[vc_row][vc_column][vc_column_text dp_text_size=”size-4″]According to drug company claims, two clinical trials have been halted in the last two days due to the deaths of six participants, including one kid.
The two trials were unrelated: they were in different phases and were testing different treatments. However, both were experimenting with new cancer treatments. The first was evaluating a treatment for acute myeloid leukaemia, or AML, while the second was testing a novel agent for ovarian cancer.
Clinical trial deaths are assumed to be uncommon. A 2019 study that looked at mortality in studies testing breast cancer medications in Germany over a decade revealed that out of more than 23,000 patients treated in 32 trials, 88 (0.4%) died on their regimens. Only 27% of the 88 deaths were determined to be due to the treatments themselves.
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According to Dr. Rebecca Gardner, interim chief medical officer of Seattle Children’s Therapeutics, the trial has been halted while the death is investigated. The deceased participant was the first to receive a greater dose of the trial medication, which combines CAR T-cells activated by the anti-cancer drug rapamycin.
The AML trial was a phase one safety research undertaken in collaboration with Seattle Children’s Hospital by the Cambridge, Massachusetts-based biotech business 2seventy bio.
“Our hearts and thoughts go out to this family and what happened to their child,” she said.
“We go into paediatric oncology to figure out ways to cure patients of their childhood cancers, and that’s what we’re all dedicated to doing.” So when something like this happens, it’s awful for the family and the team,” Gardner explained.
Gardner stated that the death was recent. Three other individuals were given a lower dose of the treatment.
“The safety of every patient who participates in our studies or is treated with our therapies is our top priority,” said Dr. Steve Bernstein, chief medical officer 2seventy bio, in a news release.
The second trial, on ovarian cancer, was in phase three, the final step before a manufacturer submits a medicine to the FDA for approval. Mersana, a Cambridge, Massachusetts-based pharmaceutical company, is investigating upifitamab rilsodotin, or UpRi, which connects cancer-killing drugs to antibodies that target tumour cells.
Mersana announced Thursday that the FDA has placed a partial clinical hold following the deaths of five research participants, a rate that was higher than intended. According to the business, approximately 560 people have taken the study medicine to date.
According to a news statement, the FDA is halting further enrollment while the bleeding events in the research, which included an undefined number of low-grade incidents as well as the deaths, are investigated. Participants in the study will continue to receive the investigational treatment.
Mersana anticipates that the FDA will request a full examination of the study drug’s safety data. It also stated that it plans to provide additional safety and efficacy data from the trial in the coming months.
The FDA has not responded to an inquiry about the trials.
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