By Debbie Strickland

Inoperable non-small cell lung cancer patients who completed a course of radiation therapy augmented by OXiGENE Inc.'s radiation sensitizer Sensamide survived a median of 22 months — twice as long as the median of patients who received radiation therapy alone.

But because of central nervous system side effects associated with Sensamide's highly concentrated form of metoclopramide, only 36 percent of the patients in the treatment group completed therapy. Among the patients who dropped out of the Phase II/III trial, median survival was no longer than the 11-month average of the control arm, whose participants received radiation alone.

For OXiGENE, the side effects were "not a surprise," said Andica Kunst, spokeswoman for the Lund, Sweden-based company, which also has a facility in New York.

"Metoclopramide has a well-documented history in the clinical literature of central nervous system side effects," she said. The effects — sedation, anxiety, restlessness and depression — are temporary and reversible, lasting three to 12 hours.

At any rate, OXiGENE decided in 1996 not to pursue approval of Sensamide, but instead to advance Neu-Sensamide, a second-generation, patented reformulation designed to, among other things, reduce the troublesome side effects of metoclopramide.

Metoclopramide is one of a class of N-substituted benzamides that inhibits a DNA repair enzyme to boost the effectiveness of radiation.

The company completed the Phase II/III Sensamide trial as part of the trial package for Neu-Sensamide, which is now in a Phase III trial for non-small cell lung cancer. Last year, OXiGENE launched a Phase I/II trial for a second Neu-Sensamide indication, glioblastoma.

The FDA has told the company that if the drug proves itself in controlled clinical trials in both indications and meets various other requirements, Neu-Sensamide could ultimately receive approval for all radiation-treated cancers.

A new drug application for non-small cell lung cancer could come in 1999.

OXiGENE is still analyzing data of the 218-patient Sensamide trial and has not yet determined whether the striking survival results achieved statistical significance. When patients who completed the trial and those who dropped out are lumped together, the median survival drops to 13 months, two months more than the control group.

In addition to Neu-Sensamide, its lead product, the company has two other product candidates in clinical trials: a third-generation radiation sensitizer, Oxi-104, now at the Phase I/II level in solid tumors; and Cordycepin, in Phase I for refractory TdT-positive leukemia.

Combretastatin, an anti-angiogenic that also attacks existing vascular systems within tumors, is expected to enter clinical trials in the second quarter of 1998.

OXiGENE has $42 million in cash and reported a net loss of $4.10 million for the first half of 1997.

The company released the Phase II/III Sensamide data last weekend and its shares (NASDAQ:OXGN) fell $5 Monday, closing at $34. The stock Tuesday dropped another $1.25 to $32.75. *