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Key Health IT Definition Expected Soon
The Office of the National Coordinator for Health Information Technology"s number-two man, Charles Friedman, told industry members that an official definition of the term "meaningful use" of health information technology is "in the works" and they should expect its release "in the not too distant future." "Meaningful use" refers to the criteria the government will use to determine whether to pay providers for adopting the technology, Modern Healthcare reports.
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Health Officials Issue Revised Pregnancy Weight-Gain Guidelines For Obese Women
The Institute of Medicine and the National Research Council on Thursday issued revised U.S. weight-gain guidelines for obese pregnant women, in response to rising levels of obesity in the country and growing evidence that weight gain can cause health problems for women and their infants, the New York Times reports. The revision, which is the first since 1990, recommends that obese women -- those with a body mass index of 30 or more -- limit their weight gain to 11 to 20 pounds over nine months. The 1990 pregnancy guidelines did not specifically address weight gain for obese women, telling them instead to follow the recommendations for overweight women. According to health officials, the changes to the recommendations for obese women were required to keep up with the changing weight patterns among women in the U.S. The New York Times reports that about 27% of women of childbearing age are considered obese, while 55% fall into the categories of overweight or obese.The recommendations for women with BMIs of less than 30 did not change. They call for overweight women -- those with a BMI of 25 to 29.9 -- to gain 15 to 25 pounds over nine months, while underweight women -- with BMIs of less than 18.5 -- should gain 28 to 40 pounds, and normal-weight women -- with BMIs of 18.6 to 24.9 -- should gain 25 to 35 pounds (Parker-Pope, New York Times, 5/29).Time reports that pregnant women who do not gain enough weight face a higher risk of stunted fetal growth and preterm delivery. However, it is more common for women to gain too much weight, placing them at higher risk for conditions like gestational diabetes and high blood pressure. In addition, their infants are at increased risk of being born earlier, larger and by cesarean section. Time reports that excessive weight gain can increase a woman"s risk of postpartum obesity and elevate risks of heart disease and stroke because most women do not lose extra pounds gained during pregnancy. Many studies also have suggested that a woman"s gestational weight can predict potential weight problems in her offspring (Kingsbury, Time, 5/28).The committee that developed and issued the revision said that the existing guidelines were essentially on target but that women and their physicians need to work harder to help women reach a normal weight before pregnancy and avoid gaining too much weight during pregnancy, according to the Los Angeles Times (Roan, Los Angeles Times, 5/29). The guidelines also recommend more nutrition and exercise counseling during pregnancy, advising physicians or midwives to consult dieticians to shape a woman"s care regardless of her initial weight, the AP/Yahoo! News reports (Neergaard, AP/Yahoo! News, 5/28). The Los Angeles Times reports that health care professionals are expected to recognize and implement some of the recommendations; however, it is not mandatory to do so.Several experts on maternal obesity and child health expressed disappointment with the guidelines, arguing that obese women should gain little to no weight during pregnancy, according to the Los Angeles Times. They also argue the new guidelines do not do enough to address obesity before pregnancy. Maxine Hayes, state health officer for the Washington State Department of Health, said, "If we wait for every woman to be advised about weight gain after they become pregnant, it"s too late. It puts women and their babies on a trajectory that is unhealthy" (Los Angeles Times, 5/29).
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Prevention Magazine™ Says "Take SunPill To Boost UV Sun Protection"
XenaCare Holdings Inc. (OTCBB:XCHO), a healthcare company specializing in the branding, retailing and internet distribution of consumer products, has announced today that in the July 2009 issue of Prevention Magazine™ an article written by Roopoka Malhorta which is about Ageless Summer Beauty - 21 fast, easy ways to look young - and stay that way - this summer and beyond states as their #1 choice was to "Try a Sun Protection pill" they further stated "ò€¦boost your UV protection by taking an antioxidant supplement such as SunPill ($20 for a month"s supply; available at http://www.sunpill.com)." According to Frank Rizzo, president of XenaCare, the SunPill can also be purchased at Walgreens, Rite-Aid, Amazon.com, Drugstore.com, CVS.com, Target.com and various other major retailers.
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Agennix Receives Fast Track Designation From FDA For Talactoferrin In Combination With Sunitinib For Renal Cell Carcinoma

Agennix announced that talactoferrin alfa (talactoferrin) has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the first-line treatment of renal cell carcinoma (RCC) in combination with sunitinib (Sutent(R) - Pfizer). The Fast Track program is designed to expedite the review of investigational drugs for the treatment of patients with serious or life-threatening diseases where there is an unmet medical need. Fast Track designations allow a company to file a New Drug Application (NDA) or Biologics License Application (BLA) on a rolling basis and permit the FDA to review the filing as it is received, rather than waiting for the complete submission prior to commencing the review process. Additionally, NDAs and BLAs for fast track development programs are eligible for priority review which may result in an abbreviated review time of six months. Additional Clinical Updates Agennix also announced that two pivotal Phase III trials in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) are underway at a number of leading U.S. clinical sites. FORTIS-M is a randomized, placebo-controlled, 720-patient trial of talactoferrin monotherapy in patients with Stage IIIB/IV NSCLC. Patients who have failed two or more prior systemic anti-cancer therapies will be randomly assigned (2:1) to receive either oral talactoferrin or placebo in additional to standard supportive care. The trial is designed to detect an improvement in overall survival in patients receiving talactoferrin, and results are expected in 2011. FORTIS-C is a randomized, placebo-controlled trial evaluating 1100 chemo-naive NSCLC patients. Newly diagnosed patients with Stage IIIB/IV NSCLC will be randomly assigned (1:1) to receive standard first-line chemotherapy with carboplatin and paclitaxel plus either oral talactoferrin or placebo. Agennix has received Fast Track designation from the FDA for both NSCLC indications as well as favorable Scientific Advice from the EMEA. Agennix has also received approval of a Special Protocol Assessment from the FDA for the FORTIS-C trial. The designs of these two Phase III trials are based on previous successful randomized, placebo-controlled, Phase II trials which both met their primary endpoint with supporting results on the secondary endpoints. "We are pleased with the continued development progress with talactoferrin including our most recent Fast Track designation and the initiation of our Phase III NSCLC trials," said Rick Barsky, Chief Executive Officer, Agennix Incorporated. "This progress, along with the recent success and renewed interest in immunotherapies, will help us reach our goal of making talactoferrin available to patients for the treatment of these devastating diseases." About Talactoferrin Talactoferrin is a novel targeted dendritic cell recruiter and activator (DCRA) being studied for the treatment of several life-threatening diseases including RCC and NSCLC. Talactoferrin mediates its anti-cancer activity by targeting dendritic cells which play an important role in activating innate and adaptive immunity. After being transported into the gut associated lymphoid tissue (GALT), the largest immune organ in the body, orally administered talactoferrin induces the recruitment of immature dendritic cells to the GALT and promotes their maturation. This unique aspect of its function results in recruitment of dendritic cells that have captured tumor antigens while in the peripheral circulation. Following maturation, these dendritic cells activate Natural Killer (NK) and Natural Killer T-cells (NK-T) of the innate immune pathway and CD8+ lymphocytes of the adaptive immune pathway. Initiating the immune response in the GALT, and away from the tumor, reduces the effect of anti-immune factors produced by the tumor. Talactoferrin Fast Track Designations Agennix has received Fast Track designation for talactoferrin for the first-line treatment of RCC in combination with sunitinib. Agennix"s RCC submission included the results from a Phase I trial, and a multi-center, single arm Phase II trial of talactoferrin in 44 patients with clear cell RCC who had failed standard therapy. Patients receiving oral talactoferrin in this Phase II trial had a median progression-free survival of 6.4 months, median overall survival of 21.1 months, and a one-year survival rate of 77%. Talactoferrin appeared to be well tolerated, which was consistent with other talactoferrin studies. The results from the Phase II trial were published in Cancer in 2008. Talactoferrin was previously awarded Fast Track designations in NSCLC both for first line treatment and for patients who have failed two or more prior systemic anti-cancer therapies. These NSCLC Fast Track designations were based upon the clinical activity and tolerability data from two randomized placebo-controlled Phase II trials. Both Phase II trials met their primary endpoint with supporting results on the secondary endpoints. About Renal Cell Carcinoma (RCC) RCC is the most common type of kidney cancer, accounting for approximately 90 percent of kidney tumors. According to the American Cancer Society, there are approximately 49,000 new cases of kidney cancer diagnosed each year in the United States. Kidney cancer is uncommon under age 45, and its incidence is highest between the ages of 55 and 84. For non-metastatic RCC, the current standard of care is surgical removal of the kidney (nephrectomy), followed by observation. If the cancer spreads beyond the kidneys, treatment may include chemotherapy, cytokine therapy, targeted therapy, and/or radiation. Currently, sunitinib is the most prescribed targeted therapy for first-line treatment of RCC. About Agennix Agennix is a private biopharmaceutical company developing a first-in-class molecule with immunological activity for the treatment of cancer and other unmet medical needs. Agennix"s lead molecule, talactoferrin, is an immunomodulatory protein with a novel mechanism of action. The Company is developing an oral liquid formulation of talactoferrin for cancer indications and a topical gel formulation for the treatment of diabetic foot ulcers. Agennix has more than 90 issued patents and more than 50 pending patents broadly protecting talactoferrin. Agennix has recently initiated Phase III trials in two non-small cell lung cancer indications (talactoferrin monotherapy in patients who have failed two or more previous therapies, and talactoferrin in combination with chemotherapy in previously untreated patients), and is planning a Phase IIb trial in patients with renal cell cancer, and Phase II trials in other cancer indications. The company has recently agreed to merge its business with GPC Biotech, a publicly traded biopharmaceutical company focused on developing anti-cancer drugs. The merger is subject to the approval of the shareholders" meeting of GPC Biotech and to further closing conditions, and is expected to be completed by the end of 2009. Forward Looking Statements This press release contains forward-looking statements, which express the current beliefs and expectations of the management of Agennix. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward-looking statements contained in this press release. There can be no guarantee that the merger with GPC Biotech will be completed. Forward-looking statements speak only as of the date on which they are made and Agennix undertakes no obligation to update these foward-looking statements even if new information becomes available in the future. Agennix


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