Myth: YOU are the problem and the reason for your cortisol levels…

Posted on December 8, 2014 by MaryO
Myth: YOU are the problem and the reason for your cortisol levels. Having issues with too much or too little cortisol, the stress hormone, means that YOU are stressing too much or are too anxious. “YOU could control your levels if you would JUST calm down!”
myth-busted
Fact: YOU are NOT the problem! The dysfunction in your body is the problem. It is true that cortisol is your stress hormone or fight or flight hormone. This hormone helps your body compensate for and deal with trauma or stress, both physical and emotional. So, yes, your body does have a reaction to stress.
However, for people with Cushing’s, that hormone goes haywire. Too much cortisol leads to Cushing’s symptoms and having too little cortisol leads to Adrenal Insufficiency. Normally, our bodies’ response to stress is to pump out 10X the amount of your baseline cortisol to cope. If it is not able to do this, it will go into shock and can lead to death unless the emergency protocol is followed with an emergency injection of steroid. No amount of coping skills can “control” one’s physiological response to stress.

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What Causes Overweight and Obesity?

Posted on November 28, 2014 by MaryO

Health Conditions

Some hormone problems may cause overweight and obesity, such as underactive thyroid (hypothyroidism), Cushing’s syndrome, and polycystic ovarian syndrome (PCOS).

Underactive thyroid is a condition in which the thyroid gland doesn’t make enough thyroid hormone. Lack of thyroid hormone will slow down your metabolism and cause weight gain. You’ll also feel tired and weak.

Cushing’s syndrome is a condition in which the body’s adrenal glands make too much of the hormone cortisol. Cushing’s syndrome also can develop if a person takes high doses of certain medicines, such as prednisone, for long periods.

People who have Cushing’s syndrome gain weight, have upper-body obesity, a rounded face, fat around the neck, and thin arms and legs.

PCOS is a condition that affects about 5–10 percent of women of childbearing age. Women who have PCOS often are obese, have excess hair growth, and have reproductive problems and other health issues. These problems are caused by high levels of hormones called androgens.

Read the entire article at http://www.nhlbi.nih.gov/health/health-topics/topics/obe/causes

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Research Study: An Open Label Study to Assess the Safety and Efficacy of COR-003 (2S, 4R-ketoconazole) in the Treatment of Endogenous Cushing’s Syndrome

Posted on November 14, 2014 by MaryO

Objectives:         

The purpose of this study is to test the effects of different doses of COR-003 on people with Cushing’s syndrome (CS) primarily by measuring the cortisol levels in urine and secondarily by measuring other health parameters such as blood pressure, weight, and liver function. This study is also being conducted to see if there is any harm caused when using COR-003.

This study is an open label study. That means both the health providers and the participants in the study are aware of the drug or treatment being given.

Eligibility:

Adult Subjects (18 years or older) with elevated levels of cortisol due to endogenous CS.

Confirmed diagnosis of persistent or recurrent CS (with or without therapy) or newly diagnosed disease, if subjects are not candidates for surgery. CS will be defined according to the criteria in the guidelines for diagnosis of CS (Nieman 2008).

Women who are pregnant or lactating are not eligible for this study.

Individuals with other health conditions or diagnoses may not be eligible for this study.

These and other eligibility criteria are best reviewed with a doctor who is participating in the study. You can also get more detailed eligibility information about the study by clicking here to visit http://www.clinicaltrials.gov.

Study Design:

  • The study will begin with a screening period to make sure subjects are eligible to participate in the study.
  • After the screening period, subjects who are eligible for participation will each be given several different doses of COR-003, to be taken orally in tablet form.
  • After an individualized dose has been selected, participants will take COR-003 for six months.
  • Finally, participants will continue in the study for an additional six months at doses to be determined by the study doctor.

 

Throughout the study, participants will meet regularly with a study doctor and will take part in a variety of medical tests to make sure they are doing well and to see if COR-003 is working.

Participants in the study should be sure they have the time to participate. Participants will generally be followed for over a year:

Study Locations

The study is currently taking place in several places around the world (United States, Belgium, France, Israel, Netherlands, Spain, and Sweden).
Additional information on the study can be found at clinicaltrials.gov through this link.

Study sponsor: Cortendo AB

For more information, please contact:

Jim Ellis at Cortendo AB tel: +1 (610) 254-9245 or jellis@cortendo.com

 

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Cortendo gains $11M for late-stage Cushing’s study

Posted on October 31, 2014 by MaryO

Cortendo is coming to America. Founded in Sweden, the little biotech has a new CEO who’s building the executive team in the Philadelphia area. And he’s dropping plans for a listing on the Oslo exchange in favor of a U.S. IPO after raising $11 million in bridge financing.

Cortendo CEO Matthew Pauls

The big idea at Cortendo is to take an existing drug–ketoconazole, which is used off-label for Cushing’s disease–and tinker with it to make it safer and more effective. HealthCap, the Third Swedish National Pension Fund (“AP3”), Storebrand and Arctic Fund Management are putting up the venture round. And their money is funding an on-going Phase III study designed to make their case with the FDA.

“It is a nice bridge to the U.S. which also allows us from funding perspective to drive that critically important Phase III to closure,” says CEO Matthew Pauls, an ex-Shire ($SHPG) and Insmed exec from the commercial side of the industry who joined the company a couple of months ago.

Cushing’s is characterized by elevated levels of cortisol, which trigger a host of serious and potentially lethal side effects. The new drug–dubbed COR-003–is designed to hit key enzymes in the cortisol synthesis pathway, using a more targeted segment of ketoconazole.

“We took basically the better half of the molecule and are using it explicitly for Cushing’s syndrome,” says the CEO. Now Cortendo–which is run by a core team of 6, which Pauls plans to expand–will drive for final late-stage data in 2017, setting up a prospective application with the FDA that could allow the company to proceed with plans to create its own commercial operations.

There are about 20,000 to 25,000 Cushing’s patients in the U.S., adds Pauls, with maybe 30,000 to 40,000 in Europe. About half of those patients can expect surgery to address the disease, with the rest candidates for medicinal therapies.

The U.S. represents the company’s largest market opportunity, says Pauls. So it makes sense to drop the Oslo listing in favor of a U.S. exchange. Exactly when that filing could come and where, he adds, hasn’t been determined yet.

– here’s the release

From http://www.fiercebiotech.com/story/little-cortendo-gains-11m-late-stage-cushings-study-hatches-us-ipo-plans/2014-10-30

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Rare neuroendocrine tumours may be misdiagnosed as Cushing’s disease

Posted on October 31, 2014 by MaryO

By Eleanor McDermid, Senior medwireNews Reporter

Ectopic tumours secreting corticotropin-releasing hormone (CRH) and adrenocorticotropic hormone (ACTH) are very rare in children and can result in a misdiagnosis of Cushing’s disease (CD), say researchers.

Three of the patients in the reported case series had pituitary hyperplasia and underwent transsphenoidal surgery for apparent CD before the tumour that was actually causing their symptoms was located. The hyperplasia was probably caused by release of CRH from the ectopic tumour, which stimulated the pituitary gland, giving the impression of an ACTH-secreting pituitary adenoma, explain Maya Lodish (National Institutes of Health, Bethesda, Maryland, USA) and study co-authors.

These three patients were part of a series of seven, which Lodish et al describe as “a relatively large number of patients, considering the infrequency of this disease.”

The patients were aged between 1.8 and 21.3 years. Three had neuroendocrine tumours located in the pancreas ranging in size from 1.4 to 7.0 cm, two had thymic carcinoids ranging from 6.0 mm to 11.5 cm, one patient had a 12.0 cm tumour in the liver and one had a 1.3 cm bronchogenic carcinoid tumour of the right pulmonary lobe.

Four of the patients had metastatic disease and, during up to 57 months of follow-up, three died of metastatic disease or associated complications and two patients had recurrent disease.

“Our series demonstrates that these are aggressive tumors with a high mortality rate,” write the researchers in the Journal of Clinical Endocrinology & Metabolism. “It is important to follow the appropriate work up, regarding both biochemical and imaging tests, which can lead to the correct diagnosis and to the most beneficial therapeutic approach.”

The team found the CRH stimulation test to be helpful, noting, for example, that none of the patients had a rise in cortisol that was consistent with CD, with all patients showing smaller responses ranging from 2% to 15%. Likewise, just one patient had an ACTH rise higher than 35% on CRH administration, and four patients had a “flat” response, which has previously been associated with ectopic neuroendocrine tumours.

Of note, six patients had normal or high plasma CRH levels, despite all having high cortisol levels, which would be expected to result in undetectable plasma CRH due to negative feedback, implying another source of CRH production. Five patients had blunted diurnal variation of both cortisol and ACTH levels consistent with Cushing’s syndrome.

The patients also underwent a variety of imaging procedures to identify the source of ACTH/CRH production, some of which, such as octreotide scans, are specialist and not available in most hospitals, the researchers note, potentially contributing to inappropriate diagnosis and management.

From http://www.news-medical.net/news/20141030/Rare-neuroendocrine-tumours-may-be-misdiagnosed-as-Cushinge28099s-disease.aspx

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