The respiratory condition that is so dangerous in Covid-19 results from a condition called a “cytokine storm.” CytoDyn (OTCQB:CYDY) believes that filling the CCR5 receptor with a harmless monoclonal body will prevent further damage.
CytoDyn reported on March 19 that its main drug candidate, leronlimab, was given IND status by the FDA for use in two Covid-19 patients in New York City.
On March 23, CytoDyn announced that additional two patients have been given leronlimab, bringing the total to four patients.
Today, March 27, the company has revealed the initial results of the use of its drug, and these are the findings:
1) Leronlimab as of today, March 27th, has been given to seven (7) patients.
2) Two patients have had their intubation tubes removed.
3) Bruce Patterson, M.D., advisor to CytoDyn, has developed “diagnostic tests to determine the efficacy and dosing of leronlimab in these severe cases of COVID-19. We found that patients with severe COVID-19 disease are in the midst of immunologic chaos which includes the cytokine storm. Our companion diagnostics showed that after three days of therapy, the immune profile in these patients approached normal levels and the levels of cytokines involved in the cytokine storm were much improved.”
This drug first came to my attention when it announced that it had a beneficial effect on the spread of breast cancer in triple negative patients, and then it reported “stunning” results in the progress of the same study. Measurements of metastatic progress were inhibited, sometimes with CTC (circulating tumor cells) dropping to zero. This company was featured in my article, A Basket of Biotechs.
In that piece, I reported from a conference call that the drug also appears, in addition to halting metastasis, to reduce the growth of new blood vessels, an essential feature of tumor growth known as angiogenesis. And that it could “re-polarize” macrophages from bad to good. Macrophages are the part of the immune system which eats foreign substances, microbes, and cancer cells.
It appears to be a remarkable drug that was originally developed against HIV, where the company is in the process of applying for a BLA (biological licensing application) to begin selling the drug. The hope is that it could be used as a one-therapy drug, which would mean HIV patients could do one injection as opposed to the burdensome daily schedule of taking multiple drugs. Also, it may work against non-alcoholic fatty liver disease (NAFLD), multiple sclerosis, and perhaps other diseases.
Meanwhile, the company is going to test the limits of its usefulness in a “basket” trial. CytoDyn has received “Institutional Review Board (IRB) approval to begin its Phase 2 clinical trial for the treatment of approximately 22 different solid tumor cancers, including melanoma, brain-glioblastoma, throat, lung, stomach, colon carcinoma, breast, testicular, ovarian, uterine, pancreas, bladder, among other indications.”
Nader Pourhassan, CEO of CytoDyn, said in the conference call that he had 24,000 vials, which he was holding back for use in the United States against the present emergency.
This is very early evidence for the use of this drug in infectious disease, but there are theoretical reasons to believe that it could work. Investors may wish to pay attention since there are so few medications which have shown this kind of promise against Covid-19, but beyond that it has remarkable possibilities for cancer, HIV, multiple sclerosis, NAFLD, and other conditions, which may make it unusually useful medication for the long term.
Disclosure: I am/we are long CYDY. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it. I have no business relationship with any company whose stock is mentioned in this article.