Coulter Corp. has paired its late-stage cancer product with moneyfrom InterWest Partners to form a new company, CoulterPharmaceutical Inc., which will take its non-Hodgkin's lymphomacandidate forward.

The new company, based in Palo Alto, Calif., formed in March andopened its doors Monday. It plans to take the product _ radioactiveiodine linked to a monoclonal antibody (B1) _ into Phase II/IIIpivotal trials in June. B1 was discovered at the Dana-Farber CancerInstitute in Boston and has been studied at the University ofMichigan.

Coulter is a private company in Miami with 5,000 employees that'sfocused on blood cell analysis systems. It gained rights to B1 andother monoclonal antibodies in 1980.

Mark Kaminski, a cancer reasearcher at Michigan,studied the antibody and published promising results in 1993. That'swhen Coulter decided it should look to take the product to the nextlevel.

Bobbie Wallace, a 13-year Coulter biomedical researcher who's nowvice president of operations for the new company said, "There werebetter ways to get this product to market without taking Coulter'sresources to do it.

"The new company consists of the product from Coulter and themoney from InterWest," a venture capital firm in Menlo Park, Calif.,she said. "The rights belong to the new company."

Forty-three patients have been treated to date with B1. The initialstudy, reported by Kaminski in the August 1993 New EnglandJournal of Medicine, showed that more than 70 percent of patientsexperienced significant tumor reduction. One-third of those in thesmall study had tumors that disappeared without recurrence.

Wallace said the Phase II/III trials will be carried out at four centersin the U.S. and one in London. Treatment consists of a single-doseintravenous infusion. Endpoints will be tumor reduction and extendedsurvival.

Patients in the early studies had failed an average of two-and-a-halfrounds of chemotherapy, Wallace said, adding that average life spanfor that group is nine months. Eighty percent of those treated with B1in early studies were alive 18 months after the 1993 article appeared,the company said.

Results have been similar, even a little better, since the original study,Wallace said. The FDA, she said, probably will want 100 patientstreated overall. Wallace wasn't sure if the agency would allow the 43already treated to be included in that total.

The new company plans to acquire two other anti-cancer treatments,one of which may be taken into Phase I studies around the end of theyear, Wallace said.

Arnold Oronsky, a general partner at InterWest, is interim presidentand CEO at Coulter Pharmaceutical. n

-- Jim Shrine

(c) 1997 American Health Consultants. All rights reserved.