Neurex Launches Phase III Program with SNX-111 for Chronic Pain
MENLO PARK, Calif. -- Jan. 16, 1996 - Neurex Corporation (NASDAQ:NXCO) announced today that it had initiated its Phase II/III program with SNX-111 to demonstrate safety and efficacy in the treatment of severe and intractable pain in patients with cancer or AIDS.
The pivotal, double-blind, cross-over study, which includes a long-term treatment phase, will target 200 patients in over 30 centers in the United States. Initial results released in May of 1995, and subsequently reported at the American Pain Society conference in November, demonstrated significant reductions in pain for these very difficult to treat patients.
"Our investigators are clearly very enthusiastic about the emerging profile of SNX-111," said Dr. Paul Goddard, Chairman and Chief Executive Officer. "Results to date suggest that patients who are resistant or non-responsive to opioid therapy respond to SNX-111 therapy with significant reduction or elimination of pain symptoms. If this clinical profile is confirmed in the ongoing clinical program, SNX-111 would have an important role in the treatment of severe pain. More than one million patients suffer from cancer pain, a significant proportion of whom experience severe chronic symptoms."
SNX-111 arose from Neurex' own discovery efforts and is the only N-type neuron specific calcium blocker currently in clinical development. SNX-111 is being developed as a treatment for chronic pain in conjunction with Medtronic using their SynchroMed implantable pump for direct administration into the fluid surrounding the spinal cord. In addition to the program in cancer pain, controlled studies for SNX-111 for non-malignant pain are expected to begin later this year.
In addition, SNX-111 is being developed by Neurex for the prevention of brain damage following ischemic events such as head trauma and stroke. Phase II studies for SNX-111 for ischemia are currently in progress.
Neurex Corporation is developing products for acute care, principally in the area of cadiorenal and neurological disease. The Company's focus is on therapies to be used in the emergency room, intensive care unit and pain clinic. Neurex' products under development,
CORLOPAM (fenoldopam) and SNX-111, are currently in human trials, each with potential in multiple indications. The Company's strategy is to discover, develop and commercialize its products for acute care treatment in hospital settings, such as emergency rooms, intensive care units and pain clinics.
CONTACT: Neurex Corporation | Paul Goddard, 415/853-1500 | or |Lippert/Heilshorn &Associates | Keith L. Lippert or Kristen Mahan, 212/838-3777
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