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PARKINSN  April 2005, Week 4

PARKINSN April 2005, Week 4

Subject:

Update of Neurologix Phase I Clinical Trial of Gene Therapy for Parkinson's Disease Presented at AANS Annual Meeting

From:

John Cottingham <[log in to unmask]>

Reply-To:

Parkinson's Information Exchange Network <[log in to unmask]>

Date:

Fri, 22 Apr 2005 22:36:06 -0500

Content-Type:

text/plain

Parts/Attachments:

Parts/Attachments

text/plain (162 lines)

The source of this article is business wire: http://tinyurl.com/d9g8z

April 22, 2005 06:30 AM US Eastern Timezone

Update of Neurologix Phase I Clinical Trial of Gene Therapy for Parkinson's
Disease Presented at AANS Annual Meeting

FORT LEE, N.J.--(BUSINESS WIRE)--April 22, 2005--Neurologix Inc.
(OTCBB:NRGX) today announced that on April 20, 2005, its scientific
co-founder, Michael G. Kaplitt, M.D. Ph.D., presented a clinical update as
the Company sponsored landmark Phase I gene therapy trial for the treatment
of Parkinson's disease nears completion. This update was given at the 73rd
annual meeting of the American Association of Neurological Surgeons (AANS)
held in New Orleans.


Dr. Kaplitt highlighted the rationale for targeting the overactive
subthalamic nucleus in Parkinson's disease patients with the GAD (glutamic
acid decarboxylase) gene, which synthesizes the major inhibitory
neurotransmitter in the brain, gamma-aminobutyric acid (GABA). He also
reported that he completed the surgical gene therapy procedure on a total
of 11 patients at The New York Presbyterian Hospital/Weill Medical College
of Cornell University. These patients are being monitored and evaluated
neurologically before and for one year after surgery by Drs. David
Eidelberg and Andrew Feigin at the North Shore Hospital Long Island Jewish
Movement Disorder Clinic. The first four patients were treated with the
lowest-dose and have now been followed for more than one year. Three of the
four patients treated in the second, mid-dose cohort have been followed for
more than six months. The remaining four patients, including three in the
highest dose cohort, have been followed for intervals up to six months.

The primary outcome measure of this phase I study is safety, and Dr.
Kaplitt reported that to date there has been no evidence of any
treatment-related adverse effects.

About the Neurologix Phase I Clinical Trial

The Phase I trial, which is the first FDA-approved clinical trial to test
gene therapy to treat Parkinson's disease, is an open-label dose-escalation
study with four patients in each of three escalating dose cohorts. The
third cohort of four patients receives 10 times the dose of the first
cohort. The 12 patients participating in the trial must have been diagnosed
with severe Parkinson's disease of at least five years duration and who no
longer adequately respond to current medical therapies.

The Gene Therapy Procedure

The surgery entails a stereotactic neurosurgical procedure performed under
local anesthesia. First, MRI is used to image the target subthalamic
nucleus (STN) region of the brain. The STN is mapped using microelectrodes
by recording from single neurons as the electrode is slowly moved towards
the STN. Once a signature firing pattern is obtained confirming that the
electrode is in the STN, the fine-wire electrode is removed, leaving only
the microelectrode sheath through which a hair-thin (170 microns) hollow
tube is inserted. Thirty-five microliters containing 3.5 billion particles
of the "AAV" (adeno associated virus) viral vector (and a correspondingly
higher dose in subsequent cohorts) containing a GAD gene (cDNA), is then
infused at 0.5 microliters/minute, together with 15 microliters of 25%
mannitol. After the 100-minute infusion period, the delivery catheter is
withdrawn and the incision is closed. No hardware is left behind following
this procedure.

"We are pleased and encouraged with our progress to date and look forward
to the next phase, which will focus on the efficacy of our proprietary
treatment for patients with this disease," said Dr. Michael Sorell, CEO of
Neurologix.

About Neurologix

Neurologix, Inc. is a development-stage company that through its subsidiary
Neurologix Research, Inc. is engaged in the research and development of
proprietary treatments for disorders of the brain and central nervous
system primarily utilizing gene therapies. The Company's initial
development efforts are focused on gene therapy for treating Parkinson's
disease and epilepsy, and its core NLX technology is currently being tested
in a Phase I human clinical trial to treat Parkinson's disease.

Cautionary Statement Regarding Forward-Looking Statements

This news release includes certain statements of Neurologix, Inc. (the
"Company") that may constitute "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, and which
are made pursuant to the Private Securities Litigation Reform Act of 1995.
These forward-looking statements and other information relating to the
Company are based upon the beliefs of management and assumptions made by
and information currently available to the Company. Forward-looking
statements include statements concerning plans, objectives, goals,
strategies, future events, or performance, as well as underlying
assumptions and statements that are other than statements of historical
fact. When used in this document, the words "expects," "anticipates,"
"estimates," "plans," "intends," "projects," "predicts," "believes," "may"
or "should," and similar expressions, are intended to identify
forward-looking statements. These statements reflect the current view of
the Company's management with respect to future events. Many factors could
cause the actual results, performance or achievements of the Company to be
materially different from any future results, performance or achievements
that may be expressed or implied by such forward-looking statements,
including, but not limited to, the following:

-- The Company is still in the development stage and has not generated any
revenues. From inception through December 31, 2004, it has incurred net
losses and negative cash flows from operating activities of $8,774,000 and
$7,741,000 respectively. Management believes that the Company will continue
to incur net losses and cash flow deficiencies from operating activities
for the foreseeable future. Because it may take years to develop, test and
obtain regulatory approval for a gene-based therapy product before it can
be sold, the Company likely will continue to incur significant losses for
the foreseeable future. Accordingly, it may never be profitable and, if it
does become profitable, it may be unable to sustain profitability.

-- If the ongoing Phase I clinical trial for treatment of Parkinson's
disease using the Company's NLX technology is unsuccessful, future
operations and the potential for profitability will be significantly
adversely affected and the business may not succeed.

-- Since the Company's existing resources will not be sufficient to enable
the Company to obtain the regulatory approvals necessary to commercialize
its current or future product candidates, it will need to raise additional
funds through public or private equity offerings, debt financings or
additional corporate collaboration and licensing arrangements. Availability
of financing depends upon a number of factors beyond the Company's control,
including market conditions and interest rates. The Company does not know
whether additional financing will be available when needed, or if
available, will be on acceptable or favorable terms to it or its stockholders.

-- There is no assurance as to when, or if, the Company will be able to
successfully complete the required preclinical testing of its gene therapy
for the treatment of epilepsy to enable it to file an Investigational New
Drug Application with the FDA for permission to begin a Phase I safety
trial or that, if filed, such permission will be granted.

Other factors and assumptions not identified above could also cause the
actual results to differ materially from those set forth in the
forward-looking statements. Additional information regarding factors that
could cause results to differ materially from management's expectations is
found in the section entitled "Risk Factors" in the Company's 2004 Annual
Report on Form 10-KSB. Although the Company believes these assumptions are
reasonable, no assurance can be given that they will prove correct.

Accordingly, you should not rely upon forward-looking statements as a
prediction of actual results. Further, the Company undertakes no obligation
to update forward-looking statements after the date they are made or to
conform the statements to actual results or changes in the Company's
expectations.

Contacts


  Neurologix, Inc.
Michael Sorell, 201-592-6451
http://www.neurologix.net
or
Investor Relations Contacts:
Lippert/Heilshorn & Associates, Inc.
Kim Sutton Golodetz ([log in to unmask])
Shayne Payne ([log in to unmask])
212-838-3777

----------------------------------------------------------------------
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December 2003, Week 5
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April 2003, Week 5
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January 2001, Week 2
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December 2000, Week 5
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December 1999, Week 5
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December 1998, Week 5
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December 1997, Week 5
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December 1995, Week 5
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