FDA asks Tiziana for more information on next 'foralumab' trial

(Sharecast News) - Biotechnology company Tiziana Life Sciences updated the market in its 'Investigational New Drug' (IND) application to the US Food and Drug Administration (FDA) on Wednesday, to initiate a phase 1 clinical trial of enteric-coated capsules of its 'foralumab' product in healthy volunteers.The AIM-traded firm said that, following the end of its 30 calendar day review, the FDA had requested more information and safety data from the ongoing phase 1 trial with nasal administration of foralumab to justify the proposed dose-range for the trial with oral administration of enteric-coated capsules.It said the stability data on the dose-range of 10mg to 250mg of foralumab was included in the submitted IND for the ongoing phase 1 trial with nasal administration.The FDA also advised the company to adequately cross-reference the submitted IND with nasal administration.As a result, Tiziana said it had withdrawn the current IND to include safety data from the ongoing trial with nasal administration, and adequately cross-reference the IND for nasal administration with solution of foralumab.The ongoing phase 1 trial with nasal administration had now completed the first two doses of 10mg and 50mg, with the highest dose of 250mg currently ongoing, which was expected to be completed by 15 May.Upon completion, the firm said the safety data from that ongoing phase 1 trial with nasal administration would be provided to the FDA as part of its revised IND for oral administration."We are in agreement and believe that FDA recommendations will further strengthen our IND for evaluation of oral enteric-coated capsules of foralumab in healthy volunteers," said Tiziana Life Sciences chief executive officer and chief scientific officer Dr Kunwar Shailubhai.As at 0842 BST, shares in Tiziana Life Sciences were down 5.74% at 57.5p.