Immunomedics Says 90 Y-Clivatuzumab Tetraxetan in Combo with Low-Dose Gemcitabine Active

Immunomedics, Inc.(Nasdaq: IMMU), a biopharmaceutical company primarily focused on thedevelopment of monoclonal antibody-based products for the targeted treatmentof cancer, autoimmune and other serious diseases, today reported that multiplecycles of therapy with the Company's pancreatic cancer therapeutic,clivatuzumab tetraxetan labeled with yttrium-90 (^90Y), in combination withlow-dose gemcitabine, produced a median overall survival (OS) of more than 5months in patients with metastatic pancreatic cancer who had received at least2 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 atthe 26^th Annual Congress of the European Association of Nuclear Medicine inLyon, France.Despite a difficult-to-treat patient population with relapsing disease, apartial response in 53 CT-assessable patients was reported at the Congress. Inaddition, median OS for patients with partial response or stable disease asbest response was longer than those with disease progression (131 days vs. 66days, respectively)."Based on these encouraging results, which have to be confirmed with a PhaseIII clinical trial, we are proceeding with our plan to initiate such trialwith clivatuzumab in this late-stage disease setting," commented Cynthia L.Sullivan, President and Chief Executive Officer. "We are preparing to openthis pivotal study before the end of 2013 or the beginning of 2014," Ms.Sullivan added.With the acronym PANCRIT, which stands for PANcreatic CancerRadioImmunotherapy 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 cancerpatients who have progressed on at least 2 prior therapies, 1 of which must bea gemcitabine-containing regimen.Target enrollment for this multicenter, international trial is 440 patients. Amajority of these patients will be recruited at clinical sites across theU.S., with additional sites in Canada, Europe and Israel participating.Patients will be randomized 2 to 1 to the treatment arm.Primary endpoint of PANCRIT will be overall survival, with objective response,progression-free survival and clinical benefit such as quality of life servingas secondary outcome measures.