The following press release was issued today:
Neurobiological Technologies, Inc. Applies for Orphan Drug Status of Xerecept(TM)
Potential Treatment for 100,000 Patients With Brain Tumors
RICHMOND, Calif., Sept. 18 /PRNewswire/ -- Neurobiological Technologies,
Inc. (Nasdaq symbol: NTII) has submitted an application with the U.S. Food and Drug Administration for orphan drug status of Xerecept for the indication of peritumoral brain edema, announced Paul Freiman, president and chief executive officer.
Peritumoral brain edema, or swelling in the brain caused by a tumor, is a serious condition affecting approximately 100,000 patients in the U.S. with brain cancer. In these patients, swelling of brain tissue frequently leads to impairment of neurological functioning, resulting in seizures, difficulty in movement, lack of coordination, and impaired mental faculties.
Later this month, the company expects to begin a Phase II human clinical trial of Xerecept for improvement of neurological deficits due to brain cancer edema. The company's objective is to confirm results of its earlier pilot trials where Xerecept was well-tolerated and appeared to improve neurological function by an average of up to 42%.
Ronald Goldblum, MD, vice president of medical affairs at NTII, said, "Peritumoral brain edema often contributes more to neurological dysfunction in patients with brain tumors than the tumor itself. Standard chronic treatment with synthetic corticosteroids often has serious adverse effects, including muscle wasting and osteoporosis. Results from our preclinical studies and pilot human clinical trials indicate that Xerecept has the potential to be safer than and just as effective as corticosteroids. We believe it could significantly improve the quality of life for these patients."
Xerecept is a trademark of Neurobiological Technologies, Inc.
The company is also developing Xerecept for the treatment of cerebral edema following traumatic brain injury (TBI). In June, the company announced that in animal models of TBI, Xerecept significantly reduced brain water content and significantly improved neurological recovery during the month following injury.
NTII is an emerging drug development company focused on the clinical testing of potential therapeutic products based on advances in neuroscience research. The company's strategy is to in-license early-stage products that have the potential to preserve neurological function by protecting nerve cells from injury. NTII is currently developing two product candidates. Xerecept is the company's synthetic preparation of the human peptide Corticotropin-Releasing Factor. Xerecept is being developed for reduction of
cerebral edema associated with brain cancer and for treatment of traumatic brain injury. Memantine is being developed as a potential neuroprotective agent. Dynorphin A, another human peptide previously tested as an analgesic agent, is available for out-licensing.
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 the company's ability to raise capital to fund operations, properly design, implement, and complete planned trials, meet regulatory requirements, demonstrate safety and efficacy for its products, manage third party contractors, and avoid infringement of third party proprietary rights, as well as other risks detailed from time to time in the company's Securities and Exchange Commission filings. Actual results may differ materially from those projected. These forward looking statements represent the company's judgment as of the date of this release. The company
disclaims, however, any intent or obligation to update these forward looking statements.
SOURCE Neurobiological Technologies, Inc.
CONTACT: Phil Fried of LifeScience Economics, 212-838-8362, for
Neurobiological Technologies, Inc.; or Victor Libet of
Neurobiological Technologies, Inc., 510-215-8000 |
