By Karen Pihl-Carey

Inex Pharmaceuticals Corp. plans to start a pivotal trial by the end of the year of its lead product, Onco TCS, an anticancer compound to treat second-relapsed aggressive non-Hodgkin's lymphoma.

The Vancouver, British Columbia-based company has submitted an application with the FDA to conduct a Phase II/III clinical trial and hopes to receive approval this quarter. The company plans to submit a similar regulatory application in Canada within the next month.

The trial should provide sufficient data for the company to seek marketing approval in 2001, Inex President and CEO David Main said.

"It's a critical step in moving us on a clinical path to commercialization," Main told BioWorld Today. "It's the last trial before seeking approval."

Onco TCS consists of the off-patent cancer drug vincristine encapsulated in Inex's patented drug delivery technology, Transmembrane Carrier Systems.

The trial will enroll about 100 patients who will be studied at up to 12 medical centers across North America. The clinical endpoint is objective response and duration of response, Main said.

"It's a design that we believe, and that the FDA has agreed to in principle, works under their accelerated development guidelines," Main said. "It's a single-arm study, which means we will not be comparing it to any other drug."

The Phase II/III trial follows a Phase IIa trial recently completed at The University of Texas M.D. Anderson Cancer Center in Houston, which demonstrated the drug was effective against relapsed non-Hodgkin's lymphoma. The company reported results from 34 patients indicating an overall response rate of 41 percent. A subset analysis of 24 patients with either aggressive or transformed non-Hodgkin's lymphoma showed a response rate of 54 percent. The Phase IIa data still is being evaluated and will be presented in December at the American Society of Hematology meeting in New Orleans.

Non-Hodgkin's lymphoma is the sixth leading cause of cancer deaths and currently affects about 240,000 people in the U.S.

In May, Inex closed on the first $7.47 million (C$11 million) tranche of an $8.14 million equity offering, involving the issuance of 5.5 million special warrants at a price of $2 each. The financing was expected to last the company through the early part of 2001. (See BioWorld Today, June 1, 1999, p. 1.)

Inex's stock (TSE:IEX) closed Friday at C$4.30, down 30 cents.