FORT LEE, N.J., Dec 13, 2007 (BUSINESS WIRE) -- Neurologix, Inc. (OTCBB:NRGX), a biotech company engaged in the
research and development of innovative gene therapies for the brain
and central nervous system, announced today that the U.S. Food and
Drug Administration has granted Fast Track Designation for the
company's experimental gene transfer procedure for the treatment of
advanced Parkinson's disease.
The Neurologix procedure delivers a gene (glutamic acid
decarboxylase, or GAD) to the subthalamic nucleus of the brain, where
it makes an inhibitory neurotransmitter called GABA that helps to
quiet the abnormal brain activity that is correlated with motor
deficits characterizing Parkinson's disease. Results of a Phase 1
clinical study showed that the Neurologix gene transfer procedure was
both well tolerated and resulted in improved motor function and brain
metabolism for patients with advanced Parkinson's disease over the
course of the one-year study. Neurologix is currently preparing to
initiate a Phase 2 study of its Parkinson's disease treatment by early
2008, subject to final FDA consent to the study protocol.
"The FDA's Fast Track Designation for this gene transfer procedure
for Parkinson's disease recognizes the need for new therapies for
patients with advanced Parkinson's disease who no longer receive
adequate benefit from their drug therapies alone," said John Mordock,
President and Chief Executive Officer of Neurologix.
Under the FDA Modernization Act of 1997, Fast Track Designation
may facilitate the development and expedite the review of a drug
candidate that is intended for the treatment of a serious
life-threatening condition and demonstrates the potential to address
an unmet medical need for such a condition. Fast Track Designation
will provide various means to expedite the development and review of
the Neurologix gene transfer procedure for Parkinson's disease,
including the facilitation of meetings and other correspondence with
FDA reviewers, consideration for priority review, and the ability to
submit portions of a Biologics License Application (BLA) early for
review as part of a "rolling" submission. The receipt of Fast Track
Designation does not, however, assure the approval of any of
Neurologix's study protocols or the ultimate approval of any BLA that
may be submitted by Neurologix to FDA for marketing approval.
Neurologix, Inc. (NRGX.OB) is a clinical-stage biotechnology
company dedicated to the discovery, development, and commercialization
of life-altering gene transfer therapies for serious disorders of the
brain and Central Nervous System (CNS). Neurologix's therapeutic
approach is built upon the groundbreaking research of its scientific
founders and advisors, whose accomplishments have formed the
foundation of gene therapy for neurological illnesses. Current company
programs address such conditions as Parkinson's disease, epilepsy and
Huntington's chorea, all of which are large markets not adequately
served by current therapeutic options. For more information, please
visit the Neurologix website at http://www.neurologix.net.
Cautionary Statement Regarding Forward-looking Statements
This news 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 a development-stage company and has not generated
any revenues. From inception through September 30, 2007, it incurred
net losses and negative cash flows from operating activities of
approximately $26.2 million and $20.3 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
In addition to the recently completed financing, 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 receive approval from the FDA on its Investigational
New Drug Application to commence a Phase I safety trial for the
treatment of epilepsy.
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 2006 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
SOURCE: Neurologix, Inc.
Marc Panoff, 201-592-6451
Chief Financial Officer, Treasurer and Secretary
Joan Kureczka, 415-821-2413 (Media)