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Registered Dietitians - A Cost Effective Investment In Health For Canadians
Dietitians of Canada (DC) released a report today describing the integral role played by registered dietitians, as members of multi-disciplinary teams that contribute to promoting and supporting health among Canadians. The Role of Registered Dietitians in Primary Health Care: Moving Forward - A National Perspective presents evidence for the cost-effectiveness of nutrition services in the prevention and treatment of chronic conditions such as diabetes, hypertension, cancer and heart disease.
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FDA Recommends Gardasil Recipients Sit, Lie Down After Receiving Vaccination
In a posting aimed at health care professionals, FDA on its Web site on Wednesday said that recipients of Merck"s human papillomavirus vaccine, Gardasil, should be closely observed afterward for 15 minutes while they remain seated or lying down to avoid the possibility of fainting, the Wall Street Journal reports. FDA said that since October 2007, Gardasil"s labeling for both health care providers and patients has included a discussion about fainting. The agency said the strengthened recommendation comes in response to reports of "traumatic injuries" among some recipients who experienced fainting (Corbett Dooren, Wall Street Journal, 6/10). Gardasil protects against the strains of HPV that cause most cases of cervical cancer and genital warts. The Centers for Disease Control and Prevention recommends that girls ages 11 and 12 receive the three-dose vaccine before they are sexually active. Girls and women ages 13 to 26 who have not been vaccinated or completed the vaccine series also should receive the vaccine (CDC fact sheet, June 2008). On Wednesday, FDA also approved changes to Gardasil materials that place warnings about fainting in a more prominent place on drug labels and handouts. The agency said that the new recommendations are intended to "prevent falls and injuries" (Wall Street Journal, 6/10).
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QLT Announces 12-month Results From Novartis Sponsored MONT BLANC Study Evaluating Standard-fluence Visudyne(R) Combination Therapy
QLT Inc. (NASDAQ: QLTI; TSX: QLT) announced that twelve-month primary analysis results from the Novartis sponsored Phase II MONT BLANC study were presented on June 14, 2009 during the 17th Congress of the European Society of Ophthalmology in Amsterdam, the Netherlands. MONT BLANC is the European study of the Novartis sponsored SUMMIT clinical trial program which investigates the efficacy and safety of combining Visudyne(R) (Novartis Pharma AG) and Lucentis(R) (Novartis Pharma AG, Genentech Inc.). SUMMIT also includes the DENALI study in the US and Canada and the EVEREST study in Asia. MONT BLANC is a 24-month randomized, double-masked, multicenter trial in patients with subfoveal choroidal neovascularization secondary to age-related macular degeneration. The purpose of the study is to evaluate whether Visudyne combined with Lucentis is not inferior to Lucentis monotherapy with respect to the mean change from baseline in visual acuity (VA) and to evaluate the proportion of patients with a treatment-free interval of at least three months duration after Month 2. At the Month 12 examination, mean VA in the Visudyne combination therapy group improved 2.5 letters from baseline compared with a 4.4 letter improvement in the Lucentis monotherapy group. In the combination therapy group, 96% of patients had a three-month treatment-free interval, compared with 92% in the Lucentis monotherapy group.
Oncology

ActoGeniX Obtains IND Approval

ActoGeniX, a development stage biopharmaceutical company, announced that the United States÷´ Food and Drug Administration (FDA) has approved the Company÷´s Investigational New Drug (IND) application for AG013, a novel therapeutic product for the treatment of oral mucositis in cancer patients. This IND application approval allows ActoGeniX to initiate a phase 1B clinical trial with AG013, which will now become the second clinical development program in ActoGeniX÷´s portfolio. Oral mucositis is a painful inflammation of the oral mucosa affecting cancer patients and making daily activities such as eating, drinking and talking difficult or impossible. It is a severe and debilitating disease for which no effective cure is available today. AG013 is based on ActoGeniX÷´s proprietary TopAct™ platform and constitutes of an oral rinsing solution that delivers a potent healing factor to the damaged mucosa in the oral cavity. In preclinical pharmacology studies AG013 has already shown significant efficacy results suggesting that it holds great promise for the treatment of oral mucositis in cancer patients. ActoGeniX÷´s phase 1B clinical study will be conducted in six major oncology centers in the US, and will mainly evaluate safety and tolerability of the new product, but will also allow the collection of efficacy data. 21 Patients will be included in this placebo-controlled, single blinded, dose escalation study, which is expected to be completed during the first half of 2010. Dr. Mark Vaeck, CEO of ActoGeniX, commented: "We are extremely pleased with this approval by the FDA, which is a clear endorsement of the quality of our preclinical data package and development plan for AG013. Oral mucositis is a very significant and underserved opportunity in the cancer supportive care market, and a novel therapeutic product in this area has huge commercial potential." Dr. Bernard Coulie, Chief Medical Officer of ActoGeniX, added: "With the advancement into clinical development of AG013, our second lead product, ActoGeniX is well on its way to effectively build a significant clinical-stage product pipeline. Moreover AG013 could become the first approved therapy for oral mucositis in patients undergoing treatment of solid tumors or head/neck cancers." About Oral mucositis Oral mucositis is the (painful) inflammation, necrosis and ulceration of the oral mucosa, affecting nearly every patient that receives radiotherapy of the head/neck region or bone marrow transplant and a large proportion of solid tumor patients treated with chemotherapy or radiation therapy. Cardinal symptoms include ulcerations, debilitating pain and inability to eat and/or sustain anti-cancer therapy. Every year approximately 4 million new cases of cancer are diagnosed in the Western World, and almost 50% of those will develop oral mucositis. The economical costs due to oral mucositis are substantial, driven by the required additional medical care and extended hospital stay. ActoGeniX


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