By Randall Osborne
InKine Pharmaceutical Inc. said its FDA-approved expansion of the Phase III trial of CBP-1011 for a blood platelet disorder may lead to a broader label for the product.
CBP-1011 is an oral glucocorticoid analogue that had been under development by CorBec Pharmaceutical Inc., of West Conschohocken, Pa., which InKine acquired late last year upon merging with Sangen Pharmaceutical Inc., of Philadelphia. (See BioWorld Today, Nov. 12, 1997, p. 1.)
The drug is used to treat idiopathic thrombocytopenia purpura (ITP), an autoimmune disorder in which the patient's immune system attacks and destroys blood platelets. ITP, which often becomes chronic, predisposes the patient to potentially severe hemorrhages and bleeding.
Currently, the main treatment for ITP is prednisone, which — unlike CBP-1011 — often has side effects such as high blood pressure and blood sugar.
As a result of the FDA's permitting the protocol change, InKine will add patients who are HIV positive, suffer from chronic ITP despite having a splenectomy, are older, or have less severe cases of thrombocytopenia.
"We'll have a variety," said Taffy Williams, president and chief operating officer of InKine, of Blue Bell, Pa. The trial will enroll 100 evaluable patients, the same number planned before the FDA's approval of the expansion.
ITP is more common in AIDS patients than in the general population, Williams said, but none of the new categories looks more promising than another in terms of market.
"They're all attractive," he said. "Nothing in the group sets them out."
A completion date for the trial has not been finalized.
"That one's tricky, because it depends on how rapidly people come in," Williams said.
Last November, when it merged with Sangen and acquired of CorBec, InKine — then named Panax Pharmaceutical Co. Ltd., and based in New York — raised $17 million in a private placement.
At the end of last year, InKine had $13.6 million in cash, with a net loss of $6.2 million for the six months ended Dec. 31, 1997.
The company's stock (NASDAQ:INKP) closed Tuesday at $1.25, up $0.062. *