By Debbie Strickland

Techniclone Corp. is seeking a more active role in an accelerated and expanded clinical trial program for its lead product, Oncolym, a radiolabeled (I-131) monoclonal antibody treatment for intermediate and high-grade B cell non-Hodgkin's lymphoma.

Los Angeles-based collaborative partner Alpha Therapeutic Corp., which has marketing rights in North and South America and Asia, has scheduled an Oct. 28 meeting with the FDA to discuss expanding and changing the protocol of the Phase III Oncolym trial to allow the participation of more and healthier patients, along with additional trial centers.

"We believe, if allowed, these changes will ease patient entry criteria for the remainder of the trial," said Jamie Oliver, who last month joined Techniclone, of Tustin, Calif., in the newly created position of vice president for clinical affairs.

Under the proposal, the number of centers would grow to 20, from six currently. The pivotal trial is expected to be completed in the second half of 1998. If all goes well, the filing of a biologics license application could come as soon as late 1998, said Lon Stone, president, CEO and chairman.

New Endpoints Proposed

In addition to more patients, Oliver said the redesigned study would involve "new initial trial endpoints which are in line with recent changes at the FDA that evaluate drug efficacy based on the combination of partial and complete remissions, rather than focusing entirely on complete remissions."

A partial remission involves tumor shrinkage of at least 50 percent. At the maximum tolerated dose in a Phase II study of Oncolym, 46 percent of patients experienced complete remissions, and an additional 23 percent experienced partial remissions.

It's important to consider partial remissions when evaluating a new cancer drug, said Stone, because "if a single agent can reduce a tumor by at least 50 percent, it certainly would have credibility to be used in combinations with other things to try to achieve complete remission."

Alpha this month submitted to the FDA data from a 12-patient imaging study that used a special measurement technique called quantitative dosimetry in order to show antibody uptake in lymphoma cells. In that study, about a gigabyte of data was generated for every patient.

Alpha, a subsidiary of Green Cross Corp., of Osaka, Japan, has taken the lead in managing the Oncolym trials, but Techniclone is now looking to redefine its role and take on management and maintenance of clinical trial sites, patient recruitment and testing, and FDA interaction.

"Alpha is a good company — they just have a different mindset," said Stone. "On big pharma's time scale, they're happy with the way they've been moving, but we're on a small biotech's time scale — we prefer to speed it up a little bit."

Techniclone has lately beefed up its capacity to manage trials, through the hiring of Oliver and other key personnel.

"We've been putting together a team here," said Stone. "We have a partnership already with Cambridge Antibody Technology for pursuing solid tumor [therapies]."

The agreement with Melbourn, U.K-based Cambridge Antibody Technology plc. is a joint venture to develop a new class of products based on fully human antibodies and Techniclone's Tumor Necrosis Therapy (TNT) technology.

Techniclone plans to file two investigational new drug applications for TNT this year. The first calls for a Phase I/II trial in patients with brain cancer, and the second most likely would initiate a Phase I/II trial in lung cancer.

Techniclone's shares (NASDAQ:TCLN) closed Friday at $3.50, up $0.50. *