NEW YORK - Tiziana Life Sciences Ltd (NASDAQ:TLSA), a biotechnology company, has reported positive qualitative results from an Expanded Access Program (EAP) for patients with non-active Secondary Progressive Multiple Sclerosis (na-SPMS). The interim data indicates that 80% of the participants showed a qualitative reduction in microglial activity after six months of treatment with intranasal foralumab, an immunomodulatory therapy.
The EAP, which allows patients with serious conditions to access investigational drugs outside of clinical trials, included 10 na-SPMS patients. Dr. Tarun Singhal, Director of the PET Imaging Program in Neurologic Diseases at Brigham and Women's Hospital and Associate Professor of Neurology at Harvard Medical School, observed a reduction in the microglial PET signal in eight out of ten patients following foralumab treatment.
The U.S. Food and Drug Administration (FDA) has recently authorized the inclusion of an additional 20 patients in the program, enabling further data collection and analysis. Tiziana has also applied for FDA Orphan Drug Designation for foralumab for the treatment of na-SPMS.
Foralumab, the only fully human anti-CD3 monoclonal antibody, is designed to modulate T cell function and reduce inflammation. This novel intranasal delivery method is being studied for its potential benefits over traditional intravenous administration, including improved efficacy and patient tolerability.
Gabriele Cerrone, Chairman and acting CEO of Tiziana, expressed enthusiasm over the preliminary results and the expansion of the EAP. The company anticipates additional quantitative analysis of the data and is also conducting a Phase 2a trial for na-SPMS.
The company emphasizes that further studies are needed to confirm these findings. Tiziana Life Sciences is focused on developing therapies that leverage innovative drug delivery technologies to enhance immunotherapy treatments for various diseases. This announcement is based on a press release statement from Tiziana Life Sciences Ltd.
InvestingPro Insights
Tiziana Life Sciences Ltd (NASDAQ:TLSA) has recently shared promising qualitative results from their Expanded Access Program, capturing the attention of both the medical community and investors. As the company continues to explore the therapeutic potential of foralumab, let's look at some key financial metrics and InvestingPro Tips that may offer additional insight into TLSA's market performance.
InvestingPro Data shows a market capitalization of $102.53 million, indicating a modest size within the biotech sector. The company's Price / Book ratio is high at 18.52 as of the last twelve months ending Q4 2023, suggesting a premium valuation compared to its book value. Moreover, TLSA has experienced a significant 1 Month Price Total Return of 43.71%, reflecting a strong recent uptick in investor interest.
In terms of InvestingPro Tips, it's worth noting that TLSA operates with a moderate level of debt, which could impact its financial flexibility. Analysts are not expecting the company to be profitable this year, which may be a point of consideration for potential investors. Despite these challenges, the company's focus on innovative drug delivery technologies and the recent positive news could be a driving force behind the stock's recent performance.
For those interested in a deeper dive into TLSA's financials and market outlook, there are additional InvestingPro Tips available. Investors can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to a total of 12 InvestingPro Tips to help make more informed investment decisions.
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