On May 11, 2020 Propanc Biopharma, Inc. (OTC: PPCB) ("Propanc" or the "Company"), a biopharmaceutical company developing new cancer treatments for patients suffering from recurring and metastatic cancer, reported on the progress of the Company, recent milestones, financial position, R&D activities and forecast till the end of 2020 and into 2021, as the Company prepares for entering clinical development for its lead product candidate, PRP, for the treatment and prevention of metastatic cancer (Press release, Propanc, MAY 11, 2020, View Source [SID1234557528]). PRP represents a new therapeutic approach, supported by a 100-year history of scientific and clinical research. As the Company enters this exciting milestone, management reflects on the significant history which led to the establishment of its R&D operations.
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A Historical Perspective – Proenzymes for Treating Cancer
Back in the early 1900’s, an Embryologist, Professor John Beard, from Edinburgh University, first proposed that pancreatic enzymes represent the body’s primary defense against cancer and would be useful as a cancer treatment. As a result, physicians in the UK and US, began injecting trypsin into patients with specific cases being quoted as achieving remarkable success. A number of physicians wrote letters citing these cases to medical journals, like, Medical Record, and The General Practitioner. However, due to a limited understanding of tumor biology, the stability of enzymes in water, especially when heated to 600C, the approach obtained mixed results and was disregarded by conventional medicine. Despite this, pancreatic enzymes were used by alternative medicine as a way to ameliorate the side effects of standard anti-cancer regimens. The U.S. Food and Drug Administration banned injection of enzymes in 1966.
Since then, several scientists endorsed Beard´s hypothesis with encouraging data from patient treatment. From the late 1990’s, work from other scientists and clinicians, including Dr. Josef Novak in the U.S. and a since retired oncologist from the Czech Republic, Dr. Frantisek Trnka, shed new light on the therapeutic potential of Professor John Beard’s insights. Extensive laboratory work undertaken over a number of years by Novak and Trnka was reported in the journal Anticancer Research in 2005. The conclusion of Novak and Trnka was the discovery that proenzyme therapy mandated first by John Beard nearly 100 years ago, shows remarkable selective effects that result in growth inhibition of tumor cells with metastatic potential.
In 2007, Dr. Julian Kenyon, Medical Director of Dove Clinic in the UK further developed the therapeutic concepts of Beard and identified strategies that could improve upon the therapeutic potential of Beard’s original ground-breaking work. Through Dove Clinic, a number of cancer patients were treated with a suppository formulation of proenzymes. Clinical effects were studied in 46 terminal patients with advanced metastatic cancers of different origin, including prostate, breast, ovarian, pancreatic, colorectal, stomach, non-small cell lung, bowel cancers and melanoma. No severe or serious adverse events were observed, as reported in the journal Scientific Reports in 2017. To assess therapeutic activity, overall survival of patients was compared to life expectancy prior to commencing treatment, with 19 from 46 patients (41.3%) having a survival time significantly longer than expected. For the whole set of cancer types, mean survival (9.0 months) was significantly higher than mean life expectancy (5.6 months).
Today, these important scientific observations support management’s view that proenzymes are selective and effective in targeting malignant tumor cells and could become an effective tool in the fight against metastatic cancer. After 13 years of R&D operations, the Company’s lead product candidate, PRP, is now a readymade pharmaceutical formula for intravenous administration of two pancreatic proenzymes, trypsinogen and chymotrypsinogen.
Recent Corporate Achievements
Recent achievements include the entering of a financing agreement for up to $3 million with an institutional investor, which will enable the Company to complete the finished product manufacture of PRP in preparation for clinical trials. An Advance Overseas Finding from Innovation and Science Australia was received, qualifying the company to receive 43.5% "cash back" benefit on overseas R&D expenses, which would not have qualified for the "cash back" without having received the Advance Overseas Finding. A first allowance for a key patent family describing different dosage regimens of proenzymes was obtained from the Australian Patent Office. Further, the Company’s lead researcher, Dr Macarena Perán (of Jaén University, Spain), was recently awarded a Professorship position at Jaén University based on pioneering research on the development and validation of new anti-tumor drugs with selectivity against cancer stem cells using proenzymes, which forms the basis of the Company’s joint research and drug discovery program for developing a backup clinical compound to PRP.
Financial Position
Since entering the recent financing agreement, the Company received a cash injection of $450,000, with up to an additional $2.55 million available upon registering for resale of all shares of common stock, or underlying securities issued to the investor. Funds raised will be used for the preparation of PRP for clinical trials as well as other working capital requirements.
R&D Activities
Preclinical development has been completed for the Company’s lead product candidate, PRP, including pharmacology and safety toxicology studies, process development activities and bioanalytical method development. The engineering run and full scale GMP manufacture of PRP will be completed in preparation for clinical trials. Validation of the bioanalytical method will also be completed.
The POP1 joint research and drug discovery program has produced synthetic recombinant versions of the two proenzymes, trypsinogen and chymotrypsinogen. The Company’s scientific researchers have developed a novel expression system and are in the process of optimizing conditions to achieve high titers of recombinant trypsinogen and chymotrypsinogen. Further, the anti-cancer effects of the synthetic versions will be tested against the naturally derived proenzymes from bovine origin.
Forecast for 2020/early 2021
The Company’s management team are encouraged by recent advancements achieved with the Company’s R&D activities, its funding, and upcoming milestones as they look to enter clinical development stage for their lead product candidate, as well advancing their joint research program to expand their product pipeline and establish a backup clinical compound to PRP. In the second half of the year and leading into 2021, the Company plans to undertake the activities necessary to initiate patient trials for PRP.
"As we navigate through unprecedented times, I am pleased with our recent progress as we fund our R&D programs through institutional investment and government funding, which has taken some time to plan, prepare and execute, especially finding the right strategic investor," said James Nathanielsz, Propanc’s Chief Executive Officer. "Rest assured, my management team and I are expending every effort to advance PRP to clinical trials, expand our product pipeline through investment in research and continue making scientific discoveries to ensure the growth of our IP portfolio. We are thinking strategically about possible avenues to fast track PRP into the clinic safely to maximize value for shareholders. Most importantly, after 13 years of R&D operations, backed by more than 100 years of scientific and clinical research, we are genuinely excited about the future prospects of our technology and its benefits for human kind."