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

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 visithttp://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 throughthis link.

Study sponsor: Cortendo AB

For more information, please contact:

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

Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H2 2014

Global Markets Direct’s, ‘Pituitary ACTH Hypersecretion (Cushing’s Disease) – Pipeline Review, H2 2014′, provides an overview of the Pituitary ACTH Hypersecretion (Cushing’s Disease)’s therapeutic pipeline.

This report provides comprehensive information on the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease), complete with comparative analysis at various stages, therapeutics assessment by drug target, mechanism of action (MoA), route of administration (RoA) and molecule type, along with latest updates, and featured news and press releases. It also reviews key players involved in the therapeutic development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and special features on late-stage and discontinued projects.

Global Markets Direct’s report features investigational drugs from across globe covering over 20 therapy areas and nearly 3,000 indications. The report is built using data and information sourced from Global Markets Direct’s proprietary databases, Company/University websites, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources, put together by Global Markets Direct’s team. Drug profiles/records featured in the report undergoes periodic updation following a stringent set of processes that ensures that all the profiles are updated with the latest set of information. Additionally, processes including live news & deals tracking, browser based alert-box and clinical trials registries tracking ensure that the most recent developments are captured on a real time basis.

The report enhances decision making capabilities and help to create effective counter strategies to gain competitive advantage. It strengthens R&D pipelines by identifying new targets and MOAs to produce first-in-class and best-in-class products.

Note*: Certain sections in the report may be removed or altered based on the availability and relevance of data for the indicated disease.

Scope

- The report provides a snapshot of the global therapeutic landscape of Pituitary ACTH Hypersecretion (Cushing’s Disease)

– The report reviews key pipeline products under drug profile section which includes, product description, MoA and R&D brief, licensing and collaboration details & other developmental activities

– The report reviews key players involved in the therapeutics development for Pituitary ACTH Hypersecretion (Cushing’s Disease) and enlists all their major and minor projects

– The report summarizes all the dormant and discontinued pipeline projects

– A review of the Pituitary ACTH Hypersecretion (Cushing’s Disease) products under development by companies and universities/research institutes based on information derived from company and industry-specific sources

– Pipeline products coverage based on various stages of development ranging from pre-registration till discovery and undisclosed stages

– A detailed assessment of monotherapy and combination therapy pipeline projects

– Coverage of the Pituitary ACTH Hypersecretion (Cushing’s Disease) pipeline on the basis of target, MoA, route of administration and molecule type

– Latest news and deals relating related to pipeline products

Reasons to buy

- Provides strategically significant competitor information, analysis, and insights to formulate effective R&D development strategies

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– Modify the therapeutic portfolio by identifying discontinued projects and understanding the factors that drove them from pipeline

Read the full report: http://ift.tt/14hYcJg

Today in Lab History

Jokichi Takamine was a Japanese-American biochemist and industrialist, born Nov. 3, 1854, who isolated the hormone produced in the adrenal gland that causes the body to respond to emergencies. This chemical was adrenalin — now called epinephrine — from the suprarenal gland. It was the first pure hormone to be isolated from natural sources.

He applied for and received a U.S. patent on the substance, and went on to make a fortune with his marketing of Adrenalin. In fact, the product that he marketed was not pure epinephrine, but a mixture of the hormone and its sibling compound, norepinephrine, or noradrenaline. It is now made synthetically. He also found takadastase, and played a key role in the introduction of phosphate fertilizer along with various other manufacturing and chemical industries to Japan.

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Epinephrine, an EpiPen or Auvi-Q/Allerject injection, should be given in the mid-anterior lateral thigh (not the outer thigh). We call this the EpiCenter of the thigh, and this video segment from the EpiCenter Medical (http://ift.tt/1x0SllT) online anaphylaxis first aid course has a thigh location graphic to help you pinpoint the most effective location for the injection.