Tiziana Life Sciences Ltd (NASDAQ:TLSA) announced that it along with its research partners at Mass General Hospital have been invited to apply for a prestigious grant from the ALS Association to fund a clinical trial evaluating its asset intranasal foralumab.
The company said the grant is offered as part of the Hoffman ALS Clinical Trial Awards Program, which helps develop new and improved therapies for ALS by supporting early-stage clinical trials.
ALS, also known as Lou Gehrig's disease, affects nerve cells in the brain and spinal cord, progressively weakening muscles.
There are limited treatment options available for individuals with ALS due to its sporadic nature and lack of clear risk factors, Tiziana noted.
Gabriele Cerrone, Tiziana CEO, said that if the company’s application is successful, the grant would support a trial involving about 20 patients in a six-month, dose titration trial of intranasal foralumab, a fully human anti-CD3 monoclonal antibody which has been shown to stimulate T regulatory cells when dosed intranasally.
"We are deeply honored to be invited by the ALS Association to apply for this grant, which represents a significant milestone in our ongoing efforts to develop an effective treatment for ALS,” Cerrone said.
“This funding would allow us to advance our clinical program and accelerate the development of our potential therapy that could make a meaningful difference in the lives of ALS patients."
Dr Suma Babu, co-director of the Neurological Clinical Research Institute at Mass General Hospital added: “This study is aimed at advancing novel treatment approaches for ALS by evaluating its effect using cutting-edge image biomarkers like positron emission tomography (PET) and key clinical outcome assessments.”