This is a randomized, placebo-controlled, crossover study of SPI-62 in subjects with ACTH-dependent Cushing’s syndrome. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo
Condition or disease
Intervention/treatment
Phase
Cushing’s Syndrome ICushing Disease Due to Increased ACTH Secretion Cortisol ExcessCortisol; Hypersecretion Cortisol Overproduction Ectopic ACTH Secretion
Drug: SPI-62 Drug: Placebo
Phase 2
Detailed Description:
This is a multicenter, randomized, placebo-controlled, Phase 2 study to evaluate the pharmacologic effect, efficacy, and safety of SPI-62 in subjects with ACTH-dependent Cushing’s syndrome. Each subject who provides consent and meets all inclusion and exclusion criteria will participate in 3 periods: a 28-day screening period (Days -35 to -8), a 7-day baseline period (Days -7 to -1), and a 24-week treatment period (Day 1 of Week 1 to Day 168 ± 3 days of Week 24). Up to 26 subjects will be enrolled with the aim that 18 subjects with Cushing’s disease will complete the study. Subjects will receive each of the following 2 treatments for 12 weeks: SPI-62 and matching placebo.
Study Design
Go to
Study Type :
Interventional (Clinical Trial)
Estimated Enrollment :
26 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Staggered parallel crossover
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
SPI-62 as a Treatment for Adrenocorticotropic Hormone-dependent Cushing’s Syndrome
Any condition that causes the adrenal gland to produce excessive cortisol results in the disorder Cushing’s syndrome. Cushing syndrome is characterized by facial and torso obesity, high blood pressure, stretch marks on the belly, weakness, osteoporosis, and facial hair growth in females.
Cushing’s syndrome has many possible causes including tumors within the adrenal gland, adrenal gland stimulating hormone (ACTH) produced from cancer such as lung cancer, and ACTH excessively produced from a pituitary tumors within the brain. ACTH is normally produced by the pituitary gland (located in the center of the brain) to stimulate the adrenal glands’ natural production of cortisol, especially in times of stress.
When a pituitary tumor secretes excessive ACTH, the disorder resulting from this specific form of Cushing’s syndrome is referred to as Cushing’s disease.
As an aside, it should be noted that doctors will sometimes describe certain patients with features identical to Cushing’s syndrome as having ‘Cushingoid’ features. Typically, these features are occurring as side effects of cortisone-related medications, such as prednisone and prednisolone.
Dr. Friedman is getting a lot of emails on booster shots versus third shots. Third shots are for immuno-compromised patients that the FDA is recommending for a small group of patients The FDA also has the intention to soon make booster doses widely available to all healthy individuals. I am writing to clarify the difference between booster shots and third doses.
Third Doses for Immuno-Compromised Patients
The purpose of a third dose of mRNA vaccine is to give immuno-compromised patients the same level of protection that two doses provide someone who has a normal immune system. It is recommended that the following people get a third dose
Been receiving cancer treatment for tumors or cancers of the blood
Received an organ transplant and are taking medicine to suppress the immune system
Received a stem cell transplant within the last two years or are taking medicine to suppress the immune system
Been diagnosed with moderate or severe immunodeficiency conditions (such as DiGeorge syndrome, Wiskott-Aldrich syndrome)
An advanced or untreated HIV infection
Been under active treatment with high-dose corticosteroids (> 20 mg of prednisone or 100 mg of hydrocortisone) or other drugs that may suppress immune response
Dr. Friedman thinks it is unlikely that any of his patients have these conditions. Patients with Cushing’s syndrome, Addison’s, diabetes or thyroid disorders do not qualify.
In contrast, a Booster Dose is for Patients With Healthy Immune Systems
A booster dose—which is different from a third dose for immuno-compromised patients—is for healthy patients and is meant to enhance immunity and may protect against new variants of the virus.The Biden administration has announced that it intends to make booster doses available for people with healthy immune systems in September 2021, after they are authorized or approved by the FDA. This has not happened yet, but when it happens, Dr. Friedman would encourage his patients to get it.
Dr. Friedman is expecting a booster shot against the Delta variant to be released in the fall of 2021 and would recommend that for his patients.
Dr. Friedman wishes everyone to stay healthy.
Virtual Patient Panel for Cushing’s Syndrome Patients
Patients that are accepted will be compensated for their participation.
Q1: Are you a U.S. Citizen and at least 18-years or older?
Q2: Have you been diagnosed with Cushing’s Disease (CD) or endogenous Cushing’s syndrome (CS)?
Q3: Did your doctor find a tumor on your Pituitary Gland?
Q4: You must currently be taking a prescription medication to treat your Cushing’s. The medication must include ONE of the following:
ketoconazole
ISTURISA® (osilodrostat)
KORLYM® (mifepristone)
SIGNIFOR® (pasireotide), OR SIGNIFOR® -LAR (pasireotide).
Q5: You must have been on your current medication for at least 1-month (ISTURISA-only), and all other Cushing’s medications for ≥3-months.
If you answered all the questions YES and are taking a prescription medication to treat your Cushing’s, please contact:
KIRSTEN YORK, Vice President of Discovery, at ENTRADA.
Cushing’s syndrome is a rare disease which affects 65 patients in one million inhabitants of the EU. Cushing’s syndrome is a state where the body is chronically exposed to a high concentration of cortisol.
The signs of the disease are often overlooked. It took 14 years to diagnose Ida with the disease and to start treating it successfully. On Cushing’s Awareness Day, Ida emphasizes the importance of communication between the patient and the doctor.
James Findling, MD, is a veteran of the endocrinology field, a clinical practitioner and a Cushing’s syndrome expert. For his efforts in these areas, particularly clinical practice, the Endocrine Society is honoring him with its Outstanding Clinical Practitioner Award at ENDO 2019 in New Orleans.
James Findling
Findling, who currently serves as director of community endocrinology services and clinical professor of medicine at the Medical College of Wisconsin in Milwaukee, has made his clinical practice a national one as, according to the Endocrine Society, he receives referrals from across the U.S. In addition, he has played an important role in Cushing’s syndrome research, including breakthroughs that the Endocrine Society has incorporated into its own clinical practice guidelines.
In a conversation with Endocrine Today, Findling discussed his serendipitous entrance into endocrinology, his own experience with medical history and his dream of playing golf with Barack Obama.
What was the defining moment that led you to your field?
Findling: In 1977, I was a resident in internal medicine at what was then the Milwaukee County General Hospital, which doesn’t exist anymore. I did an endocrinology rotation, and my attending physician was James Cerletty, MD. Endocrinology was the farthest thing from my mind as something I would be interested in, but I was assigned to do this rotation and it changed my life. I thought, “Oh my goodness. This is fascinating.” Dr. Cerletty was a fabulous teacher and great mentor. The reason I chose endocrinology was because of that 1-month rotation. I had never done it previously, and I just fell in love with it. It was primarily because of this one man, who just died recently. He changed my life.
I was a chemistry major in college, and I enjoyed the pathophysiology and the biochemistry of it. I remember in those days, it was a little bit more complicated and convoluted to assess thyroid function, and it was never something I appreciated or understood. The concepts like T3 resin uptake I didn’t quite understand. Jim Cerletty made me understand how to interpret thyroid function studies, how they were done, how T3 resin uptake was measured, and it made all the difference in the world; a light bulb went off.
What area of research in endocrinology most interests you right now and why?
Findling: Pituitary-adrenal disorders. How I got interested in that, it’s kind of an interesting story in itself. After I did the month with Dr. Cerletty, I got interested in endocrinology, and 6 months later, I was in a general medical clinic seeing a woman with obesity, hypertension and diabetes. I went in and said to the attending physician at the time, “Well, maybe she has Cushing’s syndrome,” and I got kind of reamed out. “That’s rare. Nobody has that. It’s a stupid thing to think about.” He was trying to embarrass me and it upset me. I said, “How do you know she doesn’t have Cushing’s if you don’t do the testing?”
So, I started looking into it and realized nobody knows. Maybe some of these people with obesity and hypertension do have Cushing’s syndrome, but the testing was cumbersome and stupid and didn’t make any sense to me. About that time there was an article in The New England Journal of Medicine about pituitary surgery for Cushing’s disease from UCSF. I read that and said, “That’s where I’m going. I’m going there to learn about Cushing’s.” I applied and, fortunately, I got in and the rest is history. It’s because some attending physician embarrassed me by saying, “That’s stupid. Nobody could have Cushing’s syndrome,” and I’ve spent the rest of my life trying to figure that out. It’s been my passion for the last 40 years.
What advice would you offer a student in medical school today?
Findling: You need to find something that you’re passionate about in medicine. For many young people, that requires specialization into a relatively focused area so that they can develop a higher level of expertise. For some, that may be a more general area, and for some it may be based on location. For example, they might like to be a family physician in a small town where they can do a great deal of good. Either way, you must find something that you’re passionate about within our field, because if you’re not, you’re going to be unhappy. This is hard work and you’re going to spend many hours doing this, so you better find something you enjoy doing, whatever it is. There are so many different aspects from psychiatry to surgery to hospitals. There are so many different things you can do, but you have to find something that you like.
I hear a lot about work-life balance, and I understand that particularly in young physicians, this is a critically important part of being a doctor. The problem is if you’re going to be a physician, there’s going to be a lot of work. Half of your time or more is going to be working. You better enjoy that part of it because if you don’t enjoy the work part of it, you’re not going to enjoy the life part of it.
Have you ever been fortunate enough to witness or to have been part of medical history in the making?
Findling: I was lucky to go to University of California, San Francisco. Shortly after I got there, there were several people cloning the growth hormone gene and the insulin gene. The foundation of Genentech and the idea of making growth hormone was just fermenting at UCSF when I was there. In one of the labs was Herb Boyer, PhD, who was one of the first people to clone growth hormone, and he was on the cover of Time magazine. The head of the metabolic research unit and my boss was John Baxter, MD, who was president of the Endocrine Society years ago. There is now a prize named after him; he was on the cover of The New York Times magazine. So, here I am at UCSF and somebody in the lab down the hall is on the cover of Time magazine and my boss was on the cover of The New York Times magazine, so it was an exciting time to be at UCSF in the late ’70s and early ’80s.
Another defining moment in my career from a research perspective was when I was a fellow, I had to do a project. We were seeing a lot of patients with Cushing’s — of course, that’s why I went there — and in those days we had no good imaging. There were no CT scans, no MRI, there was no way to image the pituitary gland to find out whether there was a tumor. By the late ’70s it became obvious that some patients with Cushing’s syndrome didn’t have pituitary tumors. They had tumors in their lungs and other places, and there was no good way of sorting these patients from the pituitary patients.
My mentor at UCSF, Blake Tyrrell, MD, had the idea of sampling from the jugular vein to see if there was a gradient across the pituitary. I took the project up because I didn’t think this is going to be helpful due to there being too much venous admixture in the jugular vein from other sources of cerebral venous drainage. We went into the radiology suite to do the first patient. As I was sampling blood from the peripheral veins, the interventional radiologist, David Norman, MD, says, “Would you like to sample the inferior petrosal sinus?” I said, “Why not? It sounds like a good idea to me.” That turned out to be helpful. We then studied several patients, and it eventually went to publication. Now everybody acknowledges it is necessary, maybe not in all patients with Cushing’s, but in many patients with Cushing’s to separate pituitary from nonpituitary Cushing’s syndrome.
That was kind of a defining moment in terms of my research career because it was complete serendipity. I had never even heard of this vessel before. I went to the library to get a bunch of books to try to figure out what the venous drainage of the pituitary gland looked like. That was not easy to find. That was the defining moment of my research career as a postdoctoral fellow in endocrinology at UCSF. I was blessed because there were so many people smarter than me that it was a big help and an inspiration.
What do you think will have the greatest influence on your field in the next 10 years?
Findling: Most people would say genetics. The genetic diagnosis of so many disorders and the connection of disorders because of germline mutations or somatic mutations in tumors is just exploding. Whether you talk about pheochromocytomas, pituitary tumors in Cushing’s disease or adrenal tumors, you can go on and on and on.
Genetics wasn’t even on the radar screen when I was in training, so I feel a little bit lost because I’m behind the eight ball in terms of trying to keep up with that. Nobody was talking about that back in 1979, and I wish I understood it a lot better than I do. If I was going to think that there’s going to be anything that’s going to change the future of endocrinology it’s that, and not just for diagnosis but its potential applications for therapy.
What are your hobbies/interests outside of practicing medicine?
Findling: I’m an avid golfer. I live in Wisconsin, so right now it’s only 4° — so not too much golfing going on. I golf in the summer about once a week. I have a nice group of people I play with, and its one of my passions.
I run a lot. Not in 4° weather, but when the weather’s nice I run a lot and my goal is to run a half marathon this year. I’ve done one in the past, but it’s been many years since I’ve run one. I still enjoy running. Fortunately, my hips and knees and ankles and feet are capable of withstanding it. I don’t run very far. Maybe 8 to 10 miles per week.
I enjoy gardening. My wife and I, she loves flowers and I love vegetables, so we have a nice garden we put up every spring. So that’s another passion I have. We also love live theater, so we go to a lot of theater here in Milwaukee and all over Wisconsin.
Whom do you most admire and what would you ask that person if you had 5 minutes him/her?
Findling: The person I’d most like to meet is President Barack Obama. He’s one person I have a lot of admiration for. I would tell him I want more than 5 minutes. I’d want to play golf with him. I think his skill level is about the same as mine, so we’d have a competitive game. We’d probably do a lot of trash talking along the way.
I would ask him, “How did you stay so calm and have so much grace with all the criticism he got from so many people?” Some criticism is always a little bit justified, but a lot of it was so unjustified. How did he stay so calm and not raise his voice? Sometimes when you’re getting a lot of criticism and people are saying negative things about you, how do you stay professional and graceful? It’s not easy to do.
What was the last book you read,and what did you think of it?
Findling: The last one I finished was American Dervish. It’s a novel by Ayad Akhtar, who grew up in the suburbs of Milwaukee. His parents are from Pakistan, and he grew up as a Muslim. This young man is going to be a force in American literature.
This particular book is the story of a young Pakistani-American boy growing up in the American Midwest and a growing up story with the struggle of identity and religion. It’s a fascinating read.
In fact, Akhtar has won a Pulitzer Prize for one of his plays called Disgraced. He’s just had a play on Broadway that was nominated for a Tony Award called Junk, which the Milwaukee Repertory Theater just performed here. My wife and I saw it recently and it was entertaining
Much of what he’s written is regarding Muslims and the struggles they have living in the United States. If you haven’t seen one of his plays or read any of his stuff, I think he’s going to be a real force. He’s still a young man and he’s creative and provocative. This book, as I understand it, he’s going to make it into a play, and I wouldn’t be surprised if someday it might even be a movie. It’s an interesting perspective and I enjoyed it.
Thirty-one former customers have filed suit in New Jersey State Court against Mario Badescu, Inc., a skincare company based out of Edison, New Jersey, and Mario Badescu Skin Care, Inc., a skincare salon in New York.
The plaintiffs allege that they were injured by potent and undisclosed steroids in two of Mario Badescu’s face creams, Control Cream, and Healing Cream, which were marketed as products that contained only “botanical” active ingredients that were safe for daily use. The complaint alleges that contrary to what Mario Badescu told the public, Control Cream and Healing Cream contained two steroids: hydrocortisone and triamcinolone acetonide. The complaint also alleges that Mario Badescu’s products contained higher than prescription-strength doses of triamcinolone acetonide. Both steroids pose serious health risks to both the skin and the body’s adrenal system.
The plaintiffs were unaware of the steroids in Mario Badescu’s products and used the products on their faces, usually daily, for as long as fourteen years. Many of the plaintiffs allege that they unwittingly became addicted to the steroids such that even a day without use of the Products caused severe and painful withdrawal reactions. Moreover, many of the plaintiffs allege that they suffered from steroid-related ailments while using Control Cream or Healing Cream, including cataracts, glaucoma, mood disorders, heart issues, elevated cortisol levels, adrenal system suppression and Cushing’s Syndrome. Plaintiffs allege that because they did not know they were using steroids at the time, they were unable to inform their physicians about the true source of their injuries and were repeatedly misdiagnosed by their medical providers.
“Mario Badescu secretly added an addictive prescription steroid to its cosmetic face creams, then told its customers that the creams were safe for daily use,” Plaintiffs’ counsel, Gary E. Mason said. “Our clients suffered devastating injuries as a result of this deception,” Mason added.
The plaintiffs are represented by John C. Whitfield, Gary E. Mason, Esfand Nafisi, and Caroline Ramsey Taylor of Whitfield Bryson & Mason LLP, and Michael Galpern, Andrew Bell and Janet Walsh of Locks Law Firm, LLC. For more information about the lawsuit, contact the firm by phone at (202)640-1167.
The name of the case is Restaino et al. v. Mario Badescu, Inc. et al., No. MID-L-5830-14 (N.J. Super. Ct. Law Div., filed Sept. 25, 2014).
Friday
9:00 am – 4:00 pm Exhibitors, Barrow Pituitary Center
10:00 am – 12:00 pm Educational Segments, Barrow Pituitary Center
12:00 am – 1:00 pm Lunch (included)
1:00 pm – 3:00 pm Educational Segments, Barrow Pituitary Center
5:00 pm – 8:00 pm Group outing to Scottsdale Waterfront
Saturday
10:00 am – 12:00 pm Educational Segments, Barrow Pituitary Center
12:00 am – 1:00 pm Lunch (included)
1:00 pm – 3:30 pm Educational Segments, Barrow Pituitary Center
Sunday
9:00 am – 1:30 pm Educational Segments, Wyndham Garden Phoenix Midtown
**********************************************************
Friday Educational Segments at Barrow Pituitary Center
10:00 am Managing Cushings: Navigating Through the Maze, Yuen
or
10:00 am Managing AGHD: Daily and Beyond, Knecht
11:00 am Hypothalamic Obesity: Not Just Calories In, Calories Out, Connor
12:00 pm LUNCH (included)
1:00 pm Me, Myself and My Adrenal Insufficiency, Yuen
2:00 pm Navigating the Medical Maze, Herring
Saturday Educational Segments at Barrow Pituitary Center
10:00 am Beyond AGHD and Cushings: Familial and Genetic Factors, Stratakis
11:00 am Q&A, Stratakis
12:00 pm LUNCH (included)
1:00 pm Tools for Coping with my Endocrine Disorder, Jonas
2:00 pm Finnigan and Friends: A Year in AI Training, Palmer
2:30 pm Quality of Life Study, Cushings, Edgar & Keil
or
2:30 pm Life is What You Make Of It, Jones
Sunday Educational Segments at Wyndham Garden Phoenix Midtown
9:00 am Preventing Muscle Wasting and Nutrition, Fine
10:00 am Nuances of Treating Hypothyroidism, Friedman
11:00 am Macrilen Stimulation Test for Growth Hormone Deficiency, Friedman
11:45 am The New and The Old for Diagnosing Cushing’s Syndrome, Friedman
12:30 pm Ask the Wiz, Friedman
Location
Barrow Neurological Institute at St. Joseph’s Hospital and Medical Center
Goldman Auditorium and Sonntag Pavilion
350 W. Thomas Rd.
Phoenix, AZ 85013
Transportation will be provided on Friday and Saturday between the Wyndham Hotel to Barrow for an hour prior to the segments and an hour after close of the segments. The hotel is approximately 1/2 mile away from Barrow Pituitary Center if you choose to walk or travel there on your own.
Hotel Room Rates and Reservations
Wyndham Garden Phoenix Midtown
3600 N. 2nd Ave.
Phoenix, AZ 85013
$109 per night + tax. Includes free wifi, parking and buffet breakfast
To make hotel reservations call 602-604-4900 and ask for The MAGIC Foundation guest room block. Refrigerators are first come so be sure to request one when making your reservation.
Airport Transportation
Transportation is not provided to/from the hotel from the airport. The Wyndham is approximately 9 miles from the airport. Preferred airport is Phoenix, AZ – PHX – Sky Harbor Intl.
Deadline to Register and book your hotel is January 28, 2019
This question came up on the message boards today: Anyone ever used a Rife Machine on Cushings syndrome?
My response:
I don’t think so – this is the first I have heard of a Rife Machine so I looked it up and found this info:
Quote
American scientist Royal Raymond Rife invented the Rife machine. It produces an energy similar to radio waves.
Rife’s machine built on the work of Dr. Albert Abrams. Abrams believed every disease has its own electromagnetic frequency. He suggested doctors could kill diseased or cancerous cells by sending an electrical impulse identical to the cell’s unique electromagnetic frequency. This theory is sometimes called radionics.
Rife machines are Rife’s version of the machines used by Abrams. Some people claim they can help cure cancer and treat other conditions like Lyme disease and AIDS.
