CORAL GABLES, Fla., June 30 /PRNewswire-FirstCall/ -- Catalyst
Pharmaceutical Partners, Inc. (Nasdaq: CPRX), a biopharmaceutical company
that acquires or in-licenses, develops and commercializes prescription
drugs for the treatment of drug addiction and obsessive compulsive
disorders, today announced that it has begun enrollment for its randomized,
double-blind, placebo-controlled U.S. Phase II clinical trial evaluating
CPP-109 for the treatment of patients addicted to methamphetamine. CPP-109,
an orally administered, small molecule drug which inhibits
psychostimulant-induced dopamine release, is Catalyst's version of
vigabatrin.
In April 2008, Catalyst held a kick-off training meeting in Scottsdale,
Arizona with the clinical investigators and study coordinators who will
conduct the trial. Approximately 40 attendees, including clinicians and
staff representing 15 clinical trial sites, attended the meeting. Catalyst
expects to immediately begin screening patients for inclusion in this trial
and expects initial top-line results of the Phase II clinical trial to be
available during the summer of 2009.
Catalyst's web site http://www.catalystpharma.com includes a listing of the
CPP-109 study sites and relevant contact information. For more information
about enrolling in this study, please contact the study sites directly.
Additional detailed information about the trial will soon be available on
http://www.clinicaltrials.gov (search for Catalyst).
Patrick J. McEnany, Chief Executive Officer of Catalyst, commented, "We
are excited to follow up on our cocaine trial with the initiation of our
second, large-scale U.S. Phase II trial with CPP-109, this time as a
potential treatment for methamphetamine addiction. As with cocaine, we
believe that CPP-109 may offer the potential to provide patients suffering
from methamphetamine addiction, as well as the physicians and clinicians
that treat them, with a safe and effective pharmacotherapy option."
The Phase II trial is designed as a randomized, double-blind,
placebo-controlled, intent-to-treat, multicenter trial to evaluate the
safety and efficacy of CPP-109 as a treatment for methamphetamine
addiction. The trial is expected to enroll 180 methamphetamine addicted
patients at 15 leading addiction treatment clinical centers in the United
States. Patients will be treated for a period of 12 weeks, with an
additional 12 weeks of follow-up. The primary endpoint of the study is to
demonstrate that a larger proportion of CPP-109-treated subjects than
placebo-treated subjects will be methamphetamine-free during their last two
weeks of treatment (Weeks 11 and 12). Additionally, Catalyst will be
measuring several secondary endpoints based on reduction in craving and of
methamphetamine use.
"Vigabatrin has previously shown the potential to be a non-addictive
drug treatment for cocaine and methamphetamine addiction in two pilot
studies and one Phase II double-blind trial conducted in Mexico. We are
excited to now be able to seek to determine the therapeutic benefit of our
product in methamphetamine addicted patients enrolled in a larger,
well-designed, placebo-controlled trial conducted under our sponsorship,"
said Douglas Winship, Vice President of Regulatory Operations for Catalyst.
"There are currently no adjunctive drug products approved for the treatment
of this population. As a result, drug therapies are desperately needed
which can improve abstinence achievement rates of behavioral therapy
currently obtained by addiction treatment specialists, and reduce
recidivism."
About Methamphetamine Addiction
Methamphetamine is a highly addictive stimulant that affects the
central nervous system. Abuse of the drug leads to devastating medical,
psychological and social consequences.
According to the 2005 SAMHSA Survey on Drug Use and Health, an
estimated 10.4 million people age 12 or older (4.3 percent of the
population) have tried methamphetamine at some time in their lives.
Approximately 1.3 million reported past-year methamphetamine use, and
512,000 reported current (past-month) use. Approximately 535,000 patients
sought treatment for methamphetamine and other stimulant abuse in 2006. In
addition, according to the 2006 SAMHSA Survey, an estimated 22.6 million
people in the United States suffered from dependence on illicit drugs.
According to the Office of National Drug Control Policy, the costs of
drug abuse to society were an estimated $180 billion in 2002 in the United
States. According to the United Nations Office on Drugs and Crime, in 2005
there were approximately 4.1 million users of cocaine and 2.8 million users
of amphetamine-type stimulants across Europe.
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 Brookhaven's patent portfolio 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 http://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 and those other factors described in
the Company's Annual Report on Form 10-K for 2007 and the Company's
Quarterly Report on Form 10-Q for the quarter ended March 31, 2008 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.
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[Via Healthcare]
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