/II study is now fully enrolled, so we are hopeful to continue retreatment cycles for those patients who may benefit from this experimental therapy."
"Since pancreatic cancer is the fourth leading cancer killer, we are committed to working closely with the FDA to advance the clinical development of clivatuzumab tetraxetan in accordance with our planned development timeline," Ms. Sullivan added.
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 180 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.
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials, out-licensing arrangements (including the timing and amount of contingent payments), forecasts of future operating results, potential collaborations, and capital raising activities, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, risks associated with new product development (including clinical trials outcome and regulatory requirements/actions), our dependence on our licensing partners for the further development of epratuzumab for autoimmune indications and veltuzumab for non-cancer indications, competitive risks to marketed products and availability of required financing and other sources of funds on acceptable terms, if at all, as well as the risks discussed in the Company's filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
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SOURCE: Immunomedics, Inc.