Celtic Pharma Reports Data Presented at Society for Neuro-Oncology Annual Meeting and Provides Update on Xerecept Clinical Program
NEW YORK, LONDON AND BERMUDA, December 4, 2007 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today reported interim study results for Xerecept (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 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.
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 their development 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 <http://www.celticpharma.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(r) and the ability of Celtic Pharma or Neurobiological Technologies, Inc. (NASDAQ: NTII) ("NTI") to obtain regulatory approval for XERECEPT(r), 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.
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Posted: December 2007