PharmAbcine has announced that the United States Food and Drug Administration has responded to the Investigational New Drug application they submitted on behalf of an experimental drug called TTAC-0001, which is being developed for patients with refractory or recurrent glioblastoma. The FDA has sent PharmAbcine a ‘study may proceed’ letter, which will allow them to go ahead with a planned US study of the drug. For more detailed information you can view the source press release at BusinessWire by clicking here.
Glioblastoma is a type of cancerous brain tumour. Most often, they develop in adults, although in rare cases children can also be affected. According to the American Brain Tumour Association, glioblastoma can begin as a grade IV tumour, or develop from a lower-grade astrocytic tumour, although this is less common. This form of cancer generally occurs in the cerebral hemispheres of the brain, although it can affect any area. To read more about glioblastoma, click here.
TTAC-0001 is being developed for patients who have refractory or recurrent glioblastoma. A cancer is known as ‘recurrent’ if it comes back, usually after a period of being undetectable. It may return to the same location or a different one. A ‘refractory’ cancer is one that doesn’t respond to treatment. This could include cancers that respond to treatment at first but then become resistant.
Research into TTAC-0001
TTAC-0001 is an investigational antibody drug. It has previously been researched in a Phase 2a clinical trial that took place last year in Australia. During this study, it showed an acceptable safety profile, and researchers didn’t observe hypertension, gastric or lung perforation, haemorrhage, or proteinuria during the study. According to PharmAbcine, data from this study showed that the drug has a 25% disease control rate.
Following the FDA’s positive response to the Investigational New Drug application submitted on behalf of TTAC-0001, researchers are planning to begin a Phase 2 clinical trial at sites in the US.