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Hospital Pharmacists Launch Pioneering Healthy Lifestyle Scheme, UK
Inpatients at Southampton"s teaching hospitals are to be offered advice on lifestyle and weight management as part of a radical new project. Southampton University Hospitals NHS Trust"s pharmacy team has invented an innovative plan to tackle obesity during routine risk assessments for venous thromboembolism (VTE), better known as blood clots.
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Aradigm Receives FDA Clearance For Phase IIb Clinical Trial Of Inhaled Liposomal Ciprofloxacin To Treat Bronchiectasis
Aradigm Corporation (OTCBB:ARDM) (the "Company") announced it received clearance from the U.S. Food and Drug Administration (FDA) for its inhaled liposomal ciprofloxacin Investigational New Drug (IND) application. The initial clinical protocol under this IND is an international, randomized, double-blind, placebo-controlled Phase IIb study designed to evaluate the Company"s inhaled liposomal ciprofloxacin in patients with non-cystic fibrosis bronchiectasis (BE). This orphan drug condition is a chronic severe respiratory disease and there is currently no drug specifically approved for its treatment in the U.S.
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Strengthening The Foundation Of Social Security
The U.S. Senate Special Committee on Aging will hold a hearing on Wednesday, June 17, 2009 at 2:00 pm ET, to examine the current Social Security benefit structure, and how to strengthen and reform the program for future beneficiaries. The committee will hear from witnesses on reform ideas and how to meet our retiree and disabled citizens" needs. Today, one-third of Americans 65 years and older depend on Social Security benefits to supply 90 percent of their total income.
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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