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Intarcia Enrolls First Patients in " FREEDOM " Global Phase 3 Program for ITCA 650 in Type 2 Diabetes

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BOSTON, March 21, 2013 /PRNewswire/ -- Intarcia Therapeutics, Inc. announced today the enrollment of the first patients in FREEDOM-1, the first of four planned Phase 3 clinical trials studying the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes (T2D). Intarcia is conducting the FREEDOM clinical program with strategic partner Quintiles, Inc., the world's leading clinical research organization, who will be responsible for the global implementation of all four trials. This collaboration, along with strategic input from a world-class group of renowned diabetes experts, is designed to achieve the highest standards of quality, safety and operational excellence.

(Photo: http://photos.prnewswire.com/prnh/20050301/SFTU126LOGO)

The FREEDOM clinical trial program aims to demonstrate that optimizing GLP-1 therapy with once- or twice-yearly dosing of ITCA 650 results in effective, well tolerated glycemic control that virtually ensures longer-term compliance a transformational approach to controlling T2D that aims to free patients from the frequent self-injections that all too often result in poor therapeutic compliance and control. The FREEDOM-1 study is a placebo-controlled, double-blind study involving T2D patients whose HbA1c is not controlled on zero to three oral anti-diabetes drugs and whose HbA1c measures between 7.5% and 10.0%. The 450 patients will be randomized into three groups in a 1:1:1 ratio, evaluating ITCA 650 40 mcg/d and ITCA 650 60 mcg/d versus placebo. Subjects in the active arms will be treated with 3-month devices for the first 13 weeks that deliver an initial dose of 20 mcg/d, and then treated with 6-month ITCA 650 at doses of 40 or 60 mcg/d. The primary endpoint will be change in HbA1c at 9 months; secondary endpoints include changes in weight, FPG, PPG, tolerability, and other measures of safety and efficacy.

Michelle Baron, MD, FACE, Vice President and Chief Medical Officer of Intarcia, commented on the initiation of the FREEDOM Phase 3 program: "We named our program 'FREEDOM' in recognition of the burden that patients with type 2 diabetes face every day of their lives, and our sincere hope that ITCA 650 will alleviate some of that burden by achieving glucose control in a manner that optimizes patient adherence to therapy. It is well documented that sub-optimal adherence to medication results in poor outcomes and disproportionately higher medical costs. Our goal is to demonstrate that ITCA 650 can successfully deliver up to a full year of treatment from a single placement of the mini-pump a potential breakthrough in addressing a huge unmet need in this chronic disease. We expect these studies to support regulatory submissions in both the U.S. and the EU, and anticipate the first clinical results in the second half of 2014."

"Our vision is to unleash a game-changing type 2 diabetes treatment that is so innovative and disruptive that it could truly reshape the standard of care and enable far better outcomes for the many patients suffering from this devastating disease," said Kurt Graves, Chairman, President and CEO of Intarcia. "Years of innovation and tenacity have paved the way for the first potential once-yearly type 2 diabetes medicine and the start of the FREEDOM program. We firmly believe that a once-yearly GLP-1 therapy that virtually ensures long-term compliance can do extremely well in any real-world outcomes comparative trials and in the payor-driven and outcomes-focused healthcare environment of the future. As a Company committed to delivering superior outcomes for patients, physicians, and payors, the enrollment of the first patient in our FREEDOM clinical series is very exciting and gratifying milestone for us."

Concurrent with FREEDOM-1, Intarcia will also be conducting an open-label study, called FREEDOM-1 HBL (high baseline), in patients who meet all eligibility criteria for FREEDOM-1, but whose baseline HbA1c is greater than 10%. All patients in this study will be treated with ITCA 650 20 mcg/d for the first 3 months and with ITCA 650 60 mcg/d for the next 6 months.

About the FREEDOM Program

The FREEDOM program is designed to evaluate the safety and efficacy of ITCA 650 (continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes. Intarcia expects to enroll greater than 4,000 patients at more than 500 clinical trial sites in more than 30 countries. The clinical studies will cover a broad range of patients whose diabetes is not controlled by oral anti-diabetes medications including metformin and metformin-based combinations. FREEDOM-1 is a U.S.-only, placebo-controlled, double-blind study comparing ITCA 650 doses of 40 mcg/d and 60 mcg/d to placebo; the FREEDOM-2 study will be a 500-patient, global, active-comparator controlled, double-blind, double-dummy study in patients on metformin only, comparing ITCA 650 20 mcg/d for 13 weeks plus ITCA 650 60 mcg/d for 39 weeks to patients taking sitagliptin (Januvia, Merck); FREEDOM-CVO is a global, placebo-controlled cardiovascular outcomes study that will examine the safety of ITCA 650 at 60 mcg/d vs. placebo in approximately 3,000 patients on a variety of approved anti-diabetes therapies.

About ITCA 650

ITCA 650 (continuous subcutaneous delivery of exenatide) is being developed for the treatment of type 2 diabetes. The investigational therapy employs Intarcia's proprietary technology platform involving a matchstick-size, miniature osmotic pump that is inserted subcutaneously to provide continuous and consistent drug therapy, and the company's proprietary formulation technology, which maintains stability of therapeutic proteins and peptides at human body temperatures for extended periods of time.

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Intarcia Enrolls First Patients in " FREEDOM " Global Phase 3 Program for ITCA 650 in Type 2 Diabetes

Smoke Down Prohibition III Rally By The Liberty Bell: Philadelphia Freedom In Action! – Video

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Smoke Down Prohibition III Rally By The Liberty Bell: Philadelphia Freedom In Action!
http://www.gofundme.com/2atmdg?pc=fb_cr Philadelphia, the City of Brotherly Love, Cradle of Liberty, What better place in the world to "Proclaim Liberty Thro...

By: Les Stark

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Smoke Down Prohibition III Rally By The Liberty Bell: Philadelphia Freedom In Action! - Video

Freedom Treatment Center Offers New Aftercare in Addiction Treatment

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Freedom Treatment Center is a Southern Michigan drug and alcohol addiction recovery facility with personalized programs to help people achieve and maintain sobriety. Freedom Treatment Center knows a crucial point for those in recovery is what happens after people leave the facility and stresses the importance of aftercare in addiction treatment.

Albion, MI (PRWEB) March 21, 2013

We believe aftercare is as important as the initial addiction treatment, said Freedom Treatment Center representative Brian Kuehne. We want to make sure that each student at Freedom Treatment Center remains sober and committed to their new lifestyle after they exit our program.

An effective aftercare program will include three areas that need to be addressed to achieve success. Students must be able to successfully face the substance, have a concrete plan of action and have a support network made up of family and friends. Freedom Treatment Center helps to ensure those three areas are addressed before students even leave the facility.

Successfully facing the substance comes from being exposed to the threat, while still in the safety of the facility, and learning to diminish its power. A concrete plan of action, which can be established with the help of a counselor, sets up clear-cut goals and steps on achieving those goals. An outside support network of family and friends helps by providing a listening ear, a safe environment and other support those in recovery may especially need during those first tentative weeks after leaving a treatment facility.

The window of greatest vulnerability for relapse after treatment is the first 30 to 90 days following discharge, according to The Addiction Project, a series of HBO productions created in conjunction with the National Institute on Drug Abuse, the National Institute on Alcohol Abuse and Alcoholism and the Robert Wood Johnson Foundation. The Addiction Project backs up Freedom Treatment Center's belief that an aftercare program is an essential element in any recovery program.

Located in a semi-residential pocket of Southern Michigan, Freedom Treatment Center provides the soothing and safe environment and assistance so vital for helping people overcome drug and alcohol addiction. Treatment begins with a natural detoxification and continues with counseling, education and lifestyle changes that help ensure an ongoing and successful recovery.

Nick Thiel Freedom Drug Rehab (877) 210-5311 Email Information

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Freedom Treatment Center Offers New Aftercare in Addiction Treatment

Freedom Overlooked

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TGIF: Freedom Overlooked

by Sheldon Richman

The idea of freedom counts for little in public discourse. It may come up now and then, only to be quickly shoved to the rear as something quaintly outmoded if not suggestive of paranoia.

Examples abound, and this week saw its share. The first that comes to mind is New York City Mayor Bloombergs legal setback in his attempt to prohibit restaurants from serving sodas in containers bigger than 16 ounces. A judge struck down the mayors decree as arbitrary and capricious, but much of the discussion on television news programs focused not on freedom but rather on health or pragmatic concerns: Would the ban really help combat obesity? How big a role does soda play in that problem? Would the ban help bring down the cost of medical care?

Anyone who argued that Bloombergs rule is out of bounds because it forbids a certain kind of peaceful exchange between restaurants and patrons, and that government has no moral right to interfere with voluntary exchange, would likely have been dismissed as weirdly out of touch. After all, Bloomberg has addressed the issue of freedom, hasnt he? Hes said repeatedly that his rule would violate no ones freedom because you may have your 16-ounce cup refilled as many times as you wish. All his rule would do is remind us of the health implications of drinking too much soda.

Of course, that is not all his rule would do. It would, in fact, outlaw a certain class of transactions. Its not a reminder; its a prohibition. But if you insisted on this point during the typical media discussion, you probably wouldnt be asked back the next time the issue came up. Yet its a legitimate question: Granting all the good motives in the world, how dare anyone propose that people be forced in this way?

The other example relates to the poor and was prompted by the selection of the pope. In much of the media discussion about the election at the Vatican, pundits equated concern for the poor with an embrace of government programs allegedly aimed at alleviating poverty. If you care about the poor, so goes the argument, you must favor government antipoverty programs. Contrariwise, if you oppose the programs, you are indifferent to poverty and misery.

What is remarkable is that this link is never thought to need justification. Just how does one get from We have a moral obligation to the poor to Government should force people to help the poor? Whatever one thinks of the declared moral obligation, additional argument is required to get from it to an enforceable legal obligation. Lets not forget that if someone refuses to pay taxes and announces that he will help the poor through voluntary activity, he could be imprisoned and even killed, were he to resist the states efforts to seize his money for its charitable works. Why is the freedom to help the poor privately or to abstain from helping at all not recognized as an individual right? Do those who preach the moral obligation to help the poor believe that it is proper to lock people in cages merely for choosing to discharge this obligation in their own way outside of government channels? Does the moral code that implores us to be our brothers keeper not also condemn violence? Is there no connection between compassion for the indigent and abhorrence of brutality?

Why is the neglect and even dismissal of freedom so common? Because freedom, if thought of at all, is regarded as just one of many considerations to be taken into account when judging public policy. Worse, for many people, freedom is easily outweighed by other things, such as health and the needs of others. The refusal to see freedom as just one of many competing values is regarded in many circles as a sign of immaturity or extremism. If you insist that freedom imposes constraints on our actions towards others, and if you extend this principle to government officials, you are apt to be viewed as an oddity. The maxim that each human being is an end in himself or herself, and not merely a means to the ends of others, carries little weight, despite the occasional lip service.

People who worry about obesity are free to contribute to campaigns designed to persuade us to drink less soda. Why do they turn to physical force instead? Similarly, people who want to help the poor are free to contribute their time and money to that cause and to urge others to do so. Why do they call for force? If they say private efforts are insufficient and therefore force is required, I remind them that the end does not justify the means.

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Freedom Overlooked

Freedom basketball coach earns top honor

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by Kyle Szymanski Thepress.Net

Freedom boys basketball coach Drew Torres receives the Bay Valley Athletic League Winter Boys Coach of the Year award from Freedom Athletic Director Steve Amaro during the schools recent winter sports awards.

Torres was named the Bay Valley Athletic League Winter Boys Coach of the Year. I was in shock, Torres said after receiving the award. I came in getting my certificates together, but I was caught off guard. It feels great.

Torres led the Falcons to their most successful season in school history this year. Finishing second behind Deer Valley in the BVAL standings with a record of 20-10 and 8-2 in league play, Freedom advanced to the North Coast Section semifinals before losing to San Leandro 55-53. The team also made an impressive run in the state tournament before losing to Deer Valley 83-69 in the regional quarterfinals.

While Torres leadership during games was instrumental in Freedoms success, he also made an impression off the court. Freedom Athletic Director Steve Amaro said during a recent practice that he found Torres had provided a complete meal for the team. This award couldnt have been given to a better coach. He treats his players like family, and that is wonderful.

Senior forward Ramiro Contreras believes Torress dedication to the team speaks for itself. If you knew coach Torres, he said, youd know he has a passion for the game and a passion for coaching.

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Freedom basketball coach earns top honor

David Hasselhoff sings "Looking For Freedom" at Berlin Wall to save East Side Gallery – 17.3.13 – Video

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David Hasselhoff sings "Looking For Freedom" at Berlin Wall to save East Side Gallery - 17.3.13
David Hasselhoff singsLooking For Freedom at Berlin Wall to save East Side Gallery 17.313. Uploaded by luciwest on Mar 17 2013. httpmovingpostcardcom Today David Hasselhoff came to Berlin to support the East Side Gallery a stretch of the former wall which has become both an outdoor art gallery and a memorial ever since about 20 years ago shortly after the opening of The Wall over a hundred artists from East and West Germany came together and painted murals on a remaining section of the wall ...

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David Hasselhoff sings "Looking For Freedom" at Berlin Wall to save East Side Gallery - 17.3.13 - Video

Florence Freedom to Air on 1320 WCVG

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March 19, 2013 - Frontier League (FL) Florence Freedom The Florence Freedom welcome back radio play-by-play broadcaster Steve Jarnicki as he will announce all 96 games during the 2013 regular season in addition to the playoffs should the Freedom qualify.

Jarnicki, who is the owner of his own production company, has teamed up with Great Lakes radio station 1320 AM WCVG to broadcast these games. The games can also be heard online at http://www.gospel1320.com, http://www.florencefreedom.com and are also available on your smart phone by downloading the TuneIn Radio Ap.

WCVG is a gospel formatted station and with its towers being located in Covington, they feel it's a terrific fit for everyone involved.

"When Steve contacted WCVG to discuss airing the 2013 baseball season for the Freedom, we were very curious," said Great Lakes Radio President Tim Gallagher. "After many conversations and some research into the relationship being proposed we jumped at the opportunity. The opportunity to connect WCVG to the fans of the Florence Freedom is a win-win. We are very excited for the first pitch."

Last season Jarnicki was behind the microphone for the Freedom and got to witness history firsthand as the team qualified for the postseason for the first time in franchise history. The late season run has him extremely optimistic heading into his second year with the Freedom.

"2012 was such a special season and I was fortunate to be able to broadcast all the games which included a trip to the Frontier League Championship series," said Jarnicki. With everything that the team accomplished last year, and with the players that are expected to return, it should be a fun summer of baseball and I can't wait for it to begin."

Jarnicki is a radio and TV sportscaster from Cincinnati having graduated from Sycamore High School in 2002 and Bowling Green State University in 2006 with a degree in Interpersonal Communications. Since returning to his hometown, he has provided play-by-play coverage for University of Cincinnati Baseball, Northern Kentucky University Baseball, and Simon Kenton High School basketball and football.

The Freedom will host the River City Rascals on opening night May 16. All broadcasts can be heard starting fifteen minutes prior to first pitch with the pre-game show.

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The opinions expressed in this release are those of the organization issuing it, and do not necessarily reflect the thoughts or opinions of OurSports Central or its staff.

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Florence Freedom to Air on 1320 WCVG

New Drama Club forms at Freedom Plaza

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Freedom Plaza abounds in clubs both the kind that go into golf bags and the social membership type.

Residents, of course, bring their own golf clubs when they move in, and they also bring along their own leisure-time pursuits. Eventually they meet other residents with that common interest and a mutual desire to share it, voila a Freedom Plaza club is born.

At present there are 27 resident clubs listed at Freedom Plaza. They range from the Art League and several bridge clubs, shuffleboard and the Freedom Singers to poker, pickleball, the Knit-Wits and Wood Workers. And it goes without saying that Freedom Plaza hosts a men's and women's golf club.

Management supports all of the clubs by providing space for their activities and by advertising their meetings and events. Occasionally, when transportation is needed for a special club outing, that also is made available.

The newest "kid on the block" is the Drama Club, whose members are to be known as the Plaza Players. They have had several meetings, elected officers and are in the process of drafting their mission statement. They plan to pattern their organization on that of a repertory theater company, similar to Sun City Center's Pelican Players and Performing Arts Club.

The Plaza Players are already hard at work on their first presentation, a radio show where actors read their scripts before a live audience.

In forming their new club, Freedom Plaza thespians are following a growing trend among retirement-age citizens. Senior Theater USA, a national organization, has more than 600 registered groups. The group provides Internet access to materials such as scripts, suggests sources for costumes and sets, and offers general support.

We bid a public welcome to our newest club and look forward to enjoying many forthcoming theatrical performances of the Plaza Players.

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New Drama Club forms at Freedom Plaza

Viscount’s Freedom Access Control Technology Secures Dallas High Rises

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BURNABY, British Columbia--(BUSINESS WIRE)--

Viscount Systems (VSYS), a leading-edge, high technology supplier of security systems and software, is pleased to announce that it has shipped the first of several systems to secure a multi-building high-rise complex in Dallas. The systems include a full complement of Freedom access control technology for securing doors, monitoring alarms and controlling elevators as well as MESH touch-screen systems.

We are pleased to continue to expand our regional and vertical coverage of Freedom, noted Stephen Pineau, CEO of Viscount. Our technology offers a compelling value proposition for both government and commercial end-users to improve security while reducing cost. This contract is an example of the Companys ability to serve the private sector while continuing to grow its government business.

About Viscount's Freedom Access Control Solution

Freedom is the first and only access control system that allows entry devices (ID cards, RFID readers, biometrics etc.) to be connected to standard building IT networks without requiring expensive control panels that are programmed from a PC. Freedom changes the paradigm of IT friendly access control. It eliminates up to 80% of the cost of traditional systems that require the installation of control panels. And, it utilizes existing logical IT security software (LDAP) to replace both the control panel component and the software component of traditional systems. Freedom drastically reduces system costs while providing a much more secure software solution.

About Viscount Systems

Viscount Systems Inc., designs unified IT and physical security software platforms for building security and emergency planning. Recent awards include Microsofts 2012 Be Whats Next Award, SIA Convergence Solution of the Year 2011 and Homeland Security Platinum Award for Emergency Response and Gold Award for Access Control at GOVSEC 2011.

Contact

Investor Relations: Foothills Group San Jose, CA 888-516-7415. Investors@viscount.com http://www.viscount.com

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Viscount’s Freedom Access Control Technology Secures Dallas High Rises


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