Great Lakes Clinical Trials Contributes to Successful Rheumatoid Arthritis Study

Great Lakes Clinical Trials, under the direction of our board-certified rheumatologist, Dr. Manish Jain, has contributed to the successful results of our phase 3 Rheumatoid Arthritis clinical trial program.  

"I am proud of our team's work on this program," commented Steve Satek, President of Great Lakes Clinical Trials. "The true heroes of this program are our patients who participated in this program in spite of the uncertainty of risk or benefit.  Without these individuals who volunteered their time and committed to the program, there would be no advancement in medicines, no cures and no promise of a better tomorrow." 

Highlights of the press release related to the program is provided below.  Please click here to download a PDF of the full press release.

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PRESS RELEASE

AbbVie’s Upadacitinib (ABT-494) Meets All Primary and Ranked Secondary Endpoints in Second Phase 3 Study in Rheumatoid Arthritis

SELECT-BEYOND, the second study in the robust SELECT program, demonstrated positive results with both doses (15 mg and 30 mg once-daily) meeting the primary endpoints in a difficult-to-treat patient population, over half of whom had previously been treated with two or more biologics

  • Both doses achieved low disease activity in over 40 percent of patients at week 12 and over 50 percent of patients at week 24
  • The safety profile of upadacitinib was consistent with previously reported studies, with no new safety signals detected
  • Upadacitinib, an oral agent engineered by AbbVie to selectively inhibit JAK1, is being studied as a once-daily therapy in rheumatoid arthritis in the SELECT program and across multiple immune-mediated diseases

NORTH CHICAGO, Ill., Sept. 11, 2017 – AbbVie (NYSE: ABBV), a global research and development based biopharmaceutical company, today announced positive top-line results from the Phase 3 SELECT-BEYOND clinical trial evaluating upadacitinib (ABT-494), an investigational oral JAK1-selective inhibitor, in patients with moderate to severe rheumatoid arthritis (RA) who did not adequately respond or were intolerant to treatment with biologic DMARDs (bDMARDs).  Results showed that after 12 weeks of treatment, both once-daily doses of upadacitinib (15 mg and 30 mg) met the study’s primary endpoints of ACR20 and low disease activity (LDA). All ranked secondary endpoints were also achieved with both doses. Upadacitinib is not approved by regulatory authorities and safety and efficacy have not been established. 

“We are very pleased with the positive results for upadacitinib in the SELECT-BEYOND trial. Particularly exciting is the proportion of patients who achieved clinical remission by week 12 and 24, despite having inadequate responses with previous biologic therapies,” said Michael Severino, M.D., executive vice president, research and development and chief scientific officer, AbbVie. “Together with previously reported results from SELECT-NEXT, these data further support the potential for upadacitinib to be a meaningful treatment option for rheumatoid arthritis patients. We continue to build upon our leadership in immunology as we advance the development program for upadacitinib across a broad range of immune-mediated diseases.” 

About the SELECT Study Program

The robust SELECT Phase 3 RA program evaluates more than 4,000 patients with moderate to severe rheumatoid arthritis in six studies. The studies include assessments of efficacy, safety and tolerability across multiple rheumatoid arthritis patient populations. Key measures of efficacy evaluated include ACR responses, disease activity and inhibition of radiographic progression. More information on this trial can be found at www.clinicaltrials.gov (NCT02706847, NCT03086343, NCT02629159, NCT02706873, NCT02706951, NCT02675426). 

About Upadacitinib

Discovered and developed by AbbVie, upadacitinib is an investigational oral agent engineered to selectively inhibit JAK1, which plays an important role in the pathophysiology of rheumatoid arthritis and other immune-mediated inflammatory disorders. Phase 3 trials of upadacitinib in psoriatic arthritis are ongoing and it is also being investigated to treat Crohn’s disease, ulcerative colitis, ankylosing spondylitis and atopic dermatitis.

Upadacitinib is an investigational oral agent and is not approved by regulatory authorities. Safety and efficacy have not been established. 

About AbbVie

AbbVie is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn

Forward-Looking Statements

Some statements in this news release may be forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate," "project" and similar expressions, among others, generally identify forward-looking statements. AbbVie cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially from those indicated in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges to intellectual property, competition from other products, difficulties inherent in the research and development process, adverse litigation or government action, and changes to laws and regulations applicable to our industry. 

Additional information about the economic, competitive, governmental, technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," in AbbVie's 2016 Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission. AbbVie undertakes no obligation to release publicly any revisions to forward-looking statements as a result of subsequent events or developments, except as required by law. 

References related to the above information can be found in the full press release by clicking here

Great Lakes Clinical Trials Memory Experts Invited to Present at Alzheimer's Association Research Symposium

Great Lakes Clinical Trials is honored to have two of their memory research experts, invited to speak at the 2017 Alzheimer's Association Research Symposium, hosted by the Illinois Chapter.  Dr. Linda Rice, Board-Certified Clinical Neuropsychologist will be joined by Great Lakes Clinical Trials President, Steve Satek, to present at the educational sessions on the topic of "The Genetics of Alzheimer’s Disease. 

Steve Satek

Steve Satek

Linda Rice, PhD

Linda Rice, PhD

"Many people with Alzheimer’s Disease are concerned that they have inherited the condition and may in turn pass it on," commented Mr. Satek.  "Our presentation and discussion outlines the present state of knowledge about the genetics of Alzheimer’s Disease. Genetic risk factors will be described and explained."   Attendees will also learn what researchers know about genetics, age, chromosomes and family history and how these factors are incorporated into the design of Alzheimer’s Disease clinical trials, including the new National GeneMatch research registry.

The theme of this year's symposium is "Educate. Ignite. Integrate."  National, regional and local dementia researchers and experts will present the latest and emerging dementia-related research topics including innovative care practices, technology based care and treatment options, theories and discoveries with a special focus on translating research into care.

WHERE IS IT?
This year’s Symposium is being held at the Swissôtel Chicago, with stunning views of Lake Michigan and the Chicago Skyline, the Swissôtel offers an exclusive destination setting for our full-day Symposium and expo.  The street address of the venue is 323 E Upper Wacker Dr, Chicago, IL 60601.

WHEN IS IT?
November 2, 2017 | 7:30 a.m. - 3:30 p.m.

WHO SHOULD ATTEND?
Physicians, researchers, health care professionals, professional caregivers, students and members of our community looking to enhance skill sets and gain insights on Alzheimer’s and dementia-related topics. CME and CEUs offered. 

REGISTRATION
To register for this event, click HERE to be taken to the Alzheimer's Association website.

ABOUT GREAT LAKES CLINICAL TRIALS
Great Lakes Clinical Trials is an independent, phase I-IV clinical trials center that specializes in the study of new medications for the prevention, treatment and cure of memory disorders such as Alzheimer's Disease.  With two Chicago area locations in the Andersonville neighborhood of Chicago and in Arlington Heights, the Great Lakes team have managed more than 450 clinical trials over the past 25 years and are committed to providing quality services for both study volunteers, their caregivers & the research industry. All medical services at  Great Lakes Clinical Trials are provided free-of-charge (no insurance required).  Health information is kept confidential, unless collaboration with your personal physician is requested.  A stipend will provided for your participation - amounts vary based on each study.  Free transportation is also provided for some trials.  For more information, call (773) 275-3500.

 

 

 

Steve Satek to Speak at the 2017 Global Site Solutions Summit

Steve Satek, President, GLCT

Steve Satek, President, GLCT

Steve Satek, President of Great Lakes Clinical Trials (GLCT) will be speaking at the 2017 Global Site Solutions Summit.  Mr. Satek will be joined on a panel session by Beth Harper, President of Clinical Performance Partners, Inc. and Brittany Parker, Senior Manager, Marketing and Communications at Total Clinical Trial Management to speak on the topic of  on the topic of "Improve Your Bottom Line – Hidden Strategies to Achieve Your Potential." 

These experienced industry leaders, will share their knowledge on the topics of:

  • Rescue site: Position yourself now for success, without draining your resources.
  • Generic product clinical studies: Gain real potential that will surprise you.     
  • Go beyond the BIG 10: Understand the value of a great sponsor pipeline, and connect with sponsors outside of the top 10. 

The 2017 Global Site Solution Summit will be held at the Boca Raton Resort and Club, a Waldorf Astoria Resort in Boca Raton Florida from October 6-8, 2017. 

For the last 12 years, the Global Site Solutions Summit has been committed to being “the site’s meeting.” The Summit provides a unique hub where sites, sponsors, CRO executives and regulators come together and share best practices, build their businesses, and develop new partnerships through debates, ideation sessions, workshops and focus groups 

 

Nutritional Research Study

Great Lakes Clinical Trials is looking for male and female volunteers between the ages of 18 and 79 for an investigational research study involving the daily consumption of 4 servings of a variety of muffins and rolls containing either corn oil or coconut oil over two 4-week periods.

What is the Purpose of this Study?

The main objective of this trial is to study the effects of corn oil and coconut oil on your cholesterol measurements (lipid profile). Certain components of your lipid profile are the most commonly used markers used to determine a person’s risk of having cardiovascular disease. Researchers will also study the effects of the corn and coconut oils on your blood insulin levels and markers of inflammation.

If you take part in this study, you have an equal chance (like flipping a coin) of getting one of the following during the first treatment period:

  • Study Foods made with Corn Oil
  • Study Foods made with Coconut Oil

What is my time commitment to the study?

You will be asked to visit our clinic on 7 occasions over approximately 3 months. The study visits will last between 30 and 120 minutes.

Is there a Study Stipend?

There is no cost for participation in this study. All tests and procedures are free of charge and we do not bill insurance. For your participation you will receive $10 for the initial screening visit, $15 to complete the screening visit, $100 for visits 2 and 4, $50 for visits 3, 5, and 6, and $150 for visit 7 for a total of $525 for completing the trial.

You may be able to participate if you:

  • are between 18-79 years old
  • have elevated cholesterol levels
  • are willing to consume study-related foods (muffins and rolls) daily, during two 4-week test periods
  • are able to visit our clinic 7 times over approximately 2 months

Note that other entry criteria will apply and can be discussed with our study staff.

If you are interested in joining this trial, visit our website at www.greatlakesclincialtrials.com/oilstudy or call our site directly at (773) 275-3500 to speak with one of our staff members today.

Great Lakes Clinical Trials' Generation Study Highlighted in Wall Street Journal

The following article on the Generations study and Genematch program was published in The Wall Street Journal on April 22, 2017.


NOVARTIS TESTS NEW ALZHEIMER’S DRUG ON PEOPLE WHO DON’T HAVE THE DISEASE

The hope is that early treatment to prevent Alzheimer’s from taking hold will prove more successful than efforts to halt the disease’s progress.

By Denise Roland

April 22, 2017

 

Novartis AG  thinks its best bet for testing two new Alzheimer’s drugs is on people who don’t actually have Alzheimer’s.

The Swiss drug giant is looking for people whose genes put them at high risk of developing Alzheimer’s, but who haven’t yet fallen victim to the mind-robbing disease. It hopes such early treatment proves more successful than past efforts to tackle the disease once it has taken hold.

The history of Alzheimer’s research is marked by disappointment. In November, a high-profile Eli Lilly LLY 1.87% & Co. drug called solanezumab was the latest to fail a late-stage clinical trial. That drug aimed to clear clumps of a protein called beta amyloid in the brain, which are closely linked with Alzheimer’s. So far, no company has produced a drug that can delay the progression of Alzheimer’s.

One of the new Novartis drugs, known as CAD106, is designed to boost the immune system’s ability to clear beta amyloid from the blood. The other, which Novartis is developing with Amgen Inc. and is called CNP520, aims to stop its formation in the first place.

“If an anti-amyloid strategy is going to work, the best way to do so is with prevention,” said Steven Arnold, a neurologist at Massachusetts General Hospital in Boston.

Recruiting patients to receive treatment for a disease they don’t have—and may never develop—is riven with logistical and ethical challenges.

The company is looking for people with two copies of a gene called APOE4 to participate in its study. Having two copies of the gene doesn’t inevitably lead to Alzheimer’s, but the roughly 2% of people who fit this profile are around three times as likely to develop dementia as the general population, according to a recent analysis in the scientific journal PLOS Medicine.

The Banner Alzheimer’s Institute, a Phoenix nonprofit, is helping Novartis find eligible participants with a campaign launched at the end of 2015 to test people for the APOE4 gene. The institute places television and newspaper ads, does mass mailings and runs events in clinics to publicize the program, called Genematch.

So far, around 35,000 people have signed up, agreeing to send swabs of their cheek cells for testing. “We seem to have tapped into a very motivated group of people,” said Pierre Tariot, director of Banner. “Not surprisingly, a lot of them have a family history of Alzheimer’s.”

Amyloid plaque deposition in a person with Alzheimer's dementia, left; a person who is cognitively unimpaired but at high risk for developing Alzheimer's symptoms, center, and an unimpaired person at low risk, right.

Margaret, a 71-year-old from Virginia, discovered two weeks ago that she has two copies of the APOE4 gene. She signed up for the Genematch program earlier this year after hearing about it through the hospital that is caring for her older sister, who has Alzheimer’s.

“It is shocking,” said Margaret, who declined to give her last name because she hasn’t yet told her family. But “if this works and can prevent or slow it down, then obviously I’d like to participate. That part of it is a no-brainer.”

Only a fraction those who sign up will be eligible for the trial. As well as having two copies of the APOE4 gene, participants in the Novartis study must be healthy, between the ages of 60 and 75, and have no outward signs of Alzheimer’s, such as cognitive decline. Fewer than 10% of the roughly 1,300 participants needed for the trial have been recruited so far, Dr. Tariot said.

The Genematch staff doesn’t know any individual participant’s genetic results. Instead, a computer program provides a list of names—only some of whom are genetic matches—for them to call. On that call, Genematch will tell the person they might be eligible for a trial and tell them about nearby participating hospitals.

Participants are informed of their genetic profile—usually by a genetic counselor—only after a lengthy assessment by staff at the clinical-trial site to determine that they are eligible for, and willing to enroll in, the study.

“The critical thing is that this is done in a highly ethical way,” said Vas Narasimhan, global head of drug development at Novartis. “If a patient is not selected for the study, we are not intervening to help them so there is no reason to provide them with this information.”

The Novartis study is among a small group of trials that might still vindicate the beta amyloid-targeting approach to Alzheimer’s drugs. Shown, a building on the Swiss pharmaceutical giant’s campus in Basel in 2015.

Later this year, Novartis plans to start a further trial that will be open to people who have just one copy of the APOE4 gene, Dr. Narasimhan said. Around a quarter of the population is thought to fit this profile, and they are about 1½ times as likely to develop mild cognitive impairment or dementia as the general population.

After the string of high-profile failures in amyloid-busting drugs, experts are divided over whether they are the right approach to tackling Alzheimer’s. “The field is very pessimistic right now,” said Murali Doraiswamy, director of the neurocognitive disorders program at Duke University Health System in Durham, N.C.

But the Novartis study was among a small group of trials that could still vindicate this approach, Dr. Doraiswamy said. “We’ve learned a lot from previous [failed] trials,” he said, adding that the “elegant” design of the Novartis study—in focusing on a narrow band of people known to have heightened risk of Alzheimer’s—makes it a “near-perfect model to test the amyloid thesis.”

Swedish Covenant Hospital Hosts A Free Family-Oriented Community Event

Please join Great Lakes Clinical Trials in supporting Swedish Covenant Hospital's upcoming Summer Social.  It's fun for everyone! Admission is FREE so bring the whole family to enjoy this rain or shine event:

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  • Free bike helmets (for the first 1,000 attendees) provided by Swedish Covenant Hospital
  • Live entertainment and DJ
  • Bouncy houses
  • Face painter and balloon artist
  • Helmet decorating and other kids activities
  • Summer safety giveaways and bike safety tips
  • Food trucks
  • Raffle prizes and more!

The event will be held in the parking lot of Galter LifeCenter at 5115 N. Francisco. FREE parking in Swedish Covenant Hospital’s garage (entrance at California & Winona). We will have a big bike rack and also a DIVVY station onsite.

More info:
SwedishCovenant.org/SummerSocial
 

Andersonville Businesses Donate $1,500 in Health Fair Raffle Prizes

Great Lakes Clinical Trials and the organizers of the 2017 Andersonville Health Fair would like to offer our sincere appreciation for the donations received from our community business for our raffle drawing.  All health fair visitors who stop by each of our vendor booths will be entered into drawings to win the following:

  • Platinum Package......Estimated Value $430
  • Gold Package......Estimated Value $275
  • Silver Package......Estimated Value $255
  • Bronze Package......Estimated Value $230
  • Taste of Andersonville......Estimated Value $135
  • A “Pizza” Andersonville......Estimated Value $90
  • Foot Care Gift Basket......Estimated Value $50

In total, we will be raffling off nearly $1,500 in prizes.

"I cannot be more proud to be resident and business owner in Andersonville," commented, Steve Satek, President of Great Lakes Clinical Trials and Chairman of the 2017 Andersonville Health Fair. "The amazing group of vendors we have exhibiting at the Health Fair and the quality & volume of raffle prizes from our local establishments is overwhelming!  Vendors are all donating their time and the raffle prize were also all donated, so that we could offer this Health Fair at no cost to the residents of our community." 

The event will take place at Great Lakes Clinical Trials, located at 5149 North Ashland in Chicago from 10:00-2:00pm on Saturday, April 22.  RSVP to (773) 275-3500.  No cost to participate. 

Great Lakes Clinical Trials Contributes to FDA Approval of First and Only Approved Treatment for Adults with Tardive Dyskinesia

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Great Lakes Clinical Trials is pleased to share the announcement from Neurocrine Biosciences related to the FDA Approval of INGREZZA TM (valbenazine) Capsules as the first and only FDA-approved treatment for adults with Tardive Dyskinesia (TD).

Tardive Dyskinesia is characterized by uncontrollable, abnormal and repetitive movements of the trunk, extremities and/or face and is estimated to affect at least 500,000 people in the U.S. Up until this point, there was no available treatment for this debilitating disease.  

"Our team at Great Lakes Clinical Trials is committed to improving the quality of life for patients in our community and around the world,"  commented Steve Satek, President of Great Lakes Clinical Trials. "We are proud to have participated in the development program of valbenazine and give our most sincere thanks and appreciation to the volunteers who participated in this research program at our clinic.  Without clinical trial volunteers, important medications like this would never receive FDA approval and become available by prescription."

To view the full press release from Neurocrine Biosciences, please click here.

Steve Satek Presents A Lecture Entitled "Embracing the Future of Alzheimer's Disease"

Steve Satek, Co-Founder of Great Lakes Clinical Trials

Steve Satek, Co-Founder of Great Lakes Clinical Trials

As part of the free Alzheimer’s Research: Get Informed, Get Involved lecture series sponsored by the Alzheimer's Association Greater Illinois Chapter, Steve Satek, President and Co-Founder of Great Lakes Clinical Trials will be presenting a lecture entitled "Embracing the Future of Alzheimer's Disease". The event will take place on Thursday May 4, 2017 from 2:00-3:00 p.m

"I'm proud to be involved in this lecture series," commented Mr. Satek, who also serves on the Alzheimer's Association Greater Illinois Chapter Medical & Scientific Advisory Board. "These programs provide the opportunity to discuss current trends, efforts and directions in dementia research. We are making great strides in Alzheimer's research and these presentation are a means to get the word out to those who want to make a difference in finding a prevention or cure." 

This dynamic presentation will provide the latest updates on Alzheimer's research and discuss the impact of clinical trials on the future of treatments. Join us to learn about the latest updates on Alzheimer's research, including:

• Current efforts to fight Alzheimer's disease in your community
• The role research plays in developing the next generation of treatments
• Explore the benefits of being a study participant; Engage in TrialMatch®
 

The Alzheimer's Association will also be on site to provide an overview of services and each participant will receive access to the Alzheimer's Association's TrialMatch® registry.

The event will be hosted by Loyola Gottlieb Memorial Hospital, Professional Office Building Room E, F & G, located at 701 W. North Ave in Melrose Park, IL.   Registration is required for this FREE series - to RSVP, call 847.324.0393 or email hjohnson@alz.org

To download a copy of the event flyer click HERE

 

Medical Food Research Study for Memory Lapses

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Have you or a loved one been experiencing noticeable memory lapses?  If so, this could be a condition known as Mild Cognitive Impairment.  About 50% of the population aged 65 years or older suffers from early memory impairment. Early memory impairment disrupts the day-to-day lives of many adults and may include symptoms such as: forgetting the “right word” and names/faces of individuals or difficulties in problem solving and handling complex situations.

Great Lakes Clinical Trials is conducting a study to evaluate a prescription medical food for patients with Mild Cognitive Impairment. To qualify, you must:

·      be between the ages of 65 and 85

·      be experiencing noticeable memory lapses, known as mild cognitive impairment

·      not be taking medication or over-the-counter supplements for memory loss

·      be otherwise, generally healthy 

The study lasts approximately 2 years and you will be asked to visit the clinic on 7 occasions.  The visits last between 1-3 hours in length.  If you qualify, you will receive study medications, exams and study related care at no cost.  In addition, qualified participants may receive reimbursement of up to $1,175.00 for time and travel.

To learn more about our current program, please call our patient care representatives at (773) 275-3500.  In addition, you can complete the form HERE and one of our team members will be in touch within the next business day.