"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."
Under the Orphan Drug Act (ODA), drugs, vaccines, and diagnostic agents qualify for orphan status if they are intended to treat a disease affecting less than 200,000 American citizens. Under the ODA, orphan drug sponsors qualify for seven-year FDA-administered market Orphan Drug Exclusivity (ODE), tax credits of up to 50% of R&D costs, R&D grants, waived FDA fees, protocol assistance and may get clinical trial tax incentives.
"PRP is truly a unique and exciting technology, and I am really pleased we achieved this important milestone," said Dr Julian Kenyon, Propanc Biopharma's Chief Scientific Officer. "My experience tells me that our drug has the potential to extend life meaningfully, free from the severe side effects inflicted by standard treatment approaches. Our drug is unique because it reprograms cancer cells to become benign and essentially forces them to behave as a normal cell. I look forward to seeing how PRP works in the clinic, in a controlled clinical trial."
Recent development progress for PRP includes successful completion of a GLP-compliant, 28-day repeat-dose toxicity study with no toxicological findings after administration, indicating a broad safety margin and providing sufficient data to support a safe starting dose for First-In-Human studies. The Company has also commenced development of the GMP-compliant investigational medicinal product (IMP) manufacture of PRP to support preparation of a planned clinical trial application in the UK.
Responsible for 331,000 deaths worldwide in 2012, the aggressive biology and resistance to conventional therapeutic agents leads to a typical clinical presentation of incurable disease at the time of diagnosis. Propanc Biopharma intends to introduce a new therapy which targets and eradicates cancer stem cells, the cells responsible for the aggressive dissemination, resulting in a meaningful life extension for patients.
Currently progressing towards First-In-Human studies, PRP aims to prevent tumor recurrence and metastasis from solid tumors. Eighty percent of all cancers are solid tumors and metastasis is the main cause of patient death from cancer. According to the World Health Organization, 8.2 million people died from cancer in 2012. Consequently, a report by IMS Health states innovative therapies are driving the global oncology market to meet demand, which is expected to reach $150 Billion by 2020. The Company's initial target patient populations are pancreatic, ovarian and colorectal cancers, representing a combined market segment of $14 Billion predicted in 2020, by GBI Research.
To view Propanc Biopharma's "Mechanism of Action" video on anti-cancer product candidate, PRP, please click on the following link:
Investor Relations Contact:
Consulting for Strategic Growth 1