Miami, FL – March 23, 2020 (EmergingGrowth.com NewsWire) — EmergingGrowth.com, a leading independent small cap media portal with an extensive history of providing unparalleled content for the Emerging Growth markets and companies, reports on CytoDyn, Inc. (OTCQB: CYDY).
- Trump providing daily updates on drug development
- COVID-19 compassionate use results could be imminent
- Podium announcement could ignite buying frenzy
CytoDyn Inc. (OTCMKTS: CYDY) announced today that two additional patients were treated with COVID-19 bringing the total head count to 4. Last week the company started dosing patients on Wednesday under compassionate use. The company is also awaiting the go ahead from the FDA on its phase 2 clinical trial in COVID-19 patients. The intriguing part about this development is that all the patients are located at the same medical center in New York and it appears that they were dosed in succession on Wednesday, Thursday, Friday, and Saturday. Although they have not officially been given the green light from the FDA, if results from these compassionate use patients come in positive it could precipitate an upgrade to a phase 3 trial. Based on the anemic stock reaction many investors have not calculated that into their equation to buy and that represents the opportunity. Encouraging trial results could put them on the presidents list next.
The president has been making daily updates to the country during this crisis and more recently highlighted new therapeutics like Gilead Sciences (NASDAQ: GILD) remdesivir along with Hydroxycloroquine. Trump went out of his way being optimistic about Hydroxycloroquine and the large shipment that was coming to relieve New York City. The drug manufacturer is Sanofi (NYSE: SNY) but in a global act of solidarity drug manufactures like Novartis pledged 130 million tablets, Mylan Labs (NYSE: MYL) promised 50 million tablets and Teva Pharmaceuticals (NYSE: TEVA) is donating 16 million.
Hydroxycloroquine is an anti-malaria drug, but it is not as tame as the president would have us think. There are side effect of headache, dizziness, ringing in the ears, nausea, vomiting, stomach pain, loss of appetite, mood changes, skin rash, itching, and hair loss. Most of these side effects are based on a larger dosage.
Christian Perronne, head of infectious diseases, University Hospital Raymond Poincaré, Garches, Paris, was interviewed and had an optimistic tone.
“I really believe in hydroxychloroquine. It is a drug I find rather fascinating, that has been used for decades. There have been positive results in an in vitro study and a preliminary Chinese study in 100 patients which showed that hydroxychloroquine reduced the viral load, the symptoms lasted for less time, and they are not as severe. This could reduce the number of carriers, which I find interesting from an epidemiological perspective.”
The drug is designed to reduce viral load and by doing so early takes the sting out of the disease.
Remdesivir really isn’t getting any rave reviews from the president like Hydroxycloroquine, but he did mention it was going to be approved. The market demand is telling us something very different. Many COVID-19 patients were requesting compassionate use of Remdesivir and GILD turned off the spigot over the weekend due to is “exponential increase” and “overwhelming demand.” This is clearly a case where patients are desperate to try anything and compassionate use is not an efficient process that overloads the system with paperwork and also represents delays. GILD has given emergency access to hundreds of patients in the US, Europe, and Japan but this type of demand still hasn’t tipped the FDA’s hand even though it has essentially emergency powers. Trial results are expected in early April but the lack of enthusiasm on the regulatory front is indicating that it really isn’t working that well because they haven’t filed for Breakthrough Therapy Designation (BTD).
This drug is made by Abbvie (ABBV) to treat HIV. It’s a combination of a protease inhibitor which means is binds to the building blocks the virus needs into order to replicate and an antiretroviral which interferes with the replication of the virus genetic code. This drug really didn’t do that well in a clinical trial with severe COVID-19 patients. The article in the New England Journal of Medicine demonstrated that is was a huge flop. In 199 patients there was only 1 day of improvement in the metric of median time to improvement versus the standard of care. Then 13.8% of patients experience Severe Adverse Events (SAE’s) from the drug. The underlying issue was the drugs ability to cut the viral load.
This drug is novel in its approach to the disease. All the other drugs in one fashion or another work by reducing the viral load. They are basically helping a dysfunctional immune system. Leronlimab is made by CYDY and what it does it quiet the cytokine storm which is responsible for ARDS which ultimately leads to death from organ failure and lack of Oxygen.
In the ideal situation in the above graphic, here is what happens once exposed to COVID-19. The virus is initially attacked by the innate immune system and surges with Natural Killer cells (NK) then the adaptive immune system kicks in and takes control and brings with it suppressive immune cells called macrophages that quiet the innate immune system and then works using its B Cells to create antibodies to clear the virus and the CD8+ T-cells to destroy the infected cells. The body is always trying to achieve homeostasis.
In cases with people with underlying medical conditions the immune system has doesn’t work as effectively. If the innate immune response is slow to kick it or the adaptive response kicks in to early it puts the body at a disadvantage with respect to fighting the virus. This disadvantage can be seen on the chart above. If the immune system falls below the homeostasis line that means the suppressor cells are limiting the body’s response to fight the virus and eliminate it. But it gets worse because the virus gains a foothold and releases more cytokines which attracts more immune cells and then those immune cells attract more suppressor cells make the condition even worse. All these immune cells in the lungs start attacking healthy tissue. Then fluid builds up and that will eventually lead to death unless the suppression goes down. Leronlimab interrupts the trafficking and that in turn restores homeostasis and leads to recovery.
Leronlimab stopped the trafficking of suppressor cells in cancer. Investors need to understand one very salient point. This is the smoking gun that tells us in advance that this will work. There is no difference in the Mechanism of Action (MOA) between the trafficking of suppressor cells in cancer versus a viral infection. It is for this reason that that investors who understand science will be able to predict a favorable outcome in days. Investor in CYDY that recognize that this mechanism of action is likely to work in viruses as well will find themselves in a good position if this news makes it onto Trumps podium. Trump is an absolute wild card when it comes to announcements and investors should plan their risk accordingly but it seems clear that Trump is looking for a major victory and CYDY can offer the American people that hope. Should Trump not say anything the company still has many catalysts in the near term in cancer and HIV. They have a BLA filing at the end of the month, potential licensing deals, and a possible BTD in cancer.
The stock price of CYDY has been quite steady through the stock markets crash over the past month as coronavirus cases grow. The price of GILD has definitely appreciated since the outbreak, but the market really isn’t factoring more than a bump in sales. The coronavirus market as big as it is right now is going to be subject to dislocation as vaccines from Moderna (NASDAQ: MRNA) get developed. Despite its very quick drug development CYDY investors just haven’t been quick to grasp the ramifications of an approval in COVID-19. An approval would mean jumpstarting sales all across the globe. The science supports a COVID-19 approval. So investors with an appetite for risk should be bidding the stock up in anticipation of these compassionate use trial results. If the patients live or even get discharged from the hospital there could be much fanfare. Everyone knows that Trump likes to have winners and CYDY might make it to the podium within the next week because they have been very transparent in their reporting efforts.
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