SOURCE: Celtic Pharma

June 05, 2007 07:50 ET

Celtic Pharma announces Research Update

Hamilton, Bermuda--(Marketwire - June 5, 2007) -

  CELTIC PHARMA and Neurobiological Technologies report Updated results 
      from Long-term open-label extension study for Xerecept, and its 
                       clinical develpoment status

New York, London, Bermuda, June 5, 2007 - Celtic Pharma and Neurobiological Technologies, Inc. (NTII) announced today the results of an updated ongoing report on the Xerecept 501 open-label Phase III study, as presented at the annual meeting of the American Society of Clinical Oncology. Peritumoral edema patients who have participated in one of the two Phase III, double-blinded, placebo controlled studies currently underway to assess Xerecept's dexamethasone-sparing potential are given the option of enrolling in the 501 study. To date a total of 65 patients have enrolled in the 501 study, including 11 patients who have now been on Xerecept therapy for more than one year.

The conclusions reported in the abstract of the 501 study are that long- term Xerecept therapy in these patients appears to be safe and well- tolerated, and is associated with reduced exposure to dexamethasone overall, resolution or improvement in associated steroid side effects and neurological stability or improvement. Since these peer-reviewed findings are from an open-label study, they may only be used as supportive data to proof of efficacy and safety from blinded, placebo- controlled clinical studies.

The report detailed clinical observations including that taking the date of entry into the 501 study as the baseline, of the first 30 patients to complete 12 weeks, 20 of them were able to reduce their dexamethasone dosing and eight of them discontinued dexamethasone altogether. Subsets of these typically refractory patients for whom reduced or discontinued dexamethasone therapy would not be expected included 7 out of 9 patients over 55 years old, 12 out of 17 patients with recurrent brain tumors and 19 out of 25 patients in whom prior attempts to reduce dexamethasone dosing were unsuccessful.

Celtic Pharma also recently completed an Interim Analysis of the first 100 patients enrolled in the ongoing 303 Phase III study, a double-blinded placebo-controlled pivotal trial as provided for in the study protocol. The analysis was limited in scope and no data from it may be released in order to protect the blinded integrity of the study. The 303 study has now recruited 160 patients of the 200 patients called for in the study protocol, and is scheduled to complete in early 2008.

In addition an imaging study will be initiated as soon as possible to evaluate the ability of Xerecept to reduce tumor-related edema in the brain. Celtic Pharma plans to initiate this study in the next three months, with a view to completing it in the spring of 2008. This study will complete the evaluation of the effects of Xerecept on peritumoral edema over a range of doses. Depending on the final results of the 303 study and the outcome of the imaging study, Celtic Pharma may initiate a further pivotal Phase III study in 2008 if required.

"We are encouraged by the growing body of evidence that suggests Xerecept appears to be safe and effective as a dex-sparing therapy, and look forward to completing its clinical development," said Stephen Evans- Freke, Managing General Partner of Celtic Pharma. "The side effects of high-dose corticosteroid treatment have a devastating effect on the quality-of-life of these patients and may well also impact their survival expectancy, so a treatment option that permits a significant reduction in dexamethasone usage is desperately needed."

Paul Freiman, President and CEO of NTII commented, "We are pleased with the results to date of the 501 study. The observed data provides us with a window into the real world effects of Xerecept in an ill patient population, which we hope will be supported when the Phase III studies are complete."

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

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.

For more information, please contact:

Neurobiological Technologies, Inc.
Paul Freiman
Tel: +1 (510) 595-6000

Celtic Pharma
Kathy Armstrong
Investor Relations
Tel: +1 (212) 616-4042
kathy@celticpharma.com

Media Contacts:
    
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UK:

David Yates or Anna Keeble
Tel: +44 (0) 207 267 3113
David.Yates@fd.com
Anna.Keeble@fd.com



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