Celtic Pharma Provides Update on XERECEPT(R) Clinical Program
December 05 2007 - 7:45AM
PR Newswire (US)
EMERYVILLE, Calif., Dec. 5 /PRNewswire-FirstCall/ --
Neurobiological Technologies, Inc. (NASDAQ:NTII) (NTI(R)) today
announced that Celtic Pharmaceutical Holdings L.P. ("Celtic
Pharma") presented interim results for XERECEPT(R) at the Annual
Meeting for the Society of Neuro-Oncology. Paul Freiman, President
and Chief Executive Officer of NTI, stated, "We are pleased with
our continuing involvement in the development of XERECEPT and the
prospects for this drug, which is so urgently needed." On December
4, 2007, Celtic Pharma, which acquired the rights and assets
related to XERECEPT from NTI in November 2005, issued the following
press release: "New York, London and Bermuda, December 4, 2007 -
Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today
reported interim study results for XERECEPT(R) (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(R) 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(R) 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(R) daily for at least 20 weeks. XERECEPT(R) 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(R)
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(R)." "Celtic Pharma
also announced plans to initiate an imaging study, CPDS 0701, to
assess more directly the effects of XERECEPT(R) on PBE. Sequential
brain scans from some glioblastoma patients being treated with
XERECEPT(R) 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(R) 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(R) 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(R) 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(R) 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." NTI sold the worldwide rights and assets related to
XERECEPT to Celtic Pharma in November 2005. NTI is entitled to
receive milestone payments upon the achievement of certain
regulatory objectives and, if XERECEPT, is approved for commercial
sale, NTI is entitled to receive profit-sharing payments on sales
in the United States and royalties on sales elsewhere in the world.
About Neurobiological Technologies, Inc. NTI is specialty
biopharmaceutical company with expertise in identifying and
acquiring promising drug candidates and in designing and managing
late- stage clinical trials for central nervous system conditions.
NTI is currently developing Viprinex(TM) (ancrod), a novel
reperfusion agent that is in pivotal Phase 3 trials for the
treatment of acute ischemic stroke. For more information, please
visit the company's website: http://www.ntii.com/. Forward-Looking
Statements: Except for the historical information contained herein,
the matters discussed in this press release are forward-looking
statements that involve risks and uncertainties, including the
limited control we have over the development and commercialization
of XERECEPT, as well as other risks detailed from time to time in
our Annual Report of Form 10-K and other filings with the
Securities and Exchange Commission. Actual results may differ
materially from those projected. These forward-looking statements
represent our judgment as of the date of the release. We undertake
no obligation to update these forward- looking statements.
DATASOURCE: Neurobiological Technologies, Inc. CONTACT: Paul E.
Freiman, President & CEO of Neurobiological Technologies, Inc.,
+1-510-595-6000 Web site: http://www.ntii.com/
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