Biotech’s On The Rise Says Leading Expert

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Toxicity testing of new compounds is critical for the drug development process. If you aren’t a trained expert in biotech, you may not be familiar with his process. A 28-day repeated-dose toxicity study uses the test drug on mammals to observe the effects of the test drug. This testing reveals whether or not there are toxic effects of the investigational product candidate and determines the extent of side effects the drug could produce. The completion of a successful 28-day repeated-dose toxicity study is the next step toward identifying a safe, starting dose to be administered to humans and fight disease.

More good news was released last month concerning PPCH, the Australian-based biotechnology company seeking to develop new long term treatments for cancer. Propanc announced the completion of the low dose group for the GLP-Compliant 28-day repeat-dose toxicity study for its lead product PRP, a solution for once daily intravenous administration of pancreatic proenzymes trypsinogen and chymotrypsinogen.

This is a crucial stage for testing new drugs as this stage tests the drug for both safety and efficacy. "We are very pleased to have successfully completed the first stage of our 28-day study," said James Nathanielsz, Propanc's Chief Executive Officer. "There were no clinical observations, nor any adverse effects observed from any of the animals and, in fact, all animals gained body weight within the expected range.”

FIRST-IN-MAN STUDIES EXPECTED FOR PPCH

No treatment related effects were observed in the animals in the study and the once-daily dosing by IV injection was successfully accomplished. Results from the study help provide a rationale for a safe starting dose for first-in-man studies targeted late 2017, or early 2018, depending on successful completion of manufacture of the investigational new drug (IND).

"Given we have now identified a dosing group in the 28-day study with no safety concerns, it gives us great confidence that we are close to defining a safe starting dose for our First-In-Man studies," said Professor Klaus Kutz, Propanc's Chief Medical Officer.