Next few weeks/months30 Sep 2020 09:44
Outlook
It has been a busy six months for the Company as we continue to progress our pipeline of drugs to treat rare cancers and difficult to treat autoimmune inflammatory diseases.
Tiziana is set to sponsor a Phase II nasal foralumab trial in Secondary Progressive MS Patients treated with Ocrevus (ocrelizumab). Clinical protocol for Phase 2 nasal clinical trial has been finalized and submitted to the FDA along with the Briefing package on July 22, 2020 requesting a type C meeting. The FDA response is expected back by mid October , 2020, with a clinical trialanticipated to begin in 4Q2020.
The Company is working with investigators in Brazil who will conduct a clinical trial in COVID-19 patients with nasally-administered Foralumab to evaluate its ability to suppress inflammation in the nasal and respiratory tract, the primary sites of Covid-19 induced inflamation. In view of the importance and urgency to develop an effective therapy for COVID-19 immediately, the Company, scientists at the Harvard Medical School and the scientific team at Santa Casa de Misericórdia de Santos Hospital (Jabaquara, Santos, Brazil) are working very quickly to start this clinical study in Q4 2020.
Upon successful completion of Phase I trial in healthy volunteers using our novel oral enteric-coated capsule formulation of Foralumab, Tiziana is in discussion with CROs to design and conduct a Phase II clinical trial in moderate to severe Crohn's disease patients with orally administered foralumab.
Tiziana has expedited its clinical development plan for its anti-Interleukin-6-Receptor (TZLS-501), a fully human monoclonal antibody, for the treatment of COVID-19 patients. Since April 2020, it has signed agreements with four contract research organizations ("CROs") to initiate GMP manufacturing (STC Biologics), develop inhalation technology (Sciarra Labs), conduct inhalation safety toxicity study in monkeys (ITR Laboratories Canada) and initiate a human clinical trial in COVID-19 patients (FHI Clinical). The Company intends to initiate the clinical study in Q1 2021.
Looking ahead, Tiziana is confident that it is well positioned to advance these programs to their next respective value inflection points.
HUGE!!