Neurobiological Technologies Initiates Pivotal Phase III Clinical Trial Program of XERECEPT(TM) For Brain Swelling Associated Wi
April 20 2004 - 10:00AM
PR Newswire (US)
Neurobiological Technologies Initiates Pivotal Phase III Clinical
Trial Program of XERECEPT(TM) For Brain Swelling Associated With
Brain Tumors - 200 Patients in the U.S. and Canada to Participate
in Study - RICHMOND, Calif., April 20 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NTI(R)) today announced it has
commenced its pivotal Phase III clinical program for XERECEPT(TM)
for the treatment of peritumoral cerebral edema. As part of the
program, NTI will be conducting two concurrent Phase III studies of
XERECEPT, the first of which has begun. This is considered the
first controlled study ever for peritumoral brain swelling
associated with brain tumors. The first multi-center Phase III,
placebo-controlled, randomized clinical study will be conducted at
more than 20 sites in the U.S. and Canada and will include
approximately 200 patients with peritumoral brain edema who require
chronic treatment with steroids (dexamethasone). The primary
endpoint of the study will be a 50% reduction in steroid use at the
end of the three-week treatment period. If successful, patients may
remain on XERECEPT for an additional 12 weeks. "To date, NTI has
sponsored five clinical studies of XERECEPT in symptomatic brain
tumor patients that have consistently indicated, in a dose-
dependent manner, neurological improvement in patients receiving no
or stabilized dexamethasone," said Lisa Carr, M.D., Ph.D., vice
president, medical affairs at NTI. "We believe XERECEPT could
become an important alternative to the often debilitating use of
steroids for oncologists in the treatment of peritumoral brain
swelling." "The initiation of this first Phase III trial represents
an important clinical milestone in the development of XERECEPT,"
said Paul Freiman, president and chief executive officer of NTI.
"We are extremely encouraged by the reception XERECEPT is receiving
in the clinical community and look forward to commencing the second
multi-center Phase III study in the near future with the
expectation of building a strong body of clinical data to support
our anticipated NDA filing." The second study is expected to
include approximately 120 patients with peritumoral brain edema who
are in an acute setting and require treatment with steroids or an
increase in steroid usage. XERECEPT has received orphan drug status
from the U.S. Food and Drug Administration. For the hundreds of
thousands of patients with brain tumors in the U.S., peritumoral
cerebral edema is a serious complication that can lead to major
physiological and psychological consequences. It is understood that
brain tumors promote increased vascular permeability that often
results in an excess flow of fluids to the brain tissue, resulting
in impaired neurological function and occasionally, when severe
enough, irreversible brain damage. Current treatments include high
doses of corticosteroids (dexamethasone) that, while effective, are
often associated with serious side effects such as muscle wasting,
osteoporosis, vision impairment and psychosis -- impairments that
can be more debilitating than the neurological deficits directly
related to brain swelling. Originally licensed from the Salk
Institute in 1988 and clinically developed by NTI, XERECEPT is a
synthetic mimic of the naturally occurring human neuroendocrine
hormone corticotropin releasing factor, or CRF. Human CRF is
primarily produced in the brain and is thought to be a key hormone
involved in regulating the release of natural corticosteroids by
the pituitary and adrenal glands. XERECEPT is thought to block
vascular permeability by inducing upregulation of blood-brain
barrier specific structural proteins and is being evaluated as an
alternative to dexamethasone for the treatment of peritumoral brain
edema. About Neurobiological Technologies, Inc. NTI is an emerging
drug development company focused on the clinical evaluation and
regulatory approval of neuroscience drugs. The company's strategy
is to in-license and develop early-and later-stage drug candidates
that target major medical needs and which can be rapidly
commercialized. The company's experienced management team oversees
the human clinical trials necessary to establish preliminary
evidence of efficacy and seeks partnerships with pharmaceutical and
biotechnology companies to complete development and marketing of
its product candidates. Except for the historical information
contained herein, the matters discussed in this press release are
forward-looking statements that involve risks and uncertainties,
including, but not limited to, the company's ability to
successfully develop and meet regulatory requirements for
XERECEPT(TM); design, recruit patients for and complete clinical
trials and other risks detailed from time to time in Securities and
Exchange Commission filings. Actual results may differ materially
from those projected. These forward-looking statements represent
management's judgment as of the date of the release. The company
disclaims, however, any intent or obligation to update these
forward-looking statements. DATASOURCE: Neurobiological
Technologies, Inc. CONTACT: Paul E. Freiman, President & CEO of
Neurobiological Technologies, Inc., +1-510-262-1730; Roger Pondel
or Rob Whetstone of PondelWilkinson Inc., +1-323-866-6050, for
Neurobiological Technologies, Inc. Web site: http://www.ntii.com/
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