-- Phase I/II Studies of Subcutaneous Injections of Low Dose
Veltuzumab in ITP --
-- PET Scan Results of Phase II Trial of ER-CHOP for Aggressive
Lymphoma --
NEW ORLEANS, Dec. 7, 2009 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), a biopharmaceutical company focused on developing monoclonal antibodies to treat cancer and other serious diseases, today announced that low-dose veltuzumab demonstrated promising activity in patients with relapsed immune thrombocytopenic purpura (ITP), including durable complete responses. Results from this multicenter, open-label, Phase I/II study were presented at the 51st Annual Meeting of the American Society of Hematology (ASH).
At the time of reporting, 29 patients had been enrolled into the study, of which 26 had been assessed for treatment response. The overall objective response rate was 69%, with 23% of patients having a complete response. Seven patients who had been diagnosed with the autoimmune disease one year or less had the highest objective and complete response rates of 100% and 60%, respectively. Responses occurred with both the subcutaneous and intravenous administrations, and across all dose levels, including the lowest dose of 80 mg. More importantly, among the 6 complete responders, 5 are still continuing, with 3 patients being in complete response for over 1 year.
"Compared to intravenous infusions, we believe subcutaneous injections offer practical benefits to both patients and the healthcare system," commented Cynthia L. Sullivan, President and CEO. "The study is continuing to provide additional confirmatory data for further clinical development of subcutaneous veltuzumab in ITP," Ms. Sullivan added.
Results from the Phase I portion of the study have been reported. (Please refer to the Company's press release at www.immunomedics.com/news_pdf/2009_PDF/PR06052009.pdf for more information).
Immunomedics is collaborating with Nycomed, which received the exclusive, worldwide rights to develop, manufacture and commercialize the subcutaneous formulation of veltuzumab for the treatment of all non-cancer indications.
In a separate presentation, Mayo Clinic clinical investigators reported results from their study evaluating the ability of positron-emission tomography (PET) to predict the outcome of patients with diffuse large B-cell lymphoma (DLBCL) treated with the Company's proprietary antibody, epratuzumab, in combination with rituximab and CHOP therapy (ER-CHOP). This study is part of the North Central Cancer Treatment Group's (NCCTG) Phase II trial carried out to assess the efficacy of ER-CHOP in newly diagnosed DLBCL. Final efficacy results from this study had been reported by the Mayo Clinic, during the ASCO meeting last June. (Please refer to the Company's press release at www.immunomedics.com/news_pdf/2009_PDF/PR05152009.pdf for more information).
The Phase II study enrolled a total of 80 patients to receive 6 cycles of ER-CHOP. Functional response as measured by fluorodeoxyglucose (FDG)-PET/CT were obtained from 69 and 68 patients after 2 and 6 cycles, respectively, of ER-CHOP therapy. A negative PET scan is considered a complete response (CR).
Patients that achieved a functional CR had improved overall survival (OS24) and event-free survival at 24 months (EFS24) compared to patients who failed to achieve a functional CR, suggesting achievement of PET negativity by completion of therapy is associated with a good outcome. However, early PET scanning during therapy does not significantly predict outcome. After 2 cycles of ER-CHOP therapy, EFS24 was 73% for the PET-negative patients vs 60% for the PET-positive patients; OS24 was 83% vs 73% for the PET-negative and -positive patients, respectively. In comparison, after 6 cycles of treatment, EFS24 for patients with a negative PET was 80% vs 57% for those with a positive PET and OS24 was 92% vs 57%, respectively.
The NCCTG is currently working with the Eastern Cooperative Oncology Group on the design of a Phase II/III clinical trial comparing ER-CHOP vs R-CHOP in patients with previously untreated DLBCL.
Predictive ability of PET scan results from Cycle 2 and Cycle 6
of ER-CHOP in relation to 24-month EFS and OS
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Evaluation time-
point according CR rate (1) PET scan result EFS24 OS24
to ER-CHOP cycles
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Negative 73% 83%
Cycle 2 78% (54/69) -----------------------------
Positive 60% 73%
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Negative 80% 92%*
Cycle 6 90% (61/68) -----------------------------
Positive 57% 57%
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(1) A PET-negative patient is considered a CR.
* Denotes statistically significant difference between PET-negative
and PET-positive patients (p less than or equal to 0.01)
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 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 141 patents issued in the United States and more than 300 other patents issued worldwide, 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, 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.