Strategy for Success

In terms of new drug development, most drugs "fail" in the early stages of development. It is estimated that from an initial starting pool of ~20,000 prototype molecules, only 1 will make it to market. In many cases these drug candidates fail because of safety concerns. However, by the time one gets to Phase 2 clinical trials, there is around a 20-50% chance of the drug making it to market. In order to address these concerns, Biotranslation opted to acquire an exclusive license from a major pharmaceutical company to develop one of their drugs for its use in cancer. This drug has a proven safety profile, that will enable it to go straight into a Phase 2 clinical trial. The acquisition of this drug was made possible by an angel investment from a Perth-based surgeon, Tony Robinson. 

As mentioned in the "Novel Cancer Therapy" section, we have a wealth of pre-clinical and clinical data to support the target we have chosen, and the decision to initial trial the drug as an adjunct therapy in patients. As outlined, our Senior Clinical Advisor, Dr Munoz, gained approval for the compassionate, off-label use of a substance P antagonist in cancer patients. He has been able to successfully treat a small number of patients in this way. The drug not only produced significant clinical benefits in terms of controlling the cancer, but also it was able to significantly reduce the side effects associated with either chemotherapy or radiotherapy. Hence, not only do we have a drug with a strong safety profile in human patients, and with demonstrated efficacy, but we also know that our chosen target has been validated in cancer patients.

The research team associated with Biotranslation is led by Prof Alan Nimmo. He has 40 years' experience in drug development, particularly in relation to inflammation, and has acted as a consultant for major pharmaceutical companies, including Pfizer. For the last 25 years, he has been involved in a productive collaboration with Prof Robert Vink. They have extensively looked at inflammation in the brain, and have developed novel approaches to managing that inflammation. Alan's current academic research programs are supported by the National Health & Medical Research Council (NH&MRC) and the Medical Research Futures Fund (MRFF). The research team will continue to support this project during clinical Development.

The clinical team bring critical expertise, not only in oncology, but also in the clinical use of substance P antagonists. Our Senior Clinical Advisor, Dr Munoz is a clinician, in paediatric intensive care, and a passionate medical researcher. He has spent more than 35years researching cancer and the development of novel anticancer agents. As a researcher, he has more than 120 publications in this field, whilst as a clinician, he has been involved in compassionate, off-label prescribing of substance P antagonists, establishing the validity of this novel approach to cancer therapy. Another key member is Dr Tim Wang.  Tim is a senior radiation oncologist with subspecialty interests including the management of breast cancer and melanoma. He has particular interest in advanced radiation treatment techniques including stereotactic radiosurgery (SRS). He is also interested in the interaction of radiation therapy with modern systemic therapies, such as targeted therapy and immune check point inhibitors. He is the trial chairperson of several ongoing oncology clinical trials.  Trial design will be supported by Prof Val Gebski. Prof Gebski is Head of biostatistics and research methodology at the NHMRC Clinical Trials Centre. He has extensive knowledge of clinical trial methodology, conduct and analysis and is the Group Statistician for a number of national collaborative clinical trials in oncology. 

The clinical and commercial development of a new drug relies on a highly experienced group of process managers. The Development Team at Biotranslation is made up of highly experienced individuals who have decades of experience in the global pharmaceutical industry. The team is led by Dr Pierre Vankan.  Pierre was formerly at Hoffmann-La Roche, where he was Life-Cycle Leader, with responsibility for all aspects of drug development, from the laboratory bench, through clinical trials, and into the market. Another key member is Prof. Klaus Kutz M.D., who was former Head of Clinical Pharmacology at both Sandoz (Novartis) and Sanofi (Sanofi Aventis), where he had World-wide responsibilities for Phase I, Clinical Pharmacokinetics, and Clinical Safety. Prof Kutz is also a Professor of Medicine, and his areas of expertise include oncology. The team is supported by experts in the areas of pharmaceutical manufacturing, as well as regulatory affairs. Between them, the development team have been involved in helping to bring a number of new drugs to market, including Tamiflu (oseltamivir), CellCept (mycofenelate mofetil), Dilatrend (carvedilol), Sandimmun Neoral (cyclosporine), Sandostatin (octreotide), Lamisil (terbinafine) and Plavix (clopidogrel).