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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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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Jan 29 2020 at 12:42am
Results to this trial have been so amazing that CytoDyn has filed for breakthrough designation for this new immunotherapy treatment with Leronlimab.


The first two patients have almost eliminated all metastatic tumor cells circulating in their bodies. The tumors have shrunk by more than 50% in just 18 weeks of treatment. This treatment is stunning! 

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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Jan 29 2020 at 12:44am
Just AMAZING!

VANCOUVER, Washington, Jan. 22, 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 additional promising results from its clinical trials evaluating leronlimab for the treatment of metastatic triple-negative breast cancer (mTNBC) and metastatic breast cancer (MBC).

New data from the first patient enrolled in the Company’s metastatic triple-negative breast (mTNBC) Phase 1b/2 trial continues to show no detectable levels of circulating tumor cells (CTC) or putative metastatic cells in the peripheral blood following 15 weeks of treatment with leronlimab in combination with carboplatin.

The second patient, enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, showed a 50 percent shrinkage of the primary tumor and no new metastasis in the brain after treatment with leronlimab as a monotherapy. The patient was previously treated with pertuzumab and trastuzumab for over a year and a half. This patient has been taking leronlimab since November 25, 2019 with one 700 mg dose each week.

“Recent testing of the first patient demonstrated continued absence of CTCs in all blood tubes with only one cancer-associated macrophage like cells (CAMLs) in one of two tubes. In the second patient, the follow up brain scan conducted on January 17, 2020, showed that the largest brain lesion had a greater than 4-fold reduction in size,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “Other smaller lesions on the second patient’s brain have not changed in size and cerebral edema remains at decreased levels since the last imaging studies. Taken together, these results suggest continued response of both primary and metastatic tumors to treatment with leronlimab for both the first and second patient.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added: “We are thrilled to see these additional data that further support leronlimab as a potential treatment option for patients with mTNBC and MBC. As a Company, we look forward to continuing our work in the oncology space and developing a potentially safe and effective treatment option for patients suffering from this deadly disease.”

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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Jan 29 2020 at 12:49am
There are now 4 patients enrolled in the trial and they are enrolling 3 more this next week. We should have results on patient #3 and #4 in the next few days. I will update everyone when the results are released!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 06 2020 at 2:27am
More amazing results! Initial data from the third patient in the mTNBC trial indicated the circulating tumor cells dropped to zero after two weeks of treatment with Leronlimab.

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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 06 2020 at 2:30am
VANCOUVER, Washington, Jan. 31, 2020 (GLOBE NEWSWIRE) 

New data from the first patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of circulating tumor cells (CTC) with leronlimab in combination with carboplatin at 16 weeks of treatment. In addition, this patient experienced significant reductions in epithelial-mesenchymal transition (EMT) cells dropping to zero after five weeks with treatment and currently reports zero EMT. New data from the second patient enrolled in the Company’s mTNBC Phase 1b/2 trial showed no detectable levels of CTC with leronlimab in combination with carboplatin after two weeks of treatment. This patient also showed a 70% reduction in EMT cells after just two weeks of treatment. Initial data from the third patient in the mTNBC trial indicated the CTC dropped to zero after two weeks of treatment with leronlimab.

“Remarkably, the new patient enrolled in the clinical trial showed a significant drop in CTC and a reduction of EMT cells, the putative metastatic cells from 7 per 4mL of blood to two cells in just two weeks of treatment with leronlimab in combination with carboplatin,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “The rapid response to the treatment in a pattern that is identical to previous patients is equally as remarkable and supports a predictable method of action for this drug. Additionally, no adverse effects were observed in the clinical trials, further supporting leronlimab’s potential safety profile.”

New findings from the patient enrolled through an emergency investigational new drug (IND) with stage 4 HER2+ MBC that has metastasized to the liver, lung and brain, demonstrate no new metastasis in the brain after treatment with leronlimab as the only product for the metastasis to her brain. Prior to enrolling in the trial, the patient had 18 identifiable tumor spots in the brain. Today, following two months of weekly 700 mg doses of leronlimab, there are only three identifiable lesions, as seen in an MRI. This patient’s radiologist cancelled the suggested new round of radiation due to results that he believes is due only to leronlimab.

“We are excited to see this continuous spectacular data that further supports leronlimab as a potential game-changing treatment for patients living with cancer,” said Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn. “As a company, our hope is to bring suffering patients safe and effective treatment options. Today, we have heard from over 50 individuals who are waiting to be treated with leronlimab and our regulatory team is reaching out to the FDA to organize an emergency Type C meeting to discuss the data evidenced in our clinical trials. This is an extremely exciting time for CytoDyn, as we continue to demonstrate our commitment to patients through the development of leronlimab. All patients’ oncologists and CytoDyn’s thought leaders will convene an urgent meeting to discuss strategy in order to bring immediate awareness of leronlimab’s potential for all patients with solid tumors, which could represent approximately 22 different forms of cancer.”

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Post Options Post Options   Thanks (0) Thanks(0)   Quote Suebhs Quote  Post ReplyReply Direct Link To This Post Posted: Feb 07 2020 at 1:00pm
I had my last chemo treatment yesterday for stage 1 tnbc. I was very fortunate in that it was discovered early during a routine ultrasound mammogram My oncologist participates in research studies and he was telling me they're doing very promising things right now with immunetherapy. Prayers that this will be the answer and hope for so many 🙏🙏🙏
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 14 2020 at 4:38pm
Has anyone on this site participated in this clinical trial 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 14 2020 at 5:00pm
There are 7 patients enrolled in the trial now the results continue to be stunning! I have helped 8 patients contact the trial coordinator to explore enrollment but I do not know if anyone from this site participated yet. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 14 2020 at 5:02pm
Here is the news from the company today:



CytoDyn Reports Continued Positive Clinical Data on its Phase 1b/2 mTNBC and Expanded Access Studies for MBC Ahead of Breakthrough Therapy Designation Decision From the FDA

VANCOUVER, Washington, Feb. 14, 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 continued positive data for its mTNBC and MBC patients.

Metastatic triple-negative breast cancer (mTNBC), an aggressive histological subtype, has a poor prognosis. In addition, metastatic breast cancer (MBC) is breast cancer that has spread beyond the breast and lymph nodes to other organs in the body (typically the bones, liver, lungs, or brain). Both types of cancer pose significant challenges for patients due to their aggressiveness and limited treatment options. An integral part of CytoDyn’s mission and purpose is to provide effective therapeutic solutions to these patients. Results of the first five patients are as follows:

Patient #1: Enrolled in mTNBC Phase 1b/2 - Injected on 9/27/2019. CTC (circulating tumor cells) dropped to zero in two weeks on 10/11/2019. Total CTC and EMT (Epithelial Mesenchymal Transition in Tumor Metastasis) dropped to zero after about one month of treatment with leronlimab (once-a-week 350 mg dose). After approximately four months of treatment with leronlimab and Carboplatin, the patient had zero CTC+EMT. Furthermore, the patient’s CT scan indicated a 20% tumor shrinkage within the first few weeks of treatment with leronlimab.

Patient #2: Enrolled in single IND. Patient is MBC with HER2+ stage 4 metastasis to lung, liver, and brain. Patient’s radiologist cancelled 2nd round of treatment due to leronlimab’s effect on shrinking the largest tumor in the brain by 56% and other lesions being stable. Leronlimab has, and continues to be, the only treatment in place since the measurement of brain tumor shrinkage was initiated. Patient was permitted to obtain CTC+EMT test results. After 10 weeks of treatment with leronlimab, this patient’s CTC+EMT results were zero (results reported on 2/12/2020).

Patient #3: Enrolled on 1/3/2020. This patient’s CAML counts went down from 45 to 30. CTC+EMT are stable and there has been no change in the total number.

Patient #4: Enrolled on 1/7/2020. This patient’s total CTC+EMT dropped by 75% in the first two weeks of treatment with leronlimab.

Patient #5: Enrolled on 2/4/2020. This patient’s CTC+EMT have been recorded upon enrollment and the first results are expected on 2/25/2020.

In addition to the first five patients, enrollment and treatment updates in CytoDyn’s Phase 2 protocol basket trial under its cancer IND are as follows:

Patient #6: Injected on 2/8/2020 and the first results since enrollment are due by end of February.

Patient #7: Injected on 2/13/2020.

Patients #8, 9 and 10: Completed screening for enrollment.

“The patients enrolled in the mTNBC Phase 1b/2 trial continue to demonstrate meaningful results that support the hypothesis regarding leronlimab’s mechanism of action,” said Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “In the four patients (1 with MBC, 3 with TNBC) now with results from leronlimab therapy, patients #1-3 have zero CTCs and zero EMTs and Patient #4, who has been treated with leronlimab for 2 weeks showed a decrease of CTCs and EMTs from 8 to 2. New data from Patient #2 with Stage 4 MBC and who has been treated with 10 weekly doses of leronlimab showed zero CTCs and zero EMTs, in addition to the shrinkage or disappearance of some brain metastases as previously reported.”

Nader Pourhassan, Ph.D., president and chief executive officer of CytoDyn, added: “These findings are extremely promising in light of the success rate of other treatment options. Therapeutic options for patients suffering from breast cancer are highly limited and we look forward to continuing enrollment and exploring leronlimab’s potential to treat this devastating disease. Since our basket trial for all solid tumor cancers has been initiated, we are currently screening a prostate cancer patient, and if continued positive clinical results are forthcoming from this patient, we are hopeful that this will clear the path for CytoDyn to file for Breakthrough Therapy designation for all solid tumor cancers. Our mechanism of action is not only focused on the inhibition of metastasis of solid tumor cancers, but also targets the tumor itself through macrophages, angiogenesis and T-reg.”




Edited by FullTilt - Feb 14 2020 at 5:11pm
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 12:17am
after reviewing the results I noticed the patient with Brain Mets benefited greatly from the treatment but what about her lung and liver Mets ?  Has the drug reduced those tumors like it has in the brain?
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 2:17pm
I know it has reduce the tumor in the lungs as well but I don’t know to what extent. I will find out more information next week and update you.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 3:28pm
and one final question to include in your update next week

Out of the 8 patients how many are getting the drug alone without the carboplatin and seeing good results and is this a FDA approved clinical trial 

Thank you
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