Nutritional Shake Research Study for Patients with Type 2 Diabetes

GREAT LAKES CLINICAL TRIALS is currently seeking participants for a new clinical trial
assessing the effects of nutritional shakes on glucose levels in patients with Type 2 Diabetes.

Supplemental nutrition drinks (or shakes) provide a healthy balance of protein, carbohydrate, and fat, vitamins and minerals. Diabetes-specific nutritional shakes are specially designed to deliver nutrition and minimize blood glucose spikes after consumption. When used as part of a diabetes management plan, they can help blood glucose control.

THE GOAL of our study is to assess to evaluate the impact of a complete and balanced
diabetes-specific nutritional shake consumed twice daily, on glucose control. Glucose levels will
be measured through a continuous glucose monitor which you will wear throughout the course
of the study.

TO QUALIFY, for this research study, you must be:

• generally healthy
• 30 years old, or older
• current taking oral diabetes medications at least 2 months. You will stay on your current diabetes treatment during the trial.

In addition, you must have an HbA1C value between 7-10%. We will perform a finger stick
measurement at your first visit to confirm, or in case you are not aware of your HbA1c value.

THE STUDY INVOLVES 3 VISITS TO OUR CLINIC. There will be three visits to our clinic on Day 1, Day 6 and Day 14.

• The first visit may last up to 90 minutes. After receiving your study information and
obtaining your consent to proceed, we will perform a fingerstick HbA1C measurement
to determine if your values are in the acceptable range to participate in the study. If
your HbA1c levels fall between 7 and 10% we will continue the visit to evaluate your
health to participate in the trial. If not, you will not be able to continue in the study.
During this first visit we will place a continuous glucose monitor on the back of your
upper arm.
• The second and third visits may last up to an hour.
• There will be a phone call 2-7 days after the study for safety follow-up.

COMPENSATION.  Qualified participants will receive up to $200 for their participation in this
study. Study related care and office visits are provided at no cost. Insurance is not required

TO LEARN MORE about this research program, visit our website at
www.greatlakesclinicaltrials.com or call our Patient Care Representatives at (773) 275-3500.

Probiotics in a Snack Bar?

Great Lakes Clinical Trials is looking for male and female volunteers between the ages of 18 and 65 for a investigational research study involving the consumption of a daily snack bar. Participants will be randomly assigned to consume either a standard snack bar or a snack bar containing a probiotic for a 4 week period.

The purpose of the study is to measure levels of the probiotic that pass through your gut and appear in your stool. The study will require you to collect your stool on 4 separate occasions throughout the 6-week study period. You will be provided with a stool collection kit and transport systems.

You may be able to participate if you:

• are of slender build, having a body mass index between 18.5-29.9 kg/m2. Our study staff can help determine this over the phone.
• have not taken any probiotics in last 4 weeks or antibiotics in the past 6 weeks.
• have not made any substantial dietary changes or significant weight changes in the past 4 weeks.
• do not have a history or presence of any GI condition, such as inflammatory bowel disease, IBS, chronic constipation, bowel movement irregularity or eating disorder.

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

You will be asked to visit our clinic on 6 occasions over approximately 6 weeks. One visit is simply to drop off a stool sample. The other 5 visits last between 30-90 minutes.

There is no cost for participation in this study. All medications, tests and doctor visits are free of charge and we do not bill insurance. For your participation, you will receive $25 for visits 1, 2 & 3 and $75 for visits 4, 5, and 6, for a total of up to $300 for completing the trial.

Want to learn more? Visit us at www.greatlakesclinicaltrials.com or call (773) 275-3500.

Great Lakes Clinical Trials Featured in Daily Herald Article

Great Lakes Clinical Trials is proud to have been featured in today's "Healthy You" section of the Chicagoland's leading suburban newspaper, The Daily Herald.

FAMILIES PLACE THEIR HOPES IN ALZHEIMER'S RESEARCH

Today's Daily Herald Article Featuring Great Lakes Clinical Trials

January 27, 2017
Daily Herald - Healthy You Section
Page 4

Misplacing keys, forgetting someone’s name or blanking on a phone number. We don’t pay much attention to these memory lapses when we are young; however, as we age we may start to worry about what they mean.

It’s important to know the difference between normal forgetfulness and the symptoms of a more serious problem, such as Alzheimer’s disease.

Alzheimer’s disease is more than memory loss. It is a brain disease that may remain “silent” for many years before noticeable symptoms start to show. Researchers believe Alzheimer’s can start to affect the structure of the brain as early as age 40. Eventually the disease progresses to a point where obvious symptoms can be seen, such as memory loss, reduced decision making skills or confusion with time and place.

Great Lakes Clinical Trials is a research organization committed to finding a way to stop, slow down or even prevent Alzheimer’s disease.

“We are at a time when research is advancing rapidly,” said Steve Satek, president of Great Lakes Clinical Trials and member of the Medical and Scientific Advisory Board for the Alzheimer’s Association’s Greater Illinois Chapter. “A noninvasive imaging technique called Positron Emission Tomography (PET scans) has allowed us to see inside the brains of humans and identify buildup of amyloid plaques and neurofibrillary tau tangles, that are believed to be the source of Alzheimer’s disease. A few years back the only way to visualize plaques and tangles was through an autopsy.”

PET scans are among several new procedures available to identify individuals who may be living in the “silent phase” of the disease.These individuals have little-to-no symptoms of memory loss, but a PET scan may show the signs of Alzheimer’s disease inside their brain. Researchers believe that if the medical community can break up or reduce the amount of plaques and tangles in these individuals, then these people may have a greater chance of delaying memory loss.

Promising, investigational medications that target this source of Alzheimer’s disease are now being studied in the Chicago area, at clinics like Great Lakes Clinical Trials. For these new treatments to be approved by the FDA and become available by prescription, they must first be studied in clinical trials.

“Some people I meet say they don’t want to know if they are in the silent phase. They tell me there is nothing they can do about it, so they don’t want to know,” Satek said. “I see why people may first respond that way, but when they learn of the advancements in research and the opportunities in clinical trials, they tend to change their view. They see hope.”

Across the country, volunteers for clinical trials are needed now, or this challenge will be passed to future generations. “Most of the patients we see are participating as part of their legacy.
They are doing it for their children and grandchildren,” Satek said. “Participation in clinical trials is free, including the PET scans. Insurance is not required. Patients remain under the care or their regular doctor and our board-certified physicians simply provide supplemental care. Great Lakes
may even provide free transportation for clinic visits.”

There truly is hope for a prevention or cure for Alzheimer’s disease. Whether someone has no noticeable signs of memory loss, or if they are starting to experience memory problems that are affecting daily activities, joining a research study is an option.

To learn how you can help be the solution to ending Alzheimer’s disease, call Great Lakes Clinical Trials at (773) 275-3500 or visit www.greatlakesclinicaltrials.com.

Great Lakes Clinical Trials Initiates New Alzheimer's Disease Prevention Trial

Great Lakes Clinical Trials is proud to announce the initiation of an exciting new clinical trial to assess the effectiveness of an investigational medication for preventing progression to Alzheimer's disease.  

Steve Satek, President of Great Lakes Clinical Trials, speaks frequently across the Chicagoland area on the topic of Alzheimer’s disease research:

"Many local seniors approach me, asking what they can do to help win the fight against Alzheimer's disease.  Financial donations to groups like the Alzheimer's Association do a great deal to help support research activities, however the only way we will every find the first medication to prevent, cure or simply slow down the progression of Alzheimer's disease is through the clinical trial process. That means we have an immediate need for senior volunteers to participate in studies to assess whether these medications are safe and effective.

I find that many people don’t fully understand the meaning of prevention studies and don’t know how to get involved. Our biggest challenge is getting the word out about these studies.  Once they hear about these programs, and visit our state-of-the-art clinic, they become very motived – particularly seniors who have a history of Alzheimer’s in their family.  If seniors don’t participate now to help find a cure, then the burden of studying these new medications simply gets passed down generations, to their children and grandchildren – and meanwhile, more and more seniors will continue to be diagnosed with Alzheimer’s. The time to act is now."

The new Alzheimer’s disease prevention study at Great Lakes Clinical Trials is called the “EARLY Trial”.  You can learn more about this program by visiting the study website at www.earlytrial.com.

The Alzheimer’s Association has reported that Alzheimer’s disease is the 6th leading cause of death in the United States and that 1-in-3 seniors will die of Alzheimer’s disease or another form of dementia.  It is also important to note, that beside the emotional burden placed on family caregivers, it is estimated that family caregivers spend over $5,000 a year caring for their loved one.  For some families, this means missing a vacation, but for many others, it may mean going hungry.   So, there is a clear, urgent need to find a prevention or even a way to slow down the disease.

Satek added:

"The way I explain Alzheimer’s prevention trials, is that we first need to engage motivated, generally healthy seniors, typically over the age of 60, who are currently not experiencing any memory problems. In addition to ensuring safety through medical exams and assessments of memory and cognition, we provide an investigational medication or a placebo (an inactive substance like a sugar pill) to these patients and follow them closely for several years.  Over time, we can determine if the investigational mediation is working better than the placebo to prevent or slow down the progression to Alzheimer’s disease. 

It’s important to note that participation in our research studies is always at no financial cost to our patients, including all doctor visits, exams and tests. We do not bill insurance or Medicare. Great Lakes Clinical Trials is located on the ground floor with direct street-level access - very conveneint for seniors. We even have free parking and we provide free transportation for some of our trials."

If you are interested in learning more about the different types of research studies offered by Great Lakes Clinical Trials, you can view our current study list by clicking here or you can always call our patient care representatives by calling (773) 275-3500.

Great Lakes Clinical Trials Initiates Migraine Study With Novel Investigational Drug

Great Lakes Clinical Trials has initiated a new study to assess the effectiveness and safety of a new class of medication in migraine sufferers.  This study is being conducted under the leadership of Great Lakes Clinical Trials' board-certified neurologist, John Lavaccare, MD and will begin enrolling patients on January 3rd.

You can learn more about this program on our study-specific web page by clicking here.

Great Lakes Clinical Trials Kicks Off Participation in GeneMatch Program

Great Lakes Clinical Trials is proud to be an active participant in GeneMatch.  The goal of this program is to move Alzheimer’s research forward by helping scientists recruit participants who may qualify for prevention studies.

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.

Click HERE to learn more and sign up!

Great Lakes Clinical Trials Offers Complimentary Memory Screenings

In support of November being National Alzheimer’s Disease Awareness Month, Great Lakes Clinical Trials will be offering complimentary memory screenings at their new clinic located on the campus of the Lutheran Home in Arlington Heights, IL. 

The event will take place on Friday, November 18th between the hours of 9am and 5pm. 

Appointments must be made in advance by calling (847) 368-7404.

Worried About Your Cholesterol? Don't Like Taking Medications?

Great Lakes Clinical Trials is looking for participants for a research study assessing the effectiveness of a DIETARY SUPPLEMENT on individuals with slightly elevated cholesterol levels.  The dietary supplement being studied contains plant sterols and stanols, also known as “phytosterols”.  These are substances that are naturally found in plant foods, including fruits, vegetables and vegetable oils, nuts and seeds.  

The study lasts approximately 17 weeks and participants will come to our clinic for 7 visits.  To qualify, you must:

• Be between 21-79 years old and in generally health
• Have elevated LDL cholesterol as verified by finger stick blood test at your first visit
• Not currently be taking medications or over-the-counter supplements for high cholesterol
• Be able to follow a diet to maintain body weight throughout the study
• Have not been diagnosed with diabetes or have uncontrolled high blood pressure
• Not be currently taking antidepressants

Our research is conducted by board-certified physicians under Good Clinical Practice (GCP) guidelines.  All services at Great Lakes Clinical Trials is free of charge, meaning you will not be charged for study-related care, medications, or exams.

For this study, you will receive up to $350 for your participation.

Click here TO SIGN UP or call 773-275-3500

Positive Results Announced for Great Lakes Clinical Trials Study in Females with Low Sexual Desire

For Immediate Release November 1, 2016

Bremelanotide Meets Co-Primary Endpoints in Palatin’s Phase 3 Trials for Hypoactive Sexual Desire Disorder

CRANBURY, NJ – November 1, 2016 – Palatin Technologies, Inc. (NYSE MKT: PTN), a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential, today announced positive, statistically significant top-line results from the Reconnect Studies, its Phase 3 clinical trial program of lead drug candidate bremelanotide. The Reconnect Studies, investigating bremelanotide as an on-demand treatment for premenopausal women diagnosed with hypoactive sexual desire disorder (“HSDD”), met the pre-specified co-primary efficacy endpoints in both Phase 3 clinical trials.

“We could not be more pleased with the bremelanotide Phase 3 co-primary endpoint results. Women with HSDD using bremelanotide had clinically meaningful and statistically significant improvements in their desire and associated distress which are the defining clinical issues for an HSDD diagnosis,” said Carl Spana, Ph.D., President and Chief Executive Officer of Palatin. “I am especially grateful to all of the women who volunteered to be a part of these studies. I would also like to thank Palatin’s employees and the many consultants and third-parties that contributed to the advancement of bremelanotide.”

Johna D. Lucas, M.D., Chief Medical Officer of Palatin, said, “In Phase 3 trials bremelanotide was used as needed by premenopausal women with HSDD, with a single dose self-administered in anticipation of sexual activity. The Phase 3 studies demonstrated that bremelanotide provided a meaningful benefit for those patients who responded to the drug candidate. We look forward to the opportunity to provide a new and differentiated treatment option to the many women suffering from HSDD.”

“Hypoactive sexual desire disorder is the most prevalent form of female sexual dysfunction,” said Sheryl A. Kingsberg, Ph.D., Professor of Reproductive Biology at Case Western Reserve University School of Medicine, Division Chief, OB/GYN Behavioral Medicine, at University Hospitals Cleveland Medical Center, and a clinical investigator in the Reconnect Studies. “The distress component of HSDD reflects the profound negative impact that this condition can have on women’s self-image, relationships and quality of life well outside the bedroom. In the Phase 3 trials we saw significant reduction in distress with use of bremelanotide.”

Palatin expects to present additional results from the Reconnect Studies at future sexual medicine and women’s health conferences and in peer reviewed journal publications.

Reconnect Studies Top-line Results Overview

The Reconnect Studies consist of two randomized, double-blinded, placebo-controlled Phase 3 studies, comparing the efficacy and safety of bremelanotide versus placebo in premenopausal women diagnosed with HSDD. The Reconnect Studies randomized 1,267 women with HSDD. The primary efficacy analysis population was the modified intent- to-treat (MITT) patient population, consisting of 1,202 women with HSDD in the United States and Canada. Patients self-administered either 1.75 mg of bremelanotide or placebo as needed in anticipation of sexual activity. The double blind or efficacy portion of each study consisted of a 24-week treatment evaluation period. The open-label safety extension portion of the Reconnect Studies is ongoing.

Based on discussions with the FDA, it was decided that the co-primary endpoints for the Phase 3 clinical trials were the Female Sexual Function Index: Desire Domain (FSFI-D) and Female Sexual Distress Scale-Desires/Arousal/Orgasm (FSDS-DAO) Item 13. Satisfying sexual events is a secondary endpoint. The FSFI-D is a validated patient reported outcome measurement tool of sexual desire in the context of overall sexual function. The FSDS-DAO Item 13 is a validated patient reported outcome measurement tool of distress related to sexual dysfunction, measuring personal distress associated with low sexual desire.

Clinical significance of co-primary endpoint study results was evaluated by an independent committee using multiple anchors of patient assessment of benefit, consistent with discussions with the FDA and guidance documents.

•      Clinical Significance for the FSFI-D Subscale: Based on application of three selected anchors, a median value of 0.6 was set for defining clinical significance in baseline to endpoints changes in FSFI-D subscale scores.

•      Clinical Significance for the FSDS-DAO Item 13 Score: Based on application of three selected anchors, a median value of 1.0 point improvement in FSDS-DAO Item 13 scores was set for defining clinical significance.

In the preliminary review of the overall safety population (1,247 patients), bremelanotide appeared to be well tolerated. The most frequent adverse event was nausea, which was generally mild in nature. The safety profile of bremelanotide was consistent with prior clinical experience, and no new or unusual safety issues were identified.

Conference Call/Audio Webcast Information

Palatin will host a conference call and audio webcast on Wednesday, November 2, 2016 at 9:00 a.m. Eastern Time. The live conference call can be accessed by dialing (888) 516-2443 (domestic) or (719) 457-2651 (international), and entering conference code 7590742. The audio webcast and replay can be accessed by logging on to the "Investor/Webcasts" section of Palatin's website at http://www.palatin.com. A telephone and audio webcast replay will be available approximately one hour after the completion of the call. To access the telephone replay, dial (888) 203-1112 (domestic) or (719) 457- 0820 (international), and enter passcode 7590742. The audio webcast and telephone replay will be available through November 9, 2016.

About Bremelanotide for HSDD

Palatin is developing bremelanotide as a subcutaneous, on-demand, as needed treatment for premenopausal women diagnosed with HSDD. Bremelanotide, which is a melanocortin 4 receptor agonist drug candidate, is a synthetic peptide analog of the naturally occurring hormone alpha-MSH (melanocyte-stimulating hormone). In clinical studies bremelanotide is self-administered on an as-needed (not chronic) basis in anticipation of sexual activity.

About Palatin Technologies, Inc.

Palatin Technologies, Inc. is a biopharmaceutical company developing targeted, receptor- specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. Palatin’s strategy is to develop products and then form marketing collaborations with industry leaders in order to maximize their commercial potential. For additional information regarding Palatin, please visit Palatin’s website at www.Palatin.com.

Forward-looking Statements

Statements in this press release that are not historical facts, including statements about future expectations of Palatin Technologies, Inc., such as statements about clinical trial results, potential actions by regulatory agencies including the FDA, regulatory plans, development programs, proposed indications for product candidates and market potential for product candidates, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and as that term is defined in the Private Securities Litigation Reform Act of 1995. Palatin  intends  that  such  forward-looking  statements  be  subject  to  the  safe  harborscreated thereby. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause Palatin’s actual results to be materially different from its historical results or from any results expressed or implied by such forward-looking statements. Palatin’s actual results may differ materially from those discussed in the forward-looking statements for reasons including, but not limited to, results of clinical trials, regulatory actions by the FDA and the need for regulatory approvals, Palatin’s ability to fund development of its technology and establish and successfully complete clinical trials, the length of time and cost required to complete clinical trials and submit applications for regulatory approvals, products developed by competing pharmaceutical, biopharmaceutical and biotechnology companies, commercial acceptance of Palatin’s products, and other factors discussed in Palatin’s periodic filings with the Securities and Exchange Commission. Palatin is not responsible for updating for events that occur after the date of this press release.

References

Clayton AH et al., Bremelanotide for female sexual dysfunction in premenopausal women: a randomized, placebo-controlled dose-finding trial. Women’s Health 12(3):325- 337 (2016)

Palatin Technologies Investor Inquiries:

Stephen T. Wills, CPA, MST
Chief Operating Officer / Chief Financial Officer
Tel: (609) 495-2200 / info@Palatin.com

Palatin Technologies Media Inquiries:

Paul Arndt, MBA, LifeSci Advisors, LLC Managing Director
Tel: (646) 597-

Palatin Technologies Media Inquiries:

Eliza Schleifstein
Cell: (917) 763-8106 / efscheifstein@gmail.com

Great Lakes Clinical Trials Attends Swedish Covenant Hospital Benefit

Swedish Covenant Hospital's 61st Annual Benefit Gala, Kaleidoscope, was held on October 22, 2016. The event was a huge success, breaking fundraising records by raising nearly $1 million to benefit the Patient Care Fund at Swedish Covenant Hospital. The Patient Care Fund was created to support employee-driven creative solutions to enhance the overall patient experience at Swedish Covenant Hospital. Attended by almost 900 guests including hospital physicians and community leaders, the gala was an evening of dining, celebration and entertainment complete with fabulous silent auction packages.

Great Lakes Clinical Trials was well represented by Co-Founders, Steve Satek and Dean Hervochon, along with Neuropsychologist, Dr. Linda Rice.  "We are proud to work in a community with a world-class hospital like Swedish Covenant Hospital, " commented Mr. Satek. "We have had the honor of engaging with a number of their physicians and I'm constantly amazed at not only the quality of their work, but the high level of care and compassion for their patients."

Dean Hervochon, Dr. Linda Rice, Heidi Berke and Steve Satek at Swedish Covenant Hospital's Annual Gala