FDA Accepts Samaritan's Cushing's SP-6300 IND and Clears Phase II Study

[~MaryO~]

http://www.pr.com/press-release/66302

 

FDA Accepts Samaritan's Cushing's SP-6300 IND and Clears Phase II Study

 

The U.S. Food and Drug Administration (FDA) has completed its regulatory review of Samaritan's IND (Investigational New Drug) application for Cushing's syndrome SP-6300 and declared it has not identified any deficiencies in its IND filing. Accordingly, Samaritan can proceed with its proposed Phase II clinical study of Cushing's syndrome SP-6300's efficacy in patients experiencing Hypercortisolism.

 

Las Vegas, NV, January 04, 2008 --(PR.com)-- - Three Investigational New Drugs (IND) in Pipeline

- Phase II HIV Drug SP-01A

- Phase I Alzheimer's Drug SP-233 Caprospinol

- Phase II Cushing's syndrome SP-6300

 

Samaritan Pharmaceuticals, Inc. is pleased to announce the U.S. Food and Drug Administration (FDA) has completed its regulatory review of Samaritan's IND (Investigational New Drug) application for Cushing's syndrome SP-6300 and declared it has not identified any deficiencies in its IND filing. Accordingly, Samaritan can proceed with its proposed Phase II clinical study of Cushing's syndrome SP-6300's efficacy in patients experiencing Hypercortisolism.

 

Dr. Janet Greeson, CEO of Samaritan stated, ``We are extremely pleased the FDA has cleared our IND. We have high hopes for Cushing's syndrome SP-6300's ability to modulate pathologically high cortisol levels since it demonstrated proof of concept as a cortisol modulator in Samaritan's Phase II clinical HIV trial. We believe SP-6300 can offer a unique and novel approach for a broad range of applications where cortisol levels get out of control.''

 

Cortisol is important as it performs vital tasks in the body but when it is too high or too low, it can cause physical problems. It helps maintain blood pressure and cardiovascular function, reduces the immune system's inflammatory response, balances the effects of insulin in breaking down sugar for energy, and regulates the metabolism of proteins, carbohydrates, and fats.

 

About SP-6300:

SP-6300 acts by reducing the levels of the rate-limiting enzyme HMGCoA reductase mRNA, leading to reduced activity and decreased cholesterol and corticosteroid biosynthesis.

 

See peer reviewed journal publications: http://www.samaritanpharma.com/publications_and_patents.asp

 

Samaritan Pharmaceuticals: ``Transforming Today's Science Into Tomorrow's Cures...''

Samaritan Pharmaceuticals is a life science company focused on commercializing its pipeline of innovative drugs to relieve the suffering of patients with Alzheimer's, cancer, heart disease, and infectious disease. Samaritan's business strategy is to partner drug candidates in its pipeline after Phase II (proof of concept) human studies. Samaritan has executed its first partnering agreement with Pharmaplaz, Ireland for its PII, HIV drug SP-01A. In addition, Samaritan's sales arm has acquired the marketing and sales rights to sell ten revenue-generating products in Greece and various Eastern European countries.

 

Website: http://www.samaritanpharma.com.

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Disclaimer

The company disclaims any information created by an outside party and endorses only information communicated by its press releases, filings, and Website. This news release contains forward-looking statements that reflect management's current beliefs about the potential for its drug candidates, science, and technology. However, as with any biopharmaceutical under development, there are significant risks and uncertainties in the process of development and regulatory review. There are no guarantees that products will prove to be commercially successful. For additional information about the factors that affect the company's business, please read the company's latest Form 10-K filed April 13, 2007. The company undertakes no duty to update forward-looking statements.

 

Contact:

The Investor Relations Group

Investor Relations:

Adam Holdsworth

Erica Ruderman

Rachel Colgate

212-825-3210

 

Samaritan Pharmaceuticals, Inc.

Kristi Eads

702-735-7001

 

###

Contact Information

Samaritan Pharmaceuticals

Tom Vosicky

702-735-7001

tomv@samaritanpharma.com

www.samaritanpharma.com

[denney]

Sounds like it might be another tool.

 

Just wondering about the "rate limiting" and the reduction in cholesterol...wonder if that means it affects adrenal biosynthesis on the top side at the beginning of the chain. that would be great if it would inhibit the other adrenal hormone (testosterone and others) excesses as well.

 

Wonder how you would dose someone that has cyclical patterns though. Might a low go really low? I guess they will figure all that out or let Dr. F do it later.

 

den

[denney]

Sounds like it might be another tool.

 

Just wondering about the "rate limiting" and the reduction in cholesterol...wonder if that means it affects adrenal biosynthesis on the top side at the beginning of the chain. that would be great if it would inhibit the other adrenal hormone (testosterone and others) excesses as well.

 

Wonder how you would dose someone that has cyclical patterns though. Might a low go really low? I guess they will figure all that out or let Dr. F do it later.

 

den

[Jo MacRaild]

Thats interesting Mary, Thanks

 

...inducing a reductase deficiency..Sounds like the scientists have been hard at work.. Anything that affects cholestrol metabolism, does nasty stuff to the bowels..It's the worst side effect of octerotide.. You're right Den, wonder if it will be for florids only ? Or will they bring out a home cortisol meter to use alongside it.. now that'll be n improvement !!

[ADDflower]

If this is the drug I think it is... Dr. L once said to me that it may be of the most use for people who cycle and are hard to diagnose. (like me)