Originally Posted by Krypt
LMFAO THE CEO IS PERSIAN.. IM DONE
What?
Sorry I can’t hear you with this gigantic pile of money in the way.
LMFAO THE CEO IS PERSIAN.. IM DONE
What?
Sorry I can’t hear you with this gigantic pile of money in the way.
Trump tweet:
“Tremendous progress being made on Vaccines and Therapeutics!!!”
LFG 45
Impressive Results From CytoDyn’s Phase 2 Covid-19 Trial
Download as PDFJuly 21, 2020 6:00am EDT
39% of Patients in Placebo Arm Had SAEs as Compared to Only 14% of Patients in Leronlimab Arm Had SAEs, Which Were Unrelated to Leronlimab. The Efficacy Portion of the Trial Will be Announced Along With a Full Report as Soon as Statistical Analyses are Completed
Evaluation of safety data indicates the following:
Leronlimab: 5 patients out of 56 (about 9%) reported serious adverse events, none were related to leronlimab
Placebo: 6 patients out of 28 (about 21%) reported serious adverse events
VANCOUVER, Washington, July 21, 2020 (GLOBE NEWSWIRE) -- CytoDyn Inc. (OTC.QB: CYDY), (“CytoDyn” or the “Company"), a late-stage biotechnology company developing leronlimab (PRO 140), a CCR5 antagonist with the potential for multiple therapeutic indications, announced today the results of the patient safety data from the Company’s over-enrolled COVID-19 Phase 2 trial for mild-to-moderate indications.
A total of 84 patients were treated across 8 study sites in the randomized, double-blind, placebo-controlled Phase 2 study. Fifty-six (56) patients were assigned to the leronlimab arm compared to 28 patients in the randomized placebo arm with a 2:1 active drug to placebo ratio. This trial was designed to evaluate the safety and efficacy of leronlimab and the results of efficacy portion of the data is anticipated to be released as soon as the statistical analyses of all primary and secondary endpoints are completed.
In this Phase 2 study, 34% (19 of 56 patients) treated with leronlimab compared to 50% (14 of 28 patients) treated with placebo reported at least one adverse event. A total of 19 serious adverse events (SAEs) were reported during the study. Eleven (11) SAEs were reported in 6 patients (6/28; 21.4%) receiving placebo compared to eight (8) SAEs in 5 patients (5/56; 8.9%) receiving leronlimab. None of the SAEs in the leronlimab arm were deemed related to study drug administration by the investigators. Of the 84 patients treated, one patient died 33 days after enrollment due to an event unrelated to leronlimab.
Scott Kelly, M.D., CytoDyn’s Chief Medical Officer, commented, “We are very pleased with the safety results in the double-blinded, placebo-controlled study of the mild-to-moderate COVID-19 population. When considering treatment options in the COVID-19 population, it is paramount in treating this complex disease to provide patients with therapeutic options that minimize SAEs. We believe the significant reduction in SAEs in the leronlimab group ultimately translates into improved patient clinical outcomes. Prior drugs in clinical trials for the treatment of COVID-19 have resulted in an increase in SAEs in the drug treated arm versus placebo. We are extremely proud of these results.”
Jacob Lalezari, M.D., Senior Science Advisor to CytoDyn, added, “We are delighted to see a clinically meaningful reduction in SAEs in the mild-moderate COVID-19 population. Leronlimab has been extremely well tolerated in prior clinical trials in over 750 HIV+ patients. These new safety data are therefore consistent with our prior experience and very encouraging in the COVID-19 population. The once-a-week subcutaneous administration of leronlimab is also convenient for patients and caregivers alike. We eagerly anticipate the results of the full efficacy analysis and hope to soon provide the world a broadly effective therapeutic option for this devastating pandemic.”
Nader Pourhassan, Ph.D. President and Chief Executive Officer of CytoDyn, concluded, “We are very pleased to see clear advantages for the patients in this population in leronlimab versus placebo in regards to SAEs and look forward to announcing all of the efficacy endpoints very soon. We are equally optimistic and look forward to the Data Safety Monitoring Committee’s upcoming review of the progress of our Phase 3 trial for COVID-19 patients with severe and critical indications and remain hopeful the therapeutic benefits for this patient cohort will be consistent with the results we saw from the administration of leronlimab to over 60 patients under eIND authorizations previously granted by the U.S. Food and Drug Administration.”
:moneytruck
How high is it going today Daly?
SOBCHAK SECURITY 213-799-7798
PRESIDENT JOSEPH R. BIDEN JR., THE GREAT AND POWERFUL
Hit $10 on the Dax and has come back to $8.50
why are you taking a premature victory lap? After days of hinting tremendous results from a study in moderate covid patients, the company has obfuscated by not even releasing any efficacy data. This should only be interpreted in one way: leronlimab is a JOKE!
You should get a job as a short pumper, you seem to have an aptitude for it.
The portion of SAE in the placebo group is substantially higher, do you think that’s just a coincidence?
If you are so into Bio and not just using the Google machine drum up talking points you would Already know Efficacy data takes weeks to compile. This is the top line data the FDA has asked for.
This is the Krypt response we were all expecting.
Congrats to you guys who cashed in. Still hope it’s the panacea. If it’s the panacea to your accounts, that isn’t bad either.
Wade in here Verm
Gonna need a tax attorney? Personally, I can use offsetting losses from yesterday’s SPX short lol
Hype and momo is therapeutic too.
Last edited by Sanlmar; 07-21-2020 at 05:07 AM.
Shorts are out en force. AF published another hit piece. Might turn into a “sell the news” event.
I’m still thrilled with this and am eagerly awaiting more data.
Observe a mouthbreathing 40 iq smoothbrain in his natural habitat.
Shorts are out en force. AF published another hit piece. Might turn into a “sell the news” event.
I’m still thrilled with this and am eagerly awaiting more data.
Speaking of pump .... medcram was brilliant yesterday on the subject of (frequent inexpensive) testing.. not very alt-right but even Druff admitted to following medcram a month or two ago
Well, it is just a press release. Not much to look at. I mean if it is a drug everyone can just take and it will decrease your chance of an adverse event by ~50%, that sounds better than any other therapy we have right now. But we are a long way from knowing if that is the case yet. We have to see the actual efficacy data from this study and then do a whole Phase III trial. And then they would probably have to do some sort of deal with a big Pharma for manufacturing. No way this rinky-dink company can ramp up manufacturing capacity on their own.
So let's say it is the real deal and everything goes right. How long would it take before this drug is even approved and available for the masses? And what is the chance by that point we have a vaccine and it is a moot point?
Stock is at $5.8 right now FWIW and going down. That must be all the executives selling more of their shares after the pump.
:MONEYTRUCK
OSA is not happy
Vaccine chances 0.0%.....to clarify that, meaning a vaccine that works for more than 6-12 months and has over a 50% efficacy rate.Well, it is just a press release. Not much to look at. I mean if it is a drug everyone can just take and it will decrease your chance of an adverse event by ~50%, that sounds better than any other therapy we have right now. But we are a long way from knowing if that is the case yet. We have to see the actual efficacy data from this study and then do a whole Phase III trial. And then they would probably have to do some sort of deal with a big Pharma for manufacturing. No way this rinky-dink company can ramp up manufacturing capacity on their own.
So let's say it is the real deal and everything goes right. How long would it take before this drug is even approved and available for the masses? And what is the chance by that point we have a vaccine and it is a moot point?
Stock is at $5.8 right now FWIW and going down. That must be all the executives selling more of their shares after the pump.
Well, it is just a press release. Not much to look at. I mean if it is a drug everyone can just take and it will decrease your chance of an adverse event by ~50%, that sounds better than any other therapy we have right now. But we are a long way from knowing if that is the case yet. We have to see the actual efficacy data from this study and then do a whole Phase III trial. And then they would probably have to do some sort of deal with a big Pharma for manufacturing. No way this rinky-dink company can ramp up manufacturing capacity on their own.
So let's say it is the real deal and everything goes right. How long would it take before this drug is even approved and available for the masses? And what is the chance by that point we have a vaccine and it is a moot point?
Stock is at $5.8 right now FWIW and going down. That must be all the executives selling more of their shares after the pump.
Hope is that if the data for Severe/Critical is good they will give emerg authorization while running phase 3.
That was an unimpressive press release, ok so the drug is safe....we already knew that.
Why even send that out before the real data has been analyzed?
There are currently 2 users browsing this thread. (0 members and 2 guests)
Reply With Quote