RACE (ASX:RAC) (m/c $480m + 33m options) has had a recent run since they announced earlier this month they had found three isomers of their lead cancer drug Bisantrene. They have now filed a patent for the EE isomer, which is the efficacious of the three. The isomer change is caused by light and the EE isomer degrades by the minute when exposed to light. This is the big news.
By way of background Bisantrene has been around for 40 years as a cancer treatment and was at one point approved for use in France 1988. However due to the difficulty of administration was given up on by the patent owner Pfizer.
It has two key properties – effective at killing cancer cells whilst causing minimal damage to the heart and blood vessels.
They had recent readout of a Phase 2 study using Bisantrene (RCA name RC110) in Acute Myeloid Leukemia. The trial was done in Israel and the results were significant with a 40% response rate. Plus there is all the historical data – not useful now for progressing to regulatory approval, but very helpful just the same.
RCE are now testing the EE Bisantrene (RC220) in Ph 1 combination trials in Australia, Hong Kong and South Korea.
On the webinar last night CEO Daniel Tillet was asked if the EE isomer was used on the recent successful RC110 Ph 2 trial. He replied in the affirmative.
There is two conclusions from this: RCE has known of the existence of the EE isomer for some time or Daniel is not being altogether straightforward.
Whatever, the point being for all the trials from 40 years ago and possibly the AML Ph 2 trial, may have understated the efficacy of Bisantrene due to researchers not understanding the light sensitivity of the drug.
Further assuming they are granted the isomer patent, RCE will have 20 years protection for a drug that has promising Ph 2 results. Or put another way is Ph 3 ready. In other words they already have something of real commercial value.
Big news and the way RACE tells it this isomer discovery was quite unexpected.