Tiziana Life Sciences reports positive results from second patient in multiple sclerosis study of foralumab
The patient showed improvements based on Positron Emission Tomography imaging analysis, a neurologic exam and a timed 25-foot walk test
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NASDAQ:TLSA
Tiziana Life Sciences Ltd 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. Tiziana’s lead candidate, intranasal foralumab, which is the only fully human anti-CD3 mAb, has demonstrated a favorable safety profile and clinical response in patients in studies to date.
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The patient showed improvements based on Positron Emission Tomography imaging analysis, a neurologic exam and a timed 25-foot walk test
"Treatment with intranasal foralumab is a novel physiological approach to stimulate the mucosal immune system to induce disease-modifying benefits in the [central nervous system] by dampening microglial inflammation,” said Howard Weiner, ch
Dr Kunwar Shailubhai, chief executive officer and chief scientific officer of Tiziana, commented: "The 'Holy Grail' for biologics is the 'switch' from parenteral (IV, SC) to oral administration as it is the most economical, non-invasive, an
Zak’s Small Cap Research analystJohn Vandermosten said: “Of the observations by the investigators most noteworthy was intranasal Foralumab’s effect on microglial activation as imaged by PET [positron emission tomography]"
Signs of efficacy were detected, while Tiziana’s Foralumab was well tolerated and there were no adverse effects in the six months of therapy, which will be continued
Clinical data from the first patient, having completed three of six months, revealed the treatment was well tolerated by the patient with a favourable clinical response
Financially, the group seems well set with £38.6mln in the bank as at 30 June
The pair are looking to use Tiziana’s foralumab monoclonal antibody to enhance the next generation of cancer treatments.
The US firm is hoping to use foralumab, Tiziana’s clinical-stage fully-human monoclonal antibody, as a lymphodepletion or ‘tolerising’ agent to improve the long-term success of CAR-T in cancer treatment
Through a new entity the company will list on Nasdaq and delist from London
The update comes ahead of the imminent launch of a phase II, proof-of-concept study of Foralumab
Foralumab will be given to hospitalised patients with severe coronavirus as part of the Brazil trial that will build on earlier work in mild-to-moderate cases
Dr Kevin Shutz has 19 years pharma industry experience
The nasally administered human antibody drug Foralumab has shown early promise
Earlier this week Zacks Small-Cap Research reiterated its US$7.50 valuation of the stock – more than triple the current US$2.40 share price
Tiziana Life Sciences is advancing three candidates for a variety of indications in autoimmune disease, cancer and coronavirus (COVID-19)
The latest data come from a phase I assessment of Foralumab, which is being developed for a range of diseases
This is the first time a nasally administered antibody has been given to a patient with SPMS
Various clinical and pre-clinical trials are coming up across its two main drug candidates
The firm has signed an agreement with Takanawa Japan to identify a suitable partner