Biopure submits IND for trial in patients with acute myeloid leukemia
Pregnancy and surgery patients with a serious blood disorder that causes excessive clotting have responded well to treatment with a man-made anti-clotting protein. Results from a study by researchers at Yale School of Medicine and other institutions were presented December 6 at the Annual Meeting of the American Society of Hematology (ASH) in San
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Biopure Corporation has announced that it has submitted to the Food and Drug Administration (FDA) an investigational new drug (IND) application to conduct a pilot phase 2 clinical trial of the company’s oxygen therapeutic Hemopure [hemoglobin glutamer - 250 (bovine)].
In the proposed trial Hemopure would be studied for use in the treatment of life-threatening anemia secondary to induction chemotherapy in patients with acute myeloid leukemia (AML) who refuse red blood cell transfusion.
As previously reported, the company met with the FDA in July 2008 to discuss an acceptable patient population for a new clinical trial. At that time the company proposed a trial in AML patients who will not accept blood transfusions and consequently are unable to undergo potentially life-saving induction chemotherapy because of the profound anemia the chemotherapy causes. The purpose of the proposed study would be to study the efficacy of Hemopure in delivering oxygen in the absence of red blood cell transfusion. An effective treatment for this patient population represents an unmet medical need because of an expected 100% mortality within several months without induction chemotherapy.
Blood transfusions used to treat anemia in patients with cancer are associated with an increased risk of life-threatening blood clots, at a similar rate as other treatments for cancer-induced anemia, according to scientists at the University of Rochester Medical Center. These findings, published in Tuesday’s Archives of Internal Medicine, pose a quandary for doctors who
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“New blood” can revitalize a company or a sports team. Recent research by Tel Aviv University finds that young blood does a body good as well, especially when it comes to fighting cancer. The TAU researchers, led by Prof. Shamgar Ben-Eliyahu from the Department of Psychology’s Neuroimmunology Research Unit, discovered that a transfusion of “young”
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Biothera has announced today it began dosing patients in the second arm of its metastatic colorectal cancer (mCRC) trial in August. This arm of the trial is evaluating the combination therapy of its lead drug candidate, Imprime PGG, with Erbitux, an anti-cancer monoclonal antibody from ImClone Systems. Unlike the first trial arm, the second treatment
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Delcath Systems, Inc. has announced that the first fifty percent (46 of 92) of patients have been enrolled in the Phase III clinical trial treating metastatic cutaneous and ocular melanoma to the liver. The eleven participating cancer centers in this trial continue to evaluate and enroll patients and the Company looks forward to completing enrollment
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New data shows that some sarcoma patients are benefiting from treatment with REOLYSIN, developed from a harmless virus called the reovirus that most people are exposed to at some point in their lives. Dr. Monica Mita of the Institute of Drug Development (IDD), the Cancer Therapy and Research Center at the University of Texas Health
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