MRSA, Mersa, Staph, Staff Infection, Treatment & Symptoms

New antibiotic for MRSA touted

Rib-X Pharmaceuticals Enters into Collaborative Agreement on Delafloxacin.

Under the science plan for the collaboration, Dr. David Hooper of MGH will evaluate Rib-X's novel fluoroquinolone, delafloxacin, in an established animal model to determine resistance development and to validate the activity and mechanism of action of delafloxacin against microorganisms such as methicillin-resistant Staphylococcus aureus (MRSA). "Treating infections that are resistant to the antibiotics currently available to us has become increasingly challenging," Dr. Hooper said. "We are interested to learn more about the unusual properties of this specific drug relative to other members of its class and its potential effect on controlling difficult and dangerous infections." Delafloxacin, which is ready to enter Phase 3 clinical trials, is a novel, broad-spectrum, next-generation fluoroquinolone, that has demonstrated better activity than other quinolones against Gram-positive bacteria, including isolates of MRSA that are quinolone-resistant.

Sanofi bags MRSA antibody in $375 million deal

PharmaTimes | Industry News | World News | Sanofi bags MRSA antibody in $375 million deal.

Sanofi-Aventis has signed a deal with the USA’s Alopexx Pharmaceuticals that would give it access to a first-in-class human monoclonal antibody targeted against serious infectious diseases. The collaboration centres around this new antibody, which is in preclinical development and is being studied for the prevention and treatment of methicillin-resistant S aureus (MRSA), E coli and Y pestis (the bacterium that causes plague) and other serious infections. Under the terms of the agreement, Alopexx will bring the product into Phase I trials during 2010, at which point Sanofi has an option to license. Upfront fees and R&D funding, plus regulatory and commercial milestone payments, could reach $375 million, plus royalties.

UK/Canada Network to Focus on Fighting Disease-Causing Bacteria

Network to Focus on Fighting Disease-Causing Bacteria | University of Guelph.

Clarke has long worked on these components, including enzymes that make bacterial peptidoglycans, the targets of penicillin and other drugs. Referring to MRSA and VRE, he said: “Two major clinical problems of infectious disease relate directly to the peptidoglycan wall layer.” Nearby scientists in this new network include researchers at the University of Western Ontario, McMaster University and the University of Toronto. Clarke said the project, called the U.K.-Canadian Bacterial Cell Wall Biosynthesis Network, will bring together researchers in new ways. “Some of the potential new collaborations could have happened anyway, but you don’t always recognize opportunities if you’re not sitting there together.”

Potent two-pronged antibiotic provides hope for future MRSA drugs

Potent two-pronged antibiotic provides hope for future drugs.

A two-headed compound obtained from soil bacteria may hold the key to developing the next generation of antibiotics, researchers in the UK report. The compound, called simocyclinone, was found to shut down crucial bacterial enzymes in an unusual two-pronged attack. 'We found a third angle of attack in simocyclinone,' Maxwell told Chemistry World. 'This compound simultaneously targets two binding pockets that until now were unknown.' The two binding pockets are distinct but separate, and although the individual pockets only attach weakly, together the binding is very strong, suggesting that the mechanism could be highly potent.

Teevancin ok for MRSA, but more data wanted re pneumonia

Theravance says FDA delays new Vitabiv decision - News Wires - CNBC.com.

Theravance Inc. said Friday the Food and Drug Administration delayed a decision on whether to approve its infection drug Vitabiv as a treatment for hospital-acquired pneumonia. Vitabiv, or telavancin, was approved in September as a treatment for complicated skin infections like MRSA. Theravance and its partner Astellas Pharma launched the drug Nov. 5.

Telavancin now available to treat MRSA in the United States

Theravance and Astellas Announce the Commercial Launch of VIBATIV(TM) (telavancin) in the United States.

Theravance, Inc. (NASDAQ: THRX) and Astellas Pharma US, Inc. announced today the commercial launch of VIBATIV(TM) (telavancin) in the United States. On September 11, 2009, the U.S. Food and Drug Administration (FDA) approved VIBATIV for the treatment of adult patients with complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including Staphylococcus aureus, both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA) strains. VIBATIV is a bactericidal, once-daily injectable lipoglycopeptide antibiotic discovered by Theravance.

A Looming Drug Crisis: The Dearth of New Antibiotics

A Looming Drug Crisis: The Dearth of New Antibiotics - TIME.

And because of the emergence of drug-resistant "superbugs," like Methicillin-resistant Staphylococcus aureus (MRSA), traditional antibiotics such as penicillin and its derivatives are becoming obsolete. New antibiotics are desperately needed, but the amount of money being spent on the research and development of these drugs is woefully inadequate. "The issue is quite dreadful," says Elias Mossialos, a professor of health policy at LSE and author of the report. "When you look down the pipeline, there are only a handful of new antibiotics in development, and all in the early stages."

Theravance win Canadian OK for MRSA antibiotic

Theravance Inc. won Canadian regulatory approval for its antibiotic for complicated skin infections, including those caused by the MRSA superbug, less than three weeks after landing an FDA OK.

Health Canada approved telavancin, developed by the South San Francisco company (NASDAQ: THRX). It will be marketed under the brand name Vibativ, starting in early 2010, by Astellas Pharma Canada Inc.

via sanfrancisco.bizjournals.com

One Big Antibiotic Dose Fights MRSA, Study Says

One Big Antibiotic Dose Fights MRSA, Study Says - WSJ.com.

Targanta's oritavancin has had a troubled history. It was developed by Eli Lilly & Co. in the 1990s, but never reached the market, partly because of concern over side effects. Targanta says it has resolved those issues. It licensed the drug in 2005, applied for approval from the Food and Drug Administration earlier this year, and says it expects a decision in December. Targanta's submission to the FDA was based on a normal dose of 200 milligrams per day, for up to a week. But in the new study, the company compared that treatment against one huge dose of 1,200 milligrams, given all at once in a hospital. Patients were kept in the dark about what group they were in. The results were similar: After three weeks, about 72% of the day-dose patients, and 82% of the one-big-dose patients, saw a cure or significant improvement. Each group only included about 76 patients, meaning the results are preliminary. Targanta says it's working on a bigger, more reliable study.

What Will '09 Bring In MRSA Treatment

What Will '09 Bring In Medicine?, Expert On Likely Directions In Treatment Of Obesity, Cancer, Infections, Brain Diseases, And Aging Skin - CBS News.

More hospital patients die from staph infections than from AIDS each year. But there's a breakthrough in the way hospitals will treat those infections in the future. New prevention and treatment options for the bug known officially as methicillin-resisten staphylococcus aureus have emerged. One is a protective nasal gel (XF-73), designed to kill the microbes early on, upon contact, with every breath. Past anti-MRSA drugs focused on preventing bacteria from spreading or stunting the bacteria's growth. Also, surgeons began experimenting on animals this year with MRSA-fighting stitches coated with a virus that fights the MRSA bug but doesn't affect humans. Each tiny hole for stitches is a potential entry point for MRSA or other stubborn infections, so the idea of fortifying dozens of these sites to prevent chances of future infection is brilliant.

Basilea says superbug drug gets positive opinion

UPDATE 1-Basilea says superbug drug gets positive opinion | Industries | Healthcare | Reuters.

ZURICH, Nov 21 (Reuters) - Basilea Pharmaceutica's (BSLN.S: Quote, Profile, Research, Stock Buzz) MRSA superbug antibiotic ceftobiprole has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of complicated skin and soft tissue infections, the Swiss biotech company said on Friday. The drug will be marketed under the Zevtera trade name in Europe. Recommendations for marketing approval by the CHMP are usually endorsed by the European Commission within a couple of months. Earlier this month ceftobiprole -- co-developed with Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) Janssen-Cilag unit -- received approval in Switzerland for the treatment of complicated skin and soft tissue infections including diabetic foot infections.

Arpida Comments On FDA's Anti-infective Drugs Advisory Committee Outcome

Arpida Comments On FDA's Anti-infective Drugs Advisory Committee Outcome.

Arpida (SWX: ARPN) announced that the Anti-infective Drugs Advisory Committee of the U.S. Food and Drug Administration (FDA) has voted 17 to 2 against the approval of intravenous iclaprim, an antibiotic currently in development for the treatment of patients with complicated skin and skin structure infections (cSSSIs), including those caused by methicillin-resistant Staphylococcus aureus (MRSA). Arpida remains confident in the efficacy and safety of intravenous iclaprim and its potential in combating serious resistant infections. Iclaprim has been tested against both vancomycin and linezolid, and in combined Phase III studies that included nearly 1,000 patients with cSSSI, iclaprim has been shown to have high cure rates, exceeding 90 percent in the Per-Protocol population. Iclaprim has demonstrated potent bactericidal (killing) activity against MRSA and an extended range of resistant pathogens, with a well tolerated side-effect profile. Arpida is fully committed to iclaprim's development and will continue to work with the FDA to address any questions related to iclaprim in anticipation of the drug's Prescription Drug User Fee Act (PDUFA) goal date of January 16, 2009.

Project investigating Himalayan oregano as MRSA antibacterial agent

Project investigating Himalayan oregano as MRSA antibacterial agent wins SEED award.

A research team from the University of the West of England, working in partnership with a laboratory in Delhi, a fair trade company, a community-based organisation and an environmental research institute in Himachal Pradesh in the Western Himalaya, have jointly been awarded a 2008 SEED award for their project investigating Himalayan oregano essential oil as an antibacterial agent for MRSA. Anzeige The project is part of an initiative to provide rural communities with sources of income generated from sustainable collection of non-timber forest products in the Kullu District of Himachal Pradesh. Origanum vulgare is a relatively common herb that grows in high altitude meadows throughout the Himalayan region, yet it is perceived by many villagers to have no culinary, medicinal or economic value. In Kullu oregano is often referred to as ‘bekaar gahaas’, or ‘useless grass’; even cows and goats don’t eat it.

High hopes for new MRSA antibiotic

Pharmacy Europe - High hopes for new MRSA antibiotic.

A new antibiotic that shows promise in treating the superbug MRSA and related infections is poised to enter the market after phase III ASSIST trials in the US. Intravenous iclaprim, a novel antibiotic, is reported by manufacturer Arpida to show high clinical cure rates similar to those of the comparator drug, linezolid. The test results were gathered from the ASSIST-1 and ASSIST-2, (Arpida's skin and skin structure infection study) pivotal Phase III studies involving a total of 991 patients. Data from the studies also show that iclaprim exhibited a high eradication rate for MRSA (76.4%), which was comparable to that of linezolid (78.7%).

Chinese plants to yield new drugs?

Link: HighWire Press -- Medline Abstract.

The antimicrobial activity of crude 80% ethanol extracts of 19 medicinal plants collected in Lijiang, the southwest of China, was tested against clinical strains of Methicillin-resistant Staphylococcus aureus (MRSA). All the 19 plants showed anti-MRSA activity with MIC of 1.25-3.07mg/ml. The most active antimicrobial plants were Dendrobenthamia capitata, Elsholtzia rugulosa, Elsholtzia blanda, Geranium strictipes, Polygonum multiflorum and Potentilla fulgens (MIC

Groundbreaking Discovery May Lead to Stronger Antibiotics

Link: Groundbreaking Discovery May Lead to Stronger Antibiotics.

The study led by Bushweller represents the first time scientists have cracked the code required to solve a certain class of membrane protein structure by using nuclear magnetic resonance (NMR) spectroscopy, the preeminent technique for determining the structure of organic compounds.  This novel NMR approach now gives the scientific community a brand new platform for attempting to determine structures of other important membrane proteins. "What this means is that not only did we establish NMR spectroscopy as a potent tool for the characterization of the structure, dynamics and function of integral membrane proteins, but we also discovered that the DsbB enzyme is an exciting potential new target agent for the creation of novel antibiotics," says Bushweller.  "This could give us the roadmap to an entirely new class of antibiotics."

Trius Doses First Patient In Antibacterial Phase 2 Trial

Link: Trius Doses First Patient In Antibacterial Phase 2 Trial - TR-701 Tested For Efficacy In Drug Resistant Skin Infections.

Trius Therapeutics, Inc. announced the initiation of Phase 2 testing of the oral form of its second-generation oxazolidinone antibacterial drug TR- 701. The multicenter trial will test the efficacy, safety and tolerability of once- daily doses of 200, 300 and 400 milligrams of TR-701 in complicated skin and skin structure infections (cSSSI) for five to seven days of treatment. The study follows the recently completed two-part Phase 1 study that tested the safety, tolerability and pharmacokinetics of TR-701 in single and multiple ascending doses for up to 21 days compared with Zyvox® (linezolid), the only marketed drug of the oxazolidinone class. In addition, separate food effect and microdialysis studies measuring the absorption of TR-701 in the presence and absence of food and the tissue penetration of the drug, respectively, have also been completed.

Wyeth's 'Superbug' Antibiotic, Tygacil (tigecycline), Commended For Innovation And Health Benefit

Link: Wyeth's 'Superbug' Antibiotic, Tygacil (tigecycline), Commended For Innovation And Health Benefit.

Wyeth's innovative antibiotic, Tygacil (tigecycline), developed to treat a range of superbugs, has been commended at the 2008 UK Prix Galien. The Prix Galien is the pharmaceutical industry's premier award and is designed to recognise pharmaceutical innovation and the resulting health benefits it produces. The 2008 Prix Galien awards were made last night by Professor Sir Michael Rawlins, Chairman of the National Institute for Health and Clinical Excellence (NICE), who heads the Prix Galien judging panel. Tygacil is the world's first glycylcycline intravenous antibiotic. It has an expanded broad-spectrum antibiotic activity and is the only such agent effective against resistant Gram-negative and Gram-positive organisms including the superbug MRSA- a national and global concern. As such, it offers a significant advance in the treatment of patients at risk of difficult-to-treat bacterial infections and gives doctors the confidence to successfully manage these conditions.

Arpida Completes Enrolment In Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim

Link: Arpida Completes Enrolment In Phase II "Intravenous-to-Oral" Switch Trial With Oral Iclaprim.

Arpida's leading product candidate is intravenous iclaprim, a potent antibacterial that targets severe infections requiring hospital treatment, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). The clinical programme for the first indication, complicated skin and skin structure infections (cSSSI), has been completed. The submission of the NDA to the US FDA was completed in March 2008. The FDA has defined that the Prescription Drug User Fee Act (PDUFA) goal date will be 16 January 2009. Arpida submitted a Marketing Authorisation Application for intravenous iclaprim with EMEA in July 2008. EMEA notified that it had accepted the MAA for review in August 2008.

In vitro activity of retapamulin against Staph

Link: In vitro activity of retapamulin against Staphylococcus aureus isolates resistant to fusidic acid and mupirocin -- Woodford et al. 62 (4): 766 -- Journal of Antimicrobial Chemotherapy.

Results: The S. aureus included 488 (73%) methicillin-resistant isolates (oxacillin MICs >2 mg/L), 336 isolates (51%) resistant to fusidic acid (MICs >1 mg/L) and 254 (38%) with high-level mupirocin resistance (MICs >256 mg/L); 103 (16%) isolates were resistant both to fusidic acid and to high levels of mupirocin. Retapamulin inhibited 663 (99.9%) isolates at ≤0.25 mg/L. A single methicillin-resistant S. aureus isolate, also with high-level mupirocin resistance, required a retapamulin MIC of 2 mg/L, but its reduced susceptibility to retapamulin was not associated with any mutation in ribosomal protein L3. Conclusions: Retapamulin demonstrated excellent activity in vitro against S. aureus isolates, irrespective of their level of resistance to other antibacterials. These results support the EUCAST epidemiological cut-off value for retapamulin of ≤0.5 mg/L against S. aureus.