Nutrition Research Program Expands at Great Lakes Clinical Trials

Since opening its doors nearly 2 years ago, Great Lakes Clinical Trials has been involved in a variety of nutrition and herbal supplement research programs.  These have included the study of food products on cholesterol and insulin levels, the effects of an herbal supplement on cognition, and the gastrointestinal tolerability of dietary fiber, just to name a few.

In conjunction with its partner organization, MB Clinical Research based in Glen Ellyn, IL, Great Lakes Clinical Trials will soon be starting up a series of new research studies assessing food products, oils and dietary supplements.

"These are exciting studies," commented Steve Satek, President of Great Lakes Clinical Trials. "Many local residents want to get involved in the clinical trial process, and these studies are a fantastic way to start.  Most of our nutritional studies are looking for healthy adults to participate. These are individuals who do not have major diseases, who take care of themselves and tend to prefer natural remedies over medicines."

All research activities at Great Lakes Clinical Trials are free-of-charge, including medical exams and study products.  We do not bill insurance, Medicare or Medicaid.  In addition, qualified participants will receive compensation for their participation.

"The hundreds of patients who have participated in our nutritional research programs over the past few years have been truly amazing participants," commented Dr. Emily Lindner, board-certified Internist who serves as Principal Investigator.  "These volunteers have shown commitment to the programs and have been highly compliant with taking their supplements and study products.  This results in excellent study data.  Our patients understand the purpose of clinical trials and how their participation can lead to the development of better nutritional therapies across the globe."

If you are interested in learning more about current programs, please call Great Lakes Clinical Trials at (773) 275-3500.  Our patient care representatives will go through a brief screening over the phone to find the current studies for which you may qualify, or determine if you may be best suited for future trials.   In addition, you can complete a contact form by clicking here, which adds your name to our list of interested participants which we call when new studies open.

Regeneron Announces Positive Topline Results from Phase 2/3 Fasinumab Study in Patients with Osteoarthritis Pain

May 02, 2016, 07:00 ET from Regeneron Pharmaceuticals, Inc.

TARRYTOWN, N.Y., May 2, 2016 /PRNewswire/ -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced positive topline results from a placebo-controlled Phase 2/3 study evaluating fasinumab in patients with moderate-to-severe osteoarthritis pain of the hip or knee who have a history of inadequate pain relief or intolerance to current analgesic therapies. At 16 weeks, patients treated with all four doses of fasinumab, an investigational Nerve Growth Factor (NGF) antibody, demonstrated a statistically significant improvement in pain relief, the primary endpoint of the study, as well as improvements in the secondary measure evaluating physical function.

"Chronic osteoarthritis is a common cause of pain, disability, and productivity loss for older adults," said George D. Yancopoulos, M.D., Ph.D., Chief Scientific Officer of Regeneron and President of Regeneron Laboratories. "There is a real need for new, non-opioid pain therapies that can provide relief to patients without the toxicity and potential for abuse of currently available opioid treatments. We had previously evaluated an intravenous formulation of fasinumab in osteoarthritis patients, and this is our first trial of a convenient subcutaneous monthly regimen. We look forward to continuing to study the safety and efficacy of fasinumab in our Phase 3 program."

The U.S. study enrolled 421 adult patients with moderate-to-severe osteoarthritis of the hip or knee who had a history of inadequate pain relief or intolerance to acetaminophen, and at least one oral nonsteroidal anti-inflammatory drug (NSAID) and an opioid. Patients in the study were experiencing significant pain at baseline with an average pain score of 6.3 on a 10-point scale. Patients were evaluated for pain, stiffness, and physical function using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) in addition to other measures. Patients were randomized to one of five treatment groups in a 1:1:1:1:1 fashion: fasinumab 1mg, 3mg, 6mg, 9mg, or placebo, all delivered subcutaneously every 4 weeks through week 12, with the primary efficacy measured at week 16. Following week 16, patients are being studied for an additional 20 weeks off treatment.

On the primary endpoint, fasinumab-treated patients reported less pain at 16 weeks when compared to placebo on the 10-point WOMAC subscale for pain. Results for each of the dose groups are noted below.

The safety analysis includes all results at the time of the primary efficacy analysis; complete data will be reported when all patients complete the full 36 weeks. Overall incidence of adverse events, including serious and severe events, was similar across the fasinumab groups and placebo. As expected with antibodies to NGF, there was an increase in certain neuro-musculoskeletal adverse events in the fasinumab treatment groups (17 percent combined fasinumab; 6 percent placebo) including arthralgia, paraesthesia, hypoaesthesia, and peripheral edema.

Because of prior concerns with other anti-NGF therapies regarding the possible risk of joint damage, the study incorporated extensive imaging and analyses at baseline and during the study, of index and non-index joints, with particular focus on subchondral insufficiency fractures (SIF), osteonecrosis (ON) and rapidly progressive osteoarthritis (RPOA). Approximately 2 percent of screened subjects were excluded from participation based on findings of SIF or ON on baseline imaging exams. During the study period there were no cases of ON, there was 1 case of SIF in placebo, 0, 2, 0 and 4 cases of SIF in the 1mg, 3mg, 6mg, and 9mg fasinumab dose groups respectively, and 1 case of RPOA in each of the 3mg, 6mg, and 9mg fasinumab dose groups. A modest increase in the lab value for bone-specific alkaline phosphatase, a marker of osteoblast activity, was noted in fasinumab-treated patients; there was no increase in liver ALT and AST enzymes.

The company plans to present detailed results at an upcoming medical congress.

About Regeneron Pharmaceuticals, Inc.
Regeneron (NASDAQ: REGN) is a leading science-based biopharmaceutical company based in Tarrytown, New York that discovers, invents, develops, manufactures, and commercializes medicines for the treatment of serious medical conditions. Regeneron commercializes medicines for high LDL cholesterol, eye diseases, and a rare inflammatory condition and has product candidates in development in other areas of high unmet medical need, including oncology, rheumatoid arthritis, asthma, atopic dermatitis, pain, and infectious diseases. For additional information about the company, please visit www.regeneron.com or follow @Regeneron on Twitter.

Regeneron Forward-Looking Statements and Use of Digital Media
This news release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. ("Regeneron" or the "Company"), and actual events or results may differ materially from these forward-looking statements.  Words such as "anticipate," "expect," "intend," "plan," "believe," "seek," "estimate," variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words.  These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of Regeneron's products, product candidates, and research and clinical programs now underway or planned, including without limitation fasinumab; unforeseen safety issues resulting from the administration of products and product candidates in patients, including serious complications or side effects in connection with the use of Regeneron's product candidates in clinical trials, such as the clinical development programs evaluating fasinumab; the likelihood and timing of possible regulatory approval and commercial launch of Regeneron's late-stage product candidates, such as fasinumab for patients with osteoarthritis pain or other indications; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron's ability to continue to develop or commercialize Regeneron's products and product candidates, such as fasinumab; ongoing regulatory obligations and oversight impacting Regeneron's marketed products, research and clinical programs, and business, including those relating to patient privacy; competing drugs and product candidates that may be superior to Regeneron's products and product candidates; uncertainty of market acceptance and commercial success of Regeneron's products and product candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary) on the commercial success of Regeneron's products and product candidates; the ability of Regeneron to manufacture and manage supply chains for multiple products and product candidates; coverage and reimbursement determinations by third-party payers, including Medicare and Medicaid; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its sales or other financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license or collaboration agreement, including Regeneron's agreements with Sanofi and Bayer HealthCare LLC and the collaboration agreement with Mitsubishi Tanabe Pharma Corporation relating to fasinumab, to be cancelled or terminated without any further product success; and risks associated with intellectual property of other parties and pending or future litigation relating thereto.  A more complete description of these and other material risks can be found in Regeneron's filings with the United States Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2015.  Any forward-looking statements are made based on management's current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update publicly any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (http://newsroom.regeneron.com) and its Twitter feed (http://twitter.com/regeneron). 

Contacts Regeneron:
Media Relations 
Arleen Goldenberg
Tel: + 1 (914) 847-3456
Arleen.goldenberg@regeneron.com

Investor Relations
Manisha Narasimhan, Ph.D.
Tel: +1 (914) 847-5126
Manisha.narasimhan@regeneron.com

SOURCE Regeneron Pharmaceuticals, Inc.

Great Lakes Clinical Trials Begins a Trial for Subjects with Uterine Fibroids

Under the direction of our Board-Certified Internist, Dr. Emily Lindner, Great Lakes Clinical Trials has recently initiated a clinical trial for women who are experiencing heavy periods due to Uterine Fibroids.

Uterine fibroids are noncancerous growths that develop in the wall of the uterus. The most common symptom of uterine fibroids is heavy bleeding during your period. Other symptoms include:

• Longer period duration
• Pain
• Bloating
• Pelvic Pressure

Not all women who have been diagnosed with uterine fibroids have symptoms. But if you do have symptoms, you may find them extremely disruptive to your daily life.

For this program, Dr. Lindner is collaborating with Dr. Carol Levi and Dr. Jyothi Thota.  Both areBoard-Certified OB/GYNs, affiliated with Swedish Covenant Hospital.  "We are excited to be working with the team at Swedish Covenant," commented Dr. Lindner.  "The quality clinical care and expertise in the treatment of uterine fibroids, offered by Dr. Levi and Dr. Thota, are a perfect complement to the exceptional research activities provided by my Great Lakes team."

If you are interested in learning more about this program, please visit our website at http://www.greatlakesclinicaltrials.com/uterine-fibroids or call (773) 275-3500 to speak with a Great Lakes Clinical Trials Patient Care Representative.

Great Lakes Clinical Trials Initiates A New Clinical Study for Dietary Fiber

Click below to visit our Fiber Study website page and learn more about this exciting research study.

Steve Satek to Host a Webinar for the Society for Clinical Research Sites

Methods That REALLY Work for Finding Study Opportunities

Webinar Date: March 8, 2016 @ 12:00 PM EST
Presenter: Steve Satek | Great Lakes Clinical Trials
Contact Hours: 1 Contact Hour Credit

Registration
http://myscrs.org/shop/methods-that-really-work-for-finding-study-opportunities/

Course Description
How do successful sites identify new study opportunities to sustain and grow their clinical trial business? This webinar will share specific methods to find new study opportunities, effectively market your site, and create a Business Development Plan that works. Learn about the essential infrastructure, knowledge-base and resources that are needed at a site to support these vital functions. Furthermore, explore what to do once you establish a rapport with a Sponsor/CRO: How do you maintain trust and confidence in the relationship to earn repeat business?

Learning Objectives

1. Learn the various methods of identifying new study leads and how to make the connection.
2. Understand how to develop materials to effectively promote your site.
3. Review communication methods to maintain strong sponsor relationships.

Presenter
Steve Satek, President
Great Lakes Clinical Trials

Steve Satek brings more than 25 years of research experience to Great Lakes Clinical Trials. He began his career as a bench researcher at the Northwestern University Robert H. Lurie Cancer Center and since that time has held senior management positions at the Chicago Center for Clinical Research, Radiant Research, Cognitive Drug Research and Forenap Pharma. Prior to opening Great Lakes Clinical Trials, Steve served as the Senior Vice President for a nationally-recognized consulting group, where he specialized in the design, implementation, and management of central nervous system and clinical pharmacology research programs. In that role, he worked exclusively with 12 clinical pharmacology sites and 22 late phase research clinics across the U.S., which focused in the conduct of complex psychiatric and neurological trials.

Steve offers a diverse and thorough knowledge of clinical trial operations, which has been presented at over 20 industry conferences. In addition, he has project managed and/or coordinated over 100 trials. He holds two Bachelor of Science degrees in Molecular Biology and in Biochemistry from the University of Wisconsin-Madison and an Executive MBA from the Lake Forest Graduate School of Management.

Society for Clinical Research Sites, Inc. is accredited as a provider of continuing nursing education by the American Nurses Credentialing Center’s Commission on Accreditation.

To obtain your Contact Hours for this webinar:

1. The webinar must be watched in its entirety.
2. The post webinar survey immediately following this webinar must be completed in its entirety.
3. Your contact hour certificate will be sent to you within 30 days of you viewing this webinar.
4. The contact hour certificate will be sent to the email address provided when you registered.

Planners, presenters, faculty, authors, and content reviewers do not have any relevant financial relationships with any commercial interest.

This webinar does not imply any endorsement of products or services by the Society for Clinical Research Sites or ANCC.

The materials and recording of this webinar will be available for one year as an archive, but will not award any contact hou

Steve Satek Accepts Committee Appointment with the Alzheimer's Association

Steve Satek, Great Lakes Clinical Trials President, is proud to have accepted an invitation to participate on the Alzheimer's Association, Greater Illinois Chapter, Medical and Scientific Advisory Committee for 2016.

"I am truly honored to accept this position," commented Mr. Satek.  "Our Great Lakes Clinical Trial research team has worked tirelessly to fulfill our mission of educating the people of Chicagoland about the exciting developments in Alzheimer's disease research.  The Alzheimer's Association has been an amazing leader in this area and I look forward to collaborating to expand the outreach and message across our State."

The services of the Alzheimer's Association, Greater Illinois Chapter, rank at the top in the nation and serve as the national model in many instances. Illinois is among the states with the highest estimated number of people with Alzheimer's disease, currently at 210,000.  By the year 2025, it is projected that Illinois will have 260,000 people with Alzheimer's - up by 24 percent over current numbers.  In 2016, our Chapter is committed more than ever to inform, educate, support and provide hope to all throughout Illinois who are affected by dementia.

If you or a loved one are interested in learning more about participation in Alzheimer's disease research studies, please call Great Lakes Clinical Trials at (773) 275-3500 or visit our website at www.greatlakesclinicaltrials.com

Alzheimer's Prevention Initiative: GeneMatch Program

About The Study: 

GeneMatch is a research program of the Alzheimer’s Prevention Registry to identify a large group of people interested in participating in Alzheimer’s research studies based on their genetic information. 

The information you provide will remain secure and confidential. It will be used to help potentially connect you to research studies. Whether you pursue participation in a study is entirely up to you. You are under no obligation to join any study opportunity that may be offered and can remove yourself from GeneMatch at any time.

Purpose: 

The Alzheimer’s Prevention Registry created the GeneMatch program to help match people who are 55- 75 years old to research studies based on their genetic information.

What is Involved: 

GeneMatch will provide you with a cheek swab kit to determine which copies of a gene (known as the APOE type allele) you have. You will not be told your APOE genotype as part of the GeneMatch Program.

GeneMatch may contact you about study opportunities or other based on your APOE genotype. Your interest and response to these study opportunities may be recorded and tracked by the GeneMatch team. You may be invited to complete online education modules and surveys.

Participants will be asked questions regarding the learning material and answers will be recorded and tracked by the GeneMatch team.

Eligibility Requirements: 

• Are 55 to 75 years old
• Live in the United States
• Do not have a diagnosis of cognitive impairment, such as mild cognitive impairment, Alzheimer's disease, or dementia

How to Join:

Click here to be taken to the GeneMatch website.

Is Alzheimer’s Research Really Making Progress? How Patients & Caregivers Can Help!

When Alzheimer’s disease was first described in medical literature in 1906 by Dr. Alois Alzheimer, there was little the medical community could do to treat it. Brain research was limited by the tools of the time. Research techniques advanced throughout the twentieth century, but only in the last few decades have tools such as functional magnetic resonance imaging (fMRI) allowed for the imaging of healthy brain activity. Researchers hope these developments, which have greatly added to our understanding of Alzheimer’s disease, could also be the key to creating preventative treatments.

The need for the preventative therapy for Alzheimer’s has never been so urgent. In the United States alone, the Alzheimer’s Association predicts a 40% increase in the incidence of the disease in the coming decade. In Chicago, for example, the number of residents over age 85 is predicted to triple by 2040, making Alzheimer’s and dementia treatments a pressing issue for our city.

“We see the impact of Alzheimer’s every day, both on the individuals who experience it and on their loved ones and caregivers,” says Tricia Mullin, Chicagoland Methodist Senior Services Director of Community Relations.  “Any significant advance in treatment or prevention could transform the daily lives of an enormous number of people in our community and in our city.”

While those with Alzheimer’s have access to medications that were not available even 20 years ago, these treatments still leave much to be desired.

“The currently available Alzheimer’s disease medications are all symptomatic, meaning they lessen symptoms such as memory loss and confusion,” explains Steve Satek, president of Great Lakes Clinical Trials. “Unfortunately, they don’t treat it very well; they can temporarily stop decline for six months to a few years in about half the patients who take them, but then decline comes back.” But, according to Satek, promising new research aims to target the source of the disease rather than its symptoms.

“Memory loss is a symptom of the end stage of Alzheimer’s disease, with the beginning stages marked by the formation of plaques and tangles in the brain,” Satek explains.

Long before memory loss becomes pronounced in those with Alzheimer’s disease, brain function is affected on the cellular level by these plaques and tangles. Recent advances in a specific type of brain imaging, positron emission tomography (PET) scans, allows researchers to identify these formations in the brain.

Plaques are formed by clumps of the protein beta-amyloid, which hinder brain cells’ ability to communicate with each other. Tangles are formed by a protein called tau. In a healthy brain, tau helps transport nutrients through brain cells, but in Alzheimer’s disease, the fibers of these proteins twist, causing cells to die. New efforts to prevent, slow down or halt the disease target these plaques and tangles before significant memory loss takes hold.

The progress of current research requires the participation of both healthy older adults and those experiencing memory loss. In order to advance their work, researchers require a healthy “standard” by which to measure changes in the brain and to confirm whether a preventive medication is effective.

“We are trying to stop the disease before it takes hold,” Satek says. “I believe this can happen in the next five to seven years, but one thing we know for certain is that new medications to prevent or treat Alzheimer’s disease cannot be developed without the participation in research from our senior community.”

CMSS’ Mullin agrees: “By taking part in clinical research, older adults can not only help themselves, but also be a part of improving people’s lives around the world. It’s important for older adults to know that, and we’re proud to do our part to spread the word.”

The public can access information about the latest research and clinical trials online by visiting TrialMatch®. This free, user-friendly site created by the Alzheimer’s Association research center helps patients and caregivers find clinical studies relevant to them. The National Institute of Health’s clinicaltrials.gov also lists ongoing trials, and includes information on both recruitment and results.

By Bill Lowe / Tales of Alzheimer's & Caregiving / January 5, 2016
http://mariashriver.com

Lack Of Deep Sleep May Set The Stage For Alzheimer's

Jeffrey Iliff (right) and Bill Rooney, brain scientists at Oregon Health & Science University, look over an MRI. The school has an especially sensitive MRI unit that should be able to detect precisely when during sleep the brain is being cleansed of toxins. Courtesy of Oregon Health & Science University

There's growing evidence that a lack of sleep can leave the brain vulnerable to Alzheimer's disease.

"Changes in sleep habits may actually be setting the stage" for dementia, says Jeffrey Iliff, a brain scientist at Oregon Health & Science University in Portland.

The brain appears to clear out toxins linked to Alzheimer's during sleep, Iliff explains. And, at least among research animals that don't get enough solid shut-eye, those toxins can build up and damage the brain.

Iliff and other scientists at OHSU are about to launch a study of people that should clarify the link between sleep problems and Alzheimer's disease in humans.

It has been clear for decades that there is some sort of link. Sleep disorders are very common among people with Alzheimer's disease.

For a long time, researchers thought this was simply because the disease was "taking out the centers of the brain that are responsible for regulating sleep," Iliff says. But two recent discoveries have suggested the relationship may be more complicated.

The first finding emerged in 2009, when researchers at Washington University in St. Louis showed that the sticky amyloid plaques associated with Alzheimer's develop more quickly in the brains of sleep-deprived mice.

Then, in 2013, Iliff was a member of a team that discovered how a lack of sleep could be speeding the development of those Alzheimer's plaques: A remarkable cleansing process takes place in the brain during deep sleep, at least in animals.

What happens, Iliff says, is "the fluid that's normally on the outside of the brain, cerebrospinal fluid — it's a clean, clear fluid — it actually begins to recirculate back into and through the brain along the outsides of blood vessels."

This process, via what's known as the glymphatic system, allows the brain to clear out toxins, including the toxins that form Alzheimer's plaques, Iliff says.

Jeffrey Iliff (left), a brain scientist at Oregon Health & Science University, has been studying toxin removal in the brains of mice. He'll work with Bill Rooney, director of the university's Advanced Imaging Research Center, to enroll people in a similar study in 2016. Courtesy of Oregon Health & Science University

"That suggests at least one possible way that disruption in sleep may predispose toward Alzheimer's disease," he says.

Jeffrey Iliff (left), a brain scientist at Oregon Health & Science University, has been studying toxin removal in the brains of mice. He'll work with Bill Rooney, director of the university's Advanced Imaging Research Center, to enroll people in a similar study in 2016.

To know for sure, though, researchers will have to study this cleansing process in people, which won't be easy.

Iliff studied the glymphatic system in living mice by looking through a window created in the skull. The system also involved a powerful laser and state-of-the-art microscope.

With people, "we have to find a way to see the same sort of function, but in a way that is going to be reasonably noninvasive and safe," he says.

The solution may involve one of the world's most powerful magnetic resonance imaging machines, which sits in a basement at OHSU. The MRI unit is so sensitive, it should be able to detect changes that indicate precisely when the glymphatic system gets switched on in a person's brain, says Bill Rooney, who directs the university's Advanced Imaging Research Center.

When humans enter deep sleep, and toxin removal begins, there should be a particular change in the signal coming from certain salt molecules. That would indicate that fluid has begun moving freely through the brain.

In young, healthy brains, the signal should be "robust," Rooney says, indicating that the toxin removal system is working well. In the brains of older people, and those who are likely to develop Alzheimer's, the signal should be weaker.

Rooney and Iliff have received funding from the Paul G. Allen Foundation to test their approach. They hope to begin scanning the brains of participants within a year.

One challenge, though, will be finding people able to fall asleep in the cramped and noisy tunnel of the magnetic resonance machine.

"It's a tricky thing because it's a small space," Rooney says. "But we'll make people as comfortable as possible, and we'll just follow them as they go through these natural stages of sleep."

If Rooney and Iliff are right, the experiment will greatly strengthen the argument that a lack of sleep can lead to Alzheimer's disease. It might also provide a way to identify people whose health is at risk because they aren't getting enough deep sleep, and it could pave the way to new treatments.

"It could be anything from having people exercise more regularly, or new drugs," Rooney says. "A lot of the sleep aids don't particularly focus on driving people to deep sleep stages."

John Hamilton, Correspondent, Science Desk
NPR.com:  Your Health
Updated January 4, 2016 9:25 PM ET
Published January 4, 2016 5:05 AM ET