Cancer patients with pancreatic, ovarian, or colorectal tumors have reason for hope.
A solid tumor treatment known as PRP, developed by Propanc Biopharma Inc. (PPCB), has received an Orphan Drug Designation from the U.S. Food & Drug Administration as the company prepares to move forward into first-in-human studies.
PRP is an intravenous solution designed for once-daily administration. The product contains a combination of two pancreatic proenzymes, trypsinogen and chymotrypsinogen, for the treatment of pancreatic cancer, which currently has an average survival rate of 6 months, and fewer than 5 percent of patients survive for 5 years after diagnosis.
The Orphan Drug Act (ODA), applies to drugs, vaccines, and diagnostic agents if they are intended to treat a disease affecting fewer than 200,000 Americans. The ODA allows companies sponsoring orphan drugs and other products to qualify for tax credits up to 50 percent for research and development costs, as well as research and development grants and waived FDA fees, as well as help with research protocols, seven-year FDA-administered market Orphan Drug Exclusivity, and potential tax incentives for clinical trials.
“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 bio pharmaceutical company like ours,” James Nathanielsz, Propanc Biopharma’s Chief Executive Officer, says.
“We are now firmly focused on the hard work ahead of us to proceed into first-in-human studies as soon as possible,” he says. “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,” he adds.
PRP researchers recently concluded a successful GLP-compliant, 28-day repeat-dose toxicity study that yielded no toxicological findings after administration. The data indicate a broad margin of safety that supports a safe starting dose of the drug for use in first-inhuman studies.
“Our drug is unique because it reprograms cancer cells to become benign and essentially forces them to behave as a normal cell,”says Dr. Julian Kenyon, Propanc pancreatic Biopharma’s Chief Scientific Officer.
“I look forward to seeing how PRP works in the clinic, in a controlled clinical trial,” he says.