ATLANTA, June 5 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a biopharmaceutical company focused on developing monoclonal antibodies, today reported updated clinical results with the Company’s humanized anti-CD20 (hA20) monoclonal antibody in patients with non-Hodgkin’s lymphoma (NHL) at the 42nd Annual Meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, Georgia. Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de Lille, Lille, France, was the lead investigator of this open-label, multi-center, Phase I/II, dose-escalation study.
A total of forty-seven adult patients with recurrent NHL were enrolled and were infused once weekly for four consecutive weeks with 120, 200, 375, or 750 mg/m2 of hA20. Forty-three patients had received at least one prior rituximab-containing regimen. Treatment responses from forty-two assessable patients (27 with follicular lymphoma and 15 with non-follicular lymphoma) with at least one post-treatment evaluation were reported at the meeting. The overall objective response rate (partial and completed responses) was 43% (18/42), with 17% (7/42) of patients having a complete response (CR/CRu).
In follicular lymphoma, the overall response rate was 44% (12/27), with a complete response rate of 22% (6/27). All dose groups were found to be responders, even at the lowest dose of 120 mg/m2, where 42% (5/12) were responders and 25% (3/12) had a complete response. In the most favorable patient group of FLIPI 0-1 prognostic indices, an objective response rate of 75% (6/8), with 38% (3/8) complete responses, were reported. In non-follicular lymphomas, the overall responses rate was 40% (6/15), including one complete response in marginal zone lymphoma. Importantly, B-cell depletion effects were similar between the different dose groups, while those at the lowest doses tolerated infusion times of less than 2 hours for the first infusion.
“We are pleased that our humanized anti-CD20 antibody shows not only good tolerability in these patients, but appears to be very active at doses as low as 120 mg/m2, showing similar B-cell depletion and antitumor activity as much higher doses,” commented Cynthia L. Sullivan, President and Chief Executive Officer of Immunomedics. “Now that hA20 is known to be active in NHL, we can begin evaluating it in combination with our CD22 antibody, epratuzumab, which has been reported to show evidence of improving the effects of rituximab when these two antibodies were combined in the treatment of patients with indolent and aggressive NHL,” she added.
In the current study of hA20, 45 patients received all four infusions with one rituximab-sensitive patient discontinuing treatment after developing allergic reactions at first infusion. Other than mild to moderate transient infusion reactions, predominantly with the first infusion, no significant toxicity was reported. No immunogenicity was seen in twenty-nine patients tested at least once. As expected, peripheral blood B-cell depletion occurred after the first infusion and persisted after the fourth infusion, with analysis continuing at 3 to 6 months. Earlier results from this study had previously been reported (http://www.immunomedics.com/news_pdf/2005_PDF/PR12122005.pdf).
About hA20
hA20 is a humanized monoclonal antibody that binds to the CD20 antigen on B lymphocytes. The antibody contains over 90% of human amino acid sequences, and the human framework regions are identical to epratuzumab, the Company’s CD22 humanized antibody that has been studied in over 300 NHL patients. hA20 displays similar binding avidity, specificity, and mechanisms of action, including antibody-dependent cellular cytotoxicity, complement-dependent cytotoxicity, and apoptosis, as rituximab. It has comparable in vitro and in vivo CD20 binding and efficacy against lymphoma as rituximab.
About Immunomedics
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. Our lead product candidate, epratuzumab, which development, manufacture and commercialization rights we have licensed to UCB, S.A. for the treatment of all autoimmune indications worldwide, is currently in two pivotal Phase III trials for the treatment of patients with moderate and severe lupus (ALLEVIATE A and B). 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 believe that our portfolio of intellectual property, which includes approximately 90 patents issued in the United States, and more than 250 other issued patents worldwide, protects our product candidates and technologies. Visit our web site at http://www.immunomedics.com. We also have a majority ownership in IBC Pharmaceuticals, Inc., which is developing a novel dock and lock platform technology, 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.
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), 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), 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.
For More Information: Dr. Chau Cheng Associate Director, Investor Relations & Business Analysis (973) 605-8200, extension 123 ccheng@immunomedics.com
Immunomedics, Inc.
CONTACT: Dr. Chau Cheng, Associate Director, Investor Relations & BusinessAnalysis, +1-973-605-8200, ext. 123, or ccheng@immunomedics.com
Web site: http://www.Immunomedics.com/
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