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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 15 2020 at 4:21pm
James123

I believe this is the clinical trial:


Brief Summary:

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).


Detailed Description:

Phase Ib

Phase Ib is a dose escalation phase with 3 dose levels (cohorts) of leronlimab (PRO 140) administered in combination with a fixed dose of carboplatin at AUC 5. This dose finding portion of study will follow a "3+3" designed to determine the maximum tolerated dose (MTD) of leronlimab (PRO 140) administered as subcutaneous injection in subjects with histologically confirmed mTNBC that express CCR5.

Phase II

Phase II is a single arm study with 30 patients in order to test the hypothesis that the combination of carboplatin AUC 5 intravenously and MTD of leronlimab (PRO 140) SC will increase PFS in patients with CCR5 + mTNBC.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase Ib/II Study of Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC)
Actual Study Start Date : April 22, 2019
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2022
DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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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 4:41pm
I mean it is NIH APPROVED study
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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 4:44pm
correction is it NIH APPROVED
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 9:28am
James I believe three of the first four patients are mTNBC and receiving Carboplatin along with Leronlimab in this trial. I do know that patient #2 is receiving only Leronlimab. Her last radiation treatment was last summer and they canceled her next scheduled radiation treatment because she was progressing so well in this trial. Here is the quote form the press release about her:

"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)."

When I go to NIH.gov and search the trial number NCT03838367 the trial with Leronlimab comes up. 


As far as I know this trial has not received a NIH grant. Here is the link to the trial at ClinicalTrials.gov:

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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 9:58am
 Thank you for this information 

It’s very appreciated and the drug is helping these women and that is sooooooo wonderful 

Please keep us posted on this website

I know study location is California but hopefully it will be expanded to other areas of the Country as well

😊
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Post Options Post Options   Thanks (0) Thanks(0)   Quote 123Donna Quote  Post ReplyReply Direct Link To This Post Posted: Feb 16 2020 at 12:12pm

Leronlimab (PRO 140) Combined With Carboplatin in Patients With CCR5+ mTNBC

Study Description

Brief Summary:

This is a phase Ib/II Study of Leronlimab (PRO 140) combined with Carboplatin in Patients with CCR5+ Metastatic Triple Negative Breast Cancer (mTNBC).

Study population will consist of patients with CCR5-positive, locally advanced or metastatic triple-negative breast cancer (mTNBC) who are naïve to chemotherapy in metastatic setting but have been exposed to anthracyclines and taxane in neoadjuvant and adjuvant settings (first-line).


*******************


Contacts
Contact: Kush Dhody, MBBS, MS, CCRA 301-956-2536 kushd@amarexcro.com

Locations
United States, California
Pacific Hematology Oncology Associates / Quest Clinical Research Recruiting
San Francisco, California, United States, 94115
Contact: David Ruiz    415-417-3337    david@PHOAMD.COM   
Contact: Mary Gascon    415-923-3105    mgascon@phoamd.com   
Sub-Investigator: Milana Dolezal, MD         
United States, Illinois
CD07 Investigational Site Not yet recruiting
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
CytoDyn, Inc.
Amarex Clinical Research

DX IDC TNBC 6/09 age 49, Stage 1,Grade 3, 1.5cm,0/5Nodes,KI-67 48%,BRCA-,6/09bi-mx, recon, T/C X4(9/09)
11/10 Recur IM node, Gem,Carb,Iniparib 12/10,MRI NED 2/11,IMRT Radsx40,CT NED11/13,MRI NED3/15

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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 21 2020 at 2:19pm
More incredible results! Amazing how fast this is all developing.

VANCOUVER, Washington, Feb. 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, reported that it 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, Ph.D., president and chief executive officer of CytoDyn, stated, “We currently have more than 70 patients eagerly waiting to participate in this basket trial and expect the first patient injection to take place within approximately ten days. Furthermore, overall enrollment of the trial could be completed in as little as 30 to 60 days, as this is a 30-patient trial.”

This basket trial is a 30 patient, CCR5+ Phase 2 study with locally advanced or metastatic solid tumors. Leronlimab will be administered subcutaneously as a weekly dose of 350 mg. Patients participating in this study will be allowed to receive and continue the standard-of-care chemotherapy as determined by the treating physician.

The clinical trial will take place at multiple sites across the U.S., with preliminary results on each patient expected within three to four weeks after the initial treatment with leronlimab. The primary endpoint of the basket trial is progression-free survival.

“Peripheral blood sampling from Patient #1 in the mTNBC trial, who has been on leronlimab for approximately five months, revealed no cancer cells or cancer associated cells (0 CTC, 0 EMT and 0 CAML). In addition, Patient #2, who has been on leronlimab for almost 3 months in the MBC study, with brain metastasis, continues to show in the latest CT scan, stable lesions that are now described as scar-like suggesting repair in the metastatic tumors,” added Bruce Patterson, M.D., chief executive officer and founder of IncellDx, a diagnostic partner and an advisor to CytoDyn. “These data are substantiating the relationship between CCR5 and immune cell infiltrates and response which supports the current basket trial.”

“Our current basket trial focuses on method of action (MOA) rather than a specific cancer type,” continued Dr. Pourhassan. “We are extremely pleased the central IRB provided approval to proceed with the trial in a matter of weeks. This process can often take two months or more. If leronlimab proves to be as effective in this basket trial, as we have seen in our mTNBC and MBC patients, this opens up a strong potential for CytoDyn to file for another Breakthrough Therapy designation (BTD) for the 22 cancer indications being evaluated in this trial.”

About Basket Trials
A basket trial involves a single investigational drug or drug combination that is studied across multiple cancer populations defined by disease stage, histology, number of prior therapies, genetic or other biomarkers, or demographic characteristics. It is usually designed as a single-arm, activity-estimating trial with overall response rate as the primary endpoint. A strong response signal seen in a sub-study may allow for expansion to generate data that could potentially support a marketing approval.1


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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Feb 21 2020 at 2:31pm
This is wonderful news!! It’s Amazing 😉 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post Posted: Feb 25 2020 at 9:20am
My sister in law is now going to participate in this trial. We got results today that she is both CCR5+ and PD-L1 positive. Hopefully she can combine both drugs (Keytruda + Leronlimab) with Carboplatin? 

She has recurrence only to her lymph nodes so far. The dream would be that this combo could eliminate it all, but we’ll take all the extra time we get..

I’ll keep you posted on how things go!
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Feb 25 2020 at 11:45am
Awesome! I will pray that everything works well with her with both treatments. I suspect this should be a great combination.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Mar 26 2020 at 6:08pm
Has there been anymore news on this Trial and how the patients are doing.

Can you give us an update 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 6:12am
An update on my sister in law:

She entered the program in the beginning of March. She has not done any tests after this due to the corona situation, however, she is not feeling very well, bad cough and lots of pain in her body, so she is feeling pretty sure the cancer has spread all over..She will take a new CT after Easter.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 8:14am
Did she get any of the drug administered at all?



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Post Options Post Options   Thanks (0) Thanks(0)   Quote Ditrona Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 10:26am
Yes, she was in California and got her first injection in early March. She then started on Carboplatin when she got back home. She has just been on Carboplatin for two weeks, but during these last few weeks, her condition has gotten worse. I just talked to my brother and they are taking her in to the hospital tomorrow, hopefully give her some stronger meds for her pain. 
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Apr 01 2020 at 12:46pm
I hope the company will have trial data released later this week. I will update you all when we get news.
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Post Options Post Options   Thanks (0) Thanks(0)   Quote FullTilt Quote  Post ReplyReply Direct Link To This Post Posted: Apr 03 2020 at 9:29am
 https://www.cytodyn.com/newsroom/press-releases/detail/407/cytodyn-files-request-with-fda-for-preliminary-meeting-for

The Company’s pursuit of a Breakthrough Therapy designation is further strengthened by continued strong clinical indications from mTNBC and MBC patient data

VANCOUVER, Washington, April 03, 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 that it has filed a request with the U.S. Food and Drug Administration (FDA) for a preliminary meeting to discuss new clinical data which the Company believes further supports its objective to obtain Breakthrough Therapy designation (BTD) for leronlimab in the treatment of metastatic triple-negative breast cancer (mTNBC). The FDA had previously granted Fast Track designation to leronlimab for the treatment of mTNBC. Last month, the Company reported that the FDA had recommended such a meeting to provide preliminary advice prior to resubmission of a Breakthrough Therapy designation request. Concurrent with the Company’s Phase 1b/2 trial for mTNBC and expanded access studies for MBC, it is also conducting a Phase 2 trial with leronlimab for 22 solid cancer tumors.

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. 

The Company’s Phase 1b/2 study involves monitoring of circulating tumor cells (CTC), epithelial mesenchymal transition in tumor metastasis (EMT), and cancer-associated microphages like cells (CAML) every 21 days during the treatment phase.

Nader Pourhassan, Ph.D., President and Chief Executive officer of CytoDyn, commented, “We are extremely encouraged by the test results from these patients and continue to keep the FDA current on therapeutic benefit demonstrated by leronlimab for multiple cancer indications.”

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Post Options Post Options   Thanks (0) Thanks(0)   Quote James123 Quote  Post ReplyReply Direct Link To This Post Posted: Apr 03 2020 at 9:56am
This is wonderful News on this very exciting trial
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