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Neurobiological Technologies, Inc. Announces Holding of Investigators Meeting For Phase III Trials for XERECEPT(TM)


Posted on: 12/15/2003

Press Release Source: Neurobiological Technologies, Inc.

Neurobiological Technologies, Inc. Announces Holding of Investigators Meeting For Phase III Trials for XERECEPT(TM)

Monday December 15, 8:06 am ET

RICHMOND, Calif., Dec. 15 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc., or NTIĀ®, (Nasdaq: NTII - News) today announced that it held an Investigators Meeting on December 12 that included investigators from the more than twenty sites in the United States and Canada that will be participating in the Phase III clinical trial program of XERECEPT for peritumoral brain edema. The Company has completed the manufacturing of trial drug material and expects to ship the drug in January 2004 to trial sites. XERECEPT(TM) is a synthetic preparation of the naturally occurring peptide, corticotrophin-releasing hormone (CRH). XERECEPT(TM) has received an orphan drug designation from the U.S. Food and Drug Administration (FDA).

Mr. Paul Freiman, President and Chief Executive Officer of NTI said, "While we had hoped to begin actually enrolling patients and dosing by the end of 2003, we believe that we will be able to do so early in 2004 as final steps are taken to prepare for the initiation of the trials." Mr. Freiman added, "This drug bears the potential of being an important adjuvant in the treatment of brain cancer and we look forward to the program progressing and advancing towards a New Drug Application (NDA) submission with the FDA in early 2006."

Dr. Lisa Carr, Vice President of Medical Affairs of NTI said, "The neurological deficits that most brain tumor patients experience due to the swelling around the tumor site can, in many instances, be just as debilitating as the effects of the brain tumor itself. XERECEPT(TM) offers a potentially safer alternative to the current course of therapy and therefore may allow patients to avoid or minimize the devastating side effects associated with treating peritumoral brain edema with corticosteroids."

Currently, 359,000 patients are estimated to be living with brain tumors in the United States, with an estimated 39,550 new primary brain tumor cases diagnosed in the U.S. in 2002 and an estimated 170,000 metastatic brain tumors diagnosed in the U.S. in 2002. A common and serious complication of malignant brain tumors is cerebral edema, swelling in the brain. In brain tumor patients, the tumor promotes increased permeability of small blood vessels in the brain, resulting in fluid flow into the brain, swelling of brain tissue and consequent loss of neurological function. For more than 30 years, corticosteroids have been used to treat the symptoms of peritumoral brain edema despite the detrimental side effects associated with chronic use, including muscle wasting, osteoporosis, hyperglycemia, vision problems, and psychosis. NTI has shown clinical evidence in past trials that XERECEPT(TM) may be a safer treatment than synthetic corticosteroids.

NTI is an emerging drug development company focused on the clinical evaluation and regulatory approval of neuroscience drugs. The Company's strategy is to in-license and develop early- and later-stage drug candidates that target major medical needs and which can be rapidly commercialized. The Company's experienced management team oversees the human clinical trials necessary to establish preliminary evidence of efficacy and seeks partnerships with pharmaceutical and biotechnology companies to complete development and marketing of its product candidates.

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 ability to develop and meet regulatory requirements for XERECEPT(TM); the inherent risk of failure in developing product candidates based on new technologies and other risks detailed from time to time in our Securities and Exchange Commission filings. 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 or obligation to update these forward-looking statements.

-------------------------------------------------------------------------------- Source: Neurobiological Technologies, Inc.


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