Like many I’ve build a large position, so I went back through today’s interview and wrote the following comments by Dr. Javitt down exactly as he spoke them. It’s not the entire interview, but it’s 90% of everything said of any significancen with 98/99% accuracy.
JAVITT’s Comments
* sometime next week going to see similar results in 21 patients from Houston Methodist Team in regards to improvements in chest X-rays
* This is not a randomized controlled trial it could be the placebo effect of patients that got better on their own.
* At end of the day only way to prove it’s the drug doing this is to run a randomized controlled trial where some people get the drug and some get the placebo
* That trial is underway there 86/87 people involved as of 2 hrs ago
* Our independent data safety board is going to take a look once 102 patients are enrolled
* Meanwhile we’re seeing & hearing about these EARLY results from people that were to sick to get into the trial
* Not only do they have this kind of improvement in their chest X-rays but across the board they are seeing improvements in gas levels
* Blood oxygen levels has also improved substantially along with xrays
* This drug also blocks the formation of Cytokines in the lung cells, your seeing an 80% reduction of cytokines formation in these 21 patients, but again that could be the placebo effect so just wait for results of randomized controlled trial that’s underway.
* The 6 Patients you’ve heard about from Houston Methodist were the sickest of the sick where able to see dramatic recovery results using RLF-100
* Everyone considered for their trial were already in ICU in respiratory failure
* These 6 early reported patients you’ve heard about were ALSO already in the ICU but simply TOO SICK to get into our trial, but the results that have been already reported in those 6 have been quite positive.
* There’s a treatment called ECMO where your lung is non functional to the point where they have to take the blood out of your body, they then add oxygen to your blood, and then add the blood back into your body.
* Well 5 of the 6 patients of the patients that didn’t get into the trial because they were too sick were on ECMO, and 4 of them are still alive
* Only in the last 2 weeks our friends in Brazil proved that VIP blocks replication of Coronavirus in the cells
* People were on ventilators so lungs was full of inflammatory material so we felt if we gave them drug through inhalation it wouldn’t have gotten to where it needed to go
* Normally drugs in the blood stream don’t get to the Lungs very well
* That’s why people with asthma inhale the drugs they need instead of getting injections
* But in Covid 19 when lung starts breaking down you can give a drug through intravenous drip so that it actually gets through to lining of the lung
* About to start trial for folks with earlier stages of Covid 19 That are walking and talking and NOT already in respiratory failure and they are going to inhale the drugs and the hope is they the drugs will keep Covid from replicating in the lung cells so that they don’t end up in respiratory failure
* That’s the mild to moderate clinical trial that will use the inhaled version.....while the sickest of the patients will use the intravenous version. Both can be read about on Clinicaltrials.gov
* Regarding inhaled version dosage were just trying it with mild Covid patients for the first time so we’re not sure of the exact dosage amounts yet, but we know some that when this was given to patients with Sarcoid an inflammatory lung disease, having them inhale for 5 minutes four times daily had a meaningful effect. So starting there and will increaee or decrease as needed
* Only reason we’re able to do anything inhaled trials to begin with is because one of the big drug companies got interested in VIP in the early 2000’s and they did tests on animals for years. It’s very difficult to get FDA permission to try inhaled dosage of drugs into the lung because it’s such a delicate organs so unless you prove on 4 species of animals that it’s safe to inhale the FDA won’t even let you do a trial.
* Regarding safety and adverse events said so far more than 100 people have been exposed and treated with drug intravenously so far there has NOT been a serious drug related adverse event. The drug is NOT without its side effects because it’s a very potent hormone.
* When you give this drug in high doses intravenously you can see a lowering in blood pressure but that hasn’t been seen in the inhaled version because NOT much gets into blood stream
* When you give a high dose when you are trying to rescue someone from respiratory failure in the ICU the blood pressure can go down, but the ICU doctors know how to use other drugs called pressers to make the blood pressure go back up.
* So far none of the doctors that have been ready for that effect have had a problem managing the blood pressure.
* It causes diarrhea in 1 of 6 patients in ICU patients. If talking about a drug that could save lives and prevent death, diarrhea isn’t that bad of an outcome.
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* Patients signing up for these drug trials are actually being signed up by a family member because they’re already in ICU and unconscious and unable to make these decisions themselves.
* Regarding FDA guidelines and protocols what are expectation going forward in terms of timeline for data to be available they are
* met with FDA last week, very positive scientific meeting, worked with FDA for 35 years, I’m astounded by how they’ve turned on a dime and focused themselves 100% on how to get Covid treatments to the market quicker
* FDA actually approved our IND application (which allows you to test drugs in humans) in less than 48 hours. When asked to meet with them they’ve met me in less than a week when typically 60 days is the standard meeting request time.
* Worked for 4 US Presidents, worked in the FDA for the commissioner, worked in the industry for companies trying to bring drugs through the FDA, and I’ve been a professor advising the FDA so I’ve seen them from all sides.
* On our board we have a former chief Counsel of the FDA and a former Associate Commissioner of the FDA
* When that phone call does come to tell you that they have approved your drug, the FDA is even more excited then you are.
* In terms of our trials next week will be reporting data on 21 patients from Houston Methodist trial.
* Currently 86/87 patients today but once were at 102 patients next week our Independent Data Safety Board will give us their update.
* Possible comments next week by their independent data safety board can be either 1....stop the trial because this drug is dangerous. But if that was the case we’d already know about the adverse events but as of today we haven’t seen any adverse events....they may say there’s so little difference between the drug and the placebo that the study is futile and can’t possibly prove a difference so there’s no point in continuing the trial....they could say you’re on track and if you keep showing results like this you’re going to have a successful trial so just keep doing it......or they could say the difference between the drug and the placebo is so large that you’ve already proven your point so you can stop the trial
* In addition to Houston, the University of Miami, and there’s also a very large hospital system in Miami that just started to use the drug, also U of California Irvine, and U of Louisville, probably by end of the month it’s gonna be in more than 10 hospitals
* Dr Yo has physician friends that want to use would they apply for the EIND.......We’ve stopped the EIND process at the FDAs request because the FDA has given us their Intermediate Sized Population Expanded Access Protocol approval which means instead of doctors having to sign their own emergency use INDs and need to figure out how to dose and monitor the drug we have already written all the protocols and made them available for free on our website for download to be taken to their institutional review board of the doctor seeking to use our drug and if they meet NeuroRX criteria, NeuroRX will set them up to use. Criteria includes the ICU must have already treated 100 patients with Covid 19 and in respiratory failure AND they want the investigator to have treated at least 30 patients with Covid 19 and in respiratory failure because these are sick patients with a very high risk of dying and NeuroRx simply wants their drug to be used in the BEST HANDS in a way that can help people the most.
* If gets FDA approval what’s our scalability and production capabilities
* We may be a small team but we punch above our weight.
* Our Chief of Operations spent his career at Lilly & Pfizer, last job at Pfizer was the Commercial Head of their Neuroscience Division responsible for about $10 bill of drugs
* Our whole Manufacturing program was put together by someone who was the head of the whole J&J drug portfolio
* We build our manufacturing to scale and we’re about to announce a partnership with the largest supplier of inhaled sterile drugs in the US and about to announce a partnership with a very large well known public company that can get any drug to any hospital overnight, so yes we’ve built this to scale
* By October we should be able to manufacture enough drug for 100,000 people each month
* Do you see a clinical role for inhaled version of RLF-100 for outpatient ......we expect 1/2 people enrolled in study will be people who are in fact OUTPATIENT.
* My son has actually put together a nice patient adherence system where you’ve got what’s called a nebulizer which is a hand held device that allows you to inhale drugs that’s connected by Bluetooth to the cloud so we can know when somebody took the drug and it’s also connected to a pulse oximeter which is a little wrist watch like device that measures your blood oxygen all the time.
* Remember during this pandemic people haven’t been able or willing to come to clinics as much but we expect to be able to monitor both whether their taking the drug and how it’s working for them when they do take the drug. So we do see ourselves treating the disease earlier and earlier with the hopes of keeping people out of the hospital.
* Should people take this drug long term in order to help the lung repair itself......probably yes, but we’ll have to do a study in order to show that.
* People call it a RLF-100 a drug for lack of a better a word, like insulin which is a drug even though it’s made by the body, were supplementing the body at a critical moment. One of things we learned from our Colleagues in Brazil is they looked at 25 critically ill Covid 19 people on ventilators. Of those 25 people 12 lives and 13 died. The 12 that lived all had higher natural levels of VIP in their blood compared to the ones who died. So the body knows what it’s doing and our drug is just trying to help the body.
* Why don’t we come back after Dr. Youseff releases the results next week and we’ll BOTH sit with you for an interview.
