Frequently Asked Questions

 

 

Why can't we use EBC-46 in humans now?

The development of a human pharmaceutical must follow the protocols and development procedures set down by the regulatory authorities (TGA in Australia, FDA in the USA, EMEA 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 the strict requirements prior to being allowed on to the next step. These steps have been developed to protect patients - they are there to ensure, as far as possible, the safety of the patient 

 

What is the progress with human clinical trials?

QBiotics is currently conducting a Clinical Phase I/II trial in Australia recruiting patients with refractory skin cancers.  This is primarily a safety study, to examine the toxicity profile of the drug in the human body, and efficacy is not usually expected.  It is a dose escalation study where the start dose is very low and increased gradually depending on the results of each dose.  The dose has not yet reached an optimum treatment dose.  However, sound evidence of efficacy has been noted in tumours of all patients treated.  Tumour types treated to date are melanoma, squamous cell carcinoma, basal call carcinoma and breast adenocarcinoma.  All patients have tolerated the drug very well with side effects reported to be mild, transient (dissipating within 1-2 days) and related to the mechanism of the drug.    

 

Why hasn't EBC-46 been discovered before?

EBC-46 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 EBC-46 was not due to luck, but was based on a unique and highly successful proprietary discovery technology called EcoLogic™ developed by our parent entity EcoBiotics.  EcoLogic™integrates an understanding of how rainforest systems work to discover new chemicals with potent bioactivity.

 

Why can't others replicate EBC-46?

The use of EBC-46 as an oncology product is protected by patents.

 

How is EBC-46 produced?

EBC-46 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 EBC-46 helping conservation of rainforests?

EBC-46 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?

QBiotics Limited was originally incorporated as a subsidiary company of EcoBiotics Limited in 2004. Following a number of capital raises by QBiotics since 2010 and a Demerger in December 2015, EcoBiotics owns 10.73% of QBiotics as at 31 December 2016.  EcoBiotics is the largest shareholder of QBiotics. 

EcoBiotics was established in 2000 to discover new drugs from the rainforests of tropical north Queensland. Using the EcoLogic™ system, EcoBiotics discovered EBC-46 in 2004. QBiotics was established as a separate entity to focus on the development and commercialisation of EBC-46.