Why can't we use tigilanol tiglate (EBC-46) in humans now?
The development of a human pharmaceutical must follow the protocols and development procedures set down by the regulatory authorities, such as the Therapeutic Goods Administration (TGA) in Australia, Food and Drug Administration (FDA) in the USA and the European Medicines Agency (EMA) in Europe. Each step of the development process is examined by the regulatory authorities of the country where the drug is intended to be used and the drug must pass strict requirements prior to being moved forward in the development path. These drug development steps are in place to ensure, as far as possible, the safety of the patient while providing the requisite benefits.
What is the progress with human clinical trials?
QBiotics is not able to provide treatment with tigilanol tiglate at this time. Recruitment for the two Phase I/IIA safety studies in Australia and New Zealand is now closed and QBiotics does not currently have any other open trials. QBiotics will proceed to analyse and report on the Phase I/IIA studies, and then make a determination on how best to continute with clinical development for eventual approval of tigilanol tiglate. Details of any future clinical trials will be posted on the company's website and international clinical trial registries, such as ClinicalTrials.gov.
Why hasn't tigilanol tiglate been discovered before?
Tigilanol tiglate occurs naturally in a small number of closely related plants that occur in Queensland's rainforests where it acts as a chemical deterent to predation. Unlike most approaches to finding new drugs from nature, the discovery of tigilanol tiglate was not due to luck, but was based on a unique and highly successful proprietary discovery technology called EcoLogic™ developed by EcoBiotics, which is now part of the QBiotics Group. EcoLogic™integrates an understanding of the rainforest ecosystems with specifics of mammalian biology to discover new chemicals with potent bioactivity.
Why can't others replicate tigilanol tiglate?
The use of tigilanol tiglate as an oncologic agent is protected by patents. QBiotics has obtained strong patent coverage for the drug in all major regions, which include for the composition of matter (the compound itself) and use (application as an oncology drug).
How is tigilanol tiglate produced?
Tigilanol tiglate is produced by isolation of the compound from the source plant Fontainea.
Do you harvest commercial quantities of the source materials from protected native rainforests?
We do not harvest commercial quantities of the source plant material from protected native rainforests. We are growing Fontainea in plantations for commercial scale supply of the drug.
How is successful development of tigilanol tiglate helping conservation of rainforests?
Tigilanol tiglate was discovered through applying the highly sustainable biodiscovery approach EcoLogic™. One of the EcoLogic™ parameters is to search in areas of high biodiversity. Tropical rainforests are the most biodiverse regions on earth and are thus a potential 'treasure trove' of new pharmaceuticals. Successful development of a drug sourced from these rainforests is a strong demonstration of their value and thus a very good reason for conserving them.
What is the relationship between QBiotics and EcoBiotics?
EcoBiotics was established in 2000 to discover novel, biologically active chemicals from the Queensland rainforests. QBiotics was originally incorporated as a subsidiary company of EcoBiotics in 2004 to function as a drug development company, commencing work on tigilanol tiglate in 2005.
EcoBiotics and QBiotics have now merged and are now known collectively as the QBiotics Group.