Propanc Biopharma received an Orphan Drug Designation from the FDA for the use of its lead product, PRP for the treatment of pancreatic cancer.
Propanc Biopharma (OTCQB:PPCB) received an Orphan Drug Designation from the FDA for the use of its lead product, PRP for the treatment of pancreatic cancer.
As quoted in the press release:
The approved indication is one of the most lethal malignancies with a median survival of 6 months and a 5-year survival rate of less than 5%. The lethal nature of this disease stems from its propensity to rapidly disseminate to the lymphatic system and distant organs, and is a major unmet medical issue.
“I am extremely proud of my team for this achievement, which has been a number of years in the making,” said James Nathanielsz, Propanc Biopharma’s Chief Executive Officer. “We are now firmly focused on the hard work ahead of us to proceed into First-In-Human studies as soon as possible. Receiving ODD from the FDA provides us with tremendous confidence we are on the right path, and the potential benefits to fast track the development process and receive attractive benefits for up to seven years when we achieve market approval, is very exciting for an emerging biopharmaceutical company like ours. I am truly grateful to our shareholders who continue to support our company. I hope this encourages investors to see the true value of our technology.”