Q BioMed Inc. (OTCQB:QBIO) said its potential breakthrough chemotherapy for the most common type of liver cancer had been granted orphan drug designation by the US regulator.
The Food & Drug Administration (FDA) endorsement would provide a fully-approved Uttroside-B product seven-year market exclusivity following marketing approval.
Also on offer are grant funding for clinical trials that contribute to marketing approval, protocol assistance, and tax credits.
"Orphan drug designation gives our Uttroside-B program a substantial boost, and we expect it will significantly accelerate development and reduce costs,” said Q BioMed chief executive Denis Corin.
“We are pleased that the FDA recognizes the urgent need for effective treatments for HCC, and that the agency sees the potential of Uttroside-B to address this difficult to treat cancer."
Uttroside-B is being developed to combat cellular carcinoma (HCC).
READ: Q BioMed receives further international protection for discovery
Early preclinical analysis has shown it to have ten times the potency against this form of liver cancer when compared to the standard of care drug.
Currently, there are only two approved first-line therapies for the cancer. Challenges with existing treatments include patients becoming resistant to specific drugs, adverse side effects, and high costs.
An estimated 700,000 people are diagnosed with the disease each year, with the global market for liver cancer drugs expected to grow to US$3.9 billion by 2027.
It was granted exclusive rights to the discovery by the Rajiv Gandhi Centre for Biotechnology and the Oklahoma Medical Research Foundation.
Contact the author at ian.lyall@proactiveinvestors.com