Celtic Pharma Reports Data Presented at Society for Neuro-Oncology
Annual Meeting and Provides Update on XERECEPT®
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 12 th 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
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