четверг, 14 апреля 2011 г.

Catalyst Pharmaceutical Partners Provides An Update On Its Clinical Development Plans For CPP-109

Catalyst
Pharmaceutical Partners, Inc. (Nasdaq: CPRX) today provided an update on
its clinical development plans for CPP-109, its product candidate based on
vigabatrin for the potential treatment of cocaine and methamphetamine
addiction. The Company reported that it has decided to reduce the number of
patients in its contemplated U.S. Phase II clinical trial evaluating the
use of CPP-109 in treating cocaine addiction from 375 patients to between
100 and 150 patients. The Company believes that by reducing the size of its
contemplated U.S. Phase II cocaine clinical trial, it will put the Company
on a faster path towards the "pivotal" U.S. Phase III clinical trial that
the Company expects will be required to complete the filing of an
approvable new drug application ("NDA") for CPP-109. The Company also
reported that its revised clinical development plan now includes a U.S.
Phase II clinical trial to evaluate CPP-109 for the treatment of
methamphetamine addiction. The Company believes that its revised clinical
development plan will allow it to better take advantage of its receipt of
"Fast Track" status from the U.S. Food and Drug Administration ("FDA") for
CPP-109 than its previous clinical development plan.



The Company's updated clinical research development plan for CPP-109



In the Company's Prospectus, dated November 7, 2006 (the "Prospectus"),
the Company reported that it intended to commence in the first quarter of
2007 a U.S. Phase II clinical trial for the treatment of cocaine addiction.
It also reported that while the final design of this trial and the number
of patients to be included had not yet been finalized, it anticipated at
the time that the trial would be a double-blind, randomized,
placebo-controlled trial involving approximately 375 patients. Further, the
Prospectus reported that the Company had sufficient funds to complete both
the Phase II and a Phase III clinical trial to evaluate CPP-109 for the
treatment of cocaine addiction.



Over the last few weeks, the Company's management, including its Chief
Medical Officer, Charles Gorodetzky, M.D., Ph.D., who joined the Company in
September 2006, has been discussing possible changes to the design of its
U.S. Phase II clinical trial to evaluate CPP-109 in the treatment of
cocaine addiction. In addition, during the same period discussions with
several potential clinical investigators regarding the Company's proposed
clinical trial have also occurred. Based on these recent discussions, the
Company has concluded that a smaller trial of between 100 and 150 patients
will provide relevant data in a typical U.S. cocaine addiction population
more quickly than would have been obtained in the larger U.S. Phase II
clinical trial described in the Prospectus. The Company also believes that
the smaller trial will more quickly provide the clinical basis for
designing the "pivotal" U.S. Phase III clinical trial that the Company
expects will be required to support approval for an NDA for CPP-109. As
such, the Company has decided to reduce the size of its U.S. Phase II
clinical trial to evaluate CPP-109 in the treatment of cocaine addiction
from 375 patients to between 100 and 150 patients. The trial will continue
to be a double-blind, randomized, placebo-controlled clinical trial.
















Additionally, based on the above-described discussions, the Company has
concluded that its shareholders will be better served if the Company's
current clinical development plan for CPP-109 includes the conduct of a
Phase II clinical trial evaluating the use of CPP-109 in the treatment of
methamphetamine addiction, rather than delaying such trial until the
Company secures additional funding at some time in the future. In that
regard, the Company intends to conduct a U.S. Phase II clinical trial
evaluating the use of CPP-109 in the treatment of methamphetamine
addiction. This trial is expected to be a double-blind randomized, placebo
controlled clinical trial with between 100 and 150 patients.



While the protocols for the Company's currently contemplated U.S. Phase
II clinical trials are not yet finalized, the Company expects, based on
currently available information, that it will commence its U.S. Phase II
clinical trial evaluating CPP-109 for the treatment of cocaine addiction
during the second quarter of fiscal 2007 and its U.S. Phase II clinical
trial evaluating CPP-109 for the treatment of methamphetamine addiction
during the second quarter or third quarter of fiscal 2007. In that regard,
based on currently available information, the Company expects that the
costs of both of its contemplated U.S. Phase II clinical trials will be
less than the projected cost of the proposed U.S. Phase II trial described
in the Prospectus, and that the funds available from the Company's recently
completed public offering will be sufficient to allow the Company to file
an NDA seeking approval for CPP-109.



The Company also reported that based on its current development plan,
it expects, although there can be no assurance, to have the results of the
first of its Phase II clinical trials evaluating the use of CPP-109 in the
treatment of cocaine addiction in the second quarter of fiscal 2008 and the
results of its second U.S. Phase II clinical trial evaluating the use of
CPP-109 in the treatment of methamphetamine addiction sometime shortly
thereafter.



There can be no assurance that any of the Company's clinical trials
will be successful or that the Company will obtain an approval of an NDA
for CPP- 109.



Finally, the Company reported that its U.S. Phase II trials will be
undertaken with CPP-109 manufactured by the Company's contract
manufacturer. It also reported that as stated in the Prospectus, the
Company intends to perform the studies required to demonstrate that CPP-109
is bioequivalent to "Sabril" (registered trademark of Sanofi-Aventis),
which could provide data potentially linking CPP-109 to the extensive body
of published clinical literature on vigabatrin. In that regard, the Company
will conduct these bioequivalency studies on CPP-109 prior to initiating
the U.S. Phase II clinical trials described above. The Company does not
anticipate that such study will delay the start of its U.S. Phase II
clinical trials based on its review of the testing data that it has
received to date (which data has been obtained from the ongoing testing of
the prototype CPP-109 tablets that are currently being manufactured).
However, if these bioequivalency studies are not successful, it could delay
the start of the Company's U.S. Phase II clinical trials.



Status of clinical trial in Mexico that the Company is supporting



In the Prospectus, the Company reported that in order to further the
available research on the use of vigabatrin to treat cocaine addiction, it
intended to support an investigator-sponsored clinical trial to take place
in Mexico that is being undertaken by one of the members of the Company's
Scientific Advisory Board, Jonathan Brodie, Ph.D., M.D., a Professor of
Psychiatry at New York University School of Medicine, and by Emilia
Figueroa, M.D., an addiction physician specialist who directs several
addiction clinics in Mexico. The Prospectus stated that the clinical trial
would be a double- blind, randomized, placebo-controlled trial involving
approximately 100 patients selected from a pool of cocaine-dependent prison
parolees who meet specific clinical diagnostic standards for cocaine
dependence. The Company further reported in the Prospectus that the trial
had received approval from Mexican authorities to begin enrollment.



In December 2006, a new government took office in Mexico. As a result,
new persons have been placed in charge of the governmental agencies
responsible for overseeing this trial. Such persons have sought additional
information from the principal investigators regarding the protocol and the
drug to be used for this trial. These requests have delayed the initiation
of the trial and are likely to delay the trial further.



The Company intends to financially support this trial through an
unrestricted grant to the principal investigators. While there can be no
assurance, the Company believes that this clinical trial will still provide
useful data supporting the potential efficacy of vigabatrin as a treatment
for cocaine dependency.



Catalyst Pharmaceutical Partners, Inc. is a specialty pharmaceutical
company focused on the development and commercialization of prescription
drugs for the treatment of addiction. The Company's initial product
candidate is CPP-109, which is based on the compound gamma-vinyl-GABA,
commonly referred to as vigabatrin. CPP-109 has been granted "Fast Track"
status by the FDA, which means that the FDA has recognized cocaine
addiction as an unmet medical need for which no pharmacological products
are currently approved for marketing.



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. Forward looking statements included in this press
release include the anticipated timing and costs of the Company's proposed
U.S. Phase II clinical trials evaluating CPP-109 for the treatment of
cocaine and methamphetamine addiction and the benefits that the Company
believes will be obtained from revising its clinical development plan as
described above. Many factors could adversely impact the accuracy of the
forward looking statements contained in this press release, including those
risk factors and other factors described in the Company's Prospectus and in
the Company's Quarterly Report on Form 10-Q for the third quarter of fiscal
2006. Both of these documents have been filed by the Company with the U.S.
Securities and Exchange Commission ("SEC"). Copies of the Company's filings
with the SEC are available from the SEC 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.


Catalyst Pharmaceutical Partners, Inc.

catalystpharm/

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