NEW YORK, LONDON, and HAMILTON, Bermuda, November 17 /PRNewswire/ --
Celtic Pharmaceutical Holdings, L.P. (Celtic Pharma) and NeurobiologicalTechnologies Inc. (Nasdaq: NTII) announced today that they presented a posterat the 11th Annual Meeting of the Society For Neuro-Oncology (SNO) takingplace in Orlando, Florida through November 19, 2006. The poster provided aninterim report of an open-label extension study as part of an ongoing PhaseIII clinical program for XERECEPT(R) (corticorelin acetate injection). Theopen-label extension study is evaluating XERECEPT's long-term safety andtolerability as a new potential treatment for peritumoral brain edema (PBE),or tumor-related brain swelling.
XERECEPT is an investigational new drug that may present asteroid-sparing alternative to dexamethasone. Dexamethasone is currently thestandard treatment for PBE, but is associated with debilitating side effectsincluding vision problems, muscle and bone loss, impaired wound healing andopportunistic infections. Preclinical studies have also shown dexamethasonemay increase brain tumor cell resistance to chemotherapy, inhibiting theefficacy of these targeted cancer therapies.
The interim report presented at SNO included 20 subjects who tookcorticorelin acetate for at least 4 weeks in the ongoing extension study. Ofthe subjects, 11 reduced their dexamethasone dosage during the study and 2took no concomitant dexamethasone. Improvement or resolution of steroidrelated conditions was observed in 8 of 18 (45%) of subjects with suchconditions at baseline. Typically refractory subjects whose dexamethasonedose was reduced included subjects who were more than 55 years of age, hadrecurrent brain tumors, or had failed previous attempts at dexamethasonereduction. Several of the patients showing clinical benefit from corticorelinacetate are individuals with metastatic brain tumors originating from aprimary tumor elsewhere in the body. No subject required earlydiscontinuation of treatment due to adverse events related to corticorelinacetate.
The open-label extension study is currently enrolling eligible PBEpatients with primary or secondary (metastatic) brain tumors who havecompleted one of two Phase III randomized, double-blind trials. These trialsare presently enrolling at 21 centers in the U.S. and Canada.
For more information on SNO and the ongoing meeting, please visithttp://www.soc-neuro-onc.org. For further information on XERECEPT and otherstudies, please visit http://www.braintumortrials.com.
About Celtic Pharmaceutical Holdings, L.P.
Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) is a global privateequity investment firm focused on the biotechnology and pharmaceuticalindustries. Celtic Pharma was founded by Stephen Evans-Freke and John MayoCBE and is based in Bermuda, with offices in New York and London. CelticPharma acquires and invests in late stage pharmaceutical programs and managesthese programs through to regulatory approval. Celtic Pharma's aim is tobridge the gap between the established pharmaceutical companies' new productpipeline crisis and the biotech industry's capital drought. For furtherinformation, 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 anddeveloping central nervous system related drug candidates. The Company isfocused on therapies for neurological conditions that occur in connectionwith ischemic stroke, brain cancer, Alzheimer's disease and dementia. TheCompany's strategy is to in-license and develop later-stage drug candidatesthat target major medical needs and that can be rapidly commercialized. NTI'sexperienced management team oversees the human clinical trials necessary toestablish preliminary evidence of efficacy. For further information, pleasevisit 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 includewords such as "may," "expect," "anticipate," "believe," or "plan," or similarstatements, are forward-looking statements that involve risks anduncertainties, including risks relating to the results of the clinical trialsfor XERECEPT and the ability of Celtic Pharma or NTI to obtain regulatoryapproval for XERECEPT, as well other risks detailed from time to time inNTI's Securities and Exchange Commission filings. Copies of these filings areavailable from NTI upon request. Actual results may differ materially fromthose projected. These forward-looking statements represent our judgment asof the date of the release. We disclaim, however, any intent to update theseforward-looking statements.
Web site: http://www.soc-neuro-onc.org http://www.braintumortrials.com http://www.celticpharma.com http://www.ntii.com
Celtic Pharmaceutical Holdings, L.P.
U.S.: Meghan Feeks of Richard Lewis Communications, +1-212-827-0200; or Paul Frieman of Neurobiological Technologies, Inc., +1-510-595-6000; U.K.: David Yates, or Anna Keeble, both of Financial Dynamics, +44(0)20-7831-3113, for Celtic Pharmaceutical Holdings, L.P.
|
|
Copyright © 2006 PR Newswire. All rights reserved.
|
|
|
