Tiziana Life Sciences PLC (NASDAQ:TLSA) said a second patient with Secondary Progressive Multiple Sclerosis (SPMS) in an ongoing study has shown clinical improvements following three months of treatment with its intranasal drug foralumab.
The patient showed improvements based on Positron Emission Tomography (PET) imaging analysis, a neurologic exam and a timed 25-foot walk test. These findings are consistent with the results obtained from the first patient following three months of treatment, as previously announced in March.
The study is part of an expanded access program at the Brigham and Women’s Hospital (BWH) in Boston. Both patients are continuing treatment, the company said, and are in months 13 and 4 of treatment, respectively.
READ: Tiziana Life Sciences receives FDA go-ahead to enroll more multiple sclerosis patients in expanded access program for treatment with intranasal foralumab
"We are excited about the positive clinical responses seen in 2 out of 2 SPMS patients treated so far,” CEO Kunwar Shailubhai said in a statement. "Clinical data from both patients further validate our novel intranasal therapy with foralumab, which seems to overcome the blood-brain barrier to allow therapeutic action of the drug."
The favorable safety, tolerability and clinical responses from the two SPMS patients were submitted to the US Food and Drug Administration (FDA), and the agency has allowed Tiziana to treat an additional eight SPMS patients, the company said.
The original dosing regimen with intranasal therapy with foralumab will remain the same (50 micrograms, three times a week for two weeks, followed by one week off treatment). The revised dosing regimen has a provision for dose escalation up to 100 mcg as an option to improve clinical benefit.
“Our current analyses suggest a consistency of response to intranasal foralumab, across the first two SPMS patients,” said Tarun Singhal, director of the PET Imaging Program in Neurologic Diseases at BWH. “We were also able to harmonize data across scanners and institutions, which has yielded very encouraging results. We look forward to our continued investigations of foralumab in SPMS patients, using additional PET analytical approaches.”
Tiziana Life Sciences is a clinical-stage biopharmaceutical company developing breakthrough therapies using transformational drug delivery technologies to enable alternative routes of immunotherapy. The company's innovative nasal, oral, and inhalation approaches in development have the potential to provide an improvement in efficacy as well as safety and tolerability compared to intravenous (IV) delivery.
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