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U.S. Naval Medical Research Center Proposed 'RESUS' Clinical Trial In Trauma Patients Remains On FDA Hold
Biopure Corporation (Nasdaq: BPUR) announced that the Food and Drug Administration has advised the U.S. Naval Medical Research Center (NMRC) by letter that it may not initiate a clinical trial of Biopure"s oxygen therapeutic Hemopure(R) [hemoglobin glutamer -- 250 (bovine)] under a proposed protocol submitted to the FDA in March 2009. As previously announced, the study, "Restore Effective Survival in Shock" (RESUS) was first proposed and submitted to the FDA in 2005. The proposed trial was placed on clinical hold at that time. It has been resubmitted repeatedly in response to FDA comments and to address comments made by the FDA Blood Products Advisory Committee at an open meeting held in December 2006. Each subsequent submission, including the most recent, was placed on clinical hold.

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Animal TB "Tracker" To Speed Drug And Vaccine Studies
Johns Hopkins researchers have developed a novel way to monitor in real time the behavior of the TB bacterium in mouse lungs noninvasively pinpointing the exact location of Mycobacterium tuberculosis. The new monitoring system is expected to speed up what is currently a slow and cumbersome process to test the safety and efficacy of various TB drug regimens and vaccines in animals. Plans are already under way for developing a similar system to monitor TB disease in humans.
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Provectus Reports Encouraging Clinical Data At ASCO On Treatment Of Metastatic Melanoma With PV-10
Provectus Pharmaceuticals, Inc. (OTC Bulletin Board: PVCT), a development-stage oncology and dermatology biopharmaceutical company, has announced interim data from the first 40 subjects in its Phase 2 clinical trial for the treatment of metastatic melanoma. PV-10 treatment was well tolerated and caused selective tumor destruction in the majority of subjects. Additional data on untreated tumors corroborated observations of a possible bystander effect seen during earlier Phase 1 testing. These data were presented today at the American Society of Clinical Oncology 2009 Annual Meeting, Abstract #9060, entitled "Chemoablation of melanoma with intralesional rose bengal (PV-10)," in the General Poster Session.
Mental Health

Migraine And Increased Risk Of Cardiovascular Disease: Migraine Frequency Plays A Role

Women who have migraines with aura may be more likely to have a stroke or heart attack than women who don"t have the condition, and the association varies by migraine frequency, according to research published in the June 24, 2009, online issue of Neurology®, the medical journal of the American Academy of Neurology. An aura is a visual or other sensory disturbance that occurs before the migraine starts, such as seeing bright lights. The study found that women with migraine with aura whose migraines occur at least once a week are more than four times as likely to have a stroke as women who do not have migraines. Women with migraine with aura who have migraines less than once a month were more than twice as likely to have a heart attack and nearly twice as likely to have had heart procedures such as coronary artery bypass surgery or angioplasty. In contrast, women who had migraines with aura once a month had no increased risk of stroke or heart problems. "These results should be interpreted with caution, since the number of migraine and migraine features were self-reported and there were relatively low numbers of stroke and heart problems in the large study group," said study author and member of the American Academy of Neurology Tobias Kurth, MD, ScD, of Brigham and Women"s Hospital, Harvard Medical School and INSERM, the French national research institute. "Nonetheless, more research is needed to determine how and why these differences occur and whether preventing migraines could reduce the risk of stroke and heart problems." The Women"s Health Study involved 27,798 U.S. women health professionals age 45 and older. The women had no heart or cerebrovascular problems at the start of the study and were followed for about 12 years. During that time, 706 women, or 2.5 percent of the group had cerebrovascular events, including 305 heart attacks and 310 strokes. In addition, 655 women had heart procedures such as bypass surgery. Of the 3,568 women with migraine at the start of the study, 75 percent had migraines less than once a month, 20 percent had them once a month, and 5 percent had migraines at least once a week. A total of 1,428 had migraine with aura. The study was supported by the National Heart, Lung, and Blood Institute, National Cancer Institute, Donald W. Reynolds Foundation, Leducq Foundation and Doris Duke Charitable Foundation. The American Academy of Neurology, an association of more than 21,000 neurologists and neuroscience professionals, is dedicated to promoting the highest quality patient-centered neurologic care. A neurologist is a doctor with specialized training in diagnosing, treating and managing disorders of the brain and nervous system such as multiple sclerosis, restless legs syndrome, Alzheimer"s disease, narcolepsy, and stroke. American Academy of Neurology (AAN)


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