Major pharmaceutical companies, despite having extremely large research budgets, are still unable to achieve the success hit rates from their research pipeline to provide sufficient blockbuster drugs to replace many of those coming off patent in 2012-2015. In 2012 several blockbuster brands continued to suffer loss in sales in excess of $1 billion due to patent expiry and introduction of generics. Drug companies therefore continue to seek new drug candidates from external sources to fill their pipeline.
ORIL has recognised the significantly increased value that can be achieved from developing its platform technology into products that have application in other therapeutic indications in addition to oncology.
ORIL’s lead candidate molecule ORIL007 is currently undergoing late stage preclinical studies in readiness for a Phase I trial in cancer patients in the first half of 2014. Its goal is to successfully complete Phase I, multiple Phase IB and Phase II, thereby placing the company in a stronger position for negotiations.
Cancer is a class of diseases in which a group of cells display uncontrolled growth, invasion and metastasis, making cancer a life-threatening disease and indeed is regarded by the World Health Organization as a “global burden.” Most cancer deaths are caused not by the primary tumour but by secondary tumours arising through metastasis at distant sites. Global Cancer organisations such as the WHO, UICC and Cancer Research UK estimate that the incidence of cancer will increase to almost 22 million new cases per year worldwide by 2030 (an increase of 75% from 2008) and that 1 in 3 persons will be affected by cancer in some form.
The global oncology market is expanding rapidly, in part due to the ageing population. The market dynamic is also changing as the older chemotherapeutic or cytotoxic drugs reach the end of their life cycle; they are being recognized as less than adequate due to their limited efficacy, development of resistance and very severe side-effect profiles. In the current decade, oncology has become one of the most important growth segments among the pharmaceutical markets with a major focus on targeted agents; i.e., drug treatments that preferentially target those signalling pathways that are dysregulated in tumours. Targeting therapies are proving to be less successful that hoped for as they inevitably lead to resistance and return of the cancer in a more aggressive form. There is a significant need for new, innovative therapies utilizing novel approaches. In recent years, biotech companies such as ORIL have fuelled innovation in oncology more than ever before. Reports are continually being published giving overviews of the anticancer product research, and of the oncology market as a whole. At $47.7bn in 2012, cancer is one of the largest, fastest growing markets in the pharmaceutical industry.
ORIL’s technology and products have a distinct advantage over conventional and targeted anticancer agents that invariably have adverse side effects and importantly fail to be effective after a relatively short period of time. ORIL has compared ORIL007 to several leading oncology drugs on the market and none has all the properties of ORIL007.
Furthermore, there are currently no drugs on the market for the effective treatment of pancreatic cancer and other difficult-to-treat cancers (lung, ovarian, liver, “triple-negative” breast) that may be particularly susceptible to the ORIL treatment strategy.
ORIL technology is based on the unique mode of anticancer action of ORIL’s first-in-class compounds and the associated products. The research program is balanced with ORIL’s strategy of creating value by protecting its discoveries, developments and intellectual property through patents and by applying its platform technology into a product pipeline.
The ORIL family of compounds belongs to a class known as steroid saponins which naturally occur in plants. Many, however, including ORIL’s lead candidate ORIL007, occur in only trace amounts and are subject to the vagaries of nature. ORIL has developed a novel method of synthesis for the ORIL family of compounds and new analogues via a novel key intermediate. The method provides a superior, cleaner and more selective manufacture process than alternative methods. In addition, this process has been scaled up to provide material of high purity suitable for clinical investigation. The synthetic method, which includes novel analogues, has been filed as a worldwide patent (PCT) application.
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