Intercell AG announced today preliminary clinical results on its investigational Travelers’ Diarrhea (TD) Vaccine Patch program and the decision not to pursue further the development of this vaccine candidate. The decision was made following the receipt of results of its randomized and placebo-controlled Phase III study (ELT301) with 2036 travelers from Europe to Mexico and Guatemala as well as the pilot efficacy Phase II trial (ELT209) with 723 travelers from Europe to India.

Both trials were successfully conducted according to study design, met statistical targets of enrollment, participation follow-up, subject and site compliance, and produced a firm preliminary conclusion. The vaccine was generally well tolerated and the safety profile was consistent with that observed in earlier studies.

In an earlier randomized double blind placebo-controlled Phase II field trial (ELT206) the TD vaccine candidate showed excellent immunogenicity and reduced the risk of clinically significant diarrheal episodes in U.S. travelers to Mexico and Guatemala. The Phase III trial was intended to confirm the efficacy of the investigational TD Vaccine Patch for prevention of moderate to severe diarrhea in a similar field setting.

The trials’ primary endpoints, reduction of incidence of all types of enterotoxigenic E. coli (ETEC) (defined as cases in which ETEC LT, LT/ST or ST toxins are detected in diarrheal stool samples) and/or all cause diarrhea (secondary endpoints) comparing the vaccine groups with the placebo group, were not met. Thus, in the ELT301 study a non-significant vaccine efficacy for about 35% for all type ETEC and no apparent effect on the frequency of all-cause moderate to severe diarrhea was observed. However, a statistically significant reduction of duration of all-cause diarrheal episodes and total number of unformed stools was observed, confirming observations from a previous Phase II study.

In study ELT301, the vaccine protected most against LT positive ETEC (up to 60%). However, the study was not powered to demonstrate a statistically significant efficacy against individual ETEC types. Furthermore the incidence of LT positive ETEC in both trials was lower than expected, compared to previous trials and published data.

The current trials have confirmed the previous Phase II observation of a consistent induction of protective levels of antibodies against the LT-toxin following transcutaneous immunization and using the Company’s proprietary delivery technology. This clearly supports and validates patch-based vaccination as a suitable route of immunization for future potential product candidates.

Intercell is carrying out further analysis of the trial results. However, subject to this analysis and further consultation with its partner, the Company remains committed to expanding the development of the use of patch technology for existing or novel vaccines as well as the development of the investigational Vaccine Enhancement Patch (VEP) system for vaccination against Avian H5N1 Influenza.

Following the successful progression of the S. aureus vaccine candidate with recent positive Phase II data reported by Intercell’s partner Merck & Co., Inc., the encouraging Phase II data in the Pseudomonas vaccine program and the imminent clinical entry of the Company’s novel investigational C. difficile vaccine, R&D resources will be even more focused on the development of the nosocomial franchise. Hospital-acquired infections represent a major health need and Intercell is well positioned with its portfolio to help address this medical need.

Intangible assets pertaining to the TD vaccine program and other patch programs represented a book value of EUR 167m at September 30, 2010. Intercell expects to impair all or a substantial part of these assets following an impairment analysis triggered by the study results. Such impairment will have a substantial effect on the loss for the full year 2010. In addition, Intercell does not expect to receive the previously expected milestone payments in connection with the TD program in 2010 or going forward. Intercell has decided to substantially reduce Research and Development expenses by approximately 40% in 2011 compared to 2010 and will realign its organizational structures accordingly. The measures are expected to be fully effective by mid 2011 and lead to further cost savings in 2012 and forward.

“We are extremely disappointed with these unexpected Phase II and III outcomes for our TD Vaccine Patch; however, we believe that we have a clear strategy to further develop our strong product portfolio in a balanced way. Our Japanese Encephalitis vaccine is on the market, and we have a world leading and highly attractive nosocomial vaccine franchise in advanced development and a series of promising vaccine and antibody pre-clinical candidates,” states Gerd Zettlmeissl, Chief Executive Officer of Intercell. “We have taken all necessary managerial measures to fully realign the company’s operations.”

Given this unexpected situation, Intercell has decided to postpone its R&D Day planned for Wednesday, December 15 in London and will replace it by an Analysts’ call to outline the data obtained and its strategic implications in more detail.

For more information, please visit: www.intercell.com

Popularity: 44% [?]

Sodexo applauds the Healthy Hunger-Free Kids Act, which Congress passed paving the way for more children to get healthy, nutritious school meals and to fight childhood obesity.

“This legislation will significantly improve the health, quality and wellness of school nutrition programs,” said Lorna Donatone, Sodexo education president and chief operating officer. “Sodexo is a committed partner in First Lady Michelle Obama’s Let’s Move initiative to end childhood obesity in this generation and this bill supports the work we’ve been doing to promote student well-being by improving nutritional content and creating healthy learning environments.”

The new legislation increases the funding available to local school districts through a program administered through the United States Department of Agriculture to increase student access to nutritious school meals.  Sodexo encourages eligible parents to sign up. Parents can sign up any time throughout the school year for the program.

“The national free and reduced price school meals program is a tremendous asset for families that could use a little help, but unfortunately many parents don’t know about the program or how to register for it,” said Steve Dunmore, Sodexo president education-schools. “We encourage parents who want to enroll in school meal programs to speak to the Sodexo manager at their school district.” Sodexo regularly works with its school district partners to encourage parents to enroll in school nutrition programs through parent meetings and school events.

The USDA created the free and reduced price school meals program to ensure that no child goes without food during the school day. Sodexo works with more than 480 partner school districts across the United States to raise awareness of the National School Lunch Program.

The USDA has a website dedicated specifically to the free and reduced price school meals program. The site, http://www.fns.usda.gov/cnd/frp/frp.process.htm, includes information about income eligibility guidelines and includes downloadable application forms.

Sodexo is committed to take measurable sustainable actions that ensure a brighter future in the areas of health and wellness, environmental stewardship and community development. Sodexo focuses on nutrition, achievement, environment, community and activity to promote student well-being.

Popularity: 9% [?]

Eleven men were  nabbed this month by Gaithersburg Police for trying to get intimate with minors on the Web.

Then men were from different states, including Maryland, West Virginia, Virginia and Washington DC. Cops posted a phony profile online and arranged meetups with the doomed men using phone calls and text messaging. This operation marks the first of its kind for Gaithersburg, lasting from November 15 through the 19th and included the likes of the FBI and the Montgomery County Police Department and attorney’s office.

The 25 to 48 year old men were each charged with a count of sexual solicitation of a minor and thrown in jail. Of the creeps, one was from Gaithersburg, and all  will stand trial in Montgomery County.

Popularity: 6% [?]

Food banks are vital to the community – especially this time of year. Unfortunately, some people don’t quite understand that.

Manna Food Center, based in Gaithersburg, had one of their food vans stolen Tuesday morning – and as if that wasn’t bad enough, some food was stolen from the warehouse as well. The van, a white 2001 Chevy cargo van with their logo, is exclusively used for supply pick-ups and food drives.

Luckily, the van was eventually found at around 3 pm the same day in the parking lot of an apartment complex in Rockville. Police have an arrest warrant out for the person responsible, but have yet to release names.

The local food bank has  been struggling with donations recently, but workers and volunteers say that this along with the recent acts of heartlessness from thieves won’t stop them from helping area families. Manna Development manager Natalie Corbin told the Montgomery Gazette: “Even in the midst of things like this, we’ll continue to provide the services we always have. And, any help from the community is appreciated and needed.”

Popularity: 31% [?]

Sodexo employees at eight college campuses cut kitchen waste by about one third, simply by tracking and monitoring food waste, according to the preliminary findings from the first eight weeks of a pilot study that is part of the company’s commitment to stop wasting food to curb climate change and improve business practices.

Sodexo is partnering with LeanPath, a technology company providing food waste tracking systems, to conduct the review. The pilot study focuses on kitchen – or pre-consumer – waste, not what customers throw out. The pilot study system features a tracking station where Sodexo employees enter data about what they are throwing out and why. By tracking the reason for throwing away items, Sodexo is able to correct the problem to prevent future food waste. Sodexo employees at those eight sites have dramatically reduced overproduction, spoilage, expiration and trimmings by participating in the pilot study.

“Our people have been vigilant about preventing food waste at these sites demonstrating they are extremely good stewards of the environment,” said Tom Post, president of education – campus, at Sodexo. “The pilot results show it’s possible to send less waste to landfills and to reduce costs without compromising the quality or variety of the food we serve.”

LeanPath estimates that 4 to 10 percent of the food that is purchased ends up in kitchen waste. Each participating site in the Sodexo pilot also has a Stop Waste Action Team (SWAT) composed of employees. This group reviews the waste tracking data, sets specific goals for improvement, and tests waste prevention ideas. The most effective ideas become permanent.

In September, Sodexo launched “Stop Wasting Food”, a campaign to engage its customers and employees in reducing food waste to curb climate change. To learn more, visit www.stopwastingfood.org.

Americans trash 25 percent of all the food they prepare each year, leading to 31 million tons of wasted food piling up in landfills annually. Food waste in landfills produces methane gas, which is at least 21 times more potent than carbon. Methane breaks down the ozone layer and leads to climate change.

Sodexo pilot study results come from a program initiated in early September at eight college campuses across the country to analyze and measure kitchen waste in an effort to better manage it. Colleges participating in the waste-reduction pilot program include Coe College in Cedar Rapids, Iowa, California State University of Monterey Bay in Seaside, Calif., Juniata College in Huntingdon, Pa., Linfield College in McMinnville, Ore., Marist College in Poughkeepsie, N.Y., Pomona College in Claremont, Calif., University of California at Davis, Calif.,  and University of Wisconsin in River Falls, Wis.

Popularity: 34% [?]

A local man was shocked with gunfire early Saturday while climbing through a window that he thought was his. Instead, it was the apartment window of his neighbor, who was armed with a shotgun filled with lead pellets.

The resident of Governor Square apartments in Gaithersburg called Montgomery County Police to tell them that he had shot an intruder. The confused “intruder” was taken to a local hospital where he is expected to recover.

No one has been arrested, and an investigation is ongoing.

Popularity: 34% [?]

Montgomery county is seeing an increasing number of a hot commodity stolen – airbags.

Yes, airbags.

Eight of the crash cushions have been ripped out of steering wheels and dashboards in the past two months in Montgomery County. This year, 127 have been stolen in the county, which has eclipsed the previous record of 93 stolen in 2007.

Stealing an airbag is risky business, and not just for the criminal consequence. Practically speaking, one false move and that highly compressed airbag could deploy at 125 MPH at close range in a crook’s face. Within minutes, a well-versed thief could have the bag pried out in mere minutes and be on his way to becoming up to $300 richer, thanks to shady auto repairmen using them as replacements in wrecked vehicles.

Airbags are currently the third most stolen item from vehicles, behind stereos and tires. AAA estimates around 600 are stolen each week. Honda Civics and Accords are the most frequently targeted because of their popularity. To avoid being a target, stash away all personal items, park in a well-lit area, consider getting a car alarm, and above all – lock your doors.

Popularity: 5% [?]

A union affiliated with the Service Employees International Union (SEIU) used contract negotiations to punish two employees who supported a rival union, according to a recent complaint issued by the National Labor Relations Board (NLRB).

The NLRB complaint alleges that the Rochester Regional Joint Board of Workers United, an SEIU affiliate, committed unfair labor practices by negotiating to insert new language in a labor contract that reduced the pay and work opportunities of the employees, Sharron Rodrigue and Tina Mayotte. Both are Sodexo employees who work in cafeteria and catering jobs at Empire State Plaza in Albany, NY. The NLRB is the independent federal agency empowered to protect employees’ rights to join a union and to prevent and remedy unfair labor practices committed by private sector employers or unions.

After an investigation, NLRB found there was enough evidence to support the employees’ allegations that Workers United engaged in illegal conduct against them in retaliation for their support of a rival union, Local 471-UNITE HERE. The NLRB complaint specifically alleges that during negotiations for a new contract in May 2010, Workers United, an SEIU affiliate, demanded new contract language that reduced the vacation pay of Rodrigue. The SEIU affiliate also demanded new contract language requiring that catering assignments be made based on seniority, which reduced the work opportunities and pay of Mayotte, according to the NLRB.

The NLRB alleges that the SEIU affiliate engaged in this illegal conduct to retaliate against Rodrigue and Mayotte, who supported Local 471-UNITE HERE, and also “to discourage other employees from supporting” Local 471-UNITE HERE. By this conduct, the union “has been restraining and coercing employees in the exercising of rights guaranteed” under federal labor laws, according to the complaint. As part of the remedy for the alleged unfair labor practices, the NLRB is seeking to have Workers United pay lost wages, with interest, to the affected workers.

The SEIU affiliate must file its answer to the complaint by November 10, 2010. The NLRB has scheduled a hearing on the complaint before an NLRB Administrative Law Judge for Jan. 10, 2011, in Albany, NY.

Although the two employees worked for Sodexo, the company was not accused by the employees or the NLRB of any illegal conduct and was not named by the NLRB as a party in the complaint.

Popularity: 16% [?]

Vandals set fire to two cameras used to catch speeding violators in Gaithersburg Monday, giving late commuters to work added incentive to make it on time.

One camera on Quince Orchard Road was reported to be burning at around 2:30 am Monday, and the other was found smoldering three miles west of that one at noon.

Both of the cameras are toast  and will cost $80,000 to replace due to the city’s lack of insurance.

Two other cameras were covered with spray paint early in the year, and the cameras have been targets for vandals in previous years. The main reason for this is probably the fact that the cameras have been the bearer of 33,000 citations at 40 bucks each in September alone.  The city expects to gain $17.2 million from drivers courtesy of Big Brother in fiscal 2010.

Popularity: 1% [?]

Layoffs of more than 100 firefighters is a major consequence of Montgomery County voters voting against an ambulance fee.

The proposition, which if approved would have set a countywide ambulance fee that would charge insurance companies, Medicare and Medicaid for ambulance rides, lost with 54 percent of voters having none of it. The proposition was spearheaded by newly elected incumbent County Executive Isiah Leggett, who says the fees would have generated $14 million for the fire department – which is now left wounded.

Leggett said there was a lot of misunderstanding surrounding the proposal, which is partly to blame for its failure. Given the failure, board members say that the ambulance fee is logical, given the dire situation of the fire department and what could be lost in the form of 118 employees.

The county will actively push for the ambulance fee, nonetheless.

Popularity: 2% [?]