Hamilton, Bermuda--(Marketwire - June 5, 2007) -
CELTIC PHARMA and Neurobiological Technologies report Updated results
from Long-term open-label extension study for Xerecept, and its
clinical develpoment status
New York, London, Bermuda, June 5, 2007 - Celtic Pharma and
Neurobiological Technologies, Inc. (NTII) announced today the results of
an updated ongoing report on the Xerecept 501 open-label Phase III study,
as presented at the annual meeting of the American Society of Clinical
Oncology. Peritumoral edema patients who have participated in one of the
two Phase III, double-blinded, placebo controlled studies currently
underway to assess Xerecept's dexamethasone-sparing potential are given
the option of enrolling in the 501 study. To date a total of 65 patients
have enrolled in the 501 study, including 11 patients who have now been
on Xerecept therapy for more than one year.
The conclusions reported in the abstract of the 501 study are that long-
term Xerecept therapy in these patients appears to be safe and well-
tolerated, and is associated with reduced exposure to dexamethasone
overall, resolution or improvement in associated steroid side effects and
neurological stability or improvement. Since these peer-reviewed
findings are from an open-label study, they may only be used as
supportive data to proof of efficacy and safety from blinded, placebo-
controlled clinical studies.
The report detailed clinical observations including that taking the date
of entry into the 501 study as the baseline, of the first 30 patients to
complete 12 weeks, 20 of them were able to reduce their dexamethasone
dosing and eight of them discontinued dexamethasone altogether. Subsets
of these typically refractory patients for whom reduced or discontinued
dexamethasone therapy would not be expected included 7 out of 9 patients
over 55 years old, 12 out of 17 patients with recurrent brain tumors and
19 out of 25 patients in whom prior attempts to reduce dexamethasone
dosing were unsuccessful.
Celtic Pharma also recently completed an Interim Analysis of the first 100
patients enrolled in the ongoing 303 Phase III study, a double-blinded
placebo-controlled pivotal trial as provided for in the study protocol.
The analysis was limited in scope and no data from it may be released in
order to protect the blinded integrity of the study. The 303 study has
now recruited 160 patients of the 200 patients called for in the study
protocol, and is scheduled to complete in early 2008.
In addition an imaging study will be initiated as soon as possible to
evaluate the ability of Xerecept to reduce tumor-related edema in the
brain. Celtic Pharma plans to initiate this study in the next three
months, with a view to completing it in the spring of 2008. This study
will complete the evaluation of the effects of Xerecept on peritumoral
edema over a range of doses. Depending on the final results of the 303
study and the outcome of the imaging study, Celtic Pharma may initiate a
further pivotal Phase III study in 2008 if required.
"We are encouraged by the growing body of evidence that suggests Xerecept
appears to be safe and effective as a dex-sparing therapy, and look
forward to completing its clinical development," said Stephen Evans-
Freke, Managing General Partner of Celtic Pharma. "The side effects of
high-dose corticosteroid treatment have a devastating effect on the
quality-of-life of these patients and may well also impact their survival
expectancy, so a treatment option that permits a significant reduction in
dexamethasone usage is desperately needed."
Paul Freiman, President and CEO of NTII commented, "We are pleased with
the results to date of the 501 study. The observed data provides us with
a window into the real world effects of Xerecept in an ill patient
population, which we hope will be supported when the Phase III studies
are complete."
For further information on XERECEPT and other studies, please visit
http://www.braintumortrials.com.
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 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
www.celticpharma.com
About Neurobiological Technologies, Inc.
NTI is a biotechnology company engaged in the business of acquiring and
developing central nervous system related drug candidates. The Company is
focused on therapies for neurological conditions that occur in connection
with ischemic stroke, brain cancer, Alzheimer's disease and dementia. The
Company's strategy is to in-license and develop later-stage drug
candidates that target major medical needs and that can be rapidly
commercialized. NTI's experienced management team oversees the human
clinical trials necessary to establish preliminary evidence of efficacy.
For further information, please visit NTI's website at
www.ntii.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 and the ability of Celtic Pharma or
NTI to obtain regulatory approval for XERECEPT, as well other risks
detailed from time to time in NTI's Securities and Exchange Commission
filings. Copies of these filings are available from NTI upon request.
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.
For more information, please contact:
Neurobiological Technologies, Inc.
Paul Freiman
Tel: +1 (510) 595-6000
Celtic Pharma
Kathy Armstrong
Investor Relations
Tel: +1 (212) 616-4042
kathy@celticpharma.com
Media Contacts:
FD
US:
Matt Dallas
Tel: +1 (212) 850-5627
Matt.Dallas@fd.com
UK:
David Yates or Anna Keeble
Tel: +44 (0) 207 267 3113
David.Yates@fd.com
Anna.Keeble@fd.com
This information is provided by RNS
The company news service from the London Stock Exchange