LONDON (Alliance News) - Tiziana Life Sciences PLC on Monday reported a flat loss in the first half of 2018 as expenses were broadly unchanged, while the biotechnology firm also announced that its drug foralumab has been approved for trial in the US.
The company, which is in the research and clinical stage, recorded a GBP3.86 million pretax loss in the six months to June 30, barely slimmed from its GBP3.87 million loss the prior year.
Research & development expenditure was reduced slightly to GBP2.3 million from GBP2.4 million, but other operating expenses rose a bit to GBP1.6 million from GBP1.5 million.
In a separate Monday announcement, Tiziana said an investigational new drug application for foralumab has been approved by the US Food & Drug administration, with phase one trials to begin this year. Foralumab is intended to treat neurodegenerative diseases such as amyotrophic lateral sclerosis, also known as ALS. First dosing is expected to begin by November.
Tiziana raised GBP1.7 million from the issue of 1.8 million shares during the recent half-year, while also entering loan agreements worth a combined GBP400,000. These will fund the development of its two clinical stage drugs, milciclib and foralumab, as well as for licence agreement liabilities and general working capital.
Mililciclib, the company's cancer drug, was "well tolerated by patients" in phase one and phase two clinical trials. Tiziana intends to begin a phase 2a therapy with the drug and then a phase 2b study using the drug in combination with another cancer treatment. Mililciclib is thought to be most effective in patients with hepatocellular carcinoma, a type of liver cancer.
"Following the approval of our investigational new drug application to the US Food & Drug Administration, we will proceed in [fourth quarter] 2018 to engage phase 1 clinical trials with foralumab, to be administered nasally to healthy volunteers, with the objective of demonstrating proof of concept in a potentially revolutionary approach for the treatment of neurodegenerative diseases," said Tiziana Executive Chairman Gabriele Cerrone.
"Looking forward, we are confident of being well positioned to progress these programmes to their next respective value inflection points," Cerrone added.
Shares in Tiziana were up 2.3% at 112.00 pence on Monday.