Fruits of their efforts

 

The Australian research team reported that just one injection of EBC-46 led to rapid breakdown of tumors in a range of human tumor models, suggesting the drug could be effective in treating human patients as well.

 

“We were able to achieve very strong results injecting EBC-46 directly into melanoma models, as well as cancers of the head, neck and colon,” Boyle said. “In most cases the single injection treatment caused the loss of viability of cancer cells within four hours, and ultimately destroyed the tumors.”

 

EBC-46 works in part by triggering a cellular response which effectively cuts off the blood supply to the tumor and kills it.

 

“In preclinical trials we injected it into our models and within five minutes, you see a purpling of the area that looks like a bruise,” Boyle said.

 

“About 24 hours later, the tumor area goes black, a couple of days later you see a scab and at around the 1.5 week mark, the scab falls off, leaving clean skin with no tumor,” he said. “The speed certainly surprised me.”

 

In more than 70 percent of preclinical cases, the response and cure was long-term and enduring, with very little relapse over a period of 12 months, he said.

 

EBC-46 was actually discovered by the Queensland biotechnology company EcoBiotics. It is EcoBiotics’ subsidiary, QBiotics, that is developing the drug as a human and veterinary pharmaceutical.

 

In fact, the experimental drug has been used by veterinarians to successfully destroy or shrink tumors in companion animals, including dogs, cats and horses. QBiotics is currently undertaking formal veterinary clinical trials with EBC-46 in Australia and the United States, Boyle said.

 

A final regulatory approval is still required for a human Phase 1 clinical trial.

 

“At this point, EBC-46 will only be trialed in the short-term for tumors which can be accessed by direct injection or topical application,” Boyle said. “There is no evidence to suggest EBC-46 would be effective against metastatic cancers.”

 

Ethical approval was recently granted for Phase 1 human clinical trials, but even if those proved successful, it is unlikely the drug would replace conventional chemotherapy treatment for cancer, he said.

 

“Chemotherapy is still used because it is very effective for a lot of people,” Boyle said. “But EBC-46 could perhaps be used in people who, for some reason, chemotherapy doesn’t work, or for elderly patients whose body can’t sustain another round of chemotherapy treatment.”

 

The preclinical trials at QIMR Berghofer have been largely funded by QBiotics with additional support from Australia’s National Health and Medical Research Council.

 

Dr. Victoria Gordon, CEO and managing director of EcoBiotics, and her husband, fellow scientist Dr. Paul Reddell, discovered the drug and spent years developing EBC-46 and demonstrating its effectiveness in animals, including treating hundreds of horses, dogs and cats.

 

“Paul and I discovered EBC-46 via our biodiscovery technology we call EcoLogic,” Gordon tells DDNews. “EcoLogic is based on our understanding of how the rainforest functions from an ecological point of view. Using our knowledge of plant ecological attributes and plant-animal-microbe-insect interactions, we develop collection strategies for plant material we believe will have particular bioactivity such as anticancer, antibiotics, antifungal, anti-inflammatory, etc. Our discovery success rate (at the early discovery stage) is greater than 10 times more successful than any of our competitors. For anticancer, we concentrated on how plants and mammals interact and formulated collection strategies primarily around herbivory responses in both groups.”

 

“Our company group (EcoBiotics as the parent entity and QBiotics as the subsidiary) has been contracting the QIMR for the past 14 years to work on research directed by our research managers,” she adds.

 

EBC-46 was discovered through EcoBiotics' discovery technology EcoLogic about eight years ago, according to Gordon. Prof. Peter Parsons and Boyle have been working on the early-stage preclinical development of the drug as directed and paid for by QBiotics, which has spent about AU$30 million so far and owns the patents on EBC-46 (which have now been granted in all major regions), she said, adding that Boyle’s particular focus in the development efforts thus far has been on the mechanism of action of the drug.

 

The company team (including directly employed as well as contracted participants) has worked on formal preclinical development of the drug (including such things as toxicology studies, pharmacokinetic and pharmacodymanic studies), domestication and grow-out of the source plant of EBC-46 (Blushwood), R&D as well as GMP manufacture of the active pharmaceutical ingredient and the drug product, veterinary clinical development and now human clinical development, Gordon says.

 

EcoBiotics was founded by Gordon and Reddell in 2000, based on the biodiscovery technology they developed and call EcoLogic.

 

“We have built the company up over the years and now have laboratories and offices in Far North Queensland and offices in Brisbane,” Gordon says. “We placed EBC-46 into a subsidiary company for development (QBiotics) so that we could focus the capital-raising strategy on drug development rather than drug discovery, which are two quite disparate areas.”

 

“The group is a small Australian biotechnology group,” she notes. “However, over the years we have managed to attract relatively significant funding from high-net-worth and ‘mum and dad’ type investors totaling approximately AU$42 million (about 490 shareholders in EcoBiotics and 840 shareholders in QBiotics). We now directly employ 17 people and are running 37 contracts from various providers throughout Australia, the U.S., Europe and the U.K.”