Neurologix Announces Successful Completion of First Ever Phase I Gene Therapy Trial for Parkinson's Disease
17 Octobre 2006 - 1:00PM
PR Newswire (US)
Trial Demonstrated Safety and Statistically Significant Improvement
in Both Motor Function and Brain Metabolism at One Year FORT LEE,
N.J., Oct. 17 /PRNewswire-FirstCall/ -- Neurologix, Inc. (OTC:NRGX)
(BULLETIN BOARD: NRGX) , a biotech company engaged in the
development of innovative gene therapies for disorders affecting
the brain and central nervous system, announced today that it has
successfully completed its landmark Phase I trial of gene therapy
for Parkinson's disease with statistically significant results. The
data was presented at the 36th Annual Meeting of the Society of
Neuroscience in Atlanta. In a presentation entitled "Subthalamic
GAD gene transfer improves brain metabolism associated with
clinical recovery in Parkinson's disease," Matthew J. During, MD,
D.Sc. presented findings of the open label, dose escalating,
unilateral trial, which confirmed the safety and tolerability in
all 12 patients studied out to one year. Though efficacy was only
designated as a secondary outcome, the trial also yielded
statistically significant clinical efficacy and neuro-imaging
results. At one year, all 12 patients as a group demonstrated a
clinical improvement of 25% in the Unified Parkinson's Disease
Rating Scale (UPDRS) compared to baseline (p < 0.005). Nine of
the 12 patients showed an average improvement of 37%, and five of
these patients had substantial improvement of between 40% and 65%.
"This gene therapy trial is particularly unique and the clinical
data unusually promising because the treatment was confined to just
one side of the brain," stated Dr. During. In its next trial, the
Company plans to infuse its treatment into both sides of the brain.
Clinical improvement also correlated well to metabolic brain
changes as measured by Positron Emission Tomography (PET) scan. PET
is an imaging method that measures brain metabolism following the
injection of a radioactive analog of glucose (fluorodeoxyglucose).
The PET scan data revealed a significant improvement (p < 0.001)
in brain metabolism on the treated side of the brain as compared to
the untreated side. About the Study: The Phase I trial was
performed at New York-Presbyterian Hospital/Weill Cornell Medical
Center by Michael G. Kaplitt, MD, Ph.D. and Dr. During, both
co-founders of the Company. Drs. Kaplitt and During have
collaborated in research in this field for more than 10 years. All
patients were evaluated neurologically and by PET scan by Drs.
Andrew Feigin and David Eidelberg at North Shore University
Hospital. This was a 12-patient study with four patients in each of
three dose escalating cohorts. All procedures were performed under
local anesthesia and all 12 patients were discharged from the
hospital within 48 hours of the procedure and followed for 12
months. Primary outcomes of the study design, safety and
tolerability, were successfully met. There were no adverse events
reported relating to the treatment. The gene transfer procedure
utilized the AAV (adeno-associated virus) vector, a virus that has
been used safely in a variety of clinical gene therapy trials and
the vehicle that will be used in all of the Company's first
generation products, including epilepsy and Huntington's disease.
In its Parkinson's disease trial, Neurologix used its proprietary
AAV-GAD gene transfer technology ("NLX"). "The Company is very
excited about the results of this trial. We look forward to further
validating these results in the next trial and continuing our
efforts to develop a significant new treatment for Parkinson's
disease worldwide," stated Neurologix Chief Executive Officer and
President John E. Mordock. The Annual Meeting of the Society of
Neuroscience attracts more than 30,000 clinicians and scientists
gathered from around the world to exchange ideas about cutting-edge
research on the brain, spinal cord, and nervous system in science's
fastest growing field, Neuroscience. Neurologix's initial
development efforts are focused on their core gene therapy
technology, NLX, for treating Parkinson's disease, epilepsy and
Huntington's disease. Neurologix is located in Fort Lee, NJ. More
information about the Company can be found on its website,
http://www.neurologix.net/. Cautionary Statement Regarding
Forward-looking Statements This press release includes certain
statements of 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,"
"promises," "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 June 30, 2006,
it incurred net losses and negative cash flows from operating
activities of approximately $17.3 million and $13.2 million,
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. * In order
to obtain the regulatory approvals necessary to commercialize its
current or future product candidates, from time to time the Company
will need to raise 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. * The Company will need to conduct future clinical
trials for treatment of Parkinson's disease using the Company's NLX
technology. If the trials prove unsuccessful, future operations and
the potential for profitability will be materially adversely
affected and the business may not succeed. * 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 2005 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. DATASOURCE: Neurologix, Inc. CONTACT: Marc
Panoff, Chief Financial Officer of Neurologix, Inc.,
+1-201-592-6451, ; or Jennifer Alexander of Stephenson Group,
+1-203-273-1179, , for Neurologix, Inc. Web site:
http://www.neurologix.net/
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