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Immunomedics Announces 90 Y-Clivatuzumab Tetraxetan In Combination With Low-Dose Gemcitabine Is Active In Patients With Late-Stage Pancreatic Cancer

LYON, France, Oct. 23, 2013 (GLOBE NEWSWIRE) -- Immunomedics, Inc. (Nasdaq:IMMU), 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 reported that multiple cycles of therapy with the Company's pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90 ( 90Y), in combination with low-dose gemcitabine, produced a median overall survival (OS) of more than 5 months in patients with metastatic pancreatic cancer who had received at least 2 prior treatments.

Results from the Phase Ib clinical trial were updated by Dr. William A. Wegener, Senior Vice President, Clinical Research, in an oral presentation at the 26 th Annual Congress of the European Association of Nuclear Medicine in Lyon, France.

Despite a difficult-to-treat patient population with relapsing disease, a partial response in 53 CT-assessable patients was reported at the Congress. In addition, median OS for patients with partial response or stable disease as best response was longer than those with disease progression (131 days vs. 66 days, respectively).

"Based on these encouraging results, which have to be confirmed with a Phase III clinical trial, we are proceeding with our plan to initiate such trial with clivatuzumab in this late-stage disease setting," commented Cynthia L. Sullivan, President and Chief Executive Officer. "We are preparing to open this pivotal study before the end of 2013 or the beginning of 2014," Ms. Sullivan added.

With the acronym PANCRIT, which stands for PANcreatic Cancer Radio Immunotherapy Trial, the Phase III study will be a double-blind, randomized trial of 90Y-clivatuzumab tetraxetan with low-dose gemcitabine, versus placebo and low-dose gemcitabine in metastatic pancreatic cancer patients who have progressed on at least 2 prior therapies, 1 of which must be a gemcitabine-containing regimen.

Target enrollment for this multicenter, international trial is 440 patients. A majority of these patients will be recruited at clinical sites across the U.S., with additional sites in Canada, Europe and Israel participating. Patients will be randomized 2 to 1 to the treatment arm.

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