CHM Fundamental's, page-19

Tony this is a phase 1 trial. As said before it’s a test of safety. This is the first time this drug has hit an arm (or in this case intra skull). So the IND from the FDA will require a slow dose acceleration type trial. The first dose, at a very low dose was even administered is a single point manner, which does not reflect the final dose mode. This is because the drug is being administered intracranially.The second does, still at a low dose, but higher than the first, was more representative by being at two locations. The third dose is at a higher dose, becoming even closer to the representative clinical dose. This is why the next next two cohorts results will be interesting.

Patients in this trial aren’t well. They have tried the SOC and the cancer has come back. Life expectancy is 6 to 12 months for this cohort of patient. All patients have the trial explained to them, and those in the early cohorts are told that the small dose probably won’t work. But they have no other choice for treatment. And life expectancy means they can delay to later cohorts with higher dose. It’s incredibly sad, but incredibly important. Recruitment for the trial is very hard. As the patient needs to have had SOC fail and disease progression, and at the same time be well enough to survive long enough to see how the drug works etc.

This is why the company were excited to see stable disease being seen in 75% of the early cohorts. The trial dose was so small to check for safety, they were thinking it would be insufficient for any response.

Phase two trials are used to work out the Goldilocks dose amount. That being the dose that is just right. Now because there is no effective standard of care for GBM, it is said to have an unmet need. This means, if CHM can show efficacy, they can ask for an accelerated approval pathway. Meaning, that the phase two trial may lead to drug approval. This saved CHM lots of time and money, and saves patients lives sooner.

We have been told that this phase 1 trial will lead to an expansion trial into three other solid tumor types, and then hopefully an accelerated approval trial.