Navigation Links
Catalyst Pharmaceutical Partners Announces Top-Line Results of CPP-109 Phase II Trial for Cocaine Addiction
Date:5/29/2009

Management will host Conference Call at 9:00 AM ET Today

CORAL GABLES, Fla., May 29 /PRNewswire-FirstCall/ -- Catalyst Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today announced top-line results from its U.S. Phase II clinical trial to treat cocaine addiction. The data from the trial showed that CPP-109 did not demonstrate statistical significance in the primary endpoint -- that a significantly larger proportion of CPP-109-treated subjects than placebo-treated subjects were cocaine-free during the last two weeks of the treatment period (Weeks 11 and 12). The clinical trial did not reveal any unexpected "serious" adverse events.

Complete analyses of the clinical trial data (secondary clinical end-points and safety data) are ongoing. Based on the results of these analyses, Catalyst will evaluate what measures, if any, could be applied to improve the outcome of future studies and will also determine next steps to be taken regarding the development of CPP-109 for the treatment of cocaine addiction. In addition, Catalyst intends to investigate the reasons for the disparity between these trial results and previously published clinical and non-clinical results evaluating vigabatrin as a treatment for cocaine addiction. Catalyst expects to complete the analyses during the third quarter after fully unblinding the trial data and will then formulate future development plans.

Patrick J. McEnany, Catalyst's Chairman, President and Chief Executive Officer, commented, "We are obviously disappointed in the cocaine trial results, given the positive results of three prior human trials and numerous animal studies; however, we are not ready to abandon our view that CPP-109 has the potential for use in treating cocaine addiction, which still represents a significant unmet medical need. We will carefully study the results of our trial and assess the appropriate path for conducting future clinical trials evaluating CPP-109 for the treatment of cocaine addiction. We also expect to have the results of our methamphetamine proof-of-concept study during the third quarter, which will provide us with data that we can use to assess the next steps in our strategy."

Mr. McEnany continued, "As previously reported, we have sufficient cash to complete the analysis of the results from our cocaine trial, to complete our methamphetamine proof-of-concept study and to continue our operations through the end of 2010 without additional funding. As a result, we believe that we have sufficient financial and human resources to pursue a variety of strategies, which we will discuss in detail as they are developed."

Conference Call

The Company will host a conference call today at 9:00 AM ET to discuss the trial results. Participants may call 888-715-1402 (domestic) and 913-312-1436 (international) prior to the 9:00 AM ET start time and ask for the Catalyst Pharmaceutical Partners conference call hosted by Mr. McEnany. The teleconference replay will be available two hours after completion through Friday, June 5, 2009 at 888-203-1112 (domestic) and 719-457-0820 (international). The access number is 6820448. In addition, the live webcast may be accessed at http://ir.catalystpharma.com/eventdetail.cfm?eventid=69479 and will be available for one year.

About Catalyst Pharmaceutical Partners

Catalyst Pharmaceutical Partners, Inc. is a biopharmaceutical company focused on the development and commercialization of prescription drugs for the treatment of addiction and obsessive-compulsive disorders. The Company has obtained from Brookhaven National Laboratory an exclusive worldwide license for nine patents in the United States relating to the right to use vigabatrin to treat a wide variety of substance addictions and obsessive-compulsive disorders. Catalyst has also been granted rights to Brookhaven's vigabatrin-related foreign patents or patents pending in more than 30 countries. The Company's initial product candidate based on vigabatrin is CPP-109. CPP-109 has been granted "Fast Track" status by the U.S. Food & Drug Administration ("FDA") for the treatment of cocaine addiction. This indicates that the FDA has recognized that CPP-109 is intended for the treatment of a serious or life-threatening condition for which there is no effective treatment and which demonstrates the potential to address unmet medical needs. For more information about the Company, go to www.catalystpharma.com.

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties which may cause the Company's actual results in future periods to differ materially from forecasted results. A number of factors, including our ability to successfully complete the clinical trials required for us to file a new drug application for CPP-109, our ability to complete such trials on a timely basis within the budgets we establish for such trials, our ability to protect our intellectual property, our ability to continue to list our common stock on the NASDAQ Global Market or to list our common stock on the NASDAQ Capital Market and those other factors described in the Company's Annual Report on Form 10-K for 2008 and the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2009 that the Company has filed with the U.S. Securities and Exchange Commission ("SEC"), could adversely affect the Company. Copies of the Company's filings with the SEC are available from the SEC, may be found on the Company's website or may be obtained upon request from the Company. The Company does not undertake any obligation to update the information contained herein, which speaks only as of this date.


'/>"/>
SOURCE Catalyst Pharmaceutical Partners, Inc.
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Catalyst Pharmaceutical Partners Begins Enrollment for Its U.S. Phase II Clinical Trial of CPP-109 in Patients with Cocaine Addiction
2. Catalyst Pharmaceutical Partners Reports Fourth Quarter and Year-End 2007 Financial Results
3. Catalyst Biosciences Selects Drug Development Candidate in Factor VIIa Program for Hemophilia
4. Catalyst Pharmaceutical Partners, Inc. Begins Enrollment for U.S. Phase II Clinical Trial of CPP-109 in Patients with Methamphetamine Addiction
5. Catalyst Pharmaceutical Partners Announces Publication of Animal Data Demonstrating Vigabatrin Effective for Weight Loss
6. Catalyst Reaches Enrollment Target for its U.S. Phase II Cocaine Trial
7. Thomson Scientific Publishes The Ones to Watch - A Quarterly Review of Phase Changes in the Pharmaceutical Pipeline
8. Auxilium Pharmaceuticals, Inc. Receives Clearance to Resume Clinical Trials for XIAFLEX(TM)
9. Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML
10. Solvay Pharmaceuticals, Inc. and Wyeth Pharmaceuticals Announce Receipt of an FDA Action Letter for Bifeprunox, an Investigational Treatment for Schizophrenia
11. DOV Pharmaceutical, Inc. Announces Successful Phase Ib Results for DOV 21,947
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:2/5/2016)... , Feb. 5, 2016  Aralez Pharmaceuticals Inc. ... of POZEN Inc. ("POZEN") and Tribute Pharmaceuticals Canada Inc. ("Tribute") ... and shareholders of Tribute. The combined company will operate ... company with operations in Canada , ... United States . Under the terms of the ...
(Date:2/5/2016)... February 5, 2016 --> ... report states that the global active pharmaceuticals ingredients (APIs) ... predicted to reach US$185.9 bn by 2020. It is ... 2014 to 2020. The title of the report is ... by Geography, and by Therapeutic Area) - Global Industry ...
(Date:2/5/2016)... Feb. 5, 2016  Henry Schein, Inc. (NASDAQ: HSIC ... and services to office-based dental, animal health and medical ... agreement to acquire a majority ownership interest in Dental ... in Brazil . ... Dental Cremer is the dental distribution business of Cremer ...
Breaking Medicine Technology:
(Date:2/5/2016)... ... February 05, 2016 , ... The event is being ... Block Event Center in Minneapolis, Minn. Triumph Over Parkinson’s will fund nearly $100,000 for ... of Schneiderman’s Furniture, lives with Parkinson’s disease and is the architect of this informative ...
(Date:2/5/2016)... ... , ... After years as an active staff surgeon and having served as ... Wayne Carman transitioned to chief of the Division of Plastic Surgery at what is ... chief and began a second three-year term in January of 2016. , The original ...
(Date:2/5/2016)... ... February 05, 2016 , ... Regular gym users know ... having to wait longer to access the treadmills. It’s a predictable trend. After the ... lose weight and get in shape by joining gyms, starting new walking or running ...
(Date:2/5/2016)... Georgia (PRWEB) , ... February 05, 2016 , ... Dr. ... to announce their 2nd Annual No Cost Dental Day to individuals in need. The ... The purpose of this No Cost Dental Day is to provide dental care to ...
(Date:2/5/2016)... ... February 05, 2016 , ... Health and wellness is a topic that should ... event they are experiencing an illness. Migraines are a severe form of a headache ... migraines would not wish the pain on their worst enemy, the feeling can last ...
Breaking Medicine News(10 mins):