ORLANDO, Fla., Dec. 11 /PRNewswire-FirstCall/ -- Immunomedics, Inc. , a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, presented on Sunday, December 10th, follow-up clinical data that showed the Company's humanized anti-CD20 (hA20) monoclonal antibody was active in patients with non-Hodgkin's lymphoma (NHL) at a dose as low as 120 mg/m(2). Results of this open-label, multi-center Phase I/II study were reported at the 48th Annual Meeting of American Society of Hematology (ASH) in Orlando, FL, by Franck Morschhauser, MD, Centre Hospitalier Regional Universitaire de Lille, Lille, France, the study's lead investigator.
In the United States, NHL is the most common form of blood cancer, affecting over 360,000 people. Each year, there are approximately 50,000 new cases and almost 25,000 deaths from this disease in the United States.
According to Dr. Morschhauser, "These results with hA20 compare favorably to a published report of a similar patient population retreated with rituximab after at least one prior course of this antibody, where overall and complete response rates of 40% and 11%, respectively, were observed for the usual dose of 375 mg/m(2) weekly for four weeks (TA Davis et al., J Clin Oncol 2000; 18:3135-43). Throughout the doses studied with hA20, an encouragingly high complete response rate, averaging 22%, and durable responses at each dose level were observed in these low-grade or follicular lymphoma patients."
Cynthia Sullivan, President and CEO of Immunomedics, commenting on the low-dose responses seen with hA20, said, "The difference between the two antibodies is that rituximab has been approved at a dose of 375 mg/m(2). With hA20, we can go down to 120 mg/m(2) and achieve similar response rates and B-cell depletion. The advantages of a lower dose include faster infusion rates and fewer side effects." She further commented, "Because hA20 is a humanized antibody, thus far we have not seen any immune reaction to it." Ms. Sullivan also pointed out that during the study, no serious infusion related events were reported.
A total of 57 adult patients with recurrent NHL were enrolled and were infused once weekly for four consecutive weeks with 120, 200, 375, or 750 mg/m(2) of hA20. Fifty patients had received at least one prior rituximab- containing regimen. Treatment responses from 48 assessable patients (32 with follicular lymphoma and 16 with non-follicular lymphoma) with at least one post-treatment evaluation were reported at the meeting. The overall objective response rate (partial and complete responses) was 44% (21/48), with 17% (8/48) of patients having a complete response (CR/CRu).
In the 32 patients with follicular lymphoma, the overall response rate was 47% (15/32), with a complete response rate of 22% (7/32). Responders were across all dose groups, even at the lowest dose of 120 mg/m(2) (approximately one-third the conventional dose of rituximab) where 36% (5/14) were responders and 21% (3/14) had a complete response. In non-follicular lymphomas, the overall responses rate was 38% (6/16), including one complete response in marginal zone lymphoma. Higher overall response rates with up to 50% complete responses were observed at higher doses. In a median follow-up of 11 months post therapy, 9/21(43%) had continuing responses, including 4 with long-lived responses (15-20 months).
"We expect to complete this study soon and to advance the development of this humanized CD20 antibody in NHL as well as autoimmune diseases," Ms. Sullivan said. "While we continue to discuss out-licensing this product with potential partners, we are simultaneously developing a subcutaneous formulation. hA20's efficacy at low doses given the relatively small amount of protein involved, affords us the opportunity to develop a subcutaneous formulation, potentially providing the benefits of ease of use and patient acceptance."
This study was extended to focus on accruing patients at the 120 mg/m2 dose and continuing the de-escalation of doses below 120mg/m(2). The results confirmed that hA20 was well tolerated with no serious infusion related adverse events or immune reactions to date. The humanized anti-CD20 antibody was infused usually within 2 hours and depleted circulating B-cells at all doses, even after the first week's infusion. (http://www.immunomedics.com/news_pdf/2006_PDF/PR06052006a.pdf).
About hA20
hA20 was constructed using the same human donor frameworks and methods employed to make the Company's anti-CD22 antibody, epratuzumab. Epratuzumab has been studied in over 300 non-Hodgkin's lymphoma (NHL) patients and can be infused within an hour. hA20 displays similar binding avidity, specificity, and mechanisms of action as rituximab, but has structural differences, and to date, shows an excellent safety and tolerability profile, even when infused within 2 hours. At a single low dose of 120 mg/m(2), hA20 depleted circulatory B-cells, and produced high complete responses in recurrent NHL patients with prior rituximab treatments when given once weekly over 4 concurrent weeks. Doses between 120 and 750 mg/m(2) were evaluated in this multi-center clinical trial. To-date, no patients have shown an elevated immune response to repeated injections of hA20.
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. We have recently licensed our lead product candidate, epratuzumab, to UCB, S.A. for the treatment of all autoimmune disease indications worldwide. We have retained the rights for epratuzumab in oncology indications for which UCB has been granted a buy-in option. UCB has development, manufacture and commercialization rights, and is responsible for all clinical trials evaluating epratuzumab for the treatment of patients with moderate and severe lupus. 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 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 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. Visit our web site at http://www.immunomedics.com.
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, extension 123, ccheng@immunomedics.com
Web site: http://www.immunomedics.com//
Company News On-Call: http://www.prnewswire.com/comp/113121.html /
