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 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.
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, 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
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.
SOURCE Neurologix, Inc.
CONTACT: Marc Panoff, Chief Financial Officer of Neurologix, Inc.,
+1-201-592-6451, email@example.com; or Jennifer Alexander of
Stephenson Group, +1-203-273-1179, firstname.lastname@example.org, for
/Web site: http://www.neurologix.net /