Hamilton, Bermuda--(Marketwire - December 4, 2007) -
Celtic Pharma Reports Data Presented at Society for Neuro-Oncology Annual
Meeting and Provides Update on XERECEPT(R) Clinical Program
New York, London and Bermuda, December 4, 2007 - Celtic Pharmaceutical Holdings
L.P. ("Celtic Pharma") today reported interim study results for XERECEPT®
(human corticotropin-releasing factor (hCRF)), which were presented at the 12th
Annual Meeting of the Society for Neuro-Oncology ("SNO"), and provided an update
on the XERECEPT® clinical development program.
In a poster presentation at the SNO annual meeting, which took place in Dallas,
Texas on November 15-18, 2007, Celtic Pharma disclosed interim results of an
on-going, open-label extension trial, which is evaluating the long-term safety
and efficacy of XERECEPT® as a new potential treatment for Peritumoral Brain
Edema ("PBE"), or tumor-related brain swelling. The data presented at SNO
demonstrated that 20 of the first 32 patients enrolled received XERECEPT®
daily for at least 20 weeks. XERECEPT® was well-tolerated. Nine of the 20
patients discontinued dexamethasone altogether, and steroid side effects were
resolved or improved in the majority of patients who received a reduced
dexamethasone dose. The trial is currently enrolling eligible patients with
primary or secondary (metastatic) brain tumors who have already completed one of
two Phase III randomized, double-blind trials of XERECEPT® currently underway
at 27 centers in the U.S., Canada, Australia and New Zealand.
"Side effects of high-dose corticosteroid treatment have a devastating effect on
quality-of-life and potentially on life expectancy, and any option that
significantly reduces the use of dexamethasone would be a major benefit to
patients," said Dr. Patrick O'Connor, Head of Clinical Development at Celtic
Pharma. "The interim data presented at SNO are promising and we remain
optimistic about the prospects for XERECEPT®."
Celtic Pharma also announced plans to initiate an imaging study, CPDS 0701, to
assess more directly the effects of XERECEPT® on PBE. Sequential brain scans
from some glioblastoma patients being treated with XERECEPT® suggest reduction
of edema. The imaging study will aim to establish whether this observation can
be substantiated over a larger patient population. The multicenter, open-label,
randomized study will investigate the efficacy and safety of XERECEPT® for the
reduction of PBE in patients with primary or metastatic brain tumors. The study
is targeted to begin enrolling patients in early 2008 at investigational sites
in the United States and Canada.
Separately, Celtic Pharma announced the discontinuation of enrollment in study
NTI 0302, a Phase III randomized, double-blind study comparing XERECEPT® to
dexamethasone in first line treatment of symptoms associated with PBE in
patients newly diagnosed with primary malignant glioma. The decision to
discontinue enrollment for this trial was due to slower than anticipated
recruitment and Celtic Pharma's conclusion that the new CPDS 0701 imaging study
would be a more important contributor to the overall robustness of the XERECEPT
® development program. No safety issues prompted this decision. The decision
is unrelated to the on-going NTI 0303 Phase III study, which is now close to
completing recruitment and is expected to reach final data analysis and
conclusions in 2008.
XERECEPT® is an investigational new drug that may present a steroid-sparing
alternative to dexamethasone. Dexamethasone is the only treatment currently
available for PBE, but this corticosteroid is associated with debilitating side
effects, including vision problems, muscle and bone loss, irritability, 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
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®
and the ability of Celtic Pharma or Neurobiological Technologies, Inc. (NASDAQ:
NTII) ("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.
Please Contact With Enquiries:
Celtic Pharma
Michael Earl
Managing Director - Commercial
Tel: +44 (0)207 291 5458
michael.earl@dev.celticpharma.com
Kathy Armstrong
Investor Relations
Tel: +1 (212) 616-4042
kathy@celticpharma.com
Media Contacts:
FD
US:
Jonathan Birt
Tel: +1 (212) 850-5634
jonathan.birt@fd.com
UK:
David Yates / Emma Thompson
Tel: +44 (0) 207 831 3113
david.yates@fd.com
This information is provided by RNS
The company news service from the London Stock Exchange