Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Print Release
March 12, 2020
Tenax Therapeutics Completes Enrollment in Phase 2 Pulmonary Hypertension Trial
Tenax Therapeutics, Inc. (NASDAQ: TENX) announces enrollment completed in Phase 2 levosimendan HELP study
HELP study exceeds target enrollment with 37 patients
84% initial open-label lead-in response rate to qualify for randomization
Pulmonary capillary wedge pressure (PCWP) was reduced, on average, by 7.5 mmHg during exercise following the initial levosimendan infusion
No serious drug-related adverse events have been reported to date
Top-line data expected in second quarter 2020
Contacts
Westwicke, an ICR Company
Stephanie Carrington, 646-277-1282
Stephanie.carrington@icrinc.com
Tenax Therapeutics, Inc. (Nasdaq: TENX), a specialty pharmaceutical company focused on identifying, developing and commercializing products that address cardiovascular and pulmonary diseases with high unmet medical need, today announced that it has completed enrollment of their Phase 2 clinical trial of levosimendan.
The multi-center, double-blind, placebo-controlled Phase 2 trial is designed to evaluate levosimendan in patients with pulmonary hypertension and heart failure with preserved ejection fraction (PH-HFpEF). The study is also known as the HELP Trial ( Hemodynamic Evaluation of Levosimendan in Patients with PH-HFpEF). The primary endpoint is the change from baseline Pulmonary capillary wedge pressure (PCWP) with bicycle exercise (25Watts) at week 6 following five weekly infusions of levosimendan post randomization. There is an 80% power to detect a ≥ 4.8 mmHg reduction in PCWP from baseline. The Company expects to report top-line data in the second quarter 2020.
“We are delighted that enrollment has been completed in this Phase 2 trial and anticipate top line data to be reported during the second quarter 2020 following the completion of dosing and data analysis,” stated Anthony DiTonno, CEO of Tenax Therapeutics. “Pulmonary hypertension due to left heart disease represents a significant unmet medical need given the lack of effective therapies for over an estimated two million patients in the US. Levosimendan with its triple mechanism of action has the potential to represent a breakthrough treatment option for these patients.”
Initial Response
The trial has a predefined response criterion that patients must meet following a 24-hour open-label infusion of levosimendan before they can be randomized to the 6-week double-blind phase of the trial. The criterion for randomization is a reduction in PCWP during supine exercise of 4mmHg following the open-label infusion when compared with each patient’s baseline exercise PCWP. 37 of 44 patients who received the open-label lead in infusion, approximately 84%, achieved this predefined responder criterion.
Invasive exercise hemodynamic measurements from the first 30 evaluable patients showed statistically significant improvements during the open-label lead-in phase when compared to baseline, including an average reduction in pulmonary capillary wedge pressure (PCWP) of 7.5 mmHg , an average reduction in pulmonary arterial pressure (mPAP) of 5.1 mmHg, an average reduction in right atrial pressure (RAP) of 5.0 mmHg, and an average increase in cardiac output (CO) of 0.6 liters/min. All of these open-label lead-in phase hemodynamic improvements achieved statistical significance (p≤0.01, paired t-Test)
Adverse Events
There have been no drug-related serious adverse events, and only 1 patient has withdrawn from the study prior to completing the 6-week double-blind phase of the trial . All of the patients who have completed the 6-week double-blind phase of the trial have elected to enroll in the open-label extension study.MBD
Co has basically told us that data will be positive. Just read the mid March trial enrollment update PR. Very promising they’re seeing results after like week 1 already. 5 more infusions and the patients will be ready to SMASH through those bicycle exercises lmao $TENX
All we have to do is be a Lil more patient!! Sit back have your favorite drink and get ready for the fireworks!! Lol..MBD
Bought more today. Boat is so loaded there is barely any space now even for the captain lol $TENX
TENX is so under the radar!! I have madebiiigdough in most of the biotechs! TENX is pretty much the only that has not run yet.
When the News comes, at it will ALL the money from all over will run over here to our Lil hidden gem TENX! LOL
I BELIEVE IT WILL BE THE BIGGEST RUNNER OUT OF ALL OF THEM ALL MY FRIEND!!
NOT A MATTER OF IF MY BROTHER!!!! WHEN I TRULY BELIEVE!!!! Grab all you can get your hands on if possible! JMO.... That's what I've been doing. MBD
Thank you mbd. Appreciate that google translate.
If they release cv news this will kaboom to epic proportions. $TENX
HERE YOU GO MY FRIEND! THANK GOD I COULD COPY NEWS ARTICLE!! MBD
In response to the pneumonia epidemic of new coronavirus infection, the National Health and Medical Commission issued the "Pneumonitis Diagnosis and Treatment Program for New Coronavirus Infection (Trial Version 4)", which provides clear guidance for clinical diagnosis and treatment. The article points out that the clinical manifestations of patients with viral infection are mainly fever, fatigue, dry cough, and severe cases progress rapidly to acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis and coagulopathy.
In the above clinical manifestations, septic shock is one of the more serious cases. In patients with pneumonitis infected by the new coronavirus, sepsis may occur when antibiotics are not optimally controlled. The incidence of sepsis is about 1.5% and the mortality rate is 10%, of which about 4% develop septic shock. Sepsis-related myocardial depression is called septic cardiomyopathy, and the mortality rate is as high as 50 to 70% when septic shock occurs.
In the "New Coronavirus Infected Pneumonia Diagnosis and Treatment Scheme (Trial Version 4)", for the treatment of severe and critical cases, the need for circulatory support was clearly stated, that is,
Levosimendan as a calcium sensitizer can increase cardiac output without significant changes in heart rate and myocardial oxygen consumption. In addition to improving hemodynamics, it can also improve tissue microcirculation in patients with sepsis . More importantly, Levosimendan is a long-acting heart-strengthening medicine. The injection of a single dose of Levosimendan can maintain its effect for 7-10 days.
In clinical use, a levosimendan combined with 250ml of 5% glucose solution is recommended for intravenous infusion using an infusion pump. A direct maintenance dose of 0.1 µg / kg / min is recommended for 24 hours of infusion. If the patient's blood pressure is very low, the recommended dose starts from 0.05 µg / kg / min, and after about 3 hours, the dose is adjusted to 0.1 µg / kg / min according to the patient's condition.
[Common name] Levosimendan injection
[Ingredients] Levosimendan, absolute ethanol, polyethylene glycol 400, citric acid.
[Indications] Short-term treatment of acute decompensated heart failure (ADHF).
[Dosage]
The initial loading dose is 6-12 µg / kg, the administration time is not shorter than 10 min, and then the continuous infusion is 0.1 µg / kg / min. Adjust the infusion rate between 0.05 and 0.2 µg / kg / min according to the patient's tolerance and response. The administration time for patients with acute decompensated heart failure is usually 24 hours. Monitor the ECG, blood pressure, and heart rate.
[Adverse reactions]
The most common adverse reactions were headache and hypotension. For other adverse reactions, please refer to the instructions.
[Taboo]
1. Mechanical obstructive disease that significantly affects ventricular filling or / and ejection function;
2. Severe liver and kidney (creatinine clearance
3. Patients with severe hypotension and tachycardia;
4. Patients with a history of torsional ventricular tachycardia;
5. Patients who are allergic to levosimendan or any other excipient.
[Precautions]
1. For patients with low basal blood pressure and patients at risk for hypotension, a more conservative dose is recommended;
2. Severe hypovolemia should be corrected before medication, if the blood pressure or heart rate changes excessively, the infusion rate should be reduced or the drug should be discontinued;
3. The hemodynamic effect of this product lasts for 7 ~ 10 days. After the infusion, the blood pressure should be monitored non-invasively until the blood pressure starts to rise;
4. Use with caution in patients with mild to moderate renal impairment and patients with mild to moderate liver impairment;
5. The abnormal blood potassium concentration should be corrected before medication, and the blood potassium concentration should be monitored during treatment.
Please refer to the instructions for other precautions.
For medical professionals only
Last thing I will say is GET AS MANY AS YOU CAN AT THESE RIDICULOUS LEVELS!!
TUTES AREN'T HERE TO MAKE $19 PROFIT!! THEY ARE BUYING IN FOR MILLIONS JUST LIKE I HAVE!!
Good luck my friend! One day soon we will be thanking God AND smiling all the way to the bank$$$MBD
Look at my post 8019!! The link is there, You have to click on English! MBD
I made A KILLING ON BPTH when it ran to $72.19 I believe?
Of course didn't hold until that level, but made HUUGE GAINS MY FRIEND!
Call me CRAAZY but I think TENX could do the same thing! Let me see if I can find that article. MBD
Yeah broker doesn’t let me put gtc orders for prices that far out from current mkt price.
Jeez you must have like 100K shares in your kitty. I’m catching up.
Lol...I have it at that price because I like those bank account figures!! On a SERIOUS NOTE, I just put that in GTC so my shares CAN'T be borrowed by brokerage house to sell on the market!!
What article is this? I don’t read Chinese. Can you?
What do you mean by price $72.50?
Jeez the co needs to Pr something. This low float will go to $10 imo $TENX
Hello my friend! This has been one helluva journey!! YES I am still here!!! Lol
Have NOT sold one single share!! Holding a HELLUVA LOT OF SHARES THAT I have on lockdown!! Price $72.50!! LOL
As far as data....what do I know!! I truly believe it is going to be earth shattering!!! Levosimendan is a one of a kind drug that is going to revolutionize the critical care market!!!
Data should hit imo between the 8th-12 of April!
ALL I KNOW IS IT IS COMING SOONER RATHER THAN LATER!! LOL.. Everyday is a day closer my friend!!
These little small time pennystock day traders are cracking me up!! Someone posted they flipped for $19 profit!! LMAO!!!
IR used to talk to me ALL THE TIME!!! HAVE BEEN EERILY QUIET THE LAST FEW MONTHS!!
ALL I will say imo is, IT'S COMING!! AND WHEN THE NEWS STARTS FLOWING IMO. IT'S NOT GOING TO STOP!!!
FLOOD GATES GOING TO OPEN UP AND ALOT OF REAL MONEY IS GOING TO BE MADE!!!!
If you have read my posts here LEVOSIMENDAN IS ALREADY BEING USED TO FIGHT THE CV in China and other places around the world!!! NO NEWS HAS BEEN RELEASED PUBLICLY BY COMPANY YET!!
I emailed Stephanie in regards to this, no reply my friend!! I'll tell you this. As long as I have been buying, holding and accumulating, NOT SELLING FOR LESS THAN A 7+ FIGURE PROFIT!!! Do the math my friend, and for that to happen, I don't need to double digits!!! God Bless you my friend and welcome back!
Please stay save during THESE sad and crazy times!! Keep everyone in your prayers, and ESPECIALLY OUR FIRST RESPONDDERS!!! They have a crazy and scary job to do right now!!
I have many doctors, nurses and other first responder friends who I worry about!! God please keep them ALL safe!!!! MBD
Guess what I’ve been loading last two days my old friend mbd - tenax
Really like all the 13Gs that have hit. Float is tiny with all the big boys - black rock, Armistice, etc. crowding the OS.
Will hit a buck in no time.
When are you expecting data? What has co guided. Have they done ER yet?
TENX... Dilution should be done at any moment now imo! Back to $1 plus level. Then bring on that GREAT DATA NEWS AND COVID 19 NEWS with a PARTNERSHIP!!!! MBD
TENX! When the next News release drops, the roof is going to blow off of this!! Mark my words!!!!
Look how far those legs are spread apart! MM's know what's coming! ALWAYS know before shareholders do!!!!!
It will probably be in relationship to COVID 19 imo!! Can't wait for TENX 20-30 million+ days of shares trading!!! MBD
When TENX finally pops! OMG it's going to really explode!! NEVER seen a stock held down like this!!!
News of offering closing should be forthcoming. Then I think we see some great News shortly thereafter. Followed up by Excellent data News!!! JMO...added more@.50!
..MBD
TENX is helping CV PATIENTS ALL OVER THE WORLD!!! What's it going to take for us to get some CV NEWS HERE!!!! GEEEZZZ!!! Management NEEDS to really get their heads out of the sand!!!
LEVOSIMENDAN has helped, and is continually helping China as well as other countries all over the world, recover from the CV battles!! Why NOT TELL THE WORLD!!???MBD
Click on link for the News article!!
https://k.sina.cn/article_6009754278_1663592a600100nu3y.html?from=health
Totally agree Couldn't have had an offering on a worse day! Saying that, they also released news on Patient enrollment being completed.
Love the timing or not, I TOTALLY RESPECT MANAGEMENT and the way they go about running an honest and transparent company! NEVER BEEN A PUMP COMPANY!!!
Any other company would have released enrollment news and run the stock price up then after hours released the offering news!!
This tells me that they wanted this offering done and this phase II completed ASAP!!
WHY??? I think Exciting news on data and a Partnership is looming in the background!
I can wait 6 more weeks while adding a few more blue light special shares!! Been here for well over a year what's another 6wks! Stay tuned...MBD
Geez what kind of F'n idiots do an equity offering on a day like this? Blows my mind! $TENX
Someone just picked 10k shares at a quarter! Unbelievable! The fire sale didn't last long! $TENX
TENX not going to be a hidden gem any longer!! TENX has been intentionally quiet for a reason!! Looks like the cat is out of the bag!!
Feb 6th article in regards to Levosimendan and Coronavirus!!!
Levosimendan can be used for septic shock rescue?
Concentric Butler
February 06 17:39attention
A few days ago, in response to the pneumonia epidemic of new coronavirus infection, the National Health and Medical Commission issued the "Pneumonitis Diagnosis and Treatment Program for New Coronavirus Infection (Trial Version 4)", which provides clear guidance for clinical diagnosis and treatment. The article points out that the clinical manifestations of patients with viral infection are mainly fever, fatigue, dry cough, and severe cases progress rapidly to acute respiratory distress syndrome, septic shock, difficult to correct metabolic acidosis and coagulopathy.
FULL ARTICLE BELOW!! Levosimendan as we investors are aware of ALREADY APPROVED IN 60 COUNTRIES!!!!!
https://k.sina.cn/article_6009754278_1663592a600100nu3y.html?from=health
Translate article to English for reading purposes! MBD
TENX Smart man Hardcore!! Add 125k+ to that amount my friend!! All LOCKED UP!! Long/strong...MBD
Just thinking out of the box! Enrollment for TENX should be amped up and closing allot sooner than LATER, due to the Coronavirus health crisis!!
All of the The elderly with pre existing conditions that are being affected by this awful virus, can hopefully be helped with Levosimendan, that is my prayer!
I am anticipating some BLOCKBUSTER news at anytime!! Adding more low 1.03/4's!
Don't FORGET Levosimendan is ALREADY approved in 60+ countries!!!! My Blessings to All of those families with loved ones infected by this horrible virus!! JMO..I know noone is here but me anyway!! LOLOLOL...MBD
TENX call me STUPID, but I'm buying more tomorrow and every chance I get!! Data due out anytime, and who knows about what they can do to help the elderly with pre-existing Cardiovascular Disease and Coronavirus. MBD
Coronavirus NOT going away anytime soon!! Mark my words, TENX going to come into play soon with Levosimendan!! Very interesting article by PUBLIC HEALTH!! No one is discussing the elderly dying from coronavirus with pre-existing Cardiovascular Disease!
Which Groups Are Most at Risk from the Coronavirus?
Being elderly, having an underlying illness and possibly being male all increase the risk of dying from an infection with the virus
By Sharon Begley, STAT on March 3, 2020
After taking into account the patients’ ages and smoking status, the researchers found that the 399 patients with at least one additional disease (including cardiovascular diseases, diabetes, hepatitis B, chronic obstructive pulmonary disease, chronic kidney diseases, and cancer) had a 79% greater chance of requiring intensive care or a respirator or both, or of dying, they reported last week in a paper posted to medRxiv, a preprint site that posts research before it has been peer-reviewed. The 130 with two or more additional diseases had 2.5 times the risk of any of those outcomes.
That fits with what’s known about other respiratory viruses. People with a single co-morbidity who catch avian flu (H7N9) are 3.4 times more likely than otherwise-healthy flu patients to require ventilators and other intensive care. SARS and MERS, which are also caused by coronaviruses, are more severe in patients with underlying illnesses, too.
Heart disease patients may also be more susceptible to the virus.
Breaking down the Covid-19 risk with the most common co-morbidities, the scientists found that cancer raises the risk 3.5-fold, COPD 2.6-fold, and diabetes and hypertension by about 60%. Because it isn’t unusual for someone to have an underlying disease (especially diabetes and hypertension) but not know it, the last figure is likely an underestimate.
Co-morbidities also raise the risk of dying from Covid-19. China CDC’s analysis of 44,672 patients found that the fatality rate in patients who reported no other health conditions was 0.9%. It was 10.5% for those with cardiovascular disease, 7.3% for those with diabetes, 6.3% for people with chronic respiratory diseases such as COPD, 6.0% for people with hypertension, and 5.6% for those with cancer.
JUST remaining Patient keeping the FAITH here and adding more at these levels! Our day will happen when it happens!!! MBD
$TENX is the next CODX+!! Monster move coming here this week, starting today!! MBD
Something is up here. Unusual volume and up quite a bit in after hours on Friday. This week could turn out to be very nice!
Major reversal coming soon!!! We will see how worthless the company is then!! Market jitters is what has brought this down to these RIDICULOUS LEVELS!!
Couldn't help myself, ADDED 500 more @$1.11!
Have all the PATIENCE IN THE WORLD!! I am waiting!! MBD
Need 10x from here to break even.. worthless company reverse split and lost all of it’s value...
I have ALWAYS kept it real and honest about ALL of my investments, and this one is NO different. So I will say this. I am extremely becoming impatient with TENX!!
The lack of positive movement in its share price is utterly frustrating. I have hundreds of thousands tied up in TENX!!
Have missed out on making millions of dollars elsewhere in the market!! YES , I do have many other investments, however the money that I have had tied up here for over a year+, could have reaped me EASILY 7+ figures elsewhere!!
I have done well with my other holdings, but just venting on the POOR PERFORMANCE to date with my investment here!
Ok, so after saying that, I must say that I am EAGERLY EXCITED FOR THE DAYS/WEEKS AND MONTHS AHEAD HERE!!
In my 35 + yrs of investing I have made millions and lost millions!! TENX will soon be in the category of the MILLIONS that I have made!!
Learned a VERY IMPORTANT LESSON over my many years of investing. THAT lesson is, the more I get tired and frustrated, the closer the reward is!!
Unlike MANY times before in my beginning investing, I became frustrated and sold months,weeks,days and even hours just before the reward came!! LEARNED FINALLY MANY MANY years AGO to finish the race and course that I started and be GREATLY REWARDED!! That is as long as my due diligence was still applicable to what I was expecting a company to do. In the case of TENX IT IS!! Nothing has changed, it looks even MORE AWESOME of an investment opportunity than ever before!!!
In closing, know what you OWN and remain steadfast as in the words as of Warren Buffet, as wealth is exchanged from the IMPATIENT TO THE PATIENT!!
Let's go TENX do what my dd has shown me you are primed to do!! MAKE ME MILLIONS FOR MY LONG SUFFERING PATIENCE!! LOL.. Blessings to everyone invested here in TENX! MBD
TENX, Any day now, about to make some real nice gains!!! MBD
PEOPLE sitting on the sidelines waiting for an offering! LOL not going to be one until after this runs up BIG-TIME!!!
OR better yet the announcement of a PARTNERSHIP!! Just my opinion!!! PRAYING I'm correct!! MBD
If institutions like BLACK ROCK Continue to buy, so will I!! Never in my 35+ yrs of investing have I seen a stock SO HELD DOWN AND MANIPULATED!
Sooner rather than later!! I believe the sooner is going to be EPIC!!! PATIENCE pays off BIGGG!! MBD
Yes my Detwoi pmp!! Call me STUPID but I bought 3k shares more today Between $1.20-1.25 the bulk at 1.20!!
Praying we wake up to multiple dollars and a Partnership or something Good soon!!!
One day when we least expect it my friend!! Going to be thanking God for granting me His PATIENCE all the way to the bank!! FYI.. from Mich as well! Take care homie! God Bless you! MBD
TENX 1.19 - Getting cheaper, you loading more?
Great job my friend! Now just sit back and makethebiigdough!! GOD Bless you. Going to grab a few more and round my holdings off! MBD
Huge bull pennant got mine
Hey TN Don't wait toooo LOOOONG!!! MBD
Lol... Sorry but mine are ALL safely locked up my friend! MBD
You mind selling my 7000 @ 1.38 after hours ?
Well, well!! MY 206K+ SHARES AT AN AVG OF $1.42, LOOKING MIGHTY SWEEEEEET RIGHT NOW!! WAITING FOR THE BPTH RUUUN!! MBD
Love to have the room ALL to myself!!!
I'm sure once people start hearing about my TENX party they will be showing up late as usual wanting entry!! Lol..MBD
Can't wait for the day when we do 30+million shares!! OMGGGGG, back to the $50'$+!! MBD
My gut tells me that some sort of BIGTIME partnership is in the works here!! JMO...MBD
Followers
|
123
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
8299
|
Created
|
05/19/03
|
Type
|
Free
|
Moderators |
Inclusion Criteria:
Exclusion Criteria:
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |