Del Mar Pharma’s first product candidate, VAL-083, benefits from an historical investment of more than US$50 million by the National Cancer Institute (NCI) in the United States. The drug is well-characterized and has been studied in more than 40 Phase I & Phase II human clinical trials in the United States, demonstrating efficacy in primary brain tumors and other solid tumors as well as in hematologic cancers. VAL-083 has been approved as a cancer therapy in China for the treatment of leukemia and lung cancer since the late 1980s.
We have recently filed an IND with the US FDA to begin Phase II human clinical trials with VAL-083 in patients suffering from glioblastoma multiforme (GBM), the most common and aggressive form of brain cancer.
VAL-083 Target Markets
Additional Orphan Drug Indications – AML
Glioblastoma Multiforme (GBM) – Newly diagnosed patients suffering from GBM are initially treated through invasive brain surgery, although disease progression following surgical resection is nearly 100%. Temozolomide (Temodar™) in combination with radiation is the front-line therapy for GBM following surgery. Temodar™ currently generates more than US$950 million annually in global revenues even though most patients fail to gain long-term therapeutic benefits. Approximately 60% of GBM patients treated with Temodar™ experience tumor progression within one year. Bevacizumab (Avastin™) has been approved for the treatment of GBM in patients failing Temoda™. In clinical studies, only 20% of patients failing Temodar™ respond to Avastin™ therapy. In spite of these low efficacy results, treatment of GBM in North America alone is projected to add US$200 million annually to the revenues of Avastin™. Approximately 48% of patients who are diagnosed with GBM will fail both front-line therapy and Avastin™. Based on previous human clinical data with VAL-083, we have initiated clinical studies in these end-stage patients. We estimate that the market for treating GBM patients the post-Avastin failure exceeds US$200 million annually in North America.
Additional Orphan Drug Indications – In addition to GBM, we have established a scientific rationale for the development of VAL-083 in additional high-value orphan cancer indications. Acute Myeloid Leukemia (AML) is of particular interest based on published human clinical data and lack of effective therapeutic options. We have initiated preliminary discussions with leading cancer researchers regarding the development of a clinical strategy for the development of VAL-083 in AML.
Lung Cancer – The efficacy of VAL-083 in the treatment of NSLSC has been established in both human clinical trials conducted by the NCI and by the drug’s commercial approval in China. Decision Resources, Inc., forecasts that the non-small cell lung cancer (NSCLC) drug market will exceed US$4.1 billion in 2012. We plan to establish a strong scientific and clinical rationale to support out-licensing activities to unlock the potential value of the drug in partnership with larger pharmaceutical companies with the resources and commercial infrastructure to effectively develop and launch a lung cancer product.