By Randall Osborne
After disappointing interim results, Cambridge Neuroscience Inc. has abandoned its faltering Phase III trial of its lead product, Cerestat, for trauma-related brain injuries.
"It is clearly very serious," said Elkan Gamzu, Cambridge president and CEO, who was unsure whether the company would lay off employees. "That we have not decided upon," he added.
The company's stock (NASDAQ:CNSI) closed Monday at $2.218, down 44 percent, a drop of $1.781. In June, when Cambridge temporarily suspended Cerestat from enrollment in a Phase III trial for stroke, the company's stock fell almost 60 percent. (See BioWorld Today, June 25, 1997, p.1.)
Cerestat, a small molecule, is an N-Methyl-D-Aspartate ion channel blocker that was designed to prevent nerve cell death and brain damage after head injury or stroke by preventing excessive entry of calcium into nerve cells.
Cambridge, of Cambridge, Mass., ended the brain-injury trial because a planned interim analysis found insufficient evidence of positive clinical impact. "We do know that what we have been using is very safe," Gamzu said. The company, with its partner Boehringer Ingelheim G.m.b.H., of Ingelheim, Germany, will collect more data on the more than 500 patients enrolled in the trial.
"Within the data set we have, there may be additional things," Gamzu said. The dose used in the brain-injury trial was 16 times the dose used in the stroke trial. Plasma levels of the drug will be compared with outcomes in the brain-injury trial.
The stroke trial might still resume, Gamzu said. "The implication for stroke [patients] is totally separate," he noted. Head-injury victims tend to be around age 30, mostly males otherwise healthy, whereas stroke patients typically are older with other health problems.
Although its lead product may be kaput, the company is not on its deathbed, Gamzu said. Among the products showing promise is CNS 5161 NMDA, for use against migraine pain. "It's in the clinic, and we're close to completing our first volunteer study," he said. Another molecule is being developed as an imaging agent. Also, Cambridge is seeking a corporate partner to help develop rhGGF2, a growth factor for use in multiple sclerosis patients.
"We have many molecules in-house," Gamzu said. "A couple of them look interesting and have oral bioavailability. There clearly are assets here."
Cambridge had $45.907 million in cash and equivalents as of June 30. *