Merck KGaA Resumes Vaccine Trials in Lung Cancer

Reuters

 

Germany's Merck KGaA and its U.S. partner Oncothyreon have resumed testing their experimental cancer vaccine Stimuvax on lung-cancer patients, reviving hopes for a key pipeline drug.

The U.S. Food and Drug Administration (FDA) lifted the hold it had placed on a Phase III trial called START in non-small cell lung cancer, Merck said on Thursday.

Merck and Oncothyreon also continued their INSPIRE study, which targets Asian lung-cancer patients, but the Phase III STRIDE trial in breast cancer remained suspended, it added.

Merck on March 23 stopped all tests of the vaccine on humans after a patient contracted encephalitis in another setback at the drugs unit from which Merck is trying to diversify.

Oncothyreon shares plummeted 27 percent that day and have not recovered since.

Before Wall Street opened on Thursday, the biotech firm's shares were up 6.9 percent in Frankfurt at 1002 GMT. Merck KGaA shares edged 0.1 percent lower.

"It is good news for Merck that the FDA has given the go-ahead to continue the trials in lung cancer," said WestLB analyst Cornelia Thomas.

"However, therapeutic cancer vaccines are generally high risk programmes ... we have never included any value for these programmes and will not do so now."

The first vaccine to treat cancer, Dendreon Corp's Provenge, won U.S. approval in April in a field that has been littered with failures.

Bristol-Myers Squibb as well as Transgene in an alliance with Novartis are also aiming to bring such compounds to market.

The case of brain inflammation that marred the Stimuvax programme emerged in a mid-stage trial with 30 participants where the vaccine was tested against multiple myeloma, a type of cancer affecting the bone marrow and white blood cells.

Stimuvax, based on an active ingredient known as BLP25, is designed to prime a patient's immune system against certain cancer cells after a tumour has been diagnosed.