Race Oncology Limited (RAC) is pleased to announce it has produced its first good manufacturing practice (GMP) batch of cancer drug Bisantrene.
The first batch will be enough to treat up to sixty patients, with a further four batches scheduled to be produced before the end of September.
“Race Oncology has achieved one of the most important milestones for the commercialisation of a new drug, with the production of the first GMP batch on schedule,” said Race Oncology CEO Peter Molloy.
The cancer drug was produced by the company’s manufacturer IRISYS LLC, which is based in San Diego, California.
The first batch of Bisantrene will undergo a quality control process for the next 3-4 weeks before being made available for sale under Race Oncology’s planned Named Patient Program in countries that allow its use on a compassionate basis.
“This initial production run will produce enough Bisantrene stock for several hundred courses of treatment. Following that, we are planning additional production runs early next year,” said Mr Molloy.
Bisantrene is manufactured as a lyophilised dry powder, which is reconstituted into a solution and injected into an intravenous bag that’s administered to the cancer patient.
Based on the recommended dosage over seven days of treatment, a typical adult patient with Acute Myeloid Leukaemia (AML) may require 14 vials for a single course of treatment.
Bisantrene is manufactured in 10mL vials that contain 250mg of the drug.
“Race Oncology is delivering on our strategy to achieve early commercial milestones by marketing Bisantrene to countries that allow patients to get access to this drug on a compassionate basis,” said Mr Molloy.
The initial target markets for the drug are France, Italy, Turkey and South Korea.
“Sales in these countries will allow us to generate cash flow, which will support our push towards gaining FDA approval in the United States,” said Mr Molloy.
Race Oncology estimates that by today’s standards, at least US$100 million was invested in Bisantrene before it was cast aside by Big Pharma.
Race has filed new patents on the drug and been granted an Orphan Drug Designation in the USA – giving it seven years of exclusivity in the US from the date of FDA approval.
About Race Oncology (RAC.ASX)
Race Oncology is a specialty pharmaceutical company, whose business model is to pursue later stage assets, principally in the cancer field. The company’s first asset is a chemotherapy drug, Bisantrene, which was the subject of more than 40 phase II clinical studies during the 1980s and 1990s. Race Oncology owns recent patent filings on Bisantrene and has secured Orphan Drug Designation in the US. The company’s goal is to complete development of Bisantrene and bring Bisantrene to market.
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