CORLUX for the treatment of Cushing?s Syndrome

[cat lady]

Orphan Drug Designation

 

In July 2007 Corcept announced that it received Orphan Drug Designation from the Food and Drug Administration (FDA) for CORLUX for the treatment of Cushing?s Syndrome. CORLUX is a cortisol receptor (GR-II) antagonist.

 

Orphan Drug Designation is a special status granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. Corcept has not yet determined its full development plan for the use of CORLUX to treat Cushing?s Syndrome but will file an IND shortly.

 

 

Development Plan

 

 

Corcept is still determining its development plan for Corlux for evaluating the use of Corlux for the treatment of Cushing?s Syndrome. However, an Investigational New Drug (IND) application will be submitted to the FDA in the near future, a necessary step to begin clinical trials. While the market opportunity for Cushing?s Syndrome may be small compared with that of psychotic depression, and may not be realized for several years, the granting of Orphan Drug status from the FDA provides reason to believe that Corlux may have significant value beyond PMD.

[~MaryO~]

Thanks for this great news - it's about time some meds were becoming available! Then there's the drug that Georgetown is going to use ( http://cushings.invisionzone.com/index.php?showtopic=23705 )

 

Things are looking up for Cushies...sometime!

 

Here's more on the Corlux

 

http://money.cnn.com/news/newsfeeds/articl...ire/0289905.htm

 

Corcept Therapeutics Announces Second Quarter 2007 Results

 

August 13, 2007: 04:05 PM EST

 

Corcept Therapeutics Incorporated (NASDAQ: CORT) today reported financial results for the second quarter ended June 30, 2007.

 

For the second quarter of 2007, Corcept reported a net loss of $1.4 million, or $0.04 per share, compared to a net loss of $7.9 million, or $0.35 per share, for the second quarter of 2006. For the first six months of 2007, the company reported a net loss of $4.0 million, or $0.13 per share, compared to a net loss of $14.6 million, or $0.64 per share, for the same period in 2006.

 

In June 2007, we announced the preliminary top-line results of our successful proof-of-concept study evaluating the ability of CORLUX? to mitigate weight gain associated with the use of olanzapine. This study in healthy male volunteers was initiated during the first quarter of 2006. The top line results demonstrated a statistically significant reduction in weight gain in those subjects who took olanzapine plus CORLUX compared to those who took olanzapine alone. Eli Lilly and Company provided olanzapine and financial support for this study. The purpose of this study was to explore the hypothesis that GR-II antagonists would mitigate weight gain associated with atypical antipsychotic medications.

 

In July 2007, we received Orphan Drug Designation from the Food and Drug Administration (FDA) for CORLUX for the treatment of Cushing's Syndrome. Cushing's Syndrome is a disorder caused by prolonged exposure of the body's tissues to high levels of the hormone cortisol. Sometimes called "hypercortisolism," it is relatively rare and most commonly affects adults aged 20 to 50. An estimated 10 to 15 of every one million people are affected each year.

 

Orphan Drug Designation is a special status granted by the FDA to encourage the development of treatments for diseases or conditions that affect fewer than 200,000 patients in the United States. Drugs that receive Orphan Drug Designation obtain seven years of marketing exclusivity from the date of drug approval as well as tax credits for clinical trial costs, marketing application filing fee waivers and assistance from the FDA in the drug development process. While we have not yet determined our full development plan for the use of CORLUX to treat Cushing's Syndrome, we plan to open an Investigational New Drug application (IND) in the near future.

 

In July 2007, we also executed an agreement with Xceleron Limited to conduct a human microdosing study of one of Corcept's new chemical entities, a selective GR-II antagonist, utilizing Xceleron's Accelerator Mass Spectrometry (AMS) technology. In early 2003, Corcept initiated a research program to discover and patent selective GR-II antagonists to create a pipeline of proprietary products. Three distinct series of GR-II antagonists were identified that appear to be as potent as Corcept's lead product CORLUX in blocking cortisol but, unlike CORLUX, do not appear to block the progesterone or other steroid receptors. We will evaluate one of the compounds that developed particularly high plasma and brain concentrations in an animal bioavailability study in a human microdosing study using Xceleron's AMS technology.

 

Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer, commenting on the company's clinical progress, said, "We made good progress this quarter in moving forward with our GR-II antagonist program. We obtained positive results of the weight-gain mitigation study and are pleased that we were able to replicate in humans the positive findings regarding prevention of olanzapine-induced weight gain that we had demonstrated in a rat model. We also received Orphan Drug Designation for CORLUX for the treatment of Cushing's Syndrome and began preparations with Xceleron for a human microdosing study with one of our new compounds. While we were disappointed with the top-line results of our Phase 3 trials of CORLUX for the psychotic features of psychotic depression, which were reported in late 2006 and early 2007, we are encouraged by the information that we did learn from the trials, particularly regarding what appears to be the plasma level necessary to achieve efficacy. We are planning for our next Phase 3 study, which we expect will begin enrollment in the first quarter of 2008."

 

As of June 30, 2007, Corcept had cash, cash equivalents and marketable securities of $11.9 million. The total cash used in the company's operating activities for the first six months of 2007 was $6.4 million.

 

Commenting on Corcept's financial guidance for 2007, Anne LeDoux, Corcept's Vice President and Controller, stated, "Based on the currently planned timeline of our clinical development program and our discovery research activities, we expect that cash used in operating activities in 2007 will be between $11 million and $14 million. While we believe that our current funds will enable us to continue operations into the first quarter of 2008; we will need to raise additional capital in order to fund our operations beyond that point."

 

Total operating expenses were $2.0 million for the second quarter of 2007 and $4.7 million for the first half of 2007 compared to $8.2 million and $15.3 million, respectively, in the same periods in 2006. In the second quarter and first half of 2007, research and development expenses decreased to $1.2 million and $2.8 million, respectively, from $7.0 million and $12.8 million in the same periods of 2006. This decrease was primarily related to the completion in late 2006 of the majority of activities regarding our three Phase 3 trials evaluating CORLUX for treating psychotic depression. Top-line results for two of these trials were reported during 2006, with top-line results for the third Phase 3 trial, Study 06, being reported in March 2007.

 

General and administrative expenses decreased to $793,000 for the second quarter and $1.9 million for the first half of 2007 from $1.2 million and $2.5 million, respectively, for the same periods in 2006 due to decreases in staffing and stock based compensation. The figures for the second quarter and first half of 2007 included a reversal of stock compensation expense of approximately $393,000 related to the resignation of an administrative employee.

 

During the second quarter and first half of 2007, the company recognized revenue of $374,000 and $482,000, respectively, from the collaboration with Eli Lilly and Company to conduct a proof-of-concept clinical study evaluating the ability of CORLUX to mitigate weight gain associated with the use of olanzapine. Total revenue recognized under this agreement had been $100,000 and $221,000 for the second quarter and the first half of 2006, respectively.

 

About Corcept Therapeutics Incorporated

 

Corcept Therapeutics Incorporated is a pharmaceutical company engaged in the development of GR-II antagonists for the treatment of severe psychiatric and metabolic diseases. Corcept's lead product, CORLUX, is currently in Phase 3 clinical trials for the treatment of the psychotic features of psychotic major depression, a serious psychiatric disorder that affects approximately three million people annually in the United States. Psychotic major depression, or PMD, is referred to in this release and hereinafter as "psychotic depression." There is no FDA-approved treatment for psychotic depression. The Company has conducted a proof-of-concept study evaluating the ability of CORLUX to mitigate weight gain associated with the use of olanzapine and has also received Orphan Drug Designation for CORLUX for the treatment of Cushing's Syndrome. For additional information about the company, please visit www.corcept.com.

 

Statements made in this news release, other than statements of historical fact, are forward-looking statements, including, for example, statements relating to Corcept's clinical development programs, including its ability to demonstrate the efficacy of CORLUX, its spending plans, including expectations with respect to cash used in operating activities in 2007, and plans for additional financing. Forward-looking statements are subject to a number of known and unknown risks and uncertainties that might cause actual results to differ materially from those expressed or implied by such statements. For example, there can be no assurances with respect to the commencement, cost, rate of spending, completion or success of clinical trials; there can be no assurance with respect to the consummation of financing activities; financial projections may not be accurate; or there can be no assurances that Corcept will pursue further activities with respect to clinical development of CORLUX. These and other risk factors are set forth in the Company's SEC filings, all of which are available from our website (www.corcept.com) or from the SEC's website (www.sec.gov). We disclaim any intention or duty to update any forward-looking statement made in this news release.

[MCF]

My hopes are pinned on Antalarmin and Astressin, CRH release inhibitors. But the more the merrier! My concern is the AI that could result; RU486 is also a GR agonist or antagonist, and Dr. F. says it causes severe AI.

[~MaryO~]

At least these companies are aware of Cushing's and starting to try things.

 

I'm sure that there will be a lot of failures along the way but it's a start! Talking and acting are good things

[Jo MacRaild]

Very interesting. Thanks Ladies. None of Corrines test results are back yet, surprise surprise !! But the octerotide does appear to be doing something..just not quite sure what. The sweating & flushing have subsided to just after & about an hour before the next dose is due. Any forward moves are great moves ... Just think all these studies..What a great opportunity to learn more about cushings..& we can supply lots of volunteers..

[philb]

I think that this is still current

 

http://clinicaltrialwatch.com/display/cush...Trial+Spotlight

[chanceofrain]

This is still current. I believe they just got the first study center up and going in January. I met with the heads of this study and you know, it is interesting because they say it is for cushings but they aren't really monitoring for cortisol during the study. Also, they werent sure if a concurrant hydrocortisone therapy could be used--like how with ketoconazole patients are usually put on hydrocortisone to prevent an adrenal crisis.

 

Another question to ask if you are being put on this drug is where are they getting the meds from. There was an article in the NY times about 4 months ago stating that RU486 was being made in china and run by the same plant owners who were fined for having I believe it was lead in some of the drugs. I hope this has changed but when It was broght it up to the head of the study they didnt have an answer. I will look for the article and post the link.

 

Also, the long term affects of RU486 are not well known yet. I believe it has been used for alzheimers patients in a study for 6 months at most. Not to be Debbie Downer here, I just think that before anyone voluntarily enters the study it is important to know this info. I think there are other, better studies out there for cushings.

 

I think that this is still current

 

http://clinicaltrialwatch.com/display/cush...Trial+Spotlight

[afish]

Wow this is great news! I was under the impression that the drug available for Cushing's weren't that effective! Hopefully as drug companies become more aware of this disease, better drugs will be developed!

[da89165]

My hopes are pinned on Antalarmin and Astressin, CRH release inhibitors. But the more the merrier! My concern is the AI that could result; RU486 is also a GR agonist or antagonist, and Dr. F. says it causes severe AI.

 

 

I read some research this week that stated they're finding people with Interstitial Cystitis (major bladder pain disease) have abnormally high levels of CRH. So maybe these inhibitors could help people suffering with IC as well?!?!

[chanceofrain]

http://www.nytimes.com/2008/01/31/world/asia/31pharma.html

[sowens]

There are at least three other drugs not including RU486 that have been in use for a period of time. I think I can remember 4 or 5 of them including RU486 used to treat Cushing's. Some of them cause chemical death to the Cortisol producing part of the adrenals. Some of these are used when surgery is not an option.

 

The Keto is doing it's job on me. I am starting at 400 mg x 2 daily this week. I have lost over 10 lbs, my skin is bone dry and I am working more than I could before.