Sentences with phrase «clinical hold»
The phrase "clinical hold" means that a medical study or trial is temporarily stopped by the authorities because of safety concerns or issues with the study design. It is put on hold until the concerns are resolved to ensure the well-being of the participants. Full definition
The reservoirs of two of three children quickly became infected and the trial was put on clinical hold on 30 April 2013.
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«We are also pleased that we were able to lift the earlier partial clinical hold on the high dose of SGT - 001 through our existing manufacturing process, which is an important ongoing development effort for our company.»
Juno Therapeutics has halted development of JCAR015, its lead chimeric antigen receptor (CAR) T - cell cancer immunotherapy indicated for adults with relapsed / refractory B - cell acute lymphoblastic leukemia (ALL), nearly 4 months after placing a Phase II trial of the candidate on its second clinical hold following two additional patient deaths.
Juno Therapeutics is seeking to change the protocol for the Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015, which the FDA has placed on clinical hold following the deaths of three patients, two of them last week.
Juno Therapeutics will resume its Phase II ROCKET clinical trial of its acute lymphoblastic leukemia candidate JCAR015 following the FDA's lifting of a partial clinical hold imposed last week following the deaths of three patients.
A later full clinical hold, in response to a serious adverse event in the first patient dosed with SGT - 001 in the IGNITE DMD trial, remains in place pending additional information.
Following the partial clinical hold placed on the high dose of SGT - 001 in Solid Biosciences Inc.'s (MA, USA) trial program for Duchenne muscular dystrophy, the FDA's questions regarding the manufacture of the product have been addressed, resulting in the hold being lifted.
In the ROCKET trial assessing JACR015, the first clinical hold imposed in July followed the deaths of three patients, which the company blamed on a change to the trial's original protocol to precondition patients by using a combination of cyclophosphamide and fludarabine.
But the two most recent deaths leading to the second clinical hold occurred in November after resumption of the original cyclophosphamide - only protocol, which occurred when the ROCKET trial was resumed just 2 weeks after the first hold was imposed.
Canaccord healthcare analyst John Newman, Ph.D., wrote in a note to investors that he considered the FDA's lifting of the Juno clinical hold «encouraging for all CART companies.
This week: New funding will support development of cell - based therapies and Solid Biosciences partial clinical hold is lifted.
The clinical hold had been expected to push back Juno's earlier plans to pursue FDA approval next year for JCAR015.
The clinical hold pushes back Juno's earlier plans to pursue FDA approval next year for JCAR015, a CD19 - directed chimeric antigen receptor technology (CAR - T) product candidate that has been under study in ROCKET in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia.
Juno has also said that the clinical hold on the ROCKET trial would not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company anticipates a 2018 approval.
The clinical hold, announced after the close of the NASDAQ market yesterday afternoon, soured investors on Juno enough to send shares of company stock significantly down in after - hours trading that followed a halt just before the announcement.
In response, Juno said, the FDA has asked the company to submit a Complete Response to the Clinical Hold consisting of a revised patient informed consent form, a revised investigator brochure, a revised trial protocol, and a copy of the presentation made to the agency yesterday.
For the second time in 5 months, Juno Therapeutics has put a clinical hold on a Phase II trial of JCAR015 in adult patients with relapsed or refractory B - cell acute lymphoblastic leukemia due to patient deaths.
Juno asserted that the clinical hold on the ROCKET trial did not affect plans for its other CD19 - directed CAR T - cell product candidates, including JCAR017, for which the company has launched two clinical trials now recruiting patients.
«It has come to our attention that at the time of submission of this manuscript and during peer review that the Phase I Clinical Trial as described involving ICV administration using an Ommaya reservoir was in fact already on clinical hold.
The paper was submitted to the journal 9 days after the trial was put on clinical hold, was revised 2 months later, and was not published until 2014.
We are working with the FDA to better understand the unexpected event that resulted in the clinical hold and put a plan in place to monitor and manage potential events in the future.
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