Race Oncology Ltd (ASX:RAC) has crossed a major milestone by producing its first commercial batch of cancer chemotherapy drug, Bisantrene, on schedule in the US.
Bisantrene is a cancer chemotherapy drug related to anthracyclines, a class of drugs used as the first line of treatment for acute myeloid leukemia (AML) and many other cancers.
Race’s business model is to pursue later-stage drug assets in the cancer field that have been overlooked by big pharma.
Once released for sale, the product will be available for supply to hospitals in various countries under a Named Patient Program (NPP) for AML.
The company’s first NPP market is France, followed by Italy, Turkey and South Korea.
The first production batch is expected to provide enough Bisantrene stock to treat up to sixty patients under the NPP.
A further four production batches are scheduled for completion during September, enough to treat several hundred patients.
The drug is being produced under GMP (Good Manufacturing Practice) by Race’s contract manufacturer, IRISYS LLC in San Diego, California.
IRISYS has successfully completed the formulation and process development that was needed prior to GMP production.
Race Oncology had successfully raised $2.5 million in July through a share placement at $0.20 per share.