By Frances Bishopp
In an effort to stave off negative reaction to Warner-Lambert Co.'s sale of 375,000 shares of Neurex Corp.'s stock, Neurex has reported the commencement of Phase III trials for SNX-111, a drug being developed by both Warner-Lambert and Neurex.
"We have the utmost confidence in the company and the drug," Steve Mock, director of media and community relations at Warner-Lambert, told BioWorld Today. "We sold this stock as part of an ongoing program to trim equity positions in a number of companies."
"People are trying to read into this some reflection on Neurex," Mock said, "and that is not the case. It was purely a financial decision that was not related to what we think the prospects of SNX-111 are."
Warner-Lambert actually sold the stock in November, but registered the sale with the Securities and Exchange Commission on Tuesday. Neurex stock (NASDAQ:NXCO) closed at the end of November at around $12.75 per share. On Wednesday, it lost $0.50 to close at $14.75.
Warner-Lambert, Mock said, still owns 1.49 million shares of Neurex stock, representing approximately 6.8 percent of outstanding shares, which, Mock said, "for us is substantial."
"We don't have that similar type of position in most of the companies in which we hold shares," Mock said.
Neurex, of Menlo Park, Calif. and Warner-Lambert, of Morris Plains, N.J. will commence Phase III clinical trials for SNX-111 in the treatment of head trauma in the first half of 1997, Paul Goddard, CEO of Neurex told BioWorld Today. The trials are part of a collaboration between the two companies to develop SNX-111, a chemically synthesized peptide that mimics an NSCC blocker found in the Conus snail.
When administered intrathecally (into the fluid surrounding the spinal cord), SNX-111 has proven to be an effective analgesic.
In addition, SNX-111 can be used to treat patients suffering from the consequences of both global and focal ischemia which can occur when there is an interruption to the blood flow and oxygen delivery to the brain. Ischemia-induced brain damage can be caused by events such as cardiac arrest, closed head injury, drowning and coronary artery bypass graft surgery. SNX-111 may block the biochemical cascade of reactions that ultimately results in nerve cell-death in these conditions.
The trials will be conducted in about 40 centers with approximately 800 patients, Goddard said, and will consist of a double-blind placebo controlled study with the usual standard of care in intensive care units used as background treatment, Goddard explained.
Patients, Goddard said, will be at the severe end of one scale based on neurological disabilities which will range from normal to severely disabled to unconscious to brain dead and another disability rating scale which relates purely to the neurological disability of the patient in the recovery phase.
"All patients will be severely injured and in all probability will be sufficiently ill that they are unconscious when entered into the study," Goddard said. "After head trauma," he said, "a series of events occurs which lead to overstimulation of the neurons, which, in turn, eventually lead to their dying, essentially a biochemical cascade. What you need to do is prevent those extra stimuli from occurring and thereby prevent the brain from being damaged."
"Preclinically with this drug, we have given it up to 24 hours after the insult and it worked," Goddard said. "It is the only drug that has been known preclinically to do that. We basically have a window, although it is one of the things subject to debate, but around up to 16 hours after the insult, the patient can be admitted into the study."
Warner-Lambert has paid approximately $5 million to Neurex in milestones thus far, Goddard said, and will pay for the trials, which, because the patients will be treated in intensive care units, could prove to be quite expensive. Any patient entered into the study will have the majority of his or her care paid for by the study, rather than health insurance or others means of payment.
"The issue here," Goddard said, "is if it works, the pay-off commercially and from a medical point of view is very significant."
Neurex in collaboration with Medtronic Inc., of Minneapolis, is evaluating SAX-111 in two Phase III trials for malignant and non-malignant pain. A feasibility study for treatment of post-surgical pain also is under way.
Neurex is using Medtronic's implantable pump to deliver the drug to the spine in an effort to prevent nerve cells from sending pain signals to the brain.
Neurex was founded in 1986 and went public in 1993. Its most advanced product is Corlopam, a potent dopamine (DA-1) receptor agonist that allows precise blood pressure control through systemic vasodilation. Neurex filed a new drug application with the FDA in June of 1996 for intravenous administrations of Corlopam.
As of Nov. 6, 1996, Neurex's cash position was at $89 million. *