NTII Neurobiological Technologies (MM)

Neurobiological Technologies Initiates Pivotal Phase III Clinical Trial Program of XERECEPT(TM) For Brain Swelling Associated With Brain Tumors - 200 Patients in the U.S. and Canada to Participate in Study - RICHMOND, Calif., April 20 /PRNewswire-FirstCall/ -- Neurobiological Technologies, Inc. (NTI(R)) today announced it has commenced its pivotal Phase III clinical program for XERECEPT(TM) for the treatment of peritumoral cerebral edema. As part of the program, NTI will be conducting two concurrent Phase III studies of XERECEPT, the first of which has begun. This is considered the first controlled study ever for peritumoral brain swelling associated with brain tumors. The first multi-center Phase III, placebo-controlled, randomized clinical study will be conducted at more than 20 sites in the U.S. and Canada and will include approximately 200 patients with peritumoral brain edema who require chronic treatment with steroids (dexamethasone). The primary endpoint of the study will be a 50% reduction in steroid use at the end of the three-week treatment period. If successful, patients may remain on XERECEPT for an additional 12 weeks. "To date, NTI has sponsored five clinical studies of XERECEPT in symptomatic brain tumor patients that have consistently indicated, in a dose- dependent manner, neurological improvement in patients receiving no or stabilized dexamethasone," said Lisa Carr, M.D., Ph.D., vice president, medical affairs at NTI. "We believe XERECEPT could become an important alternative to the often debilitating use of steroids for oncologists in the treatment of peritumoral brain swelling." "The initiation of this first Phase III trial represents an important clinical milestone in the development of XERECEPT," said Paul Freiman, president and chief executive officer of NTI. "We are extremely encouraged by the reception XERECEPT is receiving in the clinical community and look forward to commencing the second multi-center Phase III study in the near future with the expectation of building a strong body of clinical data to support our anticipated NDA filing." The second study is expected to include approximately 120 patients with peritumoral brain edema who are in an acute setting and require treatment with steroids or an increase in steroid usage. XERECEPT has received orphan drug status from the U.S. Food and Drug Administration. For the hundreds of thousands of patients with brain tumors in the U.S., peritumoral cerebral edema is a serious complication that can lead to major physiological and psychological consequences. It is understood that brain tumors promote increased vascular permeability that often results in an excess flow of fluids to the brain tissue, resulting in impaired neurological function and occasionally, when severe enough, irreversible brain damage. Current treatments include high doses of corticosteroids (dexamethasone) that, while effective, are often associated with serious side effects such as muscle wasting, osteoporosis, vision impairment and psychosis -- impairments that can be more debilitating than the neurological deficits directly related to brain swelling. Originally licensed from the Salk Institute in 1988 and clinically developed by NTI, XERECEPT is a synthetic mimic of the naturally occurring human neuroendocrine hormone corticotropin releasing factor, or CRF. Human CRF is primarily produced in the brain and is thought to be a key hormone involved in regulating the release of natural corticosteroids by the pituitary and adrenal glands. XERECEPT is thought to block vascular permeability by inducing upregulation of blood-brain barrier specific structural proteins and is being evaluated as an alternative to dexamethasone for the treatment of peritumoral brain edema. About Neurobiological Technologies, Inc. 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. Except for the historical information contained herein, the matters discussed in this press release are forward-looking statements that involve risks and uncertainties, including, but not limited to, the company's ability to successfully develop and meet regulatory requirements for XERECEPT(TM); design, recruit patients for and complete clinical trials and other risks detailed from time to time in Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward-looking statements represent management's judgment as of the date of the release. The company disclaims, however, any intent or obligation to update these forward-looking statements. DATASOURCE: Neurobiological Technologies, Inc. CONTACT: Paul E. Freiman, President & CEO of Neurobiological Technologies, Inc., +1-510-262-1730; Roger Pondel or Rob Whetstone of PondelWilkinson Inc., +1-323-866-6050, for Neurobiological Technologies, Inc. Web site: http://www.ntii.com/

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