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’s lead candidate molecule ORIL007 is currently undergoing late stage preclinical studies in readiness for a Phase I trial in cancer patients. Its goal is to successfully complete Phase I, multiple Phase IB and Phase II, thereby placing the company in a stronger position for the negotiation of licensing deals.
Cancer is a family of diseases that refers to an abnormal growth of cells (usually derived from a single abnormal cell). The cells have lost normal control mechanisms and thus are able to multiply continuously, invade adjacent tissues, migrate to distant parts of the body, and promote the growth of new blood vessels from which the cancer cells derive nutrients.
Cancerous (malignant) cells can develop from any tissue within the body. As cancerous cells grow and multiply, they form a mass of cancerous tissue—called a tumour—that invades and destroys normal adjacent tissues. The term tumour refers to an abnormal growth or mass. Tumours can be cancerous or noncancerous. Cancerous cells from the primary (initial) site can spread throughout the body (metastasize).
Notwithstanding the inroads taken in the understanding the underlying mechanism of action of many cancer types, the development of a wide ranging array of medicaments for treatment, and better diagnoses, cancer still remains a large and unmet medical need.
Table 1. Overview, provided by the US National Cancer Institute, of the patient populations by indication, new cases, estimated deaths and 5 year survival rates indicating whilst progress in treatments over the last thirty years has been significant, cancer remains a large and unmet medical need.
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 than hoped for as often 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.
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.
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 to make harvest in commercial quantities unattractive for both economic and environmental reasons. ORIL has developed a novel and reproducible 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 under Good Manufacturing Practice to provide material of high purity suitable for clinical investigation and provide the necessary data for Drug Master File and for the Chemistry Manufacturing & Control section of an Investigational New Drug (IND) application for the US Food & Drug Administration.
The synthetic method, which includes novel analogues, has been filed as a worldwide patent (PCT) application and has recently been granted in Australia.
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