MEDA Announces Dymista Approved by the FDA

MEDA Announces Dymista Approved by the FDA:   The U.S. Food and Drug Administration (FDA) has approved Dymista, a new patented product for treatment of seasonal allergic rhinitis (SAR). In several clinical studies, MP29-02 (tentatively called Dymista), a novel intranasal formulation of azelastine hydrochloride (above left structure)  and fluticasone propionate (right structure).  

The first study demonstrated that continuous treatment with MP29-02 for 1 year was well tolerated in patients with chronic allergic or non-allergic rhinitis, only 2.7% of patients treated with MP29-02 and 2.9% of patients treated with fluticasone propionate discontinued the study due to an adverse event. MP29-02 also provided sustained efficacy over the one-year study period. MP29-02-treated patients experienced consistently greater relief from their nasal symptoms than fluticasone treated patients over the course of the study. Statistically significant (P<.05) differences favoring MP29-02 over fluticasone were observed at months 1 through 7 and at months 9 and 11. 

The second and third studies in patients with seasonal allergic rhinitis (SAR) provided evidence that MP29-02 demonstrated significantly more effective relief of nasal symptoms (P<.05 vs. azelastine, fluticasone, and placebo) and significantly greater ocular benefits compared to placebo (P<.05) over a 2-week study period. The new data was the subject of platform presentations on Sunday, March 4, 2012 at the annual meeting of the American Academy of Allergy Asthma and Immunology (AAAAI) in Orlando, Florida. MP29-02 is currently under review by the U.S. Food and Drug Administration (FDA) for the treatment of SAR.

Ref : http://mb.cision.com/Main/357/9255877/10183.pdf

Magnesium supplement helps boost brainpower ....

Neuroscientists at MIT and Tsinghua University in Beijing show that increasing brain magnesium with a new compound enhanced learning abilities, working memory, and short- and long-term memory in rats. The dietary supplement also boosted older rats’ ability to perform a variety of learning tests.

Magnesium, an essential element, is found in dark, leafy vegetables such as spinach and in some fruits. Those who get less than 400 milligrams daily are at risk for allergies, asthma and heart disease, among other conditions. In 2004, Guosong Liu and colleagues at MIT discovered that magnesium might have a positive influence on learning and memory. They followed up by developing a new magnesium compound — magnesium-L-threonate (see structure, MgT) — that is more effective than conventional oral supplements at boosting magnesium in the brain, and tested it on rats.  

“We found that elevation of brain magnesium led to significant enhancement of spatial and associative memory in both young and aged rats,” said Liu, now director of the Center for Learning and Memory at Tsinghua University. “ 

If MgT is shown to be safe and effective in humans, these results may have a significant impact on public health.” Liu is cofounder of Magceutics, a California-based company developing drugs for prevention and treatment of age-dependent memory decline and Alzheimer’s disease.

Magnesium supplement helps boost brainpower - MIT Media Relations

Garlic Oil Component May Form Treatment to Protect Heart

A potent-smelling component of garlic oil may help release protective compounds to the heart after heart attack, during cardiac surgery, or as a treatment for heart failure.

At low concentrations, hydrogen sulfide gas has been found to protect the heart from damage. However, this unstable and volatile compound has been difficult to deliver as therapy.

Now researchers at Emory University School of Medicine have turned to diallyl trisulfide (right structure), a garlic oil component, as a way to deliver the benefits of hydrogen sulfide to the heart. Their findings suggest that doctors could use diallyl trisulfide  in many of the situations where researchers have proposed using hydrogen sulfide.

The data was presented Wednesday, Nov. 16 at the American Heart Association (AHA) Scientific Sessions conference in Orlando.

“We are now performing studies with orally active drugs that release hydrogen sulfide,” says

David Lefer, PhD, professor of surgery at Emory University School of Medicine and director of the Cardiothoracic Surgery Research Laboratory at Emory University Hospital, Midtown. “This could avoid the need to inject sulfide-delivery drugs outside of an emergency situation.”

Garlic Oil Component May Form Treatment to Protect Heart | Emory University | Atlanta, GA

Garlic compound 100 times more effective than antibiotics at fighting food borne illness...

A recent research reveals a potent effect for garlic against the bacteria Campylobacter jejuni, a leading cause of intestinal illness caused by eating undercooked poultry or foods that have been contaminated during poultry preparation. "Campylobacter is simply the most common bacterial cause of food-borne illness in the United States and probably the world," explained coauthor Michael Konkel of Washington State University's College of Veterinary Medicine.

The researchers compared the effects of diallyl sulfide (see structure),  a compound that occurs in garlic, and the antibiotics ciprofloxacin and erythromycin on biofilms formed by Campylobacter jejuni. Biofilms are colonies of bacteria protected by a film that renders them a thousand times more resistant to antibiotics than free cells. Cell death following the administration of diallyl sulfide occurred at a concentration of resveratrol that was 100-fold less than that which was effective for either antibiotic, and often took less time to work. The team found that diallyl sulfide combined with a sulfur-containing enzyme, which altered the cells' function and metabolism.

Researchers conclude that, diallyl sulphide elicits strong antimicrobial activity against planktonic and sessile C. jejuni and may have applications for reducing the prevalence of this microbe in foods, biofilm reduction and, potentially, as an alternative chemotherapeutic agent for multidrug-resistant bacterial strains.

Ref : http://jac.oxfordjournals.org/content/early/2012/04/27/jac.dks138.abstract?sid=71685bd6-4b80-4d25-b97b-9422ba1d8cc3

Combination of Two Drugs Reverses Liver Tumors.....

The combination of two inhibitors of protein mTOR stops the growth of primary liver cancer and destroys tumour cells, according to a study by researchers of the Group of Metabolism and Cancer at Bellvitge Biomedical Research Institute (IDIBELL).  

The study led by IDIBELL researchers compared the effects in mice of two inhibitors of mTOR. The first was a derivative of rapamycin, called everolimus (RAD001 - see structure below left),
which is already used as an immunosuppressant and to treat specific cancers. The second is a new generation drug that inhibits mTOR called BEZ235 (see right side structure). 

During the study, researchers found unexpectedly that the combination of the two drugs had a more potent effect than any of the two drugs separately. Coadministration of BEZ235 and RAD001 limits the development of tumour and causes the self-destruction of tumour cells.

Based on these results a clinical trial, funded by Novartis, has started in the United States to evaluate the efficacy of the combination of these two inhibitors of mTOR in humans. The study coordinator, Sara Kozma, noted that

"because rapamycin and its derivatives are already approved for the treatment of other diseases, their combination to BEZ235, would be a rapid strategy to test the efficacy of this drug and fast track its approval for clinical use."

Ref :1. http://www.idibell.cat/modul/news/en/362/combination-of-two-drugs-reverses-liver-tumours
2.http://stm.sciencemag.org/content/early/2012/04/27/scitranslmed.3003923

A new drug to manage resistant chronic pain

BL-7050 is a new chemical entity based on the molecular structure of diclofenac (Voltaren), a well-known non-steroidal anti-inflammatory drug (NSAID) widely used in the treatment of nociceptive and inflammatory pain. However, BL-7050 operates via a novel mechanism of action, namely opening specific potassium channels in nerve cells. The opening of these channels reduces the activity of the nerve cells, thereby reducing or preventing pain signals.

Neuropathic pain is a complex, chronic state of pain that results from dysfunctional or injured nerve fibers. Neuropathic pain is associated with various conditions, including shingles, diabetes and cancer and is reported to affect 1% to 3% of the population. Patients describe the symptoms as burning, stabbing, electric shock or itching sensations, which can cause extreme discomfort for extended periods of time. A variety of medications are used to treat neuropathic pain, including antidepressants and anti-seizure medicines. However, these medications have significant side effects and are not always effective.  

If this drug ultimately proves itself though all the phase clinical trials to be successful, Anaysts see it receiving possible Orphan drug status to be prescribed to patients suffering from extreme pain caused by such diseases as terminal late stage cancers and cystic fibrosis, for example.

Ref : http://www.biolinerx.com/default.asp?pageid=14&itemid=24

A new drug to manage resistant chronic pain

Two drugs better than one to treat youth with type 2 diabetes, study suggests

Two drugs better than one to treat youth with type 2 diabetes, study suggests: A combination of two diabetes drugs, metformin and rosiglitazone, was more effective in treating youth with recent-onset type 2 diabetes than metformin alone, a new study has found. Adding an intensive lifestyle intervention to metformin provided no more benefit than metformin therapy alone.

The antibiotic, amoxicillin-clavulanate, before a meal may improve small bowel motility

The antibiotic, amoxicillin-clavulanate, before a meal may improve small bowel motility: The common antibiotic, amoxicillin-clavulanate, may improve small bowel function in children experiencing motility disturbances, according to a new study.

Does Vitamin E Prevent or Promote Cancer?

In continuation of my update on Vitamin-E

The cancer preventive activity of vitamin E has been suggested by many epidemiologic studies. However, several recent large-scale human trials with α-tocopherol, the most commonly recognized and used form of vitamin E, failed to show a cancer preventive effect. The recently finished follow-up of the Selenium and Vitamin E Cancer Prevention Trial (SELECT) even showed higher prostate cancer incidence in subjects who took α-tocopherol supplementation. The scientific community and the general public are faced with a question: “Does vitamin E prevent or promote cancer?” Researchers lead by Dr. Chung S. Yang, Director of the center did experiments in animal models and tried to conclude about  the cancer preventive activity of γ- and δ-tocopherols as well as a naturally occurring mixture of tocopherols, and the lack of cancer preventive activity by α-tocopherol. 

On the basis of these results as well as information from the literature, we suggest that vitamin E, as ingested in the diet or in supplements that are rich in γ- and δ-tocopherols, is cancer preventive; whereas supplementation with high doses of α-tocopherol is not.

Ref : http://cancerpreventionresearch.aacrjournals.org/content/early/2012/04/14/1940-6207.CAPR-12-0045.abstract?sid=5d446d6b-8eb0-426f-b86a-378f60ad7d15

Clues to aspirin's anti-cancer effects revealed.....................

In continuation of my update on aspirin....

One of the world's oldest medicines may hold the secret to a very contemporary problem: preventing cancer. Exactly why salicylate shows such potential as an anti-cancer treatment remains unclear, but a new study in mice offers clues.

Salicylate, found in willow bark, has been a key ingredient in medicine cabinets for thousands of years – ancient Egyptian manuscripts describe it as a treatment for inflammation. In a modified form – aspirin – it remains a successful anti-inflammatory and analgesic. Recently, though, research has revealed a puzzling side-effect of taking aspirin: the drug seems to lower a person's chances of developing some forms of cancer.

Aspirin is rapidly broken down inside the body into salicylate, so to investigate aspirin's unexpected side-effects Grahame Hardie at the University of Dundee, UK, applied salicylate to cultured human cells derived from the kidney. He found that the drug activated AMPK, an enzyme involved in cell growth and metabolism that has been found to play a role in cancer and diabetes.

"This is an ancient herbal remedy which has probably always been part of the human diet," says Hardie. "But despite that we're still finding out how it works."

Co-author Greg Steinberg of McMaster University in Hamilton, Ontario, Canada, then tested high doses of salicylate on various types of mice. He found that those engineered to lack AMPK did not experience the same metabolic effects from salicylate as seen in mice with AMPK.

Salicylate, in a form called salsalate, has also shown promise as a treatment for insulin-resistance and type 2 diabetes. Those effects, however, appear not to be governed by AMPK. When insulin-resistant mice lacking AMPK were given salicylate, they showed the same improvement in blood glucose levels as normal mice.

"That's what makes aspirin so scientifically and clinically interesting," says Chris Paraskeva at the University of Bristol, UK, who was not involved in the work. "It potentially works through a number of different pathways."

Ref : http://www.sciencemag.org/content/early/2012/04/18/science.1215327