Incara Pharmaceutical Corp. ended three months earlier than planned its Phase II/III trial of deligoparin for the treatment of ulcerative colitis due to what its CEO called "limited financial resources."
There also was uncertainty as to whether the trial could continue without continued financial support from Incara's joint venture partner, Elan Corp. plc, of Dublin, Ireland. Additionally, Incara was notified in late July by the Nasdaq National Market that it failed to comply with the $1 minimum bid price requirement for continued listing.
Incara's stock (NASDAQ:INCR) fell 2 cents Monday to close at 18 cents.
The deligoparin trial, begun by Incara, of Research Triangle Park, N.C., in January 2001, had 138 patients, while the planned number had been 270 patients to receive the product, then called OP2000. (See BioWorld Today, Dec. 28, 2000.)
"We felt that we had overpowered the study in the beginning," Incara Chairman and CEO Clayton Duncan told BioWorld Today. "Our big question was, Is there going to be enough information [to give us a clear picture of efficacy]?' and the answer was, Yes, we believe there will be.'"
Deligoparin is being developed as part of a joint venture called Incara Development Ltd., which is owned by Incara and Elan. Incara licensed deligoparin from Opocrin SpA, of Modena, Italy, in 1998. Deligoparin is an oligosaccharide product that is a derivative of heparin, an anti-clotting agent.
The trial has effectively ended, and Incara expects to have preliminary data in September, Duncan said. The trial's primary endpoint is improvement of three or more points on the 12-point scale on the Colitis Activity Index (CAI), which measures stool frequency, bleeding, endoscopic examination and physician's global assessment, he said.
Uncertainty as to whether or not there would be continued funding from Elan also played a role in the decision, Duncan said. In July, Elan announced that it was restructuring its operations and, going forward, would focus only on the areas of neurology, pain and autoimmune diseases. Elan also said at the time that it would be shedding assets that fell outside those areas, which includes some of the 55 joint ventures it has with biotechnology companies in North America. (See BioWorld Today, Aug. 12, 2002.)
Although the joint venture has not ended, the doubt is still there, he said.
"We hadn't received any notification one way or another, but we had already planned to stop the trial at the end of the year," he said.
In light of that, Incara will "probably seek a new partner" for deligoparin, he said.
To date, Elan has invested about $19 million in the joint venture, some of which was invested as equity, Duncan said. Elan also made a $3 million equity investment in Incara designated for its catalytic antioxidant program, specifically focused on oral mucositis associated with cancer treatment. That program is scheduled to enter the clinic in May.
Duncan said he has "serious doubts" that Elan will continue with that program, since the Irish pharmaceutical company is turning its focus away from oncology.
"There are some partnering activities going on around that program," Duncan said, noting that the company always has had a diversified portfolio. "It is a broad platform addressing the damage generated by oxygen radicals, such as chronic obstructive pulmonary disorder and stroke."
Incara is scheduled to have a meeting with Nasdaq officials on Thursday to discuss the company's possible delisting, although Duncan said the company is "exploring a number of options" to prevent that from happening. For example, Incara is considering selling one of its programs. Depending on the Phase II/III deligoparin results its unveils in September, Incara also may consider going forward with a private placement, he said.
"Events will dictate which way we go," he said.
Whatever happens, Duncan didn't seem to entertain throwing in the towel, even though the company reported cash and cash equivalents of only $1.3 million for its third quarter on Aug. 13, when it reported a net loss attributable to common stockholders of $3.4 million for the quarter.
"We will be here," he said.
Incara's other program is in human liver cell therapy. At the end of July, the company received the go-ahead from the FDA to begin Phase I trials of cryopreserved human liver cells for the treatment of cirrhosis and end-stage liver disease. The company plans to begin those trials within the next two months, Duncan said.