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June 1, 2014
18:23 EDTIMMUImmunomedics reports final efficacy results of Phase Ib trial
Immunomedics reported an overall disease response rate of 41%, including 2 patients with partial response and 10 patients with stable disease as best response, in 29 patients with relapsed/refractory, metastatic pancreatic cancer treated with the investigational pancreatic cancer therapeutic, clivatuzumab tetraxetan labeled with yttrium-90, in combination with low-dose gemcitabine as a radiosensitizer. This was compared to a control group of 29 similar patients who received 90Y clivatuzumab tetraxetan without low-dose gemcitabine. Treatment responses were assessed by computed tomography based on RECIST criteria. Results from the multicenter Phase Ib study were presented by Vincent J. Picozzi Jr., M.D., Director of the Pancreas Center of Excellence at the Virginia Mason Medical Center's Digestive Disease Institute, Seattle, WA, at the 2014 Annual Meeting of the American Society of Clinical Oncology, ASCO. Within the 2 subgroups of patients, adding low-dose gemcitabine extended the median overall survival for the 29 patients in Arm A to 3.9 months, a statistically significant improvement compared with the 2.8 month median OS for the 29 patients receiving only 90Y-clivatuzumab tetraxetan in Arm B. Furthermore, for patients in Arm A, there were 48%, 34%, 21%, and 10% of patients alive at 3, 6, 9, and 12 months, respectively, indicating that the combination of radiolabeled antibody and gemcitabine improved survival throughout the study. "Based on these encouraging results, we have launched the Phase III PANCRIT-1 registration trial, positioning 90Y-clivatuzumab tetraxetan as a therapy for patients in this late-stage setting," commented Cynthia L. Sullivan, President and CEO of Immunomedics. "The primary end-point will be overall survival and the protocol allows the independent Data and Safety Monitoring Board one planned interim analysis of data on overall survival to be conducted after a predetermined number of events have occurred. We plan to complete patient accrual by the second half of 2015, with top-line results expected in the first half of 2016," Ms. Sullivan reiterated.
News For IMMU From The Last 14 Days
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November 21, 2014
08:35 EDTIMMUImmunomedics granted FDA orphan drug designation for veltuzumab
Immunomedics announced that the Office of Orphan Products Development of the FDA has granted orphan status for the use of veltuzumab, the company's humanized anti-CD20 antibody, for the treatment of pemphigus. Pemphigus is a debilitating and potentially fatal autoimmune blistering disease of the skin and mucous membranes. In most cases, irregularly-shaped, painful erosions or lesions initially develop in the mucous membranes lining the inside of the mouth. To maintain disease control typically requires long-term exposure to corticosteroids and other drugs which suppress the immune system and may themselves contribute to osteoporosis, septicemia, and other serious adverse events seen in this population.
November 20, 2014
08:37 EDTIMMUImmunomedics says partial response achieved for 11 months in IMMU-130 trial
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November 18, 2014
17:09 EDTIMMUImmunomedics veltuzumab designated for orphan status
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