Incara at FDA doorstep...

liver411

Mon Dec 10 01:35:00 PST 2001

Exclusive Reports

From the December 7, 2001 print edition



Incara at FDA doorstep

Stem therapy aims to aid liver patients



Sabine Vollmer



RESEARCH TRIANGLE PARK - Incara Pharmaceuticals Corp. is making a run for an adult liver stem cell therapy that would target patients desperate for a transplant.



The Research Triangle Park-based bio-tech company, which has struggled financially off and on in the past three years, is finalizing an investigational new drug application to the Food and Drug Administration, says Chief Executive Officer Clayton Duncan.



Incara has submitted a 50-page document and has discussed with the FDA its plan to enter first human clinical trials in the next six months.



"It's going very well," Duncan says.



The liver stem cell therapy is one of two treatments that Incara has in preclinical development. The other is a treatment for stroke and heart attack.



OP2000, the company's lead product, is in a Phase II/III clinical trial for inflammatory bowel disease. The trial is funded by Elan Corp., a Dublin, Ireland-based pharmaceutical giant whose $4.4 million investment and $4.4 million loan bailed Incara out of a cash crunch a year ago.



Incara plans to develop the liver stem cell therapy in-house, says Bennett Love, vice president of corporate planning.



The company has established a network of about five organ procurement organizations, Love says. The organizations find donor organs and arrange for transplants. Incara will receive donor livers unsuitable for transplant.



Based on a technology developed at the University of North Carolina, Incara scientists plan to isolate and harvest cells from the donor livers that have the most regenerative potential, Love says. The cells, called adult stem cells because of their regenerative powers, would then be enriched and injected in patients with advanced liver disease. About 100,000 patients waiting for liver transplants could become candidates for the therapy.



Other researchers who are working toward growing liver tissue are developing competing therapies based on embryonic stem cells.



If the FDA approves Incara's application, Love expects the company's research and development costs to increase.



In the nine months ending June 30, Incara reported $18,000 in revenues and $5.3 million in research and development expenses, filings with the Securities and Exchange Commission show. The net loss for the three quarters was $12.5 million.



In addition to the Elan partnership, common stock offerings have provided the company with cash. In August, Incara raised about $6.5 million from an offering of about 4.3 million shares. At the time, cash reserves had dwindled to about $2 million, enough for the company to survive about three months.



Two-thirds of the shares were snatched up by four investors - SAC Capital Management and Deerfield Management of New York City, Genaera Corp. of Plymouth Meeting, Pa., and DFC Capital of Greenwich, Conn.



SAC Capital is now Incara's top institutional investor, holding 1.01 million shares, or 12.1 percent ownership. The investor's biotech analyst declined to comment.



Sabine Vollmer can be reached at [email protected]









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