Healthcare Industry News: Alzheimer's
News Release - November 17, 2006
Celtic Pharma and Neurobiological Technologies Present an Update on XERECEPT(R) for Peritumoral Brain Edema at the 11th Annual Meeting of the Society for Neuro-OncologyEMERYVILLE, Calif., Nov. 17 (HSMN NewsFeed) -- 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® (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 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 www.ntii.com .
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.
Source: Neurobiological Technologies
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