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Tiziana initiates study of 'Foralumab' in coated capsule form
4th Dec 2019 15:38
(Sharecast News) - Clinical-stage biotechnology company Tiziana Life Sciences announced the initiation of a phase 1 clinical trial in healthy volunteers on Wednesday, with a proprietary oral formulation of 'Foralumab' encapsulated in enteric-coated capsules.
The AIM-traded firm said the primary objective of the single ascending dose phase 1 study, being led by Dr Tanuja Chitnis at the Brigham and Women's Hospital of Harvard Medical School, would be to determine the safety and tolerability of orally administered Foralumab.
It said the clinical protocol also included the evaluation of pharmacokinetics, to determine if there was any systemic absorption of Foralumab following oral administration.
"We are excited to initiate this trial because this is the first-ever clinical study with orally administered Foralumab in enteric-coated capsules," said Tiziana's chief executive and chief scientific officer.
"The oral route of administration is expected to minimize toxicities associated with intravenous administration of anti-CD3 mAbs and it may also improve the clinical outcome through activation of gut mucosal immunity.
"Our proprietary oral formulation technology has the potential to be useful for treatment of neurodegenerative and gastrointestinal diseases."
At 0801 GMT, shares in Tiziana Life Sciences were up 8.23% at 44.38p.
The AIM-traded firm said the primary objective of the single ascending dose phase 1 study, being led by Dr Tanuja Chitnis at the Brigham and Women's Hospital of Harvard Medical School, would be to determine the safety and tolerability of orally administered Foralumab.
It said the clinical protocol also included the evaluation of pharmacokinetics, to determine if there was any systemic absorption of Foralumab following oral administration.
"We are excited to initiate this trial because this is the first-ever clinical study with orally administered Foralumab in enteric-coated capsules," said Tiziana's chief executive and chief scientific officer.
"The oral route of administration is expected to minimize toxicities associated with intravenous administration of anti-CD3 mAbs and it may also improve the clinical outcome through activation of gut mucosal immunity.
"Our proprietary oral formulation technology has the potential to be useful for treatment of neurodegenerative and gastrointestinal diseases."
At 0801 GMT, shares in Tiziana Life Sciences were up 8.23% at 44.38p.