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New Immunotherapy Trial

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    Posted: Dec 09 2019 at 2:57am
There is a new Trial which is have been having amazing results at 8 weeks of treatment. Leronlimab (a monoclonal antibody) is given as weekly injection at 700mg with carboplatin (a chemotherapy.) These treatments have reduce the circulating tumor cells in metastatic TNBC to undetectable in the first patient and shrank the tumor size! These circulating tumor cells are the cells that travel through the blood spreading the tumors to other parts of the body. Earlier this year Leronlimab reduced the metastasis in a mouse model by 98%. Now they are proving they can stop metastasis in humans and control tumor size. This is huge news! The monoclonal antibody has very few side effects and no toxicity!

Leronlimab has been tested in over 800 HIV patients with no serious adverse events and few side effects. The trial is now open to all metastatic triple negative breast cancer patients- email me at rwshay@hotmail.com or the CEO directly at npourhassan@cytodyn.com

This monoclonal antibody will likely help any metastatic breast cancer patient. The trial only has two patients enrolled so far but the 8 week results of the first patient are stunning and they are screening patients right now and hope to have more enrolled by the end of the year.

The primary end point is progression free survival but one secondary endpoint is a reduction in circulating tumor cells. In the first patient the circulating tumor cell have been reduced to undetectable after only 8 weeks of treatment and the tumor size has shrunk.

Here is the link to the trial:

https://clinicaltrials.gov/ct2/show/NCT03838367?term=Leronlimab&cond=Triple+Negative+Breast+Cancer&cntry=US&draw=2&rank=1

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Post Options Post Options   Thanks (0) Thanks(0)   Quote sophie Quote  Post ReplyReply Direct Link To This Post Posted: Dec 10 2019 at 10:15pm
can we use this as preventive care? 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Dec 11 2019 at 9:42am
There may be a time in the future that this could be used for those at hi-risk or family history. That is likely sometime down the road. Right now they are enrolling 6 additional patients with metastatic breast cancer. They have many more patients who have contacted CytoDyn to get enrolled. The results from the first patient are outstanding at 8 weeks. I will keep everyone updated on the trial progress.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Dec 24 2019 at 9:00am
New trial results just announced.

The second patient was on MBC treatment for over 1.5 years, right after taking leronlimab, shrinkage of tumor and disappearance of several metastatic tumors. That is remarkable given the long history on the other drugs, and the difference just adding leronlimab.  

demonstrated shrinkage of tumor (via MRI) after three weeks of treatment with leronlimab.  

Patterson, “The results from two subsequent scans of the metastatic lesions for this second patient demonstrated shrinkage of the tumors at both timepoints following the first leronlimab injection, reduction in brain edema, and remarkably, disappearance of several metastatic tumors.”  

Full press release:



  
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post Posted: Jan 07 2020 at 5:51pm
This is vert interesting! My sister in law has recurrence in her lymph nodes, right now she is on Olaparib, but this sounds like a good option after! 

Excited to hear more from you when there is more results:-)!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Kellyless Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2020 at 8:17am
@Fulltilt - why aren't you doing any larger studies on TNBC patients? It sounds amazing until we get to the Two patients number. Are you looking for patient #3, or have you geared up for a trial with real numbers? Do you have a compassionate use OK from the FDA for stage 4 patients? I'm just trying to understand how your study works. I guess I'm looking for details on what you are doing right now - what's your plan for treating tnbc patients? How many are you looking to treat and how qu ickly? Can they be anywhere, with the drug given by any oncologist? or does it have to be specifically one location? Is it only given with Carboplatin for TNBC? 

Where do you stand with the FDA for use with HIV patients? 

Lastly - I see you mention NASH in that release, are you treating any NASH patients? That would be super interesting, as there's NO drugs really to treat NASH. My sister in law was diagnosed last year at age 55, she was healthy prior so it's been a shock. 
IDC, 2.2 cm, Stage IIb,lumpectomy 1/30/09 ACx4,Tx4 36 rads
6/1/16 Local recurrence same breast, same spot 1.8cm Carb.4x every 3 wks, Taxol 12x once wk. Dbl Mast. PCR!! Reconstruction fail, NED!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2020 at 8:58am
I am so sorry to hear your sister in law has recurrence. I will try to give more information in my next post.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Jan 08 2020 at 9:33am
Kellyless,

This is part of a larger study in mTNBC and they plan to enroll 30 patients for the study, Leronlimab (a monoclonal antibody) is given as weekly injection at 700mg with carboplatin (a chemotherapy.). Currently they have just injected two additional patients within the last week, bringing the total to 4 patients enrolled so far (one in the expanded access program with metastatic HER2 cancer).

The company has an expanded access program for compassionate use that the FDA has approved. If you have stage 4 cancer I would defiantly get enrolled in this trial. We are helping get patients with other types of metastatic cancer (not only breast cancer) into the expanded access program. If you need help cutting through the red tape and getting to the right person to get enrolled email me and I will help make sure we do everything to get you in. rwshay@hotmail.com

The plan is to have 4 or 5 patients with stunning results and seek breakthrough designation from the FDA to get this amazing treatment out to everyone who needs it. These studies always take so much longer than I hope they will, but as they have such great results many more patients are being enrolled at a faster rate now.

The company is completing their Biologic License Agreement with the FDA this month and hopes to be approved for HIV treatment in the next 6 months. The NASH results in animal trials were good but they are looking for a partner to do a NASH trial as it will be a longer process.

Here is a link to the trial

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