First patient enrollment in MASCOT registry represents major milestone for COMBO™ Dual Therapy Stent and OrbusNeich’s clinical program

HONG KONG, July 16, 2014 /PRNewswire/ — OrbusNeich today announced that the first patient has been enrolled in the Multinational Abluminal Sirolimus Coated BiO-Engineered StenT (MASCOT) post-marketing registry. The first COMBO™ Dual Therapy Stent implant was performed at the Amphia Hospital in Breda, The Netherlands.

Designed to assess the long-term safety and effectiveness of the COMBO Stent in routine clinical practice, the prospective, multicenter registry is the largest clinical study of the unique dual therapy stent to date, with a goal of 2,500 patients being followed for a year in up to 50 centers across Asia and Europe.

The study’s primary endpoint is device-oriented target lesion failure (TLF), defined as the composite of cardiac death, non-fatal heart attack (myocardial infarction or MI) not clearly attributable to a non-target vessel, or target lesion revascularization (TLR) from enrollment to 12 months.

The principal investigator is Prof. Antonio Colombo, M.D., San Raffaele Hospital, Milan, Italy; the director of the clinical coordinating center is Roxana Mehran, M.D., Mount Sinai Medical Center.

“Long-term safety remains an important area of clinical investigation with stents, particularly the avoidance of neoatherosclerosis and late stent thrombosis,” said Prof. Colombo. “The MASCOT registry will provide important information about the unique dual therapy approach of the COMBO Stent, which offers the possibility of functional arterial vessel healing, which we have not seen with any of the monotherapy drug eluting stents.”

“The clinical data gathered from COMBO stent trials to date show promise with respect to long-term safety and efficacy,” added Dr. Mehran. “For example, target lesion revascularization remained stable at 5.7 percent in both years two and three of the REMEDEE trial, with no thrombotic events over three years. If those results hold in the MASCOT registry, that will be good news for patients and cardiologists.”

OrbusNeich is supporting the COMBO Stent with one of the industry’s most robust clinical programs. In addition to the MASCOT registry, the REDUCE trial — which enrolled its first patient in June 2014 — aims to demonstrate the potential for a shorter period of dual antiplatelet therapy. Find more information on REDUCE here.

“The initiation of MASCOT, our largest registry trial to date, represents the commitment we have made to really understand the patient benefits of the COMBO Stent,” said B. Wayne Johnson, president and chief operating officer, OrbusNeich. “Only by delivering true vessel healing can patients feel safe for the long term. We expect the MASCOT trial to confirm what we have already seen with the COMBO Stent as it relates to vessel healing.”

New Reports From The Alzheimer’s Association International Conference® 2014 Show Progress In Early Detection, Identifying Risk Factors, And Treatment Trial Updates

COPENHAGEN, Denmark, July 16, 2014 /PRNewswire/ — New studies reported at the Alzheimer’s Association International Conference 2014 (AAIC® 2014) in Copenhagen cover the spectrum of Alzheimer’s disease and dementia research. Data includes advances in early detection and diagnosis, identifying risk factors and possible risk reduction strategies, and the first-ever long-term clinical trial of a multifaceted lifestyle change in older adults.

Also released at AAIC 2014 was new information on the basic brain science of Alzheimer’s, trends in new cases of dementia and overall numbers of people with the disease, the multiple benefits of cataract surgery for people with Alzheimer’s and additional data about drugs involved in Alzheimer’s prevention trials.

AAIC is the premier annual forum for presentation and discussion of the latest Alzheimer’s and dementia research. Bringing the world closer to breakthroughs in dementia science, AAIC 2014 brought together approximately 4,000 leading experts and researchers from 75 countries around the world, and featured more than 1,700 scientific presentations.

Potential for smell and eye tests in early detection of Alzheimer’s
Two studies from AAIC 2014 provide increasing evidence that the inability to correctly identify odors may indicate the development of cognitive impairment and Alzheimer’s disease. Based on smell identification tests, cognitive tests and brain size, researchers in one study of 215 elderly individuals found that loss of brain cell function and worsened memory were associated with smell identification ability. A second study of 757 individuals representing multiple ethnicities found that odor identification deficits were linked with an increased risk of transition from mild cognitive impairment (MCI) — a slight but noticeable and measurable decline in memory and thinking skills — to Alzheimer’s disease. For each point lower a study participant subject scored on a smell identification test, their risk for Alzheimer’s increased by about 10 percent.

Two additional studies looked at possible eye tests to detect Alzheimer’s. Preliminary results from one study, based on findings from 40 of the study’s 200 participants, suggest that there is a significant association between the level of beta-amyloid protein, the main component of Alzheimer’s brain “plaques,” in the brain and levels detected in the retina. Study participants took a proprietary supplement containing curcumin, which binds to beta-amyloid and has fluorescent properties that allow amyloid plaques to be detected on the retina of the eye with an advanced imaging technology. In another study, researchers used a new laser scanning system to measure beta-amyloid levels in the lenses of the eyes of 20 study participants with Alzheimer’s disease and 20 without the disease. When the scientists, who were unaware of the Alzheimer’s status of their subjects, compared amyloid levels based on the eye lens test to amyloid plaque buildup estimates from brain positron emission tomography (PET) scans, they were able to accurately differentiate those with Alzheimer’s disease from those without it.

Largest study of brain tau PET imaging suggests scans’ ability for early detection of dementia
The presence of “tangles” of abnormal tau protein in the brain is one of the defining characteristics of Alzheimer’s. When this protein becomes abnormal, it forms tangles of twisted fibers inside brain cells, which kills them. In a study of 52 cognitively normal seniors — the largest study of its kind to date — researchers found that tau buildup in several brain regions was closely linked with memory decline. Using a newly developed PET scan technology to “see” tau in the brains of living people, scientists found that study participants with higher levels of tau buildup in areas of the brain important to memory performed worse on memory tests over three years. The Alzheimer’s Association says the findings demonstrate the potential value of tau PET scans in early detection of dementia and in identifying participants for Alzheimer’s and dementia research studies.

Lifestyle interventions may improve memory and thinking in middle-age and older adults
A two-year randomized controlled clinical trial in Finland is the first to demonstrate that a structured program of multiple changes in lifestyle factors can improve memory and thinking in older adults at risk for cognitive impairment and Alzheimer’s. The 1,260 older adults in the trial, whose ages ranged from 60 to 77, were divided into two groups. One group received an intervention that included nutritional guidance, physical exercise, cognitive training, social activities and management of heart health risk factors, while the control group received only regular health advice. After two years, the intervention group performed significantly better on a comprehensive scale of memory and thinking, and on specific tests of memory and executive function (including planning, judgment and problem-solving).

A separate study of 329 cognitively normal middle-aged adults in the U.S. with a genetic predisposition or parental family history of Alzheimer’s found that participation in mentally stimulating activities in middle-age may help protect against the development of Alzheimer’s disease and dementia later in life. The researchers found that participants who self-reported a higher level of activities such as reading books and going to the museum, especially those who reported playing games like puzzles and cards more often, had higher test scores for memory and thinking challenges, such as planning, judgment and problem-solving. They also had greater volume in several brain regions involved in Alzheimer’s disease.

Exercise in mid- and late-life associated with decreased risk of dementia
Two studies reported at AAIC 2014 present evidence that regular physical activity may reduce the risk of Alzheimer’s and other dementias. In one study, 280 adults in the U.S. with a median age of 81 completed a questionnaire on the frequency and intensity of exercise during their lifetime. After observing the participants for about three years, the researchers found that a history of moderate physical exercise in middle age was associated with a significantly decreased risk of mild cognitive impairment (MCI). In a second study, researchers examined the frequency and intensity of exercise of 1,830 adults with normal cognition. The researchers found that light physical exercise in mid-life and late-life was associated with a decreased risk of MCI, as was vigorous physical exercise in mid-life and moderate physical exercise in late-life. The Alzheimer’s Association urges everyone to keep their brain healthy throughout their life. Tips and the latest research are at alz.org.

Late-onset high blood pressure could protect against dementia
While hypertension during midlife may increase risk for Alzheimer’s and other dementias, there is emerging evidence that its association with dementia risk may change over time, and may instead help protect against dementia in people age 90 and over. Researchers followed 625 older adults in the U.S. without dementia for up to 10 years and found that those with the onset of high blood pressure at age 80 to 89 had a significantly lower risk of developing dementia compared with participants with no history of high blood pressure. Those with the onset of hypertension at age 90 or older had even lower dementia risk.

Cataract surgery improves not only vision but cognition and quality of life
A small clinical trial in the U.S. found that cataract surgery for people with Alzheimer’s and other dementias not only improves vision but can slow decline in cognition and improve quality of life for both people with the disease and their caregivers. Preliminary analysis of results found that 20 participants who had surgery to remove cataract had significantly improved vision and quality of life compared to the eight participants who did not receive surgery. In addition, those who received the surgery experienced a reduced decline in memory and mental tasks such as planning, judgment, and problem-solving, as well as improvements in behavioral measures. Levels of perceived burden for caregivers of people in the surgical group showed improvement. The Alzheimer’s Association recommends that preferences about medical treatment and decisions should be addressed early in the disease process through the execution of advance directives.

Psychological intervention for caregivers may reduce anxiety and depression
A randomized controlled trial in the U.K. found that a psychological support program for family caregivers of people with dementia significantly reduced caregivers’ anxiety and depression, and the impact lasted for two years. In the trial, 260 family caregivers were divided into two groups. One group received standard care and the other received an intervention consisting of eight sessions that included education about dementia, caregiver stress and where to get emotional support, and techniques for dealing with caregiving challenges. Caregivers who received the eight-session intervention showed significantly better results on measures of depression, anxiety and cost of care. Researchers noted this may help caregivers stay in their role longer and provide more consistent care, which may delay placement of the person with dementia into a nursing home. The Alzheimer’s Association believes it is very important for caregivers to take care of themselves, and to reach out for help. Learn more at www.alz.org.

Diabetes drug associated with reduced risk of dementia
A study of a large German database of people age 60 or older who were free of Alzheimer’s and others dementias found that long-term use of the diabetes drug pioglitazone may reduce incidence of dementia. Researchers at AAIC 2014 presented the study, which examined more 145,712 subjects over six years. Results suggest that reduced risk of dementia was significantly associated with use of pioglitazone. Researchers noted one possible theory is the drug’s ability to suppress neuroinflammation.

Additional abnormal protein, TDP-43, found in brains of people with Alzheimer’s
Researchers identified that an abnormal protein, known as TDP-43, may play an important role in Alzheimer’s disease along with two previously identified proteins. Researchers examined the brains of 342 people identified after death as having Alzheimer’s-related changes for the presence, amount and distribution of TDP-43. More than half the brains had TDP-43. In addition, people with TDP-43 were ten times more likely to have been cognitively impaired at death than subjects without it. The scientists speculate that TDP-43 may help explain why some people have Alzheimer’s changes in their brain, but do not experience dementia. It is vitally important to fund basic research to learn more about Alzheimer’s disease, and to feed the front end of the therapy pipeline. The Alzheimer’s Association is the world’s leading nonprofit funder of Alzheimer’s disease research.

About AAIC
The Alzheimer’s Association International Conference (AAIC) is the world’s largest gathering of leading researchers from around the world focused on Alzheimer’s and other dementias. As a part of the Alzheimer’s Association’s research program, AAIC serves as a catalyst for generating new knowledge about dementia and fostering a vital, collegial research community. Scientists leading the advancement of research gather to report and discuss the most current data on the cause, diagnosis, treatment and prevention of Alzheimer’s disease and related disorders.

About the Alzheimer’s Association
The Alzheimer’s Association is the world’s leading voluntary health organization in Alzheimer care, support and research. Our mission is to eliminate Alzheimer’s disease through the advancement of research; to provide and enhance care and support for all affected; and to reduce the risk of dementia through the promotion of brain health. Our vision is a world without Alzheimer’s. Visit www.alz.org or call 800.272.3900.

ATTN: Please refer to www.alz.org/aaic/press.asp or call (312) 335-4078 for individual stories included here that were presented before Wednesday, July 16, and have come off embargo.

Aptuit Names Dr. Paul Overton Executive VP, Business Development & Marketing; Enhances Sterile Drug Product Capabilities

GREENWICH, Conn., July 16, 2014 /PRNewswire/ — Aptuit LLC has appointed Paul D. Overton, Ph.D., as Executive Vice President, Business Development and Marketing, making him responsible for all of Aptuit’s sales and marketing activities.

Jonathan Goldman, M.D., Aptuit’s Chief Executive Officer, said, “Paul’s expertise in business development, marketing and corporate leadership, as well as his hands-on work as a scientist, give him a unique skill set that will greatly benefit our clients and help in advancing Aptuit’s position as a market leader. Our team of global sales professionals has a strong understanding of market needs, and their approach to customer partnerships and problem solving will be enhanced under Paul’s leadership.”

Paul Overton successfully led the Global Sales, Marketing and Programme Management team at Huntingdon Life Sciences and grew the business significantly year on year despite the challenges in the non-clinical CRO market. He was instrumental in developing late stage discovery and translational sciences partnerships for the company. During his tenure he realigned Marketing into the Sales function and rolled out a market-leading Content Marketing Program utilizing social media. Before his association with Huntingdon, Dr. Overton held key leadership positions at Covance Laboratories, LCG Biosciences, Origin Pharmaceutical Services and Cambridge Life Sciences.

Dr. Overton, who will be based in the United Kingdom, will report directly to Dr. Goldman and will be a member of Aptuit’s Executive Committee. In accepting his new role at Aptuit, Dr. Overton stated, “I believe Aptuit has a truly unique value proposition to the pharmaceutical industry. We have the ability to deliver integrated development solutions from early discovery to patient in a timely, efficient and scientifically robust manner. I am really pleased to be part the Aptuit team and look forward to the exciting growth that is ahead for us.”

Glasgow Site Upgrades Cytotoxic Drug Product Manufacturing
Dr. Goldman also announced that a one million dollar investment in Aptuit’s Glasgow, Scotland facility financed an upgrade in the site’s sterile cytotoxic liquid and lyophilized drug product manufacturing capabilities. This upgrade, which will address the industry’s current need for capacity in cytotoxic GMP clinical supply, will be operational by January 2015. The installation of an Autofiller with Restricted Access Barrier Technology (RABs) will enable larger batch sizes for liquid and lyophilized drug products, increasing capacities from 2,000 units to more than 9,000 units. Additionally, the new equipment will achieve greater sterility assurance and operator protection.

David Stevens, Senior Director and Site Head at Aptuit Glasgow, noted that cytotoxics account for a real opportunity for Aptuit. He said, “It is expected that biopharmas will be increasing their cytotoxic injectable outsourcing over the next few years, driven by the robust demand for oncology and other high potency drugs such as Antibody Drug Conjugates (ADCs) and IV fluids requiring a quick onset of action. Our substantial experience with ADCs adds to the distinct advantage that clients have in working with us in this key area.”

Dr. Goldman concluded, “Through the high caliber of our commercial and scientific leadership, Aptuit is in prime position to deliver the drug discovery and development support that pharmaceutical companies of every size and emerging biotechs need.”

For more information, please send an email to info@aptuit.com or contact Maria Garvey, Delfino Marketing at 914-747-1400 or maria@delfino.com.

Aptuit LLC provides the most complete set of integrated early to mid-phase drug development services in the pharmaceutical industry including Drug Design & Discovery, Preclinical Biosciences, API Development and Manufacture, Solid State Chemistry, Pharmaceutical Sciences and Aptuit INDiGO® (a fixed-cost program that accelerates drug development). Fully integrated drug discovery & development services are available from a single site at The Aptuit Center for Drug Discovery & Development in Verona, Italy. The company maintains five global facilities with approximately 700 employees in Europe and the United States. Aptuit LLC is partnered with Welsh, Carson, Anderson & Stowe, one of the world’s leading private equity investors.

For more information about Aptuit, visit www.aptuit.com 

Top of the Morning: Ebola Outbreak “Out of Control”

Ebola Outbreak ‘Out of Control’…A very dire warning from MSF about the outbreak in western Africa. “MSF is having difficulty responding to the large number of new cases emerging in different locations.“We have reached our limits,” said Janssens. “Despite the human resources and equipment deployed by MSF in the three affected countries, we are no longer able to send teams to the new outbreak sites.” The scale of the current Ebola epidemic is unprecedented in terms of geographical distribution and the numbers of cases and deaths. There have been 528 cases and 337 deaths since the epidemic began, according to the latest World Health Organization (WHO) figures. An Ebola epidemic in West Africa is out of control and requires massive resources from governments and aid agencies to prevent it from spreading further, the medical charity Doctors Without Borders said Monday.” (MSF http://bit.ly/1pbLBjM)

Egypt: Al Jazeera Journalists Sentenced to Prison…The verdict comes one day after John Kerry visited Cairo, with promises to resume military aid. “Two of the journalists were sentenced to seven years in prison, and the third was given 10 years, the three additional years apparently for his possession of a single spent bullet. The case has drawn condemnation from international rights groups and Western governments because there was no publicly available evidence that the journalists had either supported the Brotherhood or broadcast anything inaccurate.”

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Africa

Chinese workers have abandoned road construction and mining exploration sites in northern Cameroon in the wake of last month’s kidnapping of 10 workers by suspected Boko Haram rebels. (VOA http://bit.ly/1lLUi1O)

Thousands of people have fled their homes in northern Liberia following an invasion of caterpillars – which have overtaken houses and schools, destroyed crops and contaminated water sources. (VOA http://bit.ly/1lLUldX)

A Sudanese woman on death row for refusing to renounce her Christian faith had her sentence canceled and was ordered released by a Khartoum court on Monday, the country’s official news agency, SUNA, reported. (VOA http://bit.ly/1lLUw9b)

South Africa’s AMCU union declared a five-month platinum strike “officially over” on Monday as thousands of miners roared their approval when leader Joseph Mathunjwa asked if they wanted to end the longest work stoppage in the country’s history. (VOA http://bit.ly/1lLUL4a)

Residents of the Central African Republic city of Bambari say that a militia attacked a nearby Muslim village and killed 18 of its inhabitants. (AP http://apne.ws/ToTl32)

At least 20 people were killed in inter-clan violence in northern Kenya on Sunday, the police said, further destabilising one of Kenya’s most volatile regions. (Reuters http://bit.ly/1rrgUEj)

Two million children under five die each year in central and western Africa, accounting for almost a third of all deaths worldwide in that age range, the UN children’s agency said. (AP http://yhoo.it/1rrh7qZ)

The first-ever United Nations Environmental Assembly is underway in Nairobi, Kenya, where more than 150 high-level delegations are addressing environmental sustainability challenges. (AP http://yhoo.it/1nYynmv)

MENA

Middle East analyst Nezar al-Sayyad said US Secretary of State John Kerry’s call on Egypt’s new leaders to embrace democracy and press freedom may fall on deaf ears because Egyptians do not seem to be interested. (VOA http://bit.ly/1rraVix)

A group of Egyptian human rights activists is calling on the United Nations to send a fact-finding mission to Egypt to investigate human rights violations against women, including sexual abuse and rape. (VOA http://bit.ly/1lLUf5Z)

The international chemical weapons watchdog charged with ridding Syria of its stockpile says it has received the last of the country’s toxic chemicals identified for removal. (VOA http://bit.ly/1rrbWXX)

Non-state armed groups in Syria have used children as young as 15 to fight in battles, sometimes recruiting them under the guise of offering education. (Humano Rights Watch http://bit.ly/1rrfQAf)

Asia

A Thai police general has announced he will give cash rewards to those turning in photos or videos of anyone illegally expressing a political stance. (VOA http://bit.ly/1lLU4HX)

Sri Lanka’s government should take action to prosecute acts of communal violence and promote peace, say observers, following the worst clashes in five years that left at least two dead and over 80 injured. (IRIN http://bit.ly/1rrewx7)

A shortage of viable evacuation centres in areas hit by Typhoon Haiyan has humanitarians and officials in the Philippines concerned that survivors will not have alternative accommodation in case of another one. (IRIN http://bit.ly/1rreJk3)

A mine in China, where people have worked for decades, leaves a nearby village poisoned by arsenic and hundreds of residents stricken with cancer. (Reuters http://yhoo.it/1nYzsL8)

The Americas

The World Health Organization says it found a strain of the polio virus at an international airport in Brazil in March, but there are no human cases. (BBC http://bbc.in/1lLVrqf)

The Argentine government publishes an advert in US newspapers denouncing the recent US Supreme Court ruling in favour of hedge fund investors holding its defaulted bonds. (BBC http://bbc.in/1lLW0QJ)

Starting this fall, 25 percent of all US hospitals — those with the worst records for infections and injuries — will lose 1 percent of every Medicare payment for a year. (NPR http://n.pr/1rrg4ak)

Opinion/Blogs

The Good and Bad News in the Fight Against Polio (UN Dispatch http://bit.ly/Tp8tNU)

Oxfam tweet stirs UK controversy for being too political (Humanosphere http://bit.ly/Tp9s0D)

Analysis: Looking beyond IGAD in South Sudan (IRIN http://bit.ly/1lLVwdo)

Eastern DRC: Stop Fixating on Conflict Minerals (Think Africa Press http://bit.ly/1rreFAR)

Somaliland’s leading lady for women’s rights: ‘It is time for men to step up’ (Guardian http://bit.ly/1lLVXED)

Transforming Development: Tackling sexual violence in war needs gender justice in peace too (IDS http://bit.ly/1nYze6E)

Is China’s Anticorruption Crackdown Really a Crackdown on Anticorruption Activists? (Global Anticorruption Blog http://bit.ly/Tp8jpY)

Pacific women and contraceptive use: what are the barriers? (DevPolicy http://bit.ly/Tp8O32)

Using Knowledge to Fight Poverty in Africa (AfricaCan End Poverty http://bit.ly/Tp9lST)

Research/Reports
Landmine ban success reaps results; strict adherence, rapid clearance, and assistance for victims remain crucial (Campaign to Ban Landmines http://bit.ly/1rrfE3X)