Celtic Pharma and Neurobiological Technologies Present an Update on XERECEPT(R) for Peritumoral Brain Edema at the 11th Annual M
November 17 2006 - 10:17AM
PR Newswire (US)
EMERYVILLE, Calif., Nov. 17 /PRNewswire-FirstCall/ -- Celtic
Pharmaceutical Holdings, L.P. (Celtic Pharma) and Neurobiological
Technologies Inc. (NASDAQ:NTII) announced today that they presented
a poster at the 11th Annual Meeting of the Society For
Neuro-Oncology (SNO) taking place in Orlando, Florida through
November 19, 2006. The poster provided an interim report of an
open-label extension study as part of an ongoing Phase III clinical
program for XERECEPT(R) (corticorelin acetate injection). The
open-label extension study is evaluating XERECEPT's long-term
safety and tolerability as a new potential treatment for
peritumoral brain edema (PBE), or tumor-related brain swelling.
XERECEPT is an investigational new drug that may present a
steroid-sparing alternative to dexamethasone. Dexamethasone is
currently the standard treatment for PBE, but is associated with
debilitating side effects including vision problems, muscle and
bone loss, impaired wound healing and opportunistic infections.
Preclinical studies have also shown dexamethasone may increase
brain tumor cell resistance to chemotherapy, inhibiting the
efficacy of these targeted cancer therapies. The interim report
presented at SNO included 20 subjects who took corticorelin acetate
for at least 4 weeks in the ongoing extension study. Of the
subjects, 11 reduced their dexamethasone dosage during the study
and 2 took no concomitant dexamethasone. Improvement or resolution
of steroid related conditions was observed in 8 of 18 (45%) of
subjects with such conditions at baseline. Typically refractory
subjects whose dexamethasone dose was reduced included subjects who
were more than 55 years of age, had recurrent brain tumors, or had
failed previous attempts at dexamethasone reduction. Several of the
patients showing clinical benefit from corticorelin acetate are
individuals with metastatic brain tumors originating from a primary
tumor elsewhere in the body. No subject required early
discontinuation of treatment due to adverse events related to
corticorelin acetate. The open-label extension study is currently
enrolling eligible PBE patients with primary or secondary
(metastatic) brain tumors who have completed one of two Phase III
randomized, double-blind trials. These trials are presently
enrolling at 21 centers in the U.S. and Canada. For more
information on SNO and the ongoing meeting, please visit
http://www.soc-neuro-onc.org/ . 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 http://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 http://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.
DATASOURCE: Neurobiological Technologies Inc. CONTACT: U.S., Meghan
Feeks of Richard Lewis Communication, +1-212-827-0200, or Paul
Frieman, +1-510-595-6000, for Neurobiological Technologies, Inc.;
or U.K., David Yates or Anna Keeble, both of Financial Dynamics,
+44-0-20-7831-3113 Web site: http://www.ntii.com/
http://www.celticpharma.com/
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