Wealth and Knowledge Report
Propanc Biopharma’s Lead Product Receives Orphan Drug Designation from the FDA
2017 has presented itself as a critical time for investors as PPCB’s lead product, PRP, takes the biotech world by storm.
World Changing Opportunity for Cancer Patients
Cancer knows no boundaries. Either you or someone you know has been either directly or indirectly affected by this terrible disease. To bring some perspective to how devastating cancer is, the World Health Organization published these absolutely astounding statistics predicting an increase of deaths related to cancer.
It is expected that the world will see…
10 Million Deaths from cancer by 2020
13 Million Deaths from cancer by 2030
Fortunately, companies like Propanc Biopharma, Inc. (PPCB) are working on treatments that could drastically lower these shockingly high death toll predictions. PPCB is well on its way well to changing the outcome for patients suffering from some of the deadliest cancers, including pancreatic cancer. Pancreatic cancer is one of the deadliest, if not the deadliest, cancer. This diagnosis gives patients a median survival rate of 6 months and less than 5% of patients live up to 5 more years.
Propanc Biopharma, Inc. (PPCB)
Watch this video on what we think may be one of the most exciting investment opportunities on the market today.
Propanc Biopharma (PPCB)’s PRP Treatment
PPCB’s lead product, PRP, is a novel, patented, formulation consisting of two proenzymes mixed in a synergetic ratio that targets solid tumors. PRP is a long-term therapy base on a pancreatic proenzyme formulation to prevent tumor recurrence and metastasis, the main cause of patient death from cancer. The Company’s initial target patient populations include pancreatic, ovarian and colorectal cancers.
How PRP Works
PRP’s anti-cancer effects block tumor growth and aggressive dissemination by:
- Controlling cancer cell migration
- Increasing the expression of the protein responsible for cell-to-cell contact
- Inhibiting tumor blood vessel formation
- Strongly suppressing cell invasion and metastasis
- Triggering cell death
- Enhancing the body’s own immune system
FDA GRANTS ORPHAN DRUG DESIGNATION FOR PPCB’s LEAD PRODUCT, PRP
On June 26th, 2017, Propanc Biopharma Inc. (PPCB) announced that the FDA approved their Orphan Drug Designation (ODD) for the use of PRP. 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. This designation helps crucial drug treatments, such as PRP, move to the medical market faster, increasing the chance to save lives.
PRP is making headway through the cancer research world as a solution for once daily intravenous administration of a combination of two pancreatic proenzymes trypsinogen and chymotrypsinogen, for the treatment of pancreatic cancer. As PRP moves toward First-In-Man Studies, the goal is for the solution 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. The World Health Organization stated that 8.2 million people died from cancer in 2012. A recent report published by IMS Health, stated that innovative therapies are driving the global oncology market to meet demand. The market expected to reach $150 Billion by 2020.
“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.”
PPCB Milestones Achieved in Q1 2017
- Approved patent allowance in the US for lead product PRP which aims to prevent tumor recurrence and metastasis in solid tumors.
- Successful completion of low dose group for GLP-compliant 28-Day repeat-dose toxicity study.
- Currently in formal preclinical development and progressing toward First-In-Man studies.
- Effectuated reverse stock split to uplist company and completed a 1-for-250 reverse split.
- CEO, James Nantanielsz, published two articles in Pharma Trade Media.
- Six patent proposals currently submitted covering several important discoveries regarding proenzymes and their anti-cancer effects.
- International Research and Development Partnerships with Universities in the US, Spain, Australia, and England for joint intellectual property ownership.
- Development of manufacturing process of drug for human use.
PPCB 2017 Q2 Milestones
- Preparation has begun for their First-In-Man studies.
- Filed a Patent Cooperation Treaty in April of 2017, seeking a single international patent approval for PRP that would simultaneously approve PRP in multiple countries.
- Received a Written Opinion from an International Search Authority regarding the novelty, inventive step, and industrial applicability of PRP, this can guide national patent offices with their patent granting decisions.
- Propanc’s Chief Executive Officer, James Nathanielsz, was interviewed on SmallCapVoice.com.
- Changed their ticker symbol to PPCB signifying their name change.
- PRP entered the Investigational Medical Product Manufacture (IMP) Stage.
- Merck Oncology’s fast track cancer treatment drug sets the stage for PRP to saturate the global cancer treatment market.
- PRP is granted Orphan Drug Designation from the FDA
PPCB 2016 Milestones
- Prepared and submitted four new patents relating to the dosing, anti-cancer effects and mechanisms of the two proenzymes against various cancers in Australia and Spain.
- Executed a manufacturing agreement with AmatsiQBiologials in Belgium beginning the process for the finished product of PRP for human use.
- Completed 14-day, dose range toxicity study in rats determining maximum toleration for further studies.
- Developed an enzyme linked immunosorbent assay (ELISA) method.
- Developed and validated a new IR (infrared) dye-labelled detection method for typsinogen and chymotrypsinogen.
- Commenced the in-life phase of a GLP-compliant, 28-day repeat dose-toxicity study for PRP in rats, which is expected to help define the safe starting dose in advanced cancer patients for the first-in-man studies.
PPCB‘s treatment has investors and medical professionals alike, extremely excited. As an investment opportunity, the stock has found support since completing its reverse split, which signals a potential move to a higher exchange. Getting involved as soon as possible could be extremely lucrative for investors as PRP heads toward its First-In-Man.