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Celtic Pharma Announces Results of XERECEPT(R) Phase 3 Clinical Program


6/1/2009 11:30:58 AM

EMERYVILLE, Calif., June 1 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) today announced that Celtic Pharmaceutical Holdings L.P. (Celtic Pharma) has announced the results from its Phase 3 Clinical Program for XERECEPT(R) in patients with edema associated with brain tumors and from preclinical studies of XERECEPT in brain tumor models.

NTI sold the worldwide rights and assets related to XERECEPT to Celtic Pharma in November 2005. If Celtic Pharma commercializes XERECEPT, NTI is entitled to receive milestone payments upon the achievement of certain regulatory approvals and NTI is also entitled to receive profit-sharing payments on sales in the United States and royalties on sales elsewhere in the world. If Celtic Pharma sells or licenses the commercialization rights to XERECEPT, NTI is entitled to a percentage of the net proceeds received by Celtic.

NTI has not reviewed the data from the clinical trials or the preclinical studies and cannot independently corroborate the results reported by Celtic Pharma.

The text of Celtic Pharma's press release is as follows:

Celtic Pharma Announces Results of a Phase III Program Evaluating XERECEPT(R) in Patients with Primary and Metastatic Brain Tumors

Administration of XERECEPT(R) in Patients with Cerebral Edema Demonstrated Clinically Significant Reductions in Steroid Usage Compared to Placebo

New Preclinical Studies Indicate XERECEPT(R) May Have Direct Anti-Tumor and Angiogenesis Inhibition Activity

New York, London and Bermuda, June 1, 2009 - Celtic Pharmaceutical Holdings L.P. ("Celtic Pharma") today reported at the American Society of Clinical Oncology meeting in Orlando the results of two randomized double-blind, placebo-controlled Phase III studies of XERECEPT(R) (corticorelin acetate), compared to dexamethasone, the current standard of care in the treatment of cerebral edema associated with brain tumors, and an open-label rollover Phase III study of XERECEPT's long-term safety and effectiveness in these patients. Celtic Pharma believes these studies demonstrate that XERECEPT(R) was well tolerated and enabled clinically significant reductions in corticosteroid use in patients with cerebral edema associated with both primary and metastatic brain tumors. The Company also announced the results of several preclinical studies demonstrating potential anti-tumor and angiogenesis inhibition effects of XERECEPT(R).

"The ability to reduce the use of steroids and concomitant reduction in adverse side effects in the treatment of patients with brain tumors is an important goal," said Lawrence Recht, MD, Professor of Neurology and Neurological Sciences, Stanford University Medical Center. "The results of these late-stage studies are encouraging, both in terms of lowering dexamethasone use over the longer-term and the impact seen in metastatic patients, a large group with limited treatment options. The preclinical tumor model studies indicate that XERECEPT(R) also has anti-tumor activity."

NTI-0303

The results from NTI-0303, a Phase III multi-center, placebo-controlled, randomized clinical study conducted at more than 25 sites in the US and Canada, showed that XERECEPT(R) enabled substantial decreases in steroid usage and its associated side effects in both acute and long-term treatment of patients with edema associated with either primary or metastatic brain tumors. The primary endpoint of this study was a composite of three factors during weeks two through five: a 50 percent reduction in dexamethasone, stable or improved Karnofsky performance status and stable or improved 10-item Neurological Examination Scores. On the primary endpoint (during weeks two through five of treatment), the study demonstrated a strong trend in favor of XERECEPT(R), though it did not reach statistical significance (p=0.1). Placebo patients tolerated a 50 percent reduction in dexamethasone dosing much better than anticipated over this time frame.

However, at weeks two, five, and eight, the XERECEPT(R) treatment group demonstrated an improved overall response rate based on the primary endpoint that was statistically significant at each time point. XERECEPT(R) demonstrated a highly statistically significant (p=0.001) improvement compared to placebo over the twelve weeks of study duration in reducing dexamethasone dose levels. Fifteen percent of patients on XERECEPT(R) were able to reach 0 mg of dexamethasone (p= 0.04) within the twelve week period.

Approximately 20 percent of the patients enrolled in NTI-0303 had metastatic brain tumors (secondary to primary tumors in the breast, lung or elsewhere). In this patient population, the primary and all secondary endpoints achieved a statistically significant advantage for XERECEPT(R) treated patients, exceeding the results observed in the overall patient cohort. This is an important finding given the 360,000 patients diagnosed annually with metastatic brain tumors in North America and Europe; moreover, patient prognosis is very poor and the treatment options are very limited.

In addition, the NTI-0303 trial showed that use of XERECEPT(R) leads to statistically significant reductions in steroid-related adverse events of myopathy (muscle weakness) and Cushingoid syndrome. Specifically, patients demonstrated a statistically significant increase in Ileopsoas muscle strength. These findings show a medically important clinical benefit for patients on XERECEPT(R).

NTI-0501

Results from NTI-0501, a Phase III open label extension study of patients rolling over from the 0302 and 0303 studies, demonstrated the long-term tolerability of XERECEPT(R). Of the 113 patients enrolled, a total of 32 patients have completed one year or more of treatment in the study. Dexamethasone dosing of all patients on study was reduced progressively over time. Patients from the placebo cohort in the blinded studies entered this study with approximately double the mean dexamethasone dosing of patients from the prior active treatment cohort. The patient dosing of dexamethasone was reduced sharply once on XERECEPT(R), such that the difference between the two was no longer significant at 4 weeks. More than 50 percent of patients completing six months on study were able to achieve a virtual or complete elimination of corticosteroid treatment, and to sustain this for extended periods of time. The NTI-0501 study also showed that XERECEPT(R) therapy was well tolerated over extended periods up to two years or more.

"We are delighted to see the results from the three Phase III studies, the analysis of the brain scans from these studies, and the intriguing preclinical data regarding XERECEPT(R)," said Stephen Evans-Freke, co-Managing General Partner of Celtic Pharma. "We are especially interested in the data from the blinded and open-label studies indicating that XERECEPT(R) may offer significant clinical benefit for metastatic patients, given the very poor options available now for this substantial patient population. We look forward to reviewing these results with FDA and their European and Japanese counterparts before determining the forward path for this promising drug."

NTI-0302

NTI-0302, a Phase III randomized, double-blind study comparing XERECEPT(R) to dexamethasone for the control of acute symptoms associated with peritumoral edema, was discontinued due to slow enrollment. The study results from the 37 patients who enrolled show that XERECEPT(R) was as effective as 4mg/day of dexamethasone in the treatment of patients presenting with an acute exacerbation of edema-associated symptoms.

Brain Scans and Preclinical Studies

Celtic Pharma has been able to collect over 500 brain scans from patients on these XERECEPT(R) studies, and has submitted them to an independent center for blinded review. This review is ongoing, and to date the scans from 93 patients have been evaluated. The review indicates 75 percent of these patients with primary and metastatic brain tumors appear to have stable disease after six months of treatment with XERECEPT(R), with nine percent of these patients showing reductions in tumor size of 50 percent or greater.

Celtic Pharma also announced today the results from several preclinical studies of XERECEPT(R) in established brain tumor models, in addition to assessment of angiogenesis inhibition potential. These placebo-controlled studies were conducted at Memorial Sloan Kettering Cancer Center in New York as well as Duke University and the Piedmont Research Center, both in North Carolina. The tumor assessment studies were conducted using both pediatric and adult human brain tumor xenografts. The mouse tumor models demonstrated statistically significant tumor regression and prolongation of survival following treatment with XERECEPT(R). XERECEPT(R) also demonstrated significant dose-related angiogenesis inhibition, comparable in this model, as assessed by the laboratory, to results seen with Sutent.(R) These preclinical findings demonstrate that XERECEPT(R) has direct antitumor and angiogenesis inhibition activity, in these models.

John Mayo, co-Managing General Partner of Celtic Pharma, said "This product has great steroid-sparing potential. The anti tumor effects observed in preclinical studies also open up further valuable market opportunities."

XERECEPT(R) is an investigational new drug under development as a steroid-sparing alternative to dexamethasone for patients with primary and metastatic brain tumors. Dexamethasone is currently the standard treatment for peritumoral brain edema, but is associated with debilitating side effects including diabetes mellitus, hypertension, muscle weakness, bone loss, 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.

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(R) and the ability of Celtic Pharma to obtain regulatory approval for XERECEPT(R). 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.

About Neurobiological Technologies, Inc.

Neurobiological Technologies, Inc. is a biopharmaceutical company historically focused on developing investigational drugs for central nervous system conditions. The company recently terminated development of its most advanced product candidate, Viprinex(TM) (ancrod), which was studied in Phase 3 clinical trials as a potential new drug to treat acute ischemic stroke. NTI has more recently chosen not to extend its early-stage research programs for Huntington's and Alzheimer's diseases. NTI has rights to receive payments from an approved drug for Alzheimer's disease and an investigational drug which has recently completed a Phase 3 trial for brain swelling.

NOTE: Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including our dependence on Celtic Pharma for the development and commercialization of XERECEPT, uncertainties relating to clinical trials and clinical trial results, and risks and uncertainties relating to the regulatory approval process, as well as other risks detailed from time to time in our filings with the Securities and Exchange Commission, including our Annual Report on Form 10-K, as updated periodically in Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Actual results may differ materially from those projected. These forward-looking statements represent our judgment as of the date of the release and we undertake no obligation to update these forward-looking statements.

CONTACT: Matthew M. Loar, CFO, Neurobiological Technologies, Inc.,
+1-510-595-6000

Web site: http://www.ntii.com/
http://www.celticpharma.com/



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