- Tiziana is developing Milciclib for the treatment of HCC, the worlds most common primary cancer and a leading cause of cancer-related death in the United States. The primary risk factor for HCC is hepatic cirrhosis.
- The American Cancer Society predicts approximately 42,810 new cases of live cancer will be diagnosed in 2020 of which approximately 30,160 will die.
- Tiziana has completed a Phase 2a trial in sorafenib-resistant HCC patients where, 14 patients completed treatments as per the protocol, 9 were approved for compassionate use and no drug related deaths occurred. Tiziana presented the Phase 2a clinical data at the 2020 Virtual American Society of Clinical Oncology (ASCO) conference.
- Tiziana anticipates initiating Phase 2b in HCC patients with Milciclib in combination with a tyrosine kinase inhibitor (regorafenib or sorafenib) in 1Q 2022.
- Milciclib is also being used in combination with regorafenib for treatment of liver transplant patients with recurrent HCC in an investigator-initiated clinical trial, as reported in an abstract presented at the 2020 ASCO Virtual Meeting. Tiziana intends to conduct a larger trial in liver transplant patients with recurrent HCC using this drug combination.