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T Demonstrates Sustained Immune Response Two Years after Treatment in See more news releases in Health Care Hospitals Medical Pharmaceuticals Pharmaceuticals Trade Show News Clinical Trials Medical DiscoveriesLAVAL, Quebec, Feb.
25, 2015 /CNW/ Pharmaceuticals International, Inc. (NYSE: VRX) (TSX: VRX) announced the presentation of new long term, preliminary results from the Phase II STAND trial demonstrating a robust immune response with PROVENGE (sipuleucel T) that continues two years louis vuitton purses with prices after completing treatment in men with biochemically recurrent prostate cancer (BRPC). The findings, along with valuable data from the ongoing Phase IV registry, PROCEED, related to increasing enrollment of African Americans in prostate cancer trials, are being presented at the 2015 Genitourinary Cancers Symposium (ASCO GU) February 26 28 in Orlando, Florida. The STAND study is a randomized, Phase II trial that consisted of two patient study groups. One group completed PROVENGE two weeks before initiation of androgen deprivation therapy (ADT) and the second received PROVENGE three months after the start of ADT. PROVENGE is not indicated for use in patients with BRPC. Preliminary results from STAND indicate that immune responses were observed in both study arms and suggest there may be a greater cellular immune response in patients who received PROVENGE prior to ADT compared with those who received PROVENGE following three months of ADT. immune responses were observed and similar between both treatment arms. "This study may also provide guidance on the optimal sequencing of immunotherapy and ADT in biochemical recurrent prostate cancer." PROVENGE, the first personalized immunotherapy, stimulates a patient's own immune system to fight cancer. and the louis vuitton purses macys European Union as a treatment for asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer. "These are very encouraging preliminary data and the longest duration of immune responses observed following PROVENGE completion in men with this particular type of prostate cancer," said Andrew S. "Dendreon louis vuitton samsung galaxy s4 case amazon and Valeant remains committed to exploring the use of PROVENGE in different prostate cancer treatment settings to provide important clinical information to practicing oncologists." In 2012, an exploratory analysis of African American patients from the PROVENGE Phase III trials suggested a positive treatment effect in this population. Building on this observation, another abstract being presented at ASCO GU highlights successful efforts that nearly doubled enrollment of African American men in the ongoing PROCEED registry. African American population, versus 5.8 percent in the PROVENGE Phase III registration trials. Before getting PROVENGE, tell your doctor if you: Have heart problems Have lung problems Have a history of stroke Take any other medicines including prescription and nonprescription drugs, vitamins, and dietary supplements. What are the possible side effects of PROVENGE? PROVENGE infusion can cause serious reactions. Tell your doctor right away if you: Have breathing problems, chest pains, racing heart or irregular heartbeats, high or low blood pressure, dizziness, fainting, nausea, or vomiting after getting PROVENGE. Any of these may be signs of heart or lung problems. Develop numbness or weakness on one side of the body, decreased vision in one eye or difficulty speaking. Any of these may be signs of a stroke. Develop symptoms of thrombosis which may include pain and/or swelling of an arm or leg with warmth over the affected area, discoloration of an arm or leg, unexplained shortness of breath or chest pain that worsens on deep breathing. Get a fever over 100 or redness or pain at the infusion or collection sites. Any of these may be signs of infection. The most common side effects of PROVENGE include chills, fatigue, fever, back pain, nausea, joint ache, and headache. These are not all the possible side effects of PROVENGE treatment. For more information, talk with your doctor. Call your doctor for medical advice about side effects. You may report side effects to louis vuitton purses in paris france the FDA at 1 800 FDA 1088 or For more information on PROVENGE, please see the Prescribing Information call 1 877 336 3736. This press release may contain forward looking statements, including, but not limited to, the results of and the observations from the STAND study and the impact thereof, the guidance provided from such study, and the plans for PROVENGE in different treatment settings. statements may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the Company's most recent annual or quarterly report and detailed from time to time in Valeant's other filings with the Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference.
Readers are cautioned not to place undue reliance on any of these forward looking statements. These forward looking statements speak only as of the date hereof. undertakes no obligation to update any of these forward looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes, except as required by law.
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