April 28, 2011

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January 19, 2011

Significant Improvement In Development Of MRSA Prevention Vaccine

The Orthopedic Research Society invited URMC researchers to present their findings on January 16, 2011, at the ORS annual meeting in Long Beach, California. The team is led by Dr Schwarz, who noted that the management of MRSA infections due to bone and joint surgery is very challenging, and therefore a vaccine to prevent the infection is badly needed. Orthopedic scientists at the University of Rochester Medical Center, USA, are a step closer to developing a vaccine to prevent life-threatening methicillin-resistant staphylococcus aureus (MRSA) infections following bone and joint surgery.

Other MRSA vaccine research has failed to produce a viable option for patients because of the inability to identify an agent that can break through the deadly bacteria's unique armor. Most other research has targeted the surface of the bacteria, but the URMC team discovered an antibody that reaches beyond the microbe's surface and can stop the MRSA bacteria from growing, at least in mice and in cell cultures.

The researchers are seeking anti-Gmd agents with the best properties for binding to Gmd and making the bacteria less viable. This work is being led by scientists at Codevax, a company started by the University of Rochester and private venture capitalists to co-develop and promote unlicensed vaccine technologies for infectious diseases. John Daiss, a scientist at Codevax, is leading the effort to find existing monoclonal antibodies with strong safety profiles - such as those used to develop the cancer drugs Herceptin and Rituxan – so that researcher can move quickly from the bench to initial clinical trials, said Edward Schwarz, professor of orthopedics and associate director of the URMC Center for Musculoskeletal Research.

Dr Schwarz and colleagues hypothesized that the best way to attack staph aureus was to target the glucosaminidase (Gmd) protein contained in the deadly bug. Gmd is known to act as a zipper on the bacteria, opening the impenetrable armor (cell wall) during cell division. In the absence of Gmd, staph aureus cannot replicate efficiently, dramatically reducing its ability to cause infections. Thus, if they could find an agent that inhibits bacterial growth and prevents the cell wall from closing during binary fission, Dr Schwarz reasoned, perhaps the bacteria itself could be destroyed. The abstract presented at ORS describes two key findings. First, the Schwarz lab discovered four anti-Gmd monoclonal antibodies that disrupt the growth of MRSA bacteria in cell cultures, by breaking the zipper and preventing cell division. The team also demonstrated exactly how the antibody works. Since MRSA is inclined to grow rapidly, as single cells, they sought an antigen that forced the bacteria cells to clump. Electron microscopy images of the bacteria exposed to the anti-Gmd antibodies show evidence of exploding staph; however, additional research is being done to confirm this mechanism of action. "A vaccine in humans would probably not be a foolproof approach to preventing infection 100 percent of the time," Dr Schwarz said. "However, even if we could reduce the risk of MRSA by 35%, that would be an enormous improvement in the field," he concluded.

Source: ThePharmaLetter.com

December 27, 2010

Isle Of Man - Community Acquired MRSA USA300 Confirmed

A NEW strain of the superbug MRSA has been detected on the Isle of Man, health bosses have revealed.
The Department of Health on the island confirmed a small number of cases of a bacterium called MRSA USA 300. It said that, unlike other strains of MRSA, it predominantly affects young, fit and healthy people.
The department added it is mainly transmitted at sports centres, gyms, swimming pools and spas. It is resistant to many antibiotics and could cause serious infection.
Dr Katie Laird, a senior lecturer at Leicester’s De Montfort University, said: “The new antibiotic-resistant strain of MRSA USA 300 is unusual in that it is associated with sporting facilities rather than the hospital environment.”

Source: Daily.Star.co.uk

December 03, 2010

CUBICIN 2-minute IV injection - New Medicine Against MRSA Approved By FDA

Cubist Pharmaceuticals, Inc. today announced that its currently-marketed antibiotic, CUBICIN (daptomycin for injection), has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection.. (NASDAQ: CBST) today announced that its currently-marketed antibiotic, CUBICIN® (daptomycin for injection), has been approved by the U.S. Food & Drug Administration (FDA) for once-a-day dosing as a 2-minute intravenous (IV) injection. CUBICIN is the only approved 2-minute IV injection for the treatment of methicillin-resistant Staphylococcus aureus (MRSA) complicated skin infections and bacteremia. In addition to 2-minute IV injection, several other changes to the CUBICIN label were incorporated. These include changes and reformatting of the Warnings and Precautions in the label, updates to the Post Marketing Experience section of the label, and re-formatting of the label to be compliant with the FDA’s Physician Labeling Rule (PLR).

“We are pleased that doctors and healthcare providers will now have this option. Having to spend only 2 minutes a day receiving CUBICIN, especially for patients in the outpatient setting, minimizes the impact that IV therapy has on their daily activities.”

The FDA originally approved CUBICIN in 2003 as a once-a-day 30-minute infusion for the treatment of complicated skin and skin structure infections (cSSSI) caused by certain Gram-positive organisms. In 2006, the FDA granted further approval of CUBICIN for the treatment of Staphylococcus aureus bacteremia, including those with right-sided infective endocarditis. To date, CUBICIN has experienced the most successful antibiotic launch in U.S. history, on a dollar sales basis. For full prescribing information, visit www.cubicin.com.

Cubist’s President and CEO Michael W. Bonney said, "We are pleased that doctors and healthcare providers will now have this option. Having to spend only 2 minutes a day receiving CUBICIN, especially for patients in the outpatient setting, minimizes the impact that IV therapy has on their daily activities."

Source: Cubist Pharmaceuticals, Inc.

November 02, 2010

New Intravenous Antibiotic For MRSA Superbug Approved By FDA

An intravenous cephalosporin antibiotic called Ceftaroline has been approved for treating community- acquired bacterial pneumonia and for acute bacterial skin and skin structure infections, including methicillin-resistant Staphylococcus aureus, the Food and Drug Administration announced on Oct. 29.

The approved prescribing information of ceftaroline states that it is indicated for:
1.) The treatment of community-acquired bacterial pneumonia (CABP) caused by susceptible isolates of the following gram-positive and gram-negative microorganisms: Streptococcus pneumoniae (including cases with concurrent bacteremia), Staphylococcus aureus (methicillin-susceptible isolates only), Haemophilus influenzae, Klebsiella pneumoniae, Klebsiella oxytoca, and Escherichia coli.
2.) The treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible isolates of the following gram-positive and gram-negative micro-organisms: Staphylococcus aureus (including methicillin-susceptible and -resistant isolates), Streptococcus pyogenes, Streptococcus agalactiae, Escherichia coli, Klebsiella pneumoniae, and Klebsiella oxytoca.

Approval was based on four phase III studies of patients aged 18 years and older. In the two studies of 1,231 patients with CABP, the effectiveness of treatment with ceftaroline was found to be comparable to that of ceftriaxone (Rocephin), the comparator drug, in the studies, according to the FDA statement announcing the approval. In the two studies of almost 1,400 patients with ABSSSIs, treatment with ceftaroline was found to be comparable to that of the combination of vancomycin (Vancocin) and aztreonam (Azactam). Diarrhea, nausea, and rash are among the most commonly reported side effects associated with ceftaroline, according to the FDA. At a meeting in September, an FDA advisory panel backed the approval of the drug for these two indications.

Ceftaroline will be marketed as Teflaro by Forest Laboratories Inc. The company plans to have the drug available in January 2011.

SOURCE:SkinAndAllergyNews.com

October 03, 2010

Discovers Of New 'Anti-Pathogenic' Drugs To Treat MRSA

A new anti-pathogenic drug has been identified that cab render methicillin resistant Staphylococcus aureus (MRSA) by preventing the production of toxins that cause disease.

The founder of the drug: Menachem Shoham, PhD, associate professor and researcher in the department of biochemistry at the Case Western Reserve University School of Medicine in the US explained that currently there are only two antibiotics available to treat MRSA (vancomycin and linezolid) and strains are emerging that are resistant even to these two remaining antibiotics.

"We have discovered potential "anti-pathogenic" drugs that block the production of toxins, thus rendering the bacteria harmless. Contrary to antibiotics, these new anti-pathogenic drugs do not kill the bacteria. And since the survival of the bacteria is not threatened by this approach, the development of resistance, like that to antibiotics, is not anticipated to be a serious problem" explained Dr. Shoham.

He identified a bacterial protein, known as AgrA, as the key molecule responsible for the release of toxins. AgrA, however, needs to be activated to induce toxin production. His goal was to block the activation of AgrA with a drug, thus preventing the cascade of toxin release into the blood that can lead to serious infections throughout the body.

The screening for AgrA inhibitors was initially carried out in a computer by docking a library of 90,000 compounds and finding out which compounds would fit best into the activation site on AgrA. Subsequently, about one hundred of the best scoring compounds were acquired and tested in the laboratory for inhibition of the production of a toxin that ruptures red blood cells. Seven of these compounds were found to be active.

Testing compounds bearing chemical similarity to the original compounds lead to the discovery of additional and more potent compounds. More than a dozen active compounds have been discovered by this method. The best drug candidate reduces red blood cell rupture to 12% of the value without the drug at a concentration of 10 µg/mL, without affecting bacterial growth.

"It is possible to inhibit virulence of MRSA without killing the bacteria," continued Dr. Shoham. "Such anti-pathogenic drugs may be used for prophylaxis or therapy by themselves or in combination with an antibiotic." This research was carried out in the laboratory of Dr. Menachem Shoham in the Department of Biochemistry at the Case Western Reserve University School of Medicine in Cleveland, Ohio.