Merck KGaA halts cancer vaccine trial

What’s always so amazing to me is the utter denial that childhood vaccines can harm our children BUT a patient contracted encephalitis (brain inflammation) during a vaccine trial and they halt the program. In case you didn’t know, a huge percentage of our children suffer from brain inflammation.

Merck KGaA halts cancer vaccine trial
By Steve Goldstein, MarketWatch
LONDON (MarketWatch) — Merck KGaA on Tuesday said it’s halting trials of a cancer vaccine after a patient contracted a brain disease.

Darmsteadt, Germany-based Merck /quotes/comstock/11e!fmrk (DE:MRK 59.21, -0.09, -0.15%) said it’s temporarily suspending its clinical program for Stimuvax after a patient in Phase II trials taking the vaccine in combination with a low-dose chemotherapy drug called cyclophosphamide contracted encephalitis, which is a form of rare brain inflammation.

The U.S. Food and Drug Administration has also put a clinical hold on Stimuvax, which is licensed from Seattle-based Oncothyreon /quotes/comstock/15*!onty/quotes/nls/onty (ONTY 3.42, -0.07, -2.01%) .

“We understand that Merck Serono is working closely with the FDA, other regulatory agencies and the patient’s physicians to evaluate the implications of this adverse reaction and to determine an appropriate course of action,” said Oncothyreon CEO Robert Kirkman.

Merck, unrelated to the American drug maker of the same name, noted that other Stimuvax studies are not used with the same intensity of cyclophosphamide.

It said the move was a “precautionary” one while it studies the “adverse event.”

Though the affected patient was using the vaccine due to multiple myeloma, Merck said late-stage trials for non-small cell lung cancer and breast cancer also are impacted.

Shares of Merck dropped 0.8% in afternoon Frankfurt trade, and the company’s stock has lost about 6% of its value over the last year.

“We have never included a [net present value] for the product in our valuation and would expect the market to have been cautious as well. Nevertheless, expect some pressure on the stock today as a result of this news,” said analysts at WestLB of Merck.

For Oncothyreon, the reaction was more severe — shares plummeted 28% in early trade.

Steve Goldstein is MarketWatch’s London bureau chief.


Merck KGaA halts cancer trial after brain inflammation case
23 March 2010
Shares in Merck KGaA have slipped this morning after the German firm suspended a mid-stage trial of its cancer vaccine Stimuvax after a patient suffered an “unexpected serious adverse reaction”, ie encephalitis.

The Darmstadt-based company noted that one of 30 patients participating in a Phase II trial of the vaccine in patients with multiple myeloma developed encephalitis, or acute inflammation of the brain. The patient received the vaccine (licensed from the USA’s Oncothyreon) in combination with “an intensified schedule of low-dose cyclophosphamide, which is not used in the other Stimuvax studies”. Merck noted that it has now stopped recruitment and treatment of patients in all studies of the vaccine, including the Phase III non-small-cell lung cancer trials called START and INSPIRE, as well as the late-stage STRIDE study in patients with breast cancer.

The company says it will work closely with the regulatory authorities, particularly with the US Food and Drug Administration (which has placed a clinical hold on the Investigational New Drug application for Stimuvax) “to evaluate the implications of the adverse reaction on the clinical development programme” for the vaccine “and determine the most suitable course of action”. Merck added that the move is a precautionary measure as it finds out what caused the patient to contract encephalitis – indeed some patients have been taking Stimuvax for eight years without any serious problems.

Some analysts are fearing the worst, however. Andrew Baum at Morgan Stanley issued a research note saying that the suspension of the clinical programme for Stimuvax “constitutes another blow to the company’s pipeline”, coming as it does on the back of regulatory rejections for Erbitux (cetuximab) as a treatment for advanced lung cancer. Merck also received a ‘refuse to file’ letter from the FDA for its oral multiple sclerosis drug cladribine in November last year, though it should be noted that regulators on this side of the Atlantic were satisfied with the submission and are reviewing the pill.

Richard Parkes at Piper Jaffray wrote that “we are surprised at such a swift decision to halt recruitment based on a single case of encephalitis, and it remains possible that other less severe signals of neurological adverse events may have contributed to the decision”.

By Kevin Grogan

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