Monthly Archives: July 2016

2 cancer drug trials

AstraZeneca’s high hopes for cancer immunotherapy were dented on Thursday as the recruitment of new patients with head and neck cancer into two clinical studies was put on hold, following instances of bleeding.

The drugmaker said the U.S. Food and Drug Administration (FDA) had placed a partial hold on enrolment into the final-stage Phase III trials involving two of its immune system-boosting drugs, although the studies are still continuing with existing patients.

Trials of durvalumab and tremelimumab in different cancer types are also progressing as planned. Durvalumab is being tested on its own and with tremelimumab in various cancers.

Expectations for the combination treatment have been building in particular in lung cancer, where the two-drug cocktail is being tested in a broad range of patients as an alternative to initial chemotherapy.

News of the problems in head and neck cancer first surfaced on the website clinicaltrials.gov, run by the U.S. National Institutes of Health, which said one of the trials, known as KESTREL, had been “suspended”.

“The trial is not suspended,” an AstraZeneca spokeswoman said. “We have a pause or a partial clinical hold on enrolment of new patients.”

Shares in AstraZeneca fell more than 4 percent in U.S. trading on concerns that the setback might signal wider problems for durvalumab.

AstraZeneca sought to play down concerns, however, stressing that pivotal data in lung cancer were still expected in the first half of 2017.

It also said that bleeding was a known complication in treating head and neck cancer, given the proximity of tumors to major blood vessels and use of prior cancer therapies, which may involve surgery and radiation.

Merck’s rival immunotherapy drug Keytruda is already approved for head and neck squamous cell carcinoma, the same condition that AstraZeneca is testing for.

Bernstein analyst Tim Anderson said there was some reference in the medical literature to a decrease in blood platelets, which are needed for clotting, when patients were given so-called CTLA4 drugs like tremelimumab, although cases were rare.

Both Anderson and Deutsche Bank’s Richard Parkes said it was unclear if bleeding constituted a real drug side effect or not.

Life changing operation

A young man with a tennis ball-size tumor in the blood vessels of his tongue struggles to breathe and risks choking daily due to the organ’s inflated size.

Central European News (CEN) reported that doctors tried to operate on 18-year-old Krzysztof Wegrzyn twice when he was a boy, but the procedures were called off because of severe blood loss. Wegrzyn, of Grojec, Poland, was born with the benign tumor haemangioma.

Wegrzyn’s family is trying to raise money so he may travel to Germany for an operation to remove the tumor. Specialists at the Zentrum Klinik fur Vasculare Maltformationen in Eberswalde, Brandenburg have said they can help, CEN reported.

“I saw a boy from Norway who underwent an operation there and he looked great,” Wegrzyn told local reporters, according to CEN. “You could not see that he had ever been ill.”

Local reports indicate Wegrzyn’s family is halfway to their goal of about $58,000 to pay for the operation.

CEN reported that if he is able to undergo the procedure, he plans to finish his studies, pass his driving test and become a chef.

“This is my biggest dream but I do not want to be disappointed,” said Wegrzyn, according to CEN.

The researchers also noted other limitations of their study, including that heart rate and blood pressure are “not optimal” measures of the activity of the autonomic nervous system, which is the part of the nervous system that controls involuntary activities such as heart rate and blood pressure, and is what the researchers were aiming to measure. More detailed measures of the autonomic nervous system’s activity should be looked at in future studies of people’s mental health, they said.