Neurobiological Technologies' Partner, Celtic Pharma, Announces Results of XERECEPT(R) Phase 3 Clinical Program
01 Juni 2009 - 2:30PM
PR Newswire (US)
EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NASDAQ:NTII) (NTI(R)) today
announced that Celtic Pharmaceutical Holdings L.P. (Celtic Pharma)
has announced the results from its Phase 3 Clinical Program for
XERECEPT(R) in patients with edema associated with brain tumors and
from preclinical studies of XERECEPT in brain tumor models. NTI
sold the worldwide rights and assets related to XERECEPT to Celtic
Pharma in November 2005. If Celtic Pharma commercializes XERECEPT,
NTI is entitled to receive milestone payments upon the achievement
of certain regulatory approvals and NTI is also entitled to receive
profit-sharing payments on sales in the United States and royalties
on sales elsewhere in the world. If Celtic Pharma sells or licenses
the commercialization rights to XERECEPT, NTI is entitled to a
percentage of the net proceeds received by Celtic. NTI has not
reviewed the data from the clinical trials or the preclinical
studies and cannot independently corroborate the results reported
by Celtic Pharma. The text of Celtic Pharma's press release is as
follows: Celtic Pharma Announces Results of a Phase III Program
Evaluating XERECEPT(R) in Patients with Primary and Metastatic
Brain Tumors Administration of XERECEPT(R) in Patients with
Cerebral Edema Demonstrated Clinically Significant Reductions in
Steroid Usage Compared to Placebo New Preclinical Studies Indicate
XERECEPT(R) May Have Direct Anti-Tumor and Angiogenesis Inhibition
Activity New York, London and Bermuda, June 1, 2009 - Celtic
Pharmaceutical Holdings L.P. ("Celtic Pharma") today reported at
the American Society of Clinical Oncology meeting in Orlando the
results of two randomized double-blind, placebo-controlled Phase
III studies of XERECEPT(R) (corticorelin acetate), compared to
dexamethasone, the current standard of care in the treatment of
cerebral edema associated with brain tumors, and an open-label
rollover Phase III study of XERECEPT's long-term safety and
effectiveness in these patients. Celtic Pharma believes these
studies demonstrate that XERECEPT(R) was well tolerated and enabled
clinically significant reductions in corticosteroid use in patients
with cerebral edema associated with both primary and metastatic
brain tumors. The Company also announced the results of several
preclinical studies demonstrating potential anti-tumor and
angiogenesis inhibition effects of XERECEPT(R). "The ability to
reduce the use of steroids and concomitant reduction in adverse
side effects in the treatment of patients with brain tumors is an
important goal," said Lawrence Recht, MD, Professor of Neurology
and Neurological Sciences, Stanford University Medical Center. "The
results of these late-stage studies are encouraging, both in terms
of lowering dexamethasone use over the longer-term and the impact
seen in metastatic patients, a large group with limited treatment
options. The preclinical tumor model studies indicate that
XERECEPT(R) also has anti-tumor activity." NTI-0303 The results
from NTI-0303, a Phase III multi-center, placebo-controlled,
randomized clinical study conducted at more than 25 sites in the US
and Canada, showed that XERECEPT(R) enabled substantial decreases
in steroid usage and its associated side effects in both acute and
long-term treatment of patients with edema associated with either
primary or metastatic brain tumors. The primary endpoint of this
study was a composite of three factors during weeks two through
five: a 50 percent reduction in dexamethasone, stable or improved
Karnofsky performance status and stable or improved 10-item
Neurological Examination Scores. On the primary endpoint (during
weeks two through five of treatment), the study demonstrated a
strong trend in favor of XERECEPT(R), though it did not reach
statistical significance (p=0.1). Placebo patients tolerated a 50
percent reduction in dexamethasone dosing much better than
anticipated over this time frame. However, at weeks two, five, and
eight, the XERECEPT(R) treatment group demonstrated an improved
overall response rate based on the primary endpoint that was
statistically significant at each time point. XERECEPT(R)
demonstrated a highly statistically significant (p=0.001)
improvement compared to placebo over the twelve weeks of study
duration in reducing dexamethasone dose levels. Fifteen percent of
patients on XERECEPT(R) were able to reach 0 mg of dexamethasone
(p= 0.04) within the twelve week period. Approximately 20 percent
of the patients enrolled in NTI-0303 had metastatic brain tumors
(secondary to primary tumors in the breast, lung or elsewhere). In
this patient population, the primary and all secondary endpoints
achieved a statistically significant advantage for XERECEPT(R)
treated patients, exceeding the results observed in the overall
patient cohort. This is an important finding given the 360,000
patients diagnosed annually with metastatic brain tumors in North
America and Europe; moreover, patient prognosis is very poor and
the treatment options are very limited. In addition, the NTI-0303
trial showed that use of XERECEPT(R) leads to statistically
significant reductions in steroid-related adverse events of
myopathy (muscle weakness) and Cushingoid syndrome. Specifically,
patients demonstrated a statistically significant increase in
Ileopsoas muscle strength. These findings show a medically
important clinical benefit for patients on XERECEPT(R). NTI-0501
Results from NTI-0501, a Phase III open label extension study of
patients rolling over from the 0302 and 0303 studies, demonstrated
the long-term tolerability of XERECEPT(R). Of the 113 patients
enrolled, a total of 32 patients have completed one year or more of
treatment in the study. Dexamethasone dosing of all patients on
study was reduced progressively over time. Patients from the
placebo cohort in the blinded studies entered this study with
approximately double the mean dexamethasone dosing of patients from
the prior active treatment cohort. The patient dosing of
dexamethasone was reduced sharply once on XERECEPT(R), such that
the difference between the two was no longer significant at 4
weeks. More than 50 percent of patients completing six months on
study were able to achieve a virtual or complete elimination of
corticosteroid treatment, and to sustain this for extended periods
of time. The NTI-0501 study also showed that XERECEPT(R) therapy
was well tolerated over extended periods up to two years or more.
"We are delighted to see the results from the three Phase III
studies, the analysis of the brain scans from these studies, and
the intriguing preclinical data regarding XERECEPT(R)," said
Stephen Evans-Freke, co-Managing General Partner of Celtic Pharma.
"We are especially interested in the data from the blinded and
open-label studies indicating that XERECEPT(R) may offer
significant clinical benefit for metastatic patients, given the
very poor options available now for this substantial patient
population. We look forward to reviewing these results with FDA and
their European and Japanese counterparts before determining the
forward path for this promising drug." NTI-0302 NTI-0302, a Phase
III randomized, double-blind study comparing XERECEPT(R) to
dexamethasone for the control of acute symptoms associated with
peritumoral edema, was discontinued due to slow enrollment. The
study results from the 37 patients who enrolled show that
XERECEPT(R) was as effective as 4mg/day of dexamethasone in the
treatment of patients presenting with an acute exacerbation of
edema-associated symptoms. Brain Scans and Preclinical Studies
Celtic Pharma has been able to collect over 500 brain scans from
patients on these XERECEPT(R) studies, and has submitted them to an
independent center for blinded review. This review is ongoing, and
to date the scans from 93 patients have been evaluated. The review
indicates 75 percent of these patients with primary and metastatic
brain tumors appear to have stable disease after six months of
treatment with XERECEPT(R), with nine percent of these patients
showing reductions in tumor size of 50 percent or greater. Celtic
Pharma also announced today the results from several preclinical
studies of XERECEPT(R) in established brain tumor models, in
addition to assessment of angiogenesis inhibition potential. These
placebo-controlled studies were conducted at Memorial Sloan
Kettering Cancer Center in New York as well as Duke University and
the Piedmont Research Center, both in North Carolina. The tumor
assessment studies were conducted using both pediatric and adult
human brain tumor xenografts. The mouse tumor models demonstrated
statistically significant tumor regression and prolongation of
survival following treatment with XERECEPT(R). XERECEPT(R) also
demonstrated significant dose-related angiogenesis inhibition,
comparable in this model, as assessed by the laboratory, to results
seen with Sutent.(R) These preclinical findings demonstrate that
XERECEPT(R) has direct antitumor and angiogenesis inhibition
activity, in these models. John Mayo, co-Managing General Partner
of Celtic Pharma, said "This product has great steroid-sparing
potential. The anti tumor effects observed in preclinical studies
also open up further valuable market opportunities." XERECEPT(R) is
an investigational new drug under development as a steroid-sparing
alternative to dexamethasone for patients with primary and
metastatic brain tumors. Dexamethasone is currently the standard
treatment for peritumoral brain edema, but is associated with
debilitating side effects including diabetes mellitus,
hypertension, muscle weakness, bone loss, impaired wound healing
and opportunistic infections. About Celtic Pharmaceutical Holdings
L.P. Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a
global private equity investment firm focused on the biotechnology
and pharmaceutical industries. Celtic Pharma was founded by Stephen
Evans-Freke and John Mayo, CBE and is based in Bermuda, with
offices in New York and London. Celtic Pharma acquires and invests
in late stage pharmaceutical programs and manages these programs
through their development to regulatory approval. Celtic Pharma's
aim is to bridge the gap between the established pharmaceutical
companies' new product pipeline crisis and the biotech industry's
capital drought. For further information, please visit Celtic
Pharma's website at http://www.celticpharma.com/. Forward-Looking
Statements Certain statements in this press release that are not
historical facts, including statements that are preceded by, or
followed by, or that include words such as "may," "expect,"
"anticipate," "believe," or "plan," or similar statements, are
forward-looking statements that involve risks and uncertainties,
including risks relating to the results of the clinical trials for
XERECEPT(R) and the ability of Celtic Pharma to obtain regulatory
approval for XERECEPT(R). Actual results may differ materially from
those projected. These forward-looking statements represent our
judgment as of the date of the release. We disclaim, however, any
intent to update these forward-looking statements. About
Neurobiological Technologies, Inc. Neurobiological Technologies,
Inc. is a biopharmaceutical company historically focused on
developing investigational drugs for central nervous system
conditions. The company recently terminated development of its most
advanced product candidate, Viprinex(TM) (ancrod), which was
studied in Phase 3 clinical trials as a potential new drug to treat
acute ischemic stroke. NTI has more recently chosen not to extend
its early-stage research programs for Huntington's and Alzheimer's
diseases. NTI has rights to receive payments from an approved drug
for Alzheimer's disease and an investigational drug which has
recently completed a Phase 3 trial for brain swelling. NOTE: Except
for the historical information contained herein, the matters
discussed in this press release are forward-looking statements that
involve risks and uncertainties, including our dependence on Celtic
Pharma for the development and commercialization of XERECEPT,
uncertainties relating to clinical trials and clinical trial
results, and risks and uncertainties relating to the regulatory
approval process, as well as other risks detailed from time to time
in our filings with the Securities and Exchange Commission,
including our Annual Report on Form 10-K, as updated periodically
in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K.
Actual results may differ materially from those projected. These
forward-looking statements represent our judgment as of the date of
the release and we undertake no obligation to update these
forward-looking statements. DATASOURCE: Neurobiological
Technologies, Inc. CONTACT: Matthew M. Loar, CFO, Neurobiological
Technologies, Inc., +1-510-595-6000 Web Site: http://www.ntii.com/
http://www.celticpharma.com/
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