An Australian immunotherapy drug will receive a huge boost when it is tested with four other new concepts across 54 clinical sites across the USA in a search for an effective treatment for ALS (a motor neuron disease).
This bold initiative will see Implicit Bioscience’s IC14 entering an elite pivotal clinical study in the first Platform Trial concept to be rolled from early 2020 by the Sean M. Healey & AMG Center for ALS at Mass General (Healey Center), subject to FDA approval.
“We brought together top leaders from around the world to dramatically rethink how we design ALS trials and create a groundbreaking platform trial program,” says Merit Cudkowicz, MD, MSc, director of the Healey Center. “Our new platform approach cuts the time to find an effective treatment in half, decreases costs by a third or more, and is supported by our patients, the FDA, ALS clinicians, ALS foundations and scientists and our pharma colleagues.”
From more than two dozen international applications, Implicit’s IC14 immunotherapy was selected for inclusion in the initial five therapeutic concepts to be tested.
“The concept of treating this devastating disease with an immunotherapy is new and builds on an encouraging pilot study in Brisbane that Dr Rob Henderson ran last year with funding from Australia’s FightMND,” said Implicit Bioscience CEO, Garry Redlich.
“This visionary design from the Healey Center at Mass General for the next phase of testing will accelerate the ability of clinical researchers to identify and test the most promising new therapies for ALS.
“The molecular target of IC14, measured in a patient’s blood, has recently been identified by our colleagues at Houston Methodist as highly associated with rapid disease progression. This potentially makes IC14 a personalized treatment for people with the most aggressive forms of this relentless disease,” said Mr Redlich.
MEDIA RELEASE
EMBARGOED UNTIL MIDNIGHT A.E.S.T., SEPTEMBER 18, 2019
Australian Immunotherapy Selected for Revolutionary US Clinical Trial Platform
Debut Brisbane, September 19, 2019 An Australian immunotherapy drug will receive a huge boost when it is tested with four other new concepts across 54 clinical sites across the USA in a search for an effective treatment for ALS (a motor neuron disease).
This bold initiative will see Implicit Bioscience’s IC14 entering an elite pivotal clinical study in the first Platform Trial concept to be rolled from early 2020 by the Sean M. Healey & AMG Center for ALS at Mass General (Healey Center), subject to FDA approval.
“We brought together top leaders from around the world to dramatically re-think how we design ALS trials and create a groundbreaking platform trial program,” says Merit Cudkowicz, MD, MSc, director of the Healey Center.
“Our new platform approach cuts the time to find an effective treatment in half, decreases costs by a third or more, and is supported by our patients, the FDA, ALS clinicians, ALS foundations and scientists and our pharma colleagues.”
From more than two dozen international applications, Implicit’s IC14 immunotherapy was selected for inclusion in the initial five therapeutic concepts to be tested.
“The concept of treating this devastating disease with an immunotherapy is new and builds on an encouraging pilot study in Brisbane that Dr. Rob Henderson ran last year with funding from Australia’s FightMND,” said Implicit Bioscience CEO, Garry Redlich.
“This visionary design from the Healey Center at Mass General for the next phase of testing will accelerate the ability of clinical researchers to identify and test the most promising new therapies for ALS.
“The molecular target of IC14, measured in a patient’s blood, has recently been identified by our colleagues at Houston Methodist as highly associated with rapid disease progression. This potentially makes IC14 a personalized treatment for people with the most aggressive forms of this relentless disease,” said Mr. Redlich.
-ENDS-