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Advaxis Receives FDA Response To Orphan Drug Filing
Advaxis, Inc. (OTCBB:ADXS) received the FDA letter late on June 1 denying the company"s request for Orphan Drug Designation (ODD) for the use of ADXS11-001 in invasive cervix cancer. The FDA stated their market definition for invasive cervical cancer prevalence (including all those who had been cured) is over the 200,000 person cutoff. Further, the applicability of ADXS11-01 for a precursor condition, cervical intraepithelial neoplasia (CIN) was considered by the ODD as an early manifestation of the disease. No prevalence estimate for CIN was provided in our original application. There was no issue raised about efficacy.

Lifestyle Program For Patients With COPD Is Health And Cost Effective
Patients with moderate COPD were randomized to receive "usual care" or to undergo an interdisciplinary, community-based program (INTERCOM) that offered an intensive lifestyle moderation phase of four months, during which patients were instructed in detail to perform two 15-minute intervals of pleasurable walking or cycling, and offered instruction in other lifestyle changes such as nutrition and smoking cessation. After the four-month introductory period, there was a less intensive 20-month maintenance during which patients were offered guidance but not intensive intervention.
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Survey Finds More Than Half Of Metro Manila Citizens Inhale Second-Hand Smoke Every Day
Today Center for Health Development - Metro Manila (CHD-MM) and World Lung Foundation (WLF) published the first results of a survey that shows 52% of Metro Manila citizens are exposed to second-hand smoke every day in workplaces, restaurants and other public spaces. The comprehensive survey of smoking knowledge, attitudes and behavior also revealed that 74% are exposed at least once per week.
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BioLineRx Announces Positive Preliminary Results From The Phase I/II Trial Of BL-1040

BioLineRx Ltd. (TASE:BLRX), a clinical stage drug development company, today announced positive preliminary results from the ongoing phase I/II clinical trial designed to assess the safety and feasibility of BL-1040, the first injectable device designed to address cardiac remodeling, in 20- 30 patients at several sites in Germany and Belgium. To date, 15 patients were successfully treated with BL-1040 with no complications. Moreover, six months follow up results from the first 5 patients show BL-1040"s efficacy in preventing cardiac remodeling and preserving cardiac function. BL-1040 represents a breakthrough approach to supporting cardiac tissue damaged as a result of acute myocardial infarction (MI), improving cardiac function and survival. BL-1040 is a resorbable liquid polymer that is administered via the coronary artery during standard catheterization and flows into the damaged heart muscle. BL-1040 undergoes a liquid to gel phase transition within the infarcted cardiac tissue and forms a protective "scaffold" that enhances the mechanical strength of the heart muscle during recovery and repair, thereby preventing pathological enlargement of the left ventricle after the MI. BL-1040 is excreted naturally from the body within six weeks after injection, leaving behind a stronger, more stable heart muscle. The safety, biocompatibility and efficacy of BL-1040 were demonstrated in pre-clinical studies performed in multiple species. BL-1040 was shown to prevent wall thinning and stabilize End Systolic Volume (ESV) and Ejection Fraction (EF). Data from the ongoing phase I/II trial confirm these findings. To date, 15 patients suffering from a significant infarction were successfully treated with BL-1040 with no complications, no arrhythmias, no elevations in cardiac enzymes and no occlusions. In addition, six months follow up data from the first 5 patients show that BL-1040 prevented End Systolic and End Diastolic Volume dilation, prevented wall thinning and preserved left ventricular dimensions. It is important to note, that patients enrolled in the study suffered a significant MI and were expected to display wall thinning and volume dilations. "BL-1040 could revolutionize the treatment of patients recovering from a massive heart attack," said Professor Jonathan Leor, Director of the Neufeld Cardiac Research Institute at Tel-Aviv University, Israel who invented BL-1040 and conducted the initial experiments together with Professor Smadar Cohen from Ben Gurion University, Israel. "We look forward to completing the trial and believe that it will continue to provide more evidence for the success of our new approach to bring effective and safe treatment for patients with injured hearts," added Professor Leor. "This is an important milestone in the development of BL-1040, BioLineRx"s innovative product candidate, which is the first treatment that attempts to treat damaged cardiac tissue resulting from an acute MI and addresses a tremendous unmet medical need," said Morris C. Laster, MD, CEO of BioLineRx. BL-1040 was in-licensed by BioLineRx from Ben-Gurion University through BGN Technologies, and it was developed by Professor Smadar Cohen and Professor Jonathan Leor from Tel Aviv University. For further information on BL-1040, please visit the BioLineRx website and BL-1040 animation at http://www.biolinerx.com/PipelineSelected.asp About Acute Myocardial Infarction Acute MI is a leading cause of morbidity and mortality in the Western world. Approximately 1.3 million cases of nonfatal MI are reported each year in the U.S. alone, with an annual incidence rate of approximately 600 cases per 100,000 people. BioLineRx


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