FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple Sclerosis [Yahoo! Finance]
Tiziana Life Sciences Ltd - Common Shares (TLSA)
Company Research
Source: Yahoo! Finance
breakthrough immunomodulation therapies via novel routes of drug delivery, today announced it has received acceptance of its submission for intranasal foralumab to receive Fast Track Designation approval for the treatment of non-active, secondary-progressive multiple sclerosis (na-SPMS) to the U.S. Food and Drug Administration (FDA). Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate shown to cause T regulatory (Treg) cell induction when dosed intranasally. At present, ten (10) na-SPMS patients have been dosed in an Intermediate-Sized Patient Population Expanded Access (ISPPEA) Program with clinically meaningful reduction in fatigue scores (MFIS) in 70% of patients, and stability of disease noted within six months in all ten patients. In addition, intranasal foralumab is currently being studied in a Phase 2a, double-blind randomized, placebo-controlled, multicenter trial in patients with na-SPMS ( NCT06292923 ). The Fast Track Designation request p
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News
- Tiziana Receives $3.4 Million in Non-Dilutive Funding [Yahoo! Finance]Yahoo! Finance
- Tiziana Receives $3.4 Million in Non-Dilutive FundingGlobeNewswire
- Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer's Disease with Foralumab [Yahoo! Finance]Yahoo! Finance
- Tiziana Life Sciences to Dose First Patient with Moderate Alzheimer’s Disease with ForalumabGlobeNewswire
- FDA Accepts Tiziana Life Sciences Fast Track Designation Submission for Treatment of Multiple SclerosisGlobeNewswire
TLSA
Sec Filings
- 6/28/24 - Form 6-K
- 6/26/24 - Form 6-K
- 6/11/24 - Form 6-K
- TLSA's page on the SEC website