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Immunomedics Awarded U.S. Patent for Humanized PAM4 Monoclonal Antibody and Its Use in the Diagnosis and Therapy of Pancreatic Cancer
Wednesday, October 17, 2007
Morris Plains, NJ -- Immunomedics, Inc. (Nasdaq: IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, announced it has received notice that its patent application for "Monoclonal antibody hPAM4" will issue as U.S. patent no. 7,282,567 today. The patent covers the composition of matter for the MUC1-antigen binding humanized antibody and its use in the diagnosis and therapy of pancreatic cancers.
"We are delighted to receive this patent award. hPAM4 is an important product candidate in our clinical pipeline. In light of the potentially-favorable risk-reward profile of this antibody for the therapy of pancreatic cancer, and assuming clinical trials will support marketing approval, we will consider developing this product through commercialization on our own," commented Cynthia L. Sullivan, Company President and CEO.
Initial clinical results from a Phase I dose-escalation study with hPAM4 labeled with the radioisotope, yttrium-90 (Y-90), in patients with unresectable and metastatic pancreatic cancer were encouraging and the study has completed patient enrollment. A second dose-escalation study using smaller Y-90 doses given repeatedly to patients and in combination with gemcitabine is planned for early 2008.
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. Preclinical studies with PAM4 labeled with the radioisotope, Yttrium-90, demonstrated favorable tumor responses, which could be further improved when given in combination with gemcitabine. The Phase I dose-escalation study in pancreatic cancer patients has also produced encouraging initial results, as presented at the Annual Meeting of the Society of Nuclear Medicine in June, 2007. Future plans include a fractionated dose-escalation study in which smaller Y-90 doses are given to patients repeatedly, in combination with gemcitabine.
About Pancreatic Cancer
According to the National Cancer Institute, pancreatic cancer is the fourth leading cause of cancer death in the United States. In 2007, an estimated 37,000 Americans will be diagnosed with the disease, and about 33,000 patients will die from it. For patients with advanced cancers, the overall 5-year survival rate of all stages is less than 1%. For those patients with small and localized disease that can be completely resected surgically, 5-year survival rates improve to 18% to 24%. Currently, the standard therapy for pancreatic cancer is gemcitabine, alone or in combination with other chemotherapeutics.
Immunomedics is a New Jersey-based biopharmaceutical company 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 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 have exclusively licensed our lead product candidate, epratuzumab, to UCB (www.ucb-group.com) for the treatment of all autoimmune disease indications worldwide. Epratuzumab's most advanced program is for the treatment of systemic lupus erythematosus (SLE). At present, there is no cure for lupus and no new lupus drug has been approved in the U.S. in the last 40 years. We have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. The Company is conducting clinical trials with veltuzumab in patients with non-Hodgkin's lymphoma, epratuzumab as a potential therapeutic for patients with lymphoma and leukemia, 90Y-epratuzumab for the therapy of patients with lymphoma, 90Y-hPAM4 for pancreas cancer therapy and milatuzumab as a therapy for patients with multiple myeloma. We believe that our portfolio of intellectual property, which includes approximately 108 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel Dock-and-Lock (DNL) methodology, 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. For additional information on us, please visit our web site at http://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, 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 partner for the further development of epratuzumab for autoimmune 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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