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The Centers for Disease Control and Prevention (CDC) has indicated thatin the United States alone, about 650,000 cancer patients undergo chemotherapy an outpatient basis each year.In the USA, the per-patient average spendon chemotherapy is $50,000 US dollars, and $30-40 billion US dollars was spent on cancer drugs in 2015. The estimated global annual expenditure on chemotherapy is$100 billion US dollars.

Despite the number of oncology products continuing to increase, some challenges persist related to conventional cancer treatments. These include poor drug solubility,the low ability of some chemotherapeutic agentsto penetrate cancer cells and traverse physiological barriers such as the blood-brain barrier, adverse treatment outcomes including toxicity and immune suppression, and a lack of efficacy in treating numerous malignancies.

We have developed of Specific Conjugate Particle (SCP) therapyto overcome those problems. Advantages include increased solubility, stability including at extremes of pH, better ability to traverse natural barriers such as the blood-brain barrier, and superior penetration into tumour cells. We have completed three clinical studies, and fourclinical studies areongoing. We have demonstrated that SCP chemotherapy has significantly better efficacy and less adverse outcomes than conventional chemotherapy. Given those promising results and the importance of making efficacious and safe therapies available to otherwise poor prognosis patients, we are pursuing an expedited (505(b)(2)) route to regulatory approval. In lightof the superior outcomes that we have documented associated with SCP therapy, we anticipate capturing a significant part of the oncology market following regulatory approval.