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MAP Pharmaceuticals Phase 3 Trial Of Levadex™ Migraine Product Candidate Meets All Four Primary Endpoints
MAP Pharmaceuticals, Inc. (Nasdaq: MAPP) announced that the efficacy portion of its first Phase 3 clinical trial evaluating its novel LEVADEX™ orally inhaled migraine therapy met all four primary endpoints. Additional endpoints showed that LEVADEX provided rapid and sustained pain relief for up to 48 hours after dosing.
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BSD Receives FDA Humanitarian Use Designation For The BSD-2000 Hyperthermia System
BSD Medical Corporation (NASDAQ:BSDM) announced that the U.S. Food and Drug Administration (FDA) has granted Humanitarian Use Device (HUD) designation for the company"s BSD-2000 Hyperthermia System for use in conjunction with radiation therapy for the treatment of cervical carcinoma patients who are ineligible for chemotherapy. This is the first of the two steps required to obtain Humanitarian Device Exemption (HDE) marketing approval, which requires BSD Medical to demonstrate the device"s safety and probable benefit in treating a disease or condition that affects fewer than 4,000 individuals in the United States per year. Now that FDA has granted the Humanitarian Use Designation for the BSD-2000, which confirms that the intended use population is fewer than 4,000 patients per year, BSD can file an HDE submission with the FDA. FDA has 75 days from the date of receipt of the HDE submission to grant or deny an HDE application. This period includes a 30-day filing period during which FDA determines whether the HDE application is sufficiently complete to permit substantive review. During this review, FDA may refine the indications for use which received HUD designation to finalize the indications for use for which HDE approval will be granted. This decision will be based on the data that are available to support the device"s HDE application. The company believes that the data previously submitted to FDA and reviewed by the agency in the company"s pending PMA application can be used to support the HDE approval, and that this previous review may expedite marketing approval for the BSD-2000.
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Secretary Of State Backs MS Society Work Retention Project
Secretary of State for work and pensions James Purnell MP is lending his support to an MS Society-led project designed to help people with chronic and fluctuating health conditions remain in work.
Oncology

Growth Factor Identified As Possible Cancer Drug Target By UNC Scientists

To grow and spread, tumors need new blood vessels, a process called angiogenesis. One growth factor that causes angiogenesis has been identified - vascular endothelial growth factor or VEGF - and drugs to inhibit VEGF are already in use. But not all tumors respond to the therapy initially or over the long term. Thus new growth factors need to be identified to aid in developing the next generation of angiogenesis inhibitors. Scientists at the UNC Lineberger Comprehensive Cancer Center report finding a new angiogenesis protein, SFRP2, found in the blood vessels of numerous tumor sites, including breast, prostate, lung, pancreas, ovarian, colon, kidney tumors, and angiosarcomas. The scientists found that SFRP2 is a potent stimulator of angiogenesis. This protein may be a favorable target for inhibiting angiogenesis which would then "starve" the tumor of its blood supply, thus destroying the cancer. "The discovery that SFRP2 stimulates angiogenesis and is present in blood vessels of a wide variety of tumors provides us with a new target for drug design," said Nancy Klauber-DeMore, M.D., senior author. The study was published online in the journal Cancer Research. Klauber-DeMore is associate professor of surgery and a member of UNC Lineberger Comprehensive Cancer Center. Based on the UNC-led team"s understanding of how this protein works in the blood vessels, scientists successfully utilized a drug, tacrolimus, which is commonly used to prevent organ transplant rejection, to inhibit the growth of angiosarcoma in pre-clinical studies. Angiosarcoma is a highly aggressive cancer that begins in the cells lining the blood or lymph vessels for which options for therapy are limited. Klauber-DeMore, as part of her medical training, completed a surgical research fellowship in the laboratory of Dr. Judah Folkman at Children"s Hospital in Boston. Folkman founded the field of angiogenesis research. Kaluber-DeMore worked with colleagues at the UNC Lineberger Comprehensive Cancer Center, the Carolina Cardiovascular Biology Center, and the Department of Dermatology at Emory University School of Medicine and the Atlanta VA Medical Center. Dianne Shaw University of North Carolina School of Medicine


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