US hospital group says patient’s condition is ‘unresponsive’ to drugs
The National Institutes of Health (NIH) has said it is monitoring a patient’s progress in a clinical trial involving a drug for the same disease.
The trial, called Otsuka, is in collaboration with Imperial College London and Imperial College Dublin and is aimed at identifying if a drug is safe and effective in a patient with lung cancer.
The NIH said on Wednesday the patient has been “in a stable and responsive state” but it was not yet clear whether he had recovered fully.
“We are monitoring the patient’s status as he progresses,” NIH spokesperson Andrea D. Loomis said.
The drug, called Tofranil, has been approved for the treatment of lung cancer by the US Food and Drug Administration (FDA).
In a statement, Imperial College said the drug was developed with the support of “over 100 research and development partners” and has been administered by patients in hospitals in Ireland and the United Kingdom.
“The study is being carried out with the full knowledge and approval of the Irish Medicines Board and UK Medicines Authority,” Imperial said.
It said the company is “in contact with the Irish and UK governments to confirm further information about this study and to provide additional updates to the public”.
A spokeswoman for Imperial College added: “The study has received full FDA approval and is currently under review.”
The drug has not yet been tested in humans.
The FDA has yet to make a final decision on the drug.
“A lot of the issues we are looking at are not yet resolved,” NIH spokeswoman Rebecca Peltier said.
“There is still a lot to work out, so it’s not something that’s finalized.”
The NIH has said Otsukas efficacy in the patients in the trial is “not yet determined” and “the trials design does not currently allow us to assess the clinical impact of the drug”.
“We’re monitoring it closely, but so far we don’t have a definitive answer yet,” she said.
The NIH also said it was reviewing the data for the drug, but that it was still too early to make decisions on the safety and efficacy of the drugs.
“For now, it’s important to keep in mind that the FDA has not given the green light to use this drug,” Peltian said.
Irish media reported that Imperial has agreed to pay up to €3m (£2.5m) to fund the study.