I saw EBC-46 available for sale online – Is it now available?
The EBC-46 products you see for sale on the internet ARE NOT EBC-46. EBC-46 (chemical name is tigilanol tiglate) is still in development for humans and is therefore not commercially available. QBiotics recently received marketing approval from the EU regulatory authority for a veterinary pharmaceutical formulation of tigilanol tiglate in Europe and the UK. An application for the US is currently under review by the Food & Drug Administration – Center for Veterinary Medicines (FDA-CVM) and the Australian Pesticides and Veterinary Medicines Authority (APVMA). This formualtion is specifically for canine indications and not for use in humans. The human programme is concentrating on the phase IIA international clinical trial (i.e. mid stage development). An extensive data set is required to support any regulatory submission for marketing approval. The data required for any product approved by a regulatory agency for use as a medicinal product needs to show that the product is made to an appropriate standard by a reputable facility and the use of the product is both safe and performs in accordance with any label claim. Use of non-registered products imitating products that are registered or in development may not be safe or efficacious (i.e. successfully treat the disease). These ‘imitation’ products may not have any active constituents (i.e. chemicals that act against the disease) and may even be harmful. Consequently, extreme caution is advised if considering using these types of products.
Why can't we use tigilanol tiglate (EBC-46) in humans now?
The development of a 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. QBiotics in currently developing tigilanol tiglate for use in humans according to this framework and will provide updates as milestones are reached.
What is the progress with human clinical trials?
Recruitment for the Phase I/IIA study is now closed and QBiotics does not currently have any other open trials. The results of the safety and tolerability trial across four Australian hospitals were positive for patients with solid tumours. These positive results support QBiotics’ plans for a Clinical Phase IIA efficacy trial which is now being planned. Details of future clinical trials will be posted on the company's website and international clinical trial registries, such as ClinicalTrials.gov.
Is whole blushwood fruit the same as tigilanol tiglate?
No it is not. Tigilanol tiglate is created by a complex purification procedure that is good manufacturing process(GMP) certified. The resulting extract(tigilanol tiglate) and the intratumoural formulation is what is then utilised for the global efficacy and safety clinical trials.
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 deterrent to predation. Unlike most approaches to finding new drugs from nature, the discovery of tigilanol tiglate was not due to luck, however, 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?
Tigilanol tiglate is created by a complex purification procedure that is good manufacturing process(GMP) certified. This process is proprietary to QBitoics. In addition, 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 by 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.