Aphton Corp. said it met with an unnamed "foreign regulatory authority," presenting Phase III data for G17DT in pancreatic cancer, and said it expects to begin preparing a regulatory filing.
The company said the most recently completed analysis showed a statistically significant overall median survival benefit of 83 percent for G17DT. The number of patients was not disclosed.
The hazard ratio - a measurement that "takes a cut in time at any point and looks at how many people are dead or alive, computing going forward the chance that one exceeds the other in terms of being alive," said Philip Gevas, chairman, president and CEO - was 0.65, showing that when measured patients receiving G17DT had a 154 percent higher likelihood of surviving longer than control patients.
Aphton was unwilling to reveal more, as there are still surviving patients in the trial. Its stock (NASDAQ:APHT) rose 32 cents Tuesday, or 14.3 percent, to close at $2.56.
Jeannette Whitmore, vice president of investor relations and corporate communications at Aphton, said the company has begun the process of compiling the data to submit for regulatory approval in the European Union, Canada and Australia. The company expects, although it is not certain, that the process should take about five months, she said.
G17DT also is in development in the U.S. In early February, Miami-based Aphton said an interim analysis of the product with chemotherapy in a Phase II metastatic stomach cancer trial showed an overall tumor response rate of 51 percent. Eighty-two percent of patients had either tumor shrinkage or stable disease, it said.
Aventis Pasteur, of Lyon, France, has co-promotion rights to Aphton's active immunization targeting gastrin or its receptors, including G17DT. In December, Aphton sold a five-year, $3 million interest-bearing note to Aventis and said it signed a letter of intent to restructure the co-marketing agreement. Also in December, Aphton sold about 1.5 million shares at $2.375 each, raising about $3.6 million. As of Sept. 30, Aphton had $8.3 million in cash and short-term investments. It had a net loss for the third quarter of $10.9 million.
The company is pursuing other financial options, Gevas told BioWorld Today. He believes Aphton will "have more than one option to choose from," he said, although none is guaranteed.