Neurobiological Technologies Inc.'s CRF data in peritumoral brain edema presented at AACR meeting.
CRF was well tolerated and patients experienced improvements in neurological symptoms such as seizures, muscle weakness, loss of coordination, and double vision.
The open-label Phase I/II study is designed to evaluate the tolerability of CRF in patients with peritumoral brain edema and to determine if the administration of CRF produced improvements in neurological symptoms or decreases in magnetic resonance imaging (MRI) measurements of peritumoral brain edema.
Swelling within the skull caused by a brain tumor may lead to loss of neurological functions, resulting in seizures, lack of coordination, and impaired mental faculties. It can be life threatening.
Patients received CRF doses of either 2 mcg/kg/hr or 4 mcg/kg/hr as 72 hour continuous infusions. The results of CRF administration to eight patients were reported in presentation. Although improvement of neurological symptoms was seen in three of the four evaluable patients in the study, MRI changes could not be consistently related to the improvements in neurological symptoms.
Primary side effects were short duration flushing, seen in seven patients. Two patients receiving the higher dose developed rapidly reversible hypotension.
Miguel A. Villalona-Calero, M.D., a researcher at the Cancer Therapy and Research Center, the University of Texas Health Science Center, presented the results. Previous to his participation in the study, eight patients had received CRF at doses of 0.66 mcg/kg/hr and 1 mcg/kg/hr as a 24 hour continuous infusion.
Because CRF was well tolerated in these patients, both dosage and duration of therapy were increased in Dr. Villalona's patients.
Preclinical studies sponsored by NTII have shown that CRF reduces the leakage of fluid from blood vessels at sites of tissue injury produced by trauma and that CRF inhibits swelling (edema) and inflammation in several inflammatory disease models.
Studies by an NTII scientific collaborator, published last month in the journal Cancer Research, showed that CRF is as effective as high-dose dexamethasone in a well-established animal model of peritumoral brain edema. Dexamethasone is effective in treating peritumoral brain edema but has major toxicity problems.
NTII is currently sponsoring open label Phase I/II clinical trials designed to evaluate the safety and effects of CRF on patients with peritumoral brain edema. The trials are designed to measure improvement in neurological function and to estimate any related changes in edema, using MRI.
Peritumoral brain edema is the lead indication for the program to develop CRF for the treatment of cerebral edema.
NTII also plans to conduct preclinical studies of CRF for the treatment of cerebral edema associated with head trauma and stroke. CRF also is being tested in a Phase II study in patients with rheumatoid arthritis (RA). NTII is seeking a development and marketing partner for CRF.
Except for the historical information contained herein, the matters discussed in this press release are forward looking statements that involve risk and uncertainties, including the ability to 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.
NTII is a biopharmaceutical company focused on the development of neuroscience-based drugs. The company's lead product candidate, Corticotropin-Releasing Factor (CRF), is a human peptide which the company believes has the potential for broad anti-inflammatory activity.
CRF is currently being developed for the reduction of edema and inflammation in patients with brain cancer and rheumatoid arthritis. In addition, Memantine is being evaluated by the company as a potential neuroprotective agent. The company is also evaluating Dynorphin A analgesic peptides as adjunctive agents to opioid analgesic therapy.
NTII is pursuing a cost-effective strategy employing a network of scientific and medical experts for early drug discovery and selected contractors for product development and manufacturing.
CONTACT: Neurobiological Technologies Inc., Richmond
Michael Ostrach, 510/215-8000
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|Date:||Apr 22, 1996|
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