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James123 View Drop Down
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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 9:52am
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 12:16pm
Originally posted by James123 James123 wrote:

is this a NIH Approved Study


James123,  It's a Phase Ib/II NIH study.  This is a very early phase study and usually needs to proceed through Phase 3 or 4 before it becomes approved and can be marketed to the general public.

Phase
The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
Phase 1
A phase of research to describe clinical trials that focus on the safety of a drug. They are usually conducted with healthy volunteers, and the goal is to determine the drug's most frequent and serious adverse events and, often, how the drug is broken down and excreted by the body. These trials usually involve a small number of participants.
Phase 2
A phase of research to describe clinical trials that gather preliminary data on whether a drug works in people who have a certain condition/disease (that is, the drug's effectiveness). For example, participants receiving the drug may be compared to similar participants receiving a different treatment, usually an inactive substance (called a placebo) or a different drug. Safety continues to be evaluated, and short-term adverse events are studied.
Phase 3
A phase of research to describe clinical trials that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Phase 4
A phase of research to describe clinical trials occurring after FDA has approved a drug for marketing. They include postmarket requirement and commitment studies that are required of or agreed to by the study sponsor. These trials gather additional information about a drug's safety, efficacy, or optimal use.

https://clinicaltrials.gov/ct2/about-studies/glossary


Edited by 123Donna - Feb 16 2020 at 6:33pm
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 16 2020 at 12:26pm
Thank you Donna 

This is very helpful 😊
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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 1:34pm
Donna 

Can I ask you one more question?  Is the Drug FDA approved at all?  When I research it online it says it’s effective the treatment of HIV so I didn’t know if it was FDA approved for that use 
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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 5:57pm
They are in the process of filing their biologic license agreement (BLA) to get FDA approval in HIV. They have been granted fast track designation with rolling review and have already submitted the first 1/3 of the BLA application, the clinical section.

Edited by FullTilt - Feb 16 2020 at 5:59pm
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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 5:59pm
Trial using Leronlimab in cancer.

The coordinator for this study is Natalie Rabb. Her email is Natalie@questclinical.com and her phone number is 415-353-0800
 
Address:
Dr. Lalezari
Quest Clinical Research
 
Dr. Dolezal
Pacific Hematology Oncology Associates
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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 6:00pm
Natalie is a very nice lady and will be very helpful!
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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 2:18pm
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 2:32pm
This is so wonderful 
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