Cortech Inc. released Phase II trial results Tuesday indicating that itslead drug, Bradycor, showed a statistically significant effect onreducing swelling of the brain in head trauma patients.
The positive trial results for the Denver-basedcompany's bradykinin antagonist follow by more than two monthsrelease of Phase II data in July revealing Bradycor showed nosignificant reduction in 28-day mortality for patients with sepsis.
The July sepsis trial results sent Cortech's stock (NASDAQ:CRTQ)down by 60 percent from $6.12 to $2.25. On Tuesday, thecompany's stock closed at $3 a share, up 50 cents or 20 percent.
Timothy Rodell, Cortech's executive vice president of operationsand product development, said data from the head trauma trial,coupled with evidence from the sepsis trial showing a trend towardimproved patient survival, indicate Bradycor has a positivebiological effect on humans and that bradykinin is an importantmediator.
Rodell said the Phase II trial for head trauma was a single-blinded,placebo-controlled study involving 20 patients. Those treated withBradycor for seven days showed a 68 percent reduction in peakintracranial pressure, a measurement of brain edema, compared withpatients receiving a placebo.
The Bradycor treated patients, Rodell said, also experienced a"clinically meaningful reduction in deterioration of neurologicalfunction as measured by the Glasgow Coma Score."
Rodell said Cortech intends to proceed with a Phase II/III trial forhead trauma patients "as quickly as possible." He said the multi-center trials would be double-blinded, placebo-controlled studies.
The company also is continuing a second Phase II trial for sepsis andhas Phase II studies of Bradycor under way for burns and multipletrauma.
Bradycor is designed to block receptors to bradykinin, which hasbeen shown to produce pain as well as initiate inflammatoryresponses and edema.
Cortech was among a parade of companies frustrated in attempts tofind a marketable treatment for sepsis. Rodell said that, in retrospect,the expectations of finding a single drug that would affect sepsiswere unrealistic. The disease is too complex and single agents won'tbe able to dent the 28-day mortality in sepsis.
"As a drug developer," Rodell said, "we have a safe compound inBradycor and it has shown activity in two different importantdiseases." n
-- Charles Craig
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