After a decade of development, Australian biotechnology company Propanc Biopharma Inc. (OTC: PPCB) is moving its cancer drug PRP closer to human trials. PRP induces cell differentiation, which causes cancer cells to become benign. Propanc’s major steps toward manufacturing PRP for testing in humans is significant both for initially proving the clinical value of PRP and for determining the best methods of manufacturing the final product. The company has continued securing international patents into 2019, and this IP development combines with production and testing progress to add to its momentum this year. Investors in Propanc can look forward to share price increases based on this progress and more to come.
Any biotechnology company must prove its scientific worth and initial market value by moving from preclinical to first-in-human testing. In preclinical testing the basic mechanism of a drug’s action is proven in laboratory animals. Those mice, rats, and other animals with similar biological mechanisms to humans are the bridge between the test tube and real-life patients with conditions the tested drug is meant to treat. Translational research depends on this transition from preclinical to clinical (human) studies. These first-in-human tests are a marker of progress but also bring uncertainty, which is why it’s so important to note that Propanc is well prepared for this stage of research.
PRP has the potential to change cancer cells from a highly motile and invasive cell type that can wreak havoc in the system back to a normally functioning cell by using pro enzymes. These pro enzymes have been shown to stop the spread of cancer in preclinical research. The company will pursue a licensing partner who can help the company further refine the pro enzymes, which are naturally derived, so that they achieve optimal effect as clinical trials progress through to approval and ultimately sales.
Best Foot Forward for FIH Trials
Propanc is currently developing bioanalytical assays and is actively engaged in fine-tuning its manufacturing activities to make PRP. Propanc plans to complete its engineering phase and process development and enter full scale GMP manufacture of its drug product for human trials.
To date, Propanc has established proof of concept in animals, completed full preclinical development program including establishing a safe starting dose for humans. It is rapidly expanding its IP portfolio with patents as it publishes several peer-reviewed scientific publications.
In addition, Propanc has conducted several scientific advisory meetings with regulators and achieved orphan drug designation for pancreatic cancer. Beyond just this one product, Propanc’s CEO James Nathanielsz has recently discussed development of backup compounds to PRP that add to the company’s R&D depth and traction in the market. He hopes that Propanc’s approach to changing the nature of cancer cells will make it a new standard for the way solid tumor cells are treated.
The FIH Factor in Biotech Stocks
Synlogic Inc (NASDAQ: SYBX) gained in January on publication of Phase I data and supporting preclinical data. Organovo Holdings, Inc (NASDAQ: ONVO) is another low-flying public company moving toward FIH trials in 2019. Solid Biosciences Inc (NASDAQ: SLDB) is an example of a company whose shares took a dive based on negative first-in-human trial results–SLDB shares fell 73% in premarket trading on February 5.
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