I asked Graham Kelly if he wanted to respond to the post made by...

I asked Graham Kelly if he wanted to respond to the post made by vrs37 today.  Here is his reply.


GK: My initial comment is that this is a sensible post with some insights into clinical design that suggests to me it is from someone with first-hand clinical trial knowledge.

vrs37:   If they think they have a biological target and their drug could help in septic shock then why not run a proof of principle trial in all comers with severe sepsis instead of just Covid? There are a million hospitalised in US alone with severe sepsis, multiple bacterial causes, nothing to do with Covid.

• GK:  On the question of why COVID-19 patients and not patients with septic shock from other infective or non-infective causes.
  • The regulatory and ethical approval processes happen to be accelerated for COVID-19 patients. For example, Ukraine has an expedited approval process. This isn’t the case with other infective or non-infective causes of septic shock
  • We need to test the rationale in patients affected by the same initiating cause. COVID-19 patients happen to be abundant and uniform in nature

vrs37:   Dose escalation & expansion is more usually seen in early oncology trials. Not sure purpose of expansion here but suppose have to see a trial protocol to understand their logic, also what markers they are looking to show benefit.

• GK::  No argument…NOX’s expertise is in oncology trial design. However, in recognising that, the clinical protocol has been designed on the advice of experts such as intensivists currently dealing with COVID-19 patients. The FDA also provided significant guidance

vrs37: What does prompt and extensive response from FDA mean? Devils in the detail but could be diplomatic way of saying FDA gave NOX’s trial a hammering.

• GK:  Prompt and extensive response from the FDA means exactly that. They responded to our pre-IND submission within 10 days and provided extensive comment on clinical trial design. They also have sought certain data which the Company is in the process of supplying.

vrs37:  : TBH this looks a bit like a case of small biotech that’s core competency is cancer diverting into new area in which it seems to have limited or no competency, based on a scientist in lab tinkering and finding possible theoretical target to justify joining Covid bandwagon. Nothing wrong with opportunism but as investor you’d want to hope the strategy is right.

• GK: Re “core competencies”, “tinkering”, “bandwagon” etc. The lab who alerted us to this opportunity happens to be at the forefront of research globally into the role of the STING signaling pathway in septic shock. When someone of that caliber

• alerts you to the fact that your drug is confirmed as a potent inhibitor of the STING signalling pathway
• and that that pathway is increasingly being seen as the prime initiator of the cytokine storm
• and that idronoxil is the only known clinic-ready inhibitor of that pathway

…… then you take it seriously.

Drug development is all about opportunity – being smart enough to recognise it and flexible enough to take advantage of it. That is what NOX is doing. It is an addendum to our main purpose which is that of bringing a drug for end-stage prostate cancer to market. But this Company isn’t going to die wondering about it making a positive contribution to a pandemic that has taken about half a million lives already.